B P5 C41 Percutaneous Coronary Intervention Flashcards
The major value of percutaneous or surgical coronary revascularization is _____.
Relief of the symptoms and signs of ischemic CAD
Greater than ____% improvement in the ischemic burden is achieved more often with PCI, and the magnitude of the residual ischemia correlates with less frequent death and MI.
> 5%
_____ was the first randomized study comparing PTCA with conventional medical therapy to be published, where PTCA resulted in an improvement in exercise duration and freedom from angina.
ACME (Angioplasty Compared to Medicine)
Identify the Trial in SIHD and PCI
2287 patients with objective evidence of ischemia and proximal angiographic CAD (≥70% visual stenosis) were randomized to optimal medical therapy (OMT) with or without PCI.
Main study findings indicated that as an initial management strategy in patients with SIHD,PCI did not reduce death,MI,or other major cardiovascular events when added to OMT
COURAGE (Clinical Outcomes Utilization Revascularization and Aggressive DruG Evaluation) trial
Primary endpoint (death or MI) was similar in the two treatment groups for the subsets with either no to mild ischemia (18% and 19%, respectively, P = 0.92) or moderate to severe ischemia (19% and 22%, respectively, P = 0.53, interaction P value = 0.65).
Identify the trial in SIHD and PCI
Stable patients with angiographic evidence of coronary artery disease (CAD) were included.
If FFR was ≤0.80, they were randomized to either PCI along with OMT or OMT alone. If FFR was greater than 0.80, they were excluded
The primary MACE endpoint of death/MI/urgent revascularization was significantly lower in the PCI + OMT arm compared with the OMT arm (4.3% vs. 12.7%, p < 0.001)
FAME-2 Trial
This was driven predominantly by a significant reduction in the need for urgent revascularization (1.6% vs. 11.1%, p < 0.001); rates of death (0.2% vs. 0.7%, p = 0.31) and MI (3.4% vs. 3.2%, p = 0.89)
Identify the trial in SIHD and PCI
230 patients with stable angina and evidence of significant single-vessel stenosis were randomized to PCI with a current-generation DES or a placebo procedure after six weeks of medical therapy optimization
No significant difference between the PCI and medical therapy groups in the primary endpoint of exercise time increment
ORBITA (Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina)
Relief from ischemia appeared to be greater among the PCI patients: on DSE peak stress wall motion score index improved more with PCI
Identify the trial in SIHD and PCI
5179 patients with stable angina and stress testing showed moderate or severe reversible ischemia on imaging tests (or severe ischemia on exercise tests without imaging) and no evidence of significant left main disease or nonobstructive CAD on CTA
Randomized to angiography + revascularization when feasible + medical therapy, or initial conservative strategy of medical therapy alone
At 5 years (median 3.2 years), the primary composite outcome (death, MI, unstable angina, heart failure or resuscitated cardiac arrest) was similar between the revascularization and medical therapy groups (16.4% vs. 18.2%; difference, −1.8 percentage points; 95% CI, −4.7 to 1.0).
ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial
CABG is associated with a late mortality benefit in certain high-risk medical and anatomic subsets such as ____.
Left main disease
Three-vessel CAD
Extensive markers of higher anatomic risk for PCI (high SYNTAX)
Diabetes and significant multivessel disease
These benefits are manifested beyond 1 year after treatment and for up to 5 years of follow-up
Early periprocedural risks, particularly for stroke, are higher with CABG, and patients have a longer in-hospital recovery period.
Asymptomatic patients or those who have only mild symptoms are generally best treated with medical therapy unless _____.
(1) One or more high-grade lesions subtend a moderate to large area of viable myocardium
(2) The patient prefers to maintain a very active lifestyle or has a high-risk occupation
(3) The procedure can be performed with a high chance of success and low likelihood of complications.
Patients who are minimally symptomatic or asymptomatic should not undergo coronary revascularization if _____.
(1) Only a small area of myocardium is at risk
(2) No objective evidence of ischemia can be detected
(3) Likelihood of success is low or the chance of complications is high
The 2014 ACC/AHA guidelines suggest an important role for the patient’s functional capacity to help with decision making (Preoperative considerations). For _____, pharmacological stress testing is indicated.
Higher risk patients (mortality >1%) + poor or unclear exercise tolerance (<4 METs)
If positive, coronary angiography and revascularization where appropriate may be indicated.
Assessment of the potential risks and benefits of PCI must address five fundamental patient-specific risk factors: _____.
(1) Extent of jeopardized myocardium
(2) Baseline lesion morphology
(3) Underlying cardiac function (e.g., LV function, rhythm stability, coexisting valvular heart disease)
(4) Presence of renal dysfunction
(5) Preexisting medical comorbid conditions that may place the patient at higher risk for PCI
The _____ subtended by the treated coronary artery is the principal consideration in assessing the acute risk associated with the PCI procedure.
Proportion of viable myocardium
PCI interrupts coronary blood flow for a period of seconds to minutes, and the ability of patients to hemodynamically tolerate a sustained coronary occlusion depends on both the _____.
(1) Extent of “downstream” viable myocardium
(2) Presence and grade of collaterals to the ischemic region
Although the risk for abrupt closure has been reduced substantially with the availability of coronary stents, when other procedural complications develop—such as a _____—rapid clinical deterioration may occur that is proportionate to the extent of jeopardized myocardium
Large side branch occlusion
Distal embolization
Perforation
No-reflow
Predictors of cardiovascular collapse with a failed PCI include the _____.
(1) Magnitude of myocardium at risk
(2) Severity of the baseline stenosis
(3) Multivessel CAD
(4) Diffuse disease
Left main coronary artery disease may be present in approximately ____% of patients who undergo coronary angiography overall, and in ____% of subjects presenting with ACS
6%
12%
LM disease is associated with a poor prognosis with medical therapy, given the large myocardial territory at risk (ranging from _____% of the myocardium depending on the coronary dominance).
75% to 100%
Revascularization is recommended by current guidelines for patients with an LM stenosis greater than or equal to _____%, regardless of symptomatic status or associated ischemic burden.
Traditionally, _____ has represented the gold standard for LM revascularization.
50%
CABG
The _____ trial randomized 1905 patients with significant LM disease and a SYNTAX score of less than 32 to CABG or PCI with a second- generation DES (Xience, Abbott Vascular, Santa Clara, CA).
At 5 years, no differences were noted for PCI versus CABG for the primary end- point (22.0% vs. 19.2%, P = 0.13).
However, all-cause mortality (13.0% vs. 9.9%), non-procedural MI (6.8% vs. 3.5%) and ID-TLR rates (16.9% vs.10%) were higher with PCI compared with CABG.
Due to violation of proportional hazards, a piecemeal hazard model analysis was used.
During the first 30 days after revascularization, PCI was associated with a lower risk of the primary endpoint (HR 0.61; 95% CI, 0.42 to 0.88), which was driven by a lower incidence of (procedural) MI (HR 0.63; 95% CI,0.42 to 0.94). Between 30 days and 1 year, the primary endpoint rates between PCI and CABG were similar (HR 1.07; 95% CI, 0.68 to 1.70), as were each of its individual components. Between 1 year and 5 years, the risk for the primary endpoint was higher in the PCI arm (HR 1.61; 95% CI, 1.23 to 2.12)
EXCEL Trial
From a PCI standpoint, _____ should be considered as standard of care for LM PCI optimization.
In addition, for distal LM lesions, a _____ strategy is superior to provisional stenting or Culotte stent- ing, with significant reductions in MACE, repeat revascularization and stent thrombosis.
IVUS and OCT
Double Kiss (DK) crush 2-stent strategy
In patients with multivessel CAD, an assessment of CAD complexity, such as the _______ score, may be useful to guide revascularization (IIB, ACC AHA 2021 Revasc Guidelines)
SYNTAX score
SYNTAX score remains the most widely used and validated risk score to guide the choice of revascularization in patients with multivessel disease.
Angiographic Features Contributing to Increasing Complexity of CAD:
Multivessel disease
Left main or proximal LAD artery lesion
Chronic total occlusion
Trifurcation lesion
Complex bifurcation lesion
Heavy calcification
Severe tortuosity
Aorto-ostial stenosis
Diffusely diseased and narrowed segments distal to the lesion
Thrombotic lesion
Lesion length >20 mm
Class I indications for Revascularization of the Infarct Artery in Patients With STEMI
STEMI and ischemic symptoms for _____________
STEMI and _______________ or hemodynamic instability
STEMI who have ______________ complications
STEMI and evidence of failed reperfusion after fibrinolytic therapy, _________________ of the infarct artery
ACC AHA 2021 Revascularization Guidelines
In patients with STEMI and ischemic symptoms for <12 hours, PCI should be performed to improve survival
In patients with STEMI and cardiogenic shock or hemodynamic instability, PCI or CABG (when PCI is not feasible) is indicated to improve survival, irrespective of the time delay from MI onset
In patients with STEMI who have mechanical complications (e.g., ventricular septal rupture, mitral valve insufficiency because of papillary muscle infarction or rupture, or free wall rupture), CABG is recommended at the time of surgery, with the goal of improving survival
In patients with STEMI and evidence of failed reperfusion after fibrinolytic therapy, rescue PCI of the infarct artery should be performed to improve clinical outcomes
Identify the trial in PCI in STEMI (ICP > 12hrs <48hrs)
Examined the benefits of PCI in reducing infarct size in asymptomatic patients with STEMI and symptom onset >12 hours but <48 hours before presentation
In this small study, an invasive strategy of coronary stenting was associated with a reduction in left ventricular infarct size (primary endpoint) compared with a conservative strategy
ACC AHA 2021 Revascularization Guidelines
BRAVE - 2 (Beyond 12 Hours Reperfusion Alternative Evaluation-2) trial
An invasive strategy was associated with a reduction in adjusted 4-year mortality rate
Identify trial in PCI in STEMI (ICP > 24hrs)
Evaluated percutaneous coronary intervention (PCI) compared with medical therapy among stable, high-risk patients with persistent total occlusion of the infarct-related artery post-myocardial infarction (MI)
Patients with persistent total occlusion of the infarct-related artery 3-28 days post-MI were randomized to PCI with stenting (n = 1,082) or medical therapy (n = 1,084).
Among stable, high-risk patients with persistent total occlusion of the infarct-related artery post-MI, performance of PCI 3-28 days post-MI was not associated with a difference in the composite of death, reinfarction, or NYHA class IV heart failure through a mean follow-up of 3 years compared with medical therapy.
ACC AHA 2021 Revascularization Guidelines
OAT (Occluded Artery Trial)
PCI was associated with a trend toward higher rates of reinfarction compared with medication therapy
Early reperfusion therapy, the goal of ST-segment elevation MI treatment, with either primary PCI or thrombolysis, is not indicated for patients who present late, often with persistent total occlusion (CLASS III)
Identify the trial of PCI of Non IRA in STEMI
Trial enrolled 4041 patients and demonstrated a 3-year reduction in the combined endpoint of death or MI with staged PCI of the non-infarct artery (performed within _________ of STEMI), compared with conservative care
COMPLETE (Complete versus Culprit Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI)
45 days
Benefits were consistent, irrespective of the timing of the non-infarct artery PCI
Identify the trial in PCI in STEMI with Cardiogenic Shock
Patients with shock caused by LV failure complicating STEMI were randomly assigned to emergency revascularization (n = 152), accomplished by either CABG or angioplasty, or to initial medical stabilization
Primary endpoint at 30 days - not significant between groups
Long term survival improved significantly in patients with cardiogenic shock who underwent early revascularization
SHOCK (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock?)
Benefit to those <75 yrs, previous MI, less than 6hrs ICP
In the SHOCK trial, there was no difference in mortality rate with PCI or CABG for those patients randomized to early revascularization, with a similar survival regardless of the mode of revascularization at 30 days and 1 year.
Identify the trial of IRA only PCI in STEMI
706 patients with cardiogenic shock onset within 12 hours in the setting of acute MI (ST- and non-ST-elevation MI)
Patients randomized to infarct artery only compared with acute multivessel revascularization at index catheterization had a lower 30-day rate of death or severe renal failure leading to renal replacement therapy
Moreover, the risk of death was lower in patients randomized to culprit-only PCI at the initial catheterization
CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock)
Multivessel PCI strategy (ACC AHA 2021 Revascularization Guidelines)
Uncomplicated PCI of the infarct artery and with low-complexity noninfarct artery disease who have normal left ventricular filling pressures and normal renal function
Normal blood pressure and heart rate
Left ventricular end-diastolic pressure <20 mm Hg,
No chronic renal or acute kidney injury, and expected total contrast volume <3X glomerular filtration rate
Simple lesion anatomy
- results of the CULPRIT-SHOCK trial showed no benefit to immediate multivessel PCI in NSTEMI.
Class I indications for revascularization in patients with NSTE ACS
In patients with NSTE-ACS who are at _______________________ and are appropriate candidates for revascularization, an invasive strategy with the intent to proceed with revascularization is indicated to reduce cardiovascular events
In patients with NSTE-ACS and ___________________ who are appropriate candidates for revascularization, emergency revascularization is recommended to reduce risk of death
n appropriate patients with NSTE-ACS who have ________________ or _________________________, an immediate invasive strategy with intent to perform revascularization is indicated to improve outcomes
ACC AHA Revasc Guidelines 2021
In patients with NSTE-ACS who are at elevated risk of recurrent ischemic events and are appropriate candidates for revascularization, an invasive strategy with the intent to proceed with revascularization is indicated to reduce cardiovascular events
In patients with NSTE-ACS and cardiogenic shock who are appropriate candidates for revascularization, emergency revascularization is recommended to reduce risk of death
In appropriate patients with NSTE-ACS who have refractory angina or hemodynamic or electrical instability, an immediate invasive strategy with intent to perform revascularization is indicated to improve outcomes
Class I indications for Revascularization to Improve Survival in SIHD Compared With Medical Therapy
Class I recommended to 2 subsets of patients:
1.
2.
ACC AHA Revascularization Guidelines 2021
- Left ventricular dysfunction and multivessel CAD
- In patients with SIHD and significant left main stenosis, CABG is recommended to improve survival
Class I indication for revascularization in patients with LVD and Multivessel CAD
In patients with SIHD and multivessel CAD appropriate for CABG with severe left ventricular systolic dysfunction (left ventricular ejection fraction ____%), CABG is recommended to improve survival
ACC AHA Revascularization Guidelines 2021
LVEF 35%
Other class I: In patients with SIHD and significant left main stenosis, CABG is recommended to improve survival
Revascularization in SIHD with Multivessel CAD and stenosis in PLAD
Is PCI recommended for multivessel CAD in improvement of survival?
In proximal LAD?
ACC AHA Revascularization Guidelines 2021
Uncertain in multivessel CAD and pLAD
Multivessel CAD:
In patients with SIHD, normal ejection fraction, significant stenosis in 3 major coronary arteries (with or without proximal LAD), and anatomy suitable for PCI, the usefulness of PCI to improve survival is uncertain (Class IIB)
In patients with SIHD, normal ejection fraction, significant stenosis in 3 major coronary arteries (with or without proximal LAD), and anatomy suitable for CABG, CABG may be reasonable to improve survival (Class IIB)
Stenosis of pLAD:
In patients with SIHD, normal left ventricular ejection fraction, and significant stenosis in the proximal LAD, the usefulness of coronary revascularization to improve survival is uncertain
Single of Double CAD not involving LAD: Class III In patients with SIHD, normal left ventricular ejection fraction, and 1- or 2-vessel CAD not involving the proximal LAD, coronary revascularization is not recommended to improve survival
Recommendations for PCI in Diabetes and SIHD
Class IIA - In patients with diabetes who have _____________ amenable to PCI and an indication for revascularization and are __________________ surgery, PCI can be useful to reduce long-term ischemic outcomes
CLass IIB - In patients with diabetes who have ___________________ and low- or intermediate-complexity CAD in the rest of the coronary anatomy, PCI may be considered an alternative to CABG to reduce major adverse cardiovascular outcomes
A. Multivessel CAD, poor candidates
B. Left main stenosis
DAPT in patients for PCI
In ACS or SIHD loading dose and daily dosing of _______ is recommended (Class IB) prior to PCI
In ACS, loading dose and daily dosing of __________ is recommended (Class IB) prior to PCI
In SIHD, loading dose and daily dosing of __________ is recommended (Class IC) prior to PCI
If for PCI within 24 hours after fibrinolytic therapy, a loading dose of _________________, followed by daily dosing (Class IC)
In ACS for PCI, reasonable to use ____________over Clopidpgrel (Class IIA)
In <75 yrs, undergoing PCI within 24 hours after fibrinolytic therapy, ______________ may be a reasonable alternative to clopidogrel
Class III - use of ______________ if with history of stroke or TIA
A. Aspirin - load then daily dose
B. P2Y12 inhibitor - load then daily dose
C. Clopidogrel - load then daily dose
D. Clpidogrel 300mg
D. Ticagrelor
E. Prasugrel
Identify the trial in DAPT in patients for Elective PCI
This trial compared pretreatment compared with no pretreatment with clopidogrel prior to elective PCI
Demonstrated a reduction in ischemic events, including the risk of death, MI, or stroke, with a loading dose of clopidogrel and treatment up to 9 months after elective PCI.
CREDO (Clopidogrel for the Reduction of Events During Observation) trial
There was a trend toward a lower event rate when preloading with a 300-mg clopidogrel dose was given >3 hours before PCI. A 600-mg loading dose of clopidogrel is associated with a shorter time to platelet inhibition and therefore is the preferred dose. T
Identify the trial of DAPT among STEMI post Fibrinolysis
Evaluate treatment with clopidogrel compared with placebo among patients with ST elevation myocardial infarction (MI) treated with an initial medical management strategy
clopidogrel pretreatment in conjunction with fibrino lytic therapy resulted in a 46% reduction in the rate of cardiovascular death or recurrent MI or stroke at 30 days
CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy) trial
Clopidogrel is the only P2Y12 inhibitor agent studied in patients immediately after the administration of fibrinolytic therapy.
Identify the trial in DAPT undergoing PCI in ACS
Evaluate treatment with a novel thienopyridine, prasugrel, compared with clopidogrel among patients undergoing planned percutaneous coronary intervention (PCI) for an acute coronary syndromes (ACS)
Among patients undergoing planned PCI for an acute coronary syndromes, treatment with the novel thienopyridine, prasugrel, was associated with a reduction in the composite endpoint of CV death, MI or stroke at a median follow-up of 14.5 months compared with clopidogrel.
TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel–Thrombolysis In Myocardial Infarction 38)
Bleeding rates were especially high in elderly patients (≥75 years) and those with reduced body weight (<60 kg [132 lb]). Thus prasugrel should be avoided in such patients unless they are at high risk for thrombosis, in which case a 5-mg maintenance dose is preferred.
Identify the trial of DAPT in patients with ACS for PCI
Evaluate the safety and efficacy of treatment with ticagrelor, a novel reversible oral P2Y12 receptor antagonist, compared with clopidogrel among patients with an acute coronary syndrome (ACS) with or without ST-segment elevation
Among patients with STE or non-STE ACS, treatment with the novel reversible oral P2Y12 receptor antagonist ticagrelor significantly reduced the composite endpoint of death from vascular causes, MI, or stroke by 12 months compared with clopidogrel, without an excess in the primary safety endpoint of major bleeding.
PLATelet inhibition and patient Outcomes - PLATO
Results of post-hoc analyses also suggest that for patients with ACS in whom an invasive strategy is planned, ticagrelor is associated with superior outcomes compared with clopidogrel, without a significant increase in the risk of major bleeding. Similarly, ticagrelor reduces total and subsequent ischemic events in these patients as compared with clopidogrel over 6-12 months, without an increase in recurrent bleeding.
Identify the trials of IV P2Y12 (CANGRELOR) in patients undergoing PCI
“CHAMPION” trials
- CHAMPION ____________ - lower rates of prespecified secondary outcomes of stent thrombosis and death
- CHAMPION _______ - did not show a reduction in the primary outcome i.e., death, MI, or ischemia-driven revascularization at 48 hours) with cangrelor.
- CHAMPION ___________ - primary endpoint, which included death, MI, ischemiadriven revascularization, or stent thrombosis, was significantly reduced with cangrelor; reduction in periprocedural MI and intraprocedural stent thrombosis
- PLATFORM
- PCI
- PHOENIX
Class IIB - in patients undergoing PCI who are P2Y12 inhibitor naïve, intravenous cangrelor may be reasonable to reduce periprocedural ischemic events
Indications in the use of Intravenous Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing PCI
1.
2.
3.
Large thrombus burden
No reflow
Slow flow
Class IIA - In patients with ACS undergoing PCI with large thrombus burden, no-reflow, or slow flow, intravenous glycoprotein IIb/IIIa inhibitor agents are reasonable to improve procedural success
Class III for SIHD undergoing PCI
Identify the trial in the use of IV Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing PCI among SIHD
Pretreatment with abciximab and a 600mg loading dose of clopidogrel had outcomes similar to those of patients receiving clopidogrel alone
Major bleeding was not significantly different between the 2 groups, although the rate of severe thrombocytopenia was significantly higher in the abciximab group
ISAR-REACT (iNtracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) trial
DAPT Loading and Maintenance Doses
Aspirin
Clopidogrel
Ticagrelor
Prasugrel
IV Antiplatelet Doses
Abciximab (GPI)
Eptifibatide (GPI)
Tirofiban (GPI)
Cangrelor
ASA - 162-325mg; 75-100mg OD
Clopidogrel - 600mg; 75mg OD
Ticagrelor - 180mg; 90mg BID
Prasugrel - 60mg; 10mg OD
Abciximab - Bolus of 0.25 mg/kg; 0.125 mg/kg/min infusion (maximum 10 g/min) for 12 h
Eptifibatide - Double bolus of 180 ug/kg (given at a 10-min interval); 2.0 mg/kg/min for up to 18 h
Tirofiban - Bolus of 25 ug/kg over 3 min; 0.15 mg/kg/min for up to 18 h
Cangrelor - Bolus 30ug/kg; Maintenance infusion 4 mg/kg/min for at least 2 h or duration of the procedure, whichever is longer
Class I Recommendations for Anticoagulation in Patients Undergoing PCI
In patients undergoing PCI, administration of intravenous ___________________ is useful to reduce ischemic events
In patients with heparin-induced thrombocytopenia undergoing PCI, _______________ or _____________ should be used to replace UFH to avoid thrombotic complications
A. Unfractionated heparin (UFH)
B. Bilavirudin or Argatroban - direct thrombin, do not bind to PF 4
Class IIB - In patients undergoing PCI, bivalirudin may be a reasonable alternative to UFH
Class IIB - In patients treated with upstream subcutaneous enoxaparin for unstable angina or NSTE-ACS, the use of intravenous enoxaparin may be considered at the time of PCI to reduce ischemic events
Class III - In patients on therapeutic subcutaneous enoxaparin, in whom the last dose was administered within 12 hours of PCI, UFH should not be used for PCI and may increase bleeding
Duration of Dual Antiplatelet post PCI
SIHD - DES - Class I: At least ______ months with ASA + Clopidogrel
SIHD - BMS - Class I: At least ______ month with ASA + Clopidogrel
ACS - Class I: At least ________ months with ASA + Clopi/Ticag/Prasugrel
- 6 months
- 1 month
- 12 months
Class IIA - In selected patients undergoing PCI, shorter-duration DAPT (1–3 months) is reasonable, with subsequent transition to P2Y12 inhibitor monotherapy to reduce the risk of bleeding events
Class IIB - may be reasonable discontinue P2Y12 to 3 months (SIHD+DES) or 6 months (ACS0 if with bleeding on DAPT
Class IIB - may be reasonable to continue DAPT >6 months (SIHD+DES) >1month (SIHD+DES) >12 months (ACS) if no high bleeding risk and no significant overt bleeding on DAPT
Trials supporting recommendations for Antiplatelet Therapy with AF after PCI
- _________________ - randomized patients with atrial fibrillation undergoing PCI and found that apixaban, as compared with warfarin, reduced the rate of bleeding and was associated with a lower incidence of the combined endpoint of death or hospitalization
- _________________ - compared edoxaban and P2Y12 monotherapy with triple therapy with a vitamin K antagonist
- AUGUSTUS (Safety and Efficacy of Apixaban Versus Vitamin K Antagonist and Aspirin Versus Aspirin Placebo in Patients With Atrial Fibrillation and ACS and/or PCI)
- ENTRUST-AF-PCI (Edoxaban–Based Versus Vitamin K Antagonist–Based Antithrombotic Regimen After Successful Coronary Stenting in Patients With Atrial Fibrillation)
The ____________________ subtended by the treated coronary artery is the principal consideration in assessing the acute risk associated with the PCI procedure.
A. Proportion of viable myocardium
Possible complications - large side branch occlusion, distal embolization, perforation, or no-reflow—rapid clinical deterioration may occur that is proportionate to the extent of jeopardized myocardium
Predictors of cardiovascular collapse with a failed PCI include the magnitude of myocardium at risk, the severity of the baseline stenosis, multivessel CAD, and the presence of diffuse disease.
True or False
Revascularization is recommended by current guidelines for patients with an LM stenosis greater than or equal to 50%, regardless of symptomatic status or associated ischemic burden.
True
Remember class I dinications for revasc among LM - sila lang may Class 1
Identify the trial of PCI in LM disease
1800 patients, compared 1st generation (paclitaxeleluting) stent vs. CABG
Rates higher with PCI vs. CABG at 12 months (17.8% vs. 12.4%; p = 0.002) driven by repeat revascularization (13.5% vs. 5.9%, respectively; P < 0.001).
PCI did not meet criteria for noninferiority.
Death and MI similar, stroke rate higher with CABG.
Among patients with low scores (≤22), there was no significant difference in the primary outcome between PCI and CABG patients, but with intermediate or with high scores (>33), MACCE rates were lower with CABG
LM subset: MACCE at 5 years, mortality, repeat revascularization higher in PCI arm
Results with PCI were slightly better for left main only or left main + one-vessel disease, compared with left main + two or threevessel disease
SYNTAX Trial
Identify trial of PCI in LM Disease
1905 patients, compared 2nd-generation DES (everolimus-eluting) vs. CABG
At 3-year follow-up, death, MI, or stroke occurred with similar frequency in the PCI and CABG groups meeting the noninferiority assumption for PCI compared with CABG.
Mortality at 3 years similar while ischemia-driven revascularization was higher with PCI. On the other hand, stent thrombosis or graft occlusion were lower with PCI
At 5 years, no differences were noted for PCI vs. CABG for the primary endpoint
However, all-cause mortality (13% vs. 9.9%), non-procedural MI (6.8% vs. 3.5%) and ID-TLR rates (16.9% vs. 10%) were higher with PCI compared with CABG
EXCEL trial
From a PCI standpoint, intravascular imaging using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) should be considered as standard of care for LM PCI optimization
For distal LM lesions, a double kiss (DK) crush 2-stent strategy is superior to provisional stenting or Culotte stenting, with significant reductions in MACE, repeat revascularization and stent thrombosis.
Identify trials on PCI of Chronic Total Occlusions
- ______________ : CTO PCI vs no CTO PCI - no difference in LVEF and LVEDV assessed on cMRI at 4 months
- ______________ : CTO PCI + OMT vs. OMT alone - no difference in death, MI, stroke, or repeat revascularization at 3 years; similar SAQ angina
- ______________ : CTO PCI + OMT vs. OMT alone - improved QOL in CTO PCI (primary); no difference in 1 year death or non-fatal MI (secondary)
- EXPLORE
- DECISION - CTO
- EURO - CTO
Class IIB - In patients with suitable anatomy who have refractory angina on medical therapy, after treatment of nonCTO lesions, the benefit of PCI of a CTO to improve symptoms is uncertain
_____ occur in many patients with severe (>70% stenosis) CAD and are the most important factor leading to referral for CABG procedures rather than PCI
Chronic coronary occlusions
The four main aspects of CTO anatomy that are important to note in CTO lesions
(1) Proximal cap morphology
(2) Occlusion length, course, and composition (e.g., calcium)
(3) Quality of the distal vessel
(4) Characteristics of the collateral circulation
Tools such as the _____ score have been developed to estimate the likelihood of successful antegrade guidewire crossing
J-CTO score (Multicenter CTO Registry of Japan)
Once the chronic total occlusion (CTO) has been crossed, ____ may be used to reduce late clinical recurrence, with liberal use of intravascular imaging to optimize stent deployment.
DES
Three distinct pathophysiologic processes lead to SVG failure:
_____________ and ____________ - 1st week to 1st month after CABG
___________________ - due to arterialization of venous conduit, 1 month to 1 year
_____________________ - beyond 1 year
Major considerations during PCI:
1. SVG-PCI typically have extensive plaque burden predisposing to __________________ of friable atheromatous material during PCI; ___________________ rates can be as high as 15% to 20%
2. High rates of _________________ during follow-up.
A. Thrombosis and technical failure
B. Intimal Hyperplasia
C. Atherosclerosis
- Distal embolization; slow flow and no-relow
- Restenosis
Management:
Embolism - use of embolic protection devices (EPDs) - Class IIA 2018 ESC
No reflow - direct stenting rather than predilation, appropriate stent sizing (minimizing oversizing); administration of arterial vasodilators (e.g., nitroprusside, v apamil, adenosine)
Class IIA - In select patients with previous CABG undergoing PCI of a SVG, the use of an embolic protection device, when technically feasible, is reasonable to decrease the risk of distal embolization
SVGs are unique in that three distinct pathophysiologic processes lead to SVG failure:
After CABG:
1st wk - 1 mo after CABG: Thrombosis and technical failure is the predominant mechanism
1 mo - 1 yr: Intimal hyperplasia (arterialization of the venous conduit)
> 1 yr: Atherosclerosis
There are two major considerations of SVG-PCI:
(1) Distal embolization and no-reflow in the acute phase
(2) High rates of restenosis during follow-up
SVG-PCI can be challenging because they typically have extensive plaque burden predisposing to distal embolism of friable atheromatous material during PCI; slow and no-reflow rates can be as high as 15% to 20%, and are substantially higher than native coronary artery PCI.41
Strategies to minimize slow/no-reflow include _____.
(1) Direct stenting rather than predilation
(2) Appropriate stent sizing (minimizing over- sizing)
(3) Use of embolic protection devices (EPDs) when feasible (2011 ACC/AHA Class I vs 2018 ESC/EACTS Class IIa)
When no-reflow occurs, administration of _____ into the SVG may improve flow into the distal native circulation, but the risk for death or MI is still substantially increased.
Arterial vasodilators:
Verapamil
Adenosine
Nitroprusside
Identify the trial
880 patients with two- and three-vessel CAD were randomized to PCI with secondgeneration everolimus-eluting stents or CABG; LM excluded
Complete revasculariization occurred more frequently in the CABG group than in the PCI
The primary end point (death, MI, or target-vessel revascularization at 2 years) occurred more often in the PCI group (noninferior)
At 4.6 years, the primary end point occurred more often with PCI
All-cause mortality was similar while spontaneous MIs and repeat revascularization were significantly higher after PCI.
BEST trial (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease)
The goals in approaching bifurcation lesions are to:
(1) Maximize flow in both the parent vessel while maintaining flow in the side branch
(2) Prevent side branch occlusion or compromise;
(3) Maximize long-term patency of both parent vessel and side branch
(4) Minimize procedure time and radiation
In bifurcation lesions
When a two-stent strategy is felt to be necessary upfront, the ____________________ appears to have the best angiographic and clinical outcomes. This is particularly important for bifurcation PCI subtending large areas of myocardium such as the distal left main.
Double-kissing crush technique
Extensive coronary calcification also renders the vessel wall rigid, which necessitates higher balloon inflation pressure to achieve complete stent expansion and, on occasion, leads to “undilatable” lesions that resist any balloon expansion pressure that can be achieved.
In this setting, _____ can address vessel wall calcification and facilitate stent delivery and complete stent expansion
Atherectomy
Conventional angiography has poor sensitivity for the detection of coronary thrombus, but the presence of a large, angiographically apparent coronary thrombus heightens the risk for _____.
Procedural complications
In the set- ting of contemporary primary PCI for STEMI, routine manual catheter aspiration of thrombus appears to have no significant effect on mortal- ity and may increase the risk of stroke,50 but it may be helpful in select patients.
Identify the trial on revascularization in patients with DM and Multivessel CAD
Compare outcomes between DM patients with MVD who underwent percutaneous coronary intervention (PCI) versus CABG
The primary outcome (allcause mortality, nonfatal MI, or nonfatal stroke) at 5 years was worse in patients treated with PCI than in those who underwent CABG
There was a significantly increased long-term risk for all-cause mortality and nonfatal MI with PCI as opposed to CABG
CABG was associated with an increased risk for nonfatal stroke
Incidence of the primary endpoint was higher among PCI patients irrespective of SYNTAX score
FREEDOM Trial (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease)
Patients with DM and MVD, CABG is superior to DES PCI, and should remain the revascularization strategy of choice in this patient population. CABG resulted in lower rates of death and MI, but higher risk of stroke
The recommendations from contemporary guidelines favor CABG over PCI as the optimal revascularization strategy in patients with DM and multivessel disease.
Identify the trial of revascularization in patients with LVD
Evaluate medical therapy versus surgical therapy for patients with obstructive coronary artery disease (CAD) and congestive heart failure (CHF; LV ejection fraction ≤0.35)
Eligibility:
CAD suitable for CABG
LVEF <35%
For medical tx:
Absence of left main CAD, as defined by an intraluminal stenosis of ≥50%
Absence of Canadian Cardiovascular Society (CCS) class III angina or greater (angina markedly limiting ordinary activity)
In patients with ischemic LV systolic dysfunction (ischemic cardiomyopathy), CABG + medical therapy resulted in higher mortality at 30 days, but with a significant improvement in long-term mortality (out to 10 years) compared with medical therapy alone. CV mortality and morbidity were both lower with CABG
STICH (Surgical Treatment for Ischemic Heart Failure) trial
Long term outcomes seen in STITCH-Extended Study (STITCHES trial) 10 years follow up
In STITCH
Over 6 years of follow-up, the primary outcome of all-cause mortality was similar between the CABG + medical therapy versus medical therapy arms; CV mortality was lower in the CABG + medical therapy, as well as all-cause mortality or CV hospitalization
At 10 years, mortality benefit was noted for CABG
In the subgroup that underwent myocardial viability testing, there seemed to be no difference in outcomes in the adjusted analysis between patients who demonstrated viability versus those who did not, irrespective of treatment strategy. Given the overall benefit noted with CABG in these patients over medical management alone, this argues against routine viability testing in all patients with ischemic cardiomyopathy prior to consideration for revascularization
LV function is an important predictor of outcome during PCI.
For each 10% decrement in resting LV ejection fraction (EF), the risk for in-hospital mortality following PCI increases approximately _____.
Each 10% decrease in LVEF = 2-fold increase in in-hospital mortality
The landmark _____ trial showed that early revascularization (87% overall,including angioplasty in 54.5% [bare-metal stent use 35.7% overall], CABG in 37.5%) resulted in a mortality benefit at 6 months in patients presenting with post-MI shock (although this was not noted at 30 days).
This benefit was sustained out to 6 years of follow-up.
SHOCK Trial
Both, US and European guidelines recommend emergent angiography as a class I recommendation for patients with MI-shock.
Further, till recently, guidelines encouraged operators to perform multivessel PCI of all critical stenosis, in addition to the culprit lesion for patients with MI-shock (class IIa recommendation)
_____ trial showed a significant clinical benefit of a culprit-lesion-only strategy compared with immediate multi-vessel PCI, with a reduction in the primary endpoint of 30-day mortality or renal replacement therapy (45.9% vs. 55.4%; RR 0.83; 95% CI 0.71 to 0.96; p = 0.01).
30-day mortality was also reduced with culprit-vessel only PCI (43.3% vs.51.5%;p= 0.03).66 At 1 year, the difference in all-cause mortality between the two strategies was nominally significant (50.0% vs. 56.9%, RR 0.88, 95% CI 0.76 to 1.01), while rates of recurrent infarction were similar (1.7% vs. 2.1%).
Repeat revascularization was performed at a greater than three-fold higher rate in the culprit-only arm (32.3% vs.9.4%, RR 3.44, 95% CI 2.39 to 4.95).
CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock)
Based on this trial, the ESC 2018 revascularization guidelines now advise against routine immediate multivessel PCI (Class IIIB recommendation); no updates to the US guidelines have been issued yet.
Cardiogenic Shock
Defined as a pulmonary capillary wedge pressure (PCWP) _____ and a cardiac index (CI) _____ , typically with a systolic blood pressure _____ mm Hg
A. > 18 mm Hg
B. < 2.2 L/min/m2
C. ≤ 90 mm Hg
SCAI shock classification:
Stage A “At Risk”.
* Not currently experiencing signs or symptoms of CS, but is at risk for its development.
* Acute MI, acute and/or acute on chronic HF symptoms.
Stage B “Beginning” Cardiogenic Shock.
* Clinical evidence of relative hypotension or tachycardia without hypoperfusion.
Stage C “Classic” Cardiogenic Shock.
* Hypoperfusion that requires intervention (inotrope, pressor or mechanical support, ECMO) beyond volume resuscitation to restore perfusion.
* Present with relative hypotension.
Stage D “Deteriorating or Doom”.
* Similar to category C but is getting worse.
* Failure to respond to initial interventions.
Stage E “Extremis”.
* Circulatory collapse, frequently (but not always) in refractory cardiac arrest with ongoing CPR or are being supported by multiple simultaneous acute interventions including ECMo-facilitated CPR.
* Multiple clinicians at bedside laboring to address multiple simultaneous issues related to the lack of clinical stability of the patient.
Identify SCAI Shock Classification
A patient that manifests with hypoperfusion that requires intervention (inotrope, pressor or mechanical support, ECMO) beyond volume resuscitation to restore perfusion. These patients typically present with relative hypotension.
Stage C “Classic” Cardiogenic Shock
Classification:
Stage A “At Risk” A patient who is not currently experiencing signs or symptoms of cardiogenic shock, but is at risk for its development. These patients may include those with acute myocardial infarction, acute and/or acute on chronic heart failure symptoms.
Stage B “Beginning” Cardiogenic Shock A patient who has clinical evidence of relative hypotension or tachycardia without hypoperfusion
Stage C “Classic” Cardiogenic Shock A patient that manifests with hypoperfusion that requires intervention (inotrope, pressor or mechanical support, ECMO) beyond volume resuscitation to restore perfusion. These patients typically present with relative hypotension.
Stage D “Deteriorating or Doom” A patient that is similar to category C but is getting worse. They have failure to respond to initial interventions.
Stage E “Extremis” A patient with circulatory collapse, frequently (but not always) in refractory cardiac arrest with ongoing cardiopulmonary resuscitation (CPR) or are being supported by multiple simultaneous acute interventions including ECMo-facilitated CPR.
The risk for cholesterol embolization syndrome is related to ____ in an ascending or descending atherosclerotic aorta from which cholesterol crystals are released
Manipulation of the catheter
Although the risk associated with hemodialysis is less than ___% in cases of uncomplicated contrast-induced nephropathy, in-hospital mortality in the setting of hemodialysis exceeds 30%
HD risk in uncomplicated CIN: < 3%
HD case in-hospital mortality: > 30%
_____________________ expands the coronary lumen by stretching and tearing the atherosclerotic plaque and vessel wall and, to a lesser extent, by redistributing atherosclerotic plaque along its longitudinal axis.
Balloon angioplasty
In balloon angioplasty, the elastic recoil of the stretched vessel wall generally leaves a ____% residual diameter stenosis, and the vessel expansion can result in propagation of coronary dissections and lead to abrupt vessel closure in 5% to 8% of patients.
Restenosis rates at 6 months are as high as _____.
Residual diameter stenosis due to elastic recoil:
30-35%
Restenosis at 6 mo: 30-49%
Coronary stents have emerged as the predominant form of PCI and are currently used in more than 90% of PCI procedures worldwide.They act as ____.
(1) Scaffolds for arterial dissection flaps, thereby lowering the incidence of vessel closure and need for emergency CABG;
(2) Lessen the frequency of restenosis because of their effect in preventing arterial recoil, which is the primary mechanism of restenosis with balloon angioplasty
___________________ has US FDA approval for a new 1-month DAPT labeling among patients at high bleeding risk. This is also the only DES that is available for PCI in very small (2.0 mm) or very large (5.0 mm) vessels.
Resolute Onyx
thinner struts in Resolute Onyx, improved radiographic visibility.
The three components of a conventional DES (also called durable polymer [DP]-DES) are a _____.
(1) Balloon-expandable metallic stent
(2) Durable or resorbable polymer coating that provides sustained drug delivery
(3) Pharmacologic agent used to limit intimal hyperplasia
____ (also known as ABT-578) is a rapamycin analogue released from a phosphorylcholine-coated stent that was initially evaluated in the Endeavor stent.
Trial?
Zotarolimus
In the RESOLUTE All Comers Trial of 2292 patients, the Resolute zotarolimus-eluting stent was found to be noninferior to everolimus-eluting stents for the primary endpoint of target-lesion failure (8.2% vs. 8.3%, respectively; p < 0.001 for noninferiority).
At 5 years of follow-up, there were no significant differences between the two second-generation DP-DES in target-lesion failure, its components, or stent thrombosis.
_____ is a semisynthetic analogue of sirolimus (rapamycin), with both immunosuppressive and antiproliferative effects.
Everolimus
The ____ (Cordis,Warren,New Jersey) contains 140 μg/cm2 of sirolimus, a naturally occurring immunosuppressive agent that causes cytostatic inhibition of cell proliferation. Sirolimus is released from a biostable polymer over 30 days
Trial?
Cypher stent
The pivotal SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial included 1058 patients with a single newly diagnosed target lesion (mean reference vessel diameter, 2.80 mm) in a de novo coronary artery, who were randomly assigned to treatment with a sirolimus-eluting stent or a BMS.
The primary clinical endpoint of 8-month target vessel failure, which included target-vessel revascularization, death, or MI, was reduced from 21% in patients treated with BMS to 8.6% in patients treated with sirolimus-eluting stents (P < 0.001), primarily driven by a reduction in the rate of target-vessel revascularization (8.6% vs. 21.0%, p < 0.001). This difference was sustained at 5 years.
The _____ stent (Boston Scientific, Marlborough, Massachusetts) is composed of a stainless steel stent platform, a polyolefin polymer derivative,and the microtubular stabilizing agent paclitaxel,which has anti-inflammatory effects while also inhibiting both cell migration and division. Release of paclitaxel is completed within 30 days of implan- tation, although a substantial portion (>90%) of the paclitaxel remains within the polymer indefinitely.
Trial?
Taxus stent
The pivotal TAXUS-IV (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent IV) trial randomly assigned 1314 patients with single de novo coronary lesions (mean reference vessel diameter, 2.75 mm) to either a Taxus stent or a BMS.The rate of ischemia-driven target-vessel revascularization at 9 months was significantly lower with Taxus (3% vs. 11.3%, p < 0.001), and remained significantly reduced at 5 years as well.The TAXUS stent is no longer manufactured.
In the _____ trial,1197 patients were assigned to treatment with the Endeavor zotarolimus-eluting PC polymer–coated stent or BMS.
The 9-month primary endpoint of target-vessel failure was reduced from 15.1% with the BMS to 7.9% with the Endeavor stent (P < 0.0001). Interestingly, late lumen loss was higher with the Endeavor stent co pared with both first-generation DES.This was felt to be a stent design issue rather than a drug-failure issue; zotarolimus was eluted within a few weeks from the polymer, with 95% of the drug released within about two weeks.
Accordingly, Endeavor-ZES was redesigned as Resolute-ZES with an alternative polymer that extended the delivery of zotarolimus (85% within 60 days and the remainder by 180 days)
ENDEAVOR-II Trial
The _____ program showed superior outcomes of everolimus-eluting stents (Xience) to first-generation DES, primarily paclitaxel-eluting stents. For instance, in SPIRIT IV, a large, randomized comparison of the everolimus- and paclitaxel-eluting stents in 3687 patients, the pri- mary endpoint of target-lesion failure at 1 year was significantly lower in the everolimus-eluting stent arm (4.2% vs. 6.8%, p = 0.001). Rates of MI (1.9% vs. 3.1%, p = 0.02) and stent thrombosis (0.17% vs. 0.85%, p = 0.004) were also lower with everolimus-eluting stents.
SPIRIT
Among the DES
Lowest for target vessel revasc - ______________
Lowest for definite/probable stent thrombosis - _________
BEST for long term stent thrombosis rate - __________
- Sirolimus
- Everolimus
- Everolimus
_______________________ involves the use of a noncompliant balloon with three to four longitudinally mounted microsurgical atherotomes to cause scoring of atheromatous plaque and severing of elastic and fibrotic continuity of the vessel wall, resulting in plaque compression
Cutting balloon angioplasty
Mainly utilized in patients with ostial, non-passable, or bifurcation lesions, which are only mildly calcified.
It is also used in the setting of in-stent restenosis.
Restenosis typically occurs as a result of ______________________ within the stent.
Excessive intimal hyperplasia
This risk is increased in patients with small reference vessel size, smaller post-procedural luminal diameter or high degree of residual stenosis, long lesion length, diabetes, and presence of untreated edge dissection
One advantage of BMS is that the duration of DAPT post-PCI can be as short as_________________, which is appealing for certain subgroups of patients such as those needing urgent non-cardiac surgery, high bleeding risk or known or suspected medication noncompliance.
4 to 6 weeks
Stent designs that incorporate bioabsorbable polymers
1. ________________ - drug and polymer are both eluted/degraded over a period of time, leaving behind a BMS in the vessel
2. _______________ - polymer and stent scaffold are both resorbed once the drug has been eluted, thus leaving nothing behind in the vessel
3. _______________ - polymer-free stents, where the drug is coated directly onto the stent frame, and elutes over a month or so, leaving behind a BMS
- Bioabsorbable polymer drug-eluting stents (BP-DES)
- Bioresorbable vascular scaffold (BVS)
- Drug-coated stent
Issues with non-absorbable scaffolding:
_______________ due to uncovered stent struts
Impaired coronary vasomotion due to retention of obstructive scaffolding
_______________ due to retained scaffolding
Chronic inflammation due to retained foreign-body metal
- Very stent thrombosis
- Decreased luminal size
_________________ refers to removal (rather than simple displacement) of the obstructing atherosclerotic plaque. By removing plaque or improving lesion wall compliance in severely calcified or fibrotic lesions, atherectomy can provide a larger final minimal lumen diameter than can be achieved by balloon angioplasty alone
Give 2 types
1.
2.
A. Atherectomy
- Rotational
- Orbital
Class IIA - In patients with fibrotic or heavily calcified lesions, plaque modification with rotational atherectomy can be useful to improve procedural success (ACC AHA 2021 REVASC GUIDELINES)
The most commonly used atherectomy device and removes atheromatous plaque by abrasion of the inelastic calcified plaque with microscopic (20 to 50 μm) diamond chips embedded on the surface of a rapidly rotating (160,000 rpm) olive-shaped atherectomy burr.
Currently reserved for __________________________ that cannot be dilated with balloon angioplasty or those that prevent the delivery of coronary stents.
A. Rotablator Rotational Atherectomy System (Boston Scientific)
B. Ostial and heavily calcified lesions
This utilizes a crown for sanding the hard components of plaque with higher speeds will increase centrifugal force, which in turn results in larger orbital diameter
Orbital atherectomy (Diamondback 360, Cardiovascular Systems Inc., St. Paul, Minnesota)
This involves utilizing predominantly the photoacoustic effects of laser energy to cause tissue absorption, and thereby plaque ablation
This technique has utility in SVGs, densely fibrotic or very thrombotic lesions, CTOs, etc
Excimer laser angioplasty (ECLA)
Class IIB - In patients with fibrotic or heavily calcified lesions, plaque modification with orbital atherectomy, balloon atherotomy, laser angioplasty, or intracoronary lithotripsy may be considered to improve procedural success ACC AHA 2021 Revasc Guidelines
__________________ transforms electrical energy into mechanical energy during low-pressure balloon inflation.
In contrast to debulking and atherectomy techniques, the calcium fragments resulting from the IVL therapy remain in situ, thus reducing the likelihood of distal embolization.
The Intravascular Lithotripsy (IVL) System (Shockwave Medical Inc, Santa Clara, California)
This uses high-speed saline jets within the tip of the catheter create intense local suction by the Venturi effect; surrounding blood, thrombus, and saline are pulled into the lumen of the catheter opening, and the debris is propelled proximally through the catheter lumen
The AngioJet rheolytic thrombectomy catheter
2 types of thrombectomy devices: simple catheter aspiration; mechanical aspiration
In the _____ trial, there were significant reductions in all-cause (4.7% vs. 7.6%, p= 0.04) and cardiovascular (3.6% vs. 6.7%, p = 0.02) mortality at 1 year, with a trend towards reduction in subacute and late stent thrombosis with adjunctive aspiration thrombectomy compared with conventional PCI alone.
TAPAS (Thrombus Aspiration during Percutaneous Coronary Intervention in Acute Myocardial Infarction Study) Trial
This led to a class IIa recommendation for use in the 2009 and 2013 ACC/AHA STEMI guidelines
Trials did not show a benefit with aspiration thrombectomy during primary PCI. ____ trialwas the largest of these (n = 10,732).
No differences in clinical outcomes were observed at 6 months in favor of aspiration thrombectomy compared with conventional primary PCI, including in the primary MACE outcome (6.9% vs. 7.0%, p = 0.86), car- diovascular death (3.1% vs. 3.5%, p = 0.34) or stent thrombosis (1.5% vs. 1.7%, p = 0.42); stroke rates were higher with aspiration thrombectomy (0.7% vs. 0.3%, p= 0.02).
TOTAL (Thrombectomy with PCI vs. PCI Alone in patients with STEMI) trial
Based on this evidence, routine aspiration thrombectomy was downgraded to a class III recommendation in the 2015 ACC/AHA STEMI guidelines.
In patients with STEMI, routine aspiration thrombectomy before primary PCI is not useful
The advent of embolic protection systems has reduced the risk for postprocedural adverse events following SVG PCI. In particular, distal embolization causes postprocedural elevation of cardiac enzymes in almost ___% of patients after SVG PCI,and this enzyme elevation can be associated with substantial morbidity and mortality.
20%
Currently only two distal embolic protection devices are available in the United States
1.
2.
FilterWireEZ (Boston Scientific, Natick, Massachusetts)
SpiderFx (Medtronic)
________________________ is an accurate and lesion-specific physiologic test that provides a functional assessment of the presence of a reduction in flow, and correlates well with ischemia as detected by nuclear scintigraphy.
Formula?
Normal values _______
Cut off to define flow limiting and associated with ischemia _______
Cut off that excludes ischemia in 90% of patients __________
A. Fractional flow reserve (FFR)
Formula = ratio of coronary pressure distal to a coronary artery stenosis (Pd) and aortic pressure (Pa) under conditions of maximal hyperemia (IV or intracoronary Adenosine)
OR
FFR = Pd/Pa
Normal: 0.94 - 1.0
< 0.75 - ischemia
> 0.80 - excludes ischemia
Class IA - In patients with angina or an anginal equivalent, undocumented ischemia, and angiographically intermediate stenoses, the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) is recommended to guide the decision to proceed with PCI
ACC AHA 2021 Revasc Guidelines
The use of FFR is endorsed as a class ___ recommendation for patients with SIHD and intermediate lesions in the 2011 ACC/AHA/SCAI PCI guidelines
Class IIa
Identify the trial in Coronary Physiology and PCI
Patients with multivessel disease, in whom a decision was made to stent all stenoses >50%, were randomized to either routine angiography-guided PCI, or FFR-guided PCI, in which FFR was measured in all significant stenoses, with stenting only of those lesions with an FFR ≤0.8
FFR guidance resulted in fewer overall stented lesions. MACE at 1 year, a composite of death, MI, repeat revascularization, was significantly lower in the FFR group with a reduction in death and MI at 1 year as well. These results were sustained out to 5 years of follow-up
FAME (Fractional Flow Reserve versus Angiography for M tivessel Evaluation) trial
Identify the trial
Stable patients who were appropriate candidates for PCI and who had angiographic evidence of coronary artery disease were included. If FFR was ≤0.80, they were randomized to either PCI or OMT
If FFR was >0.80, they were included in a registry (OMT)
The primary MACE endpoint of death/MI/urgent revascularization was significantly lower in the PCI + OMT arm compared with the OMT arm. This was driven predominantly by a significant reduction in the need for urgent revascularization; rates of death and MI were similar (up to 5 years). There is also a significant improvement in angina symptoms up to 5 years of follow-up.
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2
(FAME-2)
Cut off < 0.8 to do revasc
In patients with evidence of angiographically significant disease, but negative FFR, OMT alone is associated with low event rates.
Identify the trial
The goal of the trial was to demonstrate the noninferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) for patients with three-vessel disease
FFR-guided PCI using current-generation DES did not meet criteria for noninferiority compared with CABG among patients with angiographic three-vessel disease. At 3 years, no difference was noted between the two arms but MI and repeat revascularization were both higher with PCI.
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3
(FAME-3)
Cut off for revasc - < 0.8
Summary of the Famous FAME trials
FAME - FFR guided PCI vs _________________
FAME-2 - FFR guided PCI vs _______________
FAME- 3 - FFR guided PCI vs ______________ in _______________ disease
Cut off for revasc for all trials _________
- Angiography guided PCI; superior FFR guided PCI
- OMT; superior FFR guided PCI
- CABG; multivessel 3 vessel disease; non-inferior; higher rates of MI and repeat revasc
Cut off - FFR < 0.8
Use of FFR in stable angina with intermediate and severe lesions:
- Intermediate lesion: FFR recommended
- Severe lesion:
70-90% stenosis: FFR recommended
>90% stenosis: FFR NOT Recommended
Use of FFR in UA/ACS:
Culprit lesion: FFR NOT recommended
Non-culprit lesion: FFR recommended
This is a resting translesional pressure ratio taken during a specific diastolic interval in which the natural microvascular resistance is constant and low, and therefore meets the criteria of FFR without inducing hyperemia (i.e., without the need for adenosine)
Formula?
Cut off for revasc - ___________
Cut off as negative - __________
instantaneous wave-free ratio (iFR)
Revasc - IFR </= 0.89
Negative - IFR > 0.94
Identify the trial
Evaluate if functional lesion assessment by instantaneous wave-free ratio (iFR) would be noninferior to fractional flow reserve (FFR) among patients with stable angina or acute coronary syndromes
Patients undergoing functional assessment of an indeterminant coronary lesion were randomized to iFR (n =1,242) versus FFR (n =1,250). Revascularization was recommended if the iFR value was ≤0.89 or the FFR value was ≤8.0
The primary outcome, incidence of all-cause death, MI, or unplanned revascularization at 12 months, occurred in 6.8% of the iFR group versus 7.0% of the FFR group (p < 0.001 for noninferiority).
Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization
(DEFINE-FLAIR)
Among patients undergoing functional determination of an indeterminant coronary stenosis for stable or unstable coronary disease, iFR was noninferior to FFR. The threshold to revascularize was ≤0.89 for iFR and ≤0.80 for FFR.
Identify the trial
Evaluate if functional lesion assessment by instantaneous wave-free ratio (iFR) would be noninferior to FFR among patients with stable angina or acute coronary syndromes
Patients undergoing functional assessment of an indeterminant coronary lesion were randomized to iFR (n = 1,019) versus FFR (n = 1,018). Revascularization was recommended if the iFR value was ≤0.89 or the FFR value was ≤0.80
The primary outcome, incidence of all-cause death, MI, or unplanned revascularization at 12 months, occurred in 6.7% of the iFR group versus 6.1% of the FFR group (p = 0.007 for noninferiority). The results were the same among tested subgroups.
Instantaneous Wave-Free Ratio versus Fractional Flow Reserve in Patients with Stable Angina Pectoris or Acute Coronary Syndromes
(iFR-SWEDEHEART)
Among patients undergoing functional determination of an indeterminant coronary stenosis for stable or unstable coronary disease, iFR was noninferior to FFR. The threshold to revascularize was ≤0.89 for iFR and ≤0.80 for FFR. Adverse cardiac events were similar between study groups at 12 months and 5 years
Identify trials for FFR Guided PCI of Non Culprit Lesions in STEMI
________________ - Immediate non-culprit vessel PCI vs FFR guided staged revascularization of non-culprit vessels
________________ - Complete FFR guided revasc of non-infarct vessel vs no intervention with blinded FFR assessment
A. DANAMI-3-PRIMULTI - Mortality, MI, ID-TLR of non-infract vessel was lower with FFR guided PCI
B. COMPARE-ACUTE - All cause mortality, nonfatal MI, revasc and CV events lower in FFR guided PCI arm, mostly driven by reduction for repeat revasc
IVUS vs OCT
Greater resolution ________
Penetration depth in soft tissue ________
Requires clearance of blood ___________
Issues with backscatter from blood __________
Aorto ostial lesion visualization ______________
Plaque burden at lesions site ___________
Lipidic plaque eval and cap thickness ___________
OCT
IVUS
OCT
IVUS (moderate or severe backscattering)
IVUS
IVUS
OCT
IVUS criteria for functionally significant lesion
A. Ischemia detection (native CAD other than LM)
B. Ischemia detection (LM)
C. Adequacy of stenting
A. Ischemia detection (non-LM)
MLD ≤ 1.8 mm
MLA < 2.7 - 4.0 mm2
CFR < 2.0
FFR < 0.75 - 0.80
B. Ischemia detection (LM)
MLD < 2.8 mm
MLA < 6.0 mm2
CFR < 2.0
FFR < 0.75 - 0.80
C.Adequacy of stenting
MLA > 9.0 mm2 (>80% reference area)
FFR ≥ 0.90
Percutaneous mechanical support devices for cardiogenic shock - FOR RV SUPPORT
Impella RP
TandemHeart RA-PA
VA-ECMO
Percutaneous mechanical support devices for cardiogenic shock - FOR LV SUPPORT
IABP
Impella
TendemHeart
iVAC 2L
_____________ is still the most widely used MCS device in CS, primarily due to ease of use and widespread availability
May be useful when LV function is severely compromised or when the PCI target lesion supplies a substantial portion of viable myocardium
IABP
The _____ approach (either right or left sided) is the most commonly used vascular access site in the United States and provides the advantages of large vessel size (typical common femoral artery diameter is 6 to 8 mm) and the ability to accommodate larger (>6 Fr) sheath sizes, including MCS.
Femoral
In addition, because of the typically straight path from the femoral artery to the ascending aorta, the femoral approach provides excellent guide catheter support and manipulability and access to the venous system through the adjacent femoral vein
Complications of femoral access
Above the inguinal ligament __________
Below the inguinal ligament or distal to femoral bifurcation __________
A. Retroperitoneal hemorrhage
B. Pseudoaneurysms, AVF
The presence of _____ limit use of the femoral approach in some patients.
(1) Severe peripheral arterial disease
(2) Peripheral vascular bypass graft
(3) Requirement for immobilization after the procedure
Factors predisposing patients to increased risk for serious vascular complications after PCI include _____.
Older age
Female sex
Larger vascular sheath size
Low body mass index
Renal insufficiency
Degree of anticoagulation during the procedure
The location of the entry point for transfemoral access predicts the risk and type of vascular complication. If the access site is above the level of the inguinal ligament, the risk for _____ increases substantially. If the access site is distal to the femoral bifurcation, _____.
Major vascular complications of the femoral approach include _____ which are associated with a 2- to 10-fold increased risk for death in the first 30 days after PCI.
Above the inguinal ligament:
Retroperitoneal hemorrhage
Distal to the femoral bifurcation:
Pseudoaneurysms (0.4%)
Arteriovenous fistulas (0.2%)
Major vascular complications:
Limb-threatening ischemia (0.1%)
Retroperitoneal hemorrhage (0.4%)
The ____ approach provides direct access to the ascending aorta and has the unique advantage of allowing immediate mobilization following PCI.
Radial approach
In the _____ trial, 7021 patients with ACS under- going PCI were randomly assigned to either femoral or radial access.
Although the overall trial was negative for a benefit of radial over femoral access for the primary endpoint at 30 days, there was a significant reduction among STEMI patients (n = 1958; 30-day death, MI, stroke for radial vs. femoral: 3.1% vs. 5.2%, p = 0.026; p for interaction = 0.025), and in the highest volume radial centers
RIVAL (Radial vs Femoral Access for Coronary Intervention)
Currently approved vascular closure devices fall into three categories:
(1) Sealant devices, including collagen-based and thrombin-based systems, which leave no mechanical anchor inside or outside the vessel;
(2) Mechanical closure devices, including suture-mediated and nitinol clip–based systems, which provide immediate secure closure to the vessel
(3) Hybrid closure devices, such as the dissolvable AngioSeal device (St. Jude Medical, Minneapolis, Minnesota),which use a combination of collagen sealant and internal mechanical closure to induce rapid hemostasis
Identify the trial
Compared the safety and efficacy of a short-duration dual antiplatelet therapy (DAPT) (3 months) followed by ticagrelor monotherapy compared with longer duration DAPT (12 months) among patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) and with ≥1 high risk feature of ischemia or bleeding
Groups - DAPT with aspirin and ticagrelor for 3 months followed by ticagrelor monotherapy (n = 3,555) or continued DAPT ticagrelor + aspirin (n = 3,564) for an additional 12 months
Results showed short-duration DAPT (3 months) followed by ticagrelor monotherapy for 12 months results in less bleeding compared with longer-duration DAPT (additional 12 months)
TWILIGHT Trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention)
Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke
Use of the combination of aspirin and clopidogrel (or in older studies, ticlopidine) for _____ days was essential to pre- vent stent thrombosis after BMS placement.
14-28 days
_____________ does not appear to have a role in the treatment of medically managed patients with ACS, and may increase bleeding risk without an ischemic benefit
Prasugrel
A loading dose of _____ mg of clopidogrel rather than 300 mg results in more rapid (<2 hours) platelet inhibition and improved clinical outcomes, including lower rates of stent thrombosis.
600 mg
For post-PCI patients receiving a BMS, current guidelines recommend clopidogrel for a minimum of ____ month and ideally up to ____ months (unless the patient has an increased risk for bleeding, in whom it should be given for a minimum of _____ weeks).
1-12 months
2 weeks - increased bleeding risk
In the _____ trial, 13,608 patients with moderate- to high-risk ACS undergoing scheduled PCI were randomly assigned to receive prasugrel (60-mg loading dose and 10-mg daily maintenance dose) or clopidogrel (300-mg loading dose and 75-mg daily maintenance dose) for 6 to 15 months.
The primary efficacy endpoint—a composite of death from cardiovascular causes, nonfatal MI, or nonfatal stroke—occurred in 12.1% of patients receiving clopidogrel and in 9.9% of those receiving prasugrel (P < 0.001).
Prasugrel was also associated with significant reductions in rates of MI (9.7% for clopidogrel versus 7.4% for prasugrel; P < 0.001), urgent target-vessel revascularization (3.7% versus 2.5%; P < 0.001), and stent thrombosis (2.4% vs. 1.1%; P < 0.001).
On the other hand, major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (P = 0.03), with more frequent rates of life-threatening bleeding occurring in the prasugrel group (1.4% vs. 0.9% with clopidogrel; P = 0.01), including fatal bleeding (0.4% vs. 0.1%, respectively; P = 0.002).
TRITON-TIMI 38 Trial
In _____ trial, 18,624 patients with ACS, with or without ST-segment elevation, were randomly assigned to treatment with ticagrelor (180-mg loading dose, then 90 mg twice daily) or clopidogrel (300- to 600-mg loading dose, then 75 mg daily) for 12 months.
The primary endpoint—a composite of death from vascular causes,MI, or stroke at 12 months—occurred in 9.8% of patients receiving ticagrelor and in 11.7% of those receiving clopidogrel (hazard ratio, 0.84; P < 0.001).
Ticagrelor was also associated with significant reductions in MI alone (5.8% vs. 6.9% in clopidogrel group; P = 0.005) and in death from vascular causes (4.0% vs. 5.1%, respectively; P = 0.001).
No significant difference in overall rates of major bleeding was observed between the ticagrelor and clopidogrel groups (11.6% and 11.2%, respectively; P = 0.43), but ticagrelor was associated with a higher rate of major bleed- ing not related to CABG (4.5% vs. 3.8%; P = 0.03).
PLATO trial
A pooled analysis of the _____ studies (69% of patients with PCI for ACS) noted a 19% relative risk reduction (RRR) in periprocedural death, MI, ischemia-driven revascularization, and stent thrombosis with a 39% RRR in stent thrombosis alone (cangrelor vs. clopidogrel 0.5% vs. 0.8%; p = 0.008)
CHAMPION
The ____________________score was developed to help further refine individualized treatment by determining which patients are most likely to benefit from or be harmed by continuation of DAPT beyond 12 months.
PRECISE-DAPT
_____ is a chimeric human-murine monoclonal antibody that irreversibly binds to the platelet GP IIb/IIIa receptor on human plate- lets. It also binds to the vitronectin (avB3) receptor found on platelets and to vessel wall endothelial and smooth muscle cells.
Abciximab
Recommended dosage: 0.25 mg/kg by IV bolus, followed by a continuous IV infusion of 0.125 μg/kg/min (to a maximum of 10 μg/ min) for 12 hours.
Abciximab can be administered safely in patients with renal insufficiency, and platelet infusions can reverse the effect of this agent (although repeated transfusions may be necessary)
_____ is a cyclic peptide derivative that reversibly binds GP IIb/ IIIa..
Eptifibatide
Recommended Dosage: double eptifibatide bolus (180-μg/kg boluses 10 minutes apart) and infusion dose (2.0 μg/kg/min for 18 to 24 hours) result in sufficient platelet inhibition to prevent ischemic events in patients undergoing PCI.
Addition of eptifibatide to a 600-mg loading dose of clopidogrel also causes incremental platelet inhibition.
The eptifibatide infusion must be reduced to 1 μg/kg/min in patients with a creatinine clearance lower than 50 mL/min.
Platelet transfusions do not reverse the platelet inhibition with eptifibatide, although by 4 hours after cessation of the infusion, patients have safely undergone CABG
_____, a small peptidomimetic molecule, has also undergone evaluation for its adjunctive benefit during urgent PCI but was found to be inferior to abciximab for prevention of ischemic events during PCI.
Tirofiban
Recommended dosage: initial rate of 25 μg/ kg administered over ≤5 minutes and then continued at 0.15 μg/kg/ min for 18-24 hours.
Patients with severe renal insufficiency (CrCl <30 mL/min) should receive half the usual rate of infusion.
Subsequent studies have suggested that the tirofiban bolus dose given in the initial PCI studies may not have produced an optimal antiplatelet effect during PCI, but larger bolus doses can improve the inhibition of platelet aggregation
UFH is the most commonly used thrombin inhibitor during PCI. UFH consists of a mixture of polysaccharide chains that exert an anticoagulant effect by facilitating activation of antithrombin III, which in turn inactivates factors IIa (thrombin), IXa, and Xa.
UFH
Weight-adjusted heparin dosing regimens of 50 to 70 IU/kg help avoid “overshooting” the ACT.
ACT target:
> 250 to 300 seconds if no GP IIb/IIIa inhibitor is given
> 200 to 250 seconds if a GP IIb/ IIIa inhibitor is given.
Routine use of IV heparin after PCI is no longer indicated.
If no closure device has been used, early sheath removal is encouraged when the ACT falls to < 150 to 180 seconds
If the last dose of enoxaparin was administered less than 8 hours before PCI, ______. If the last dose of enoxaparin was given between 8 and 12 hours, a _____ enoxaparin should be administered. If the dose was administrated more than 12 hours before PCI, _____ is indicated
Last dose before PCI:
< 8hrs: no additional antithrombin is needed
8-12 hrs: 0.3 mg/kg bolus of IV
> 12 hours: conventional anticoagulation therapy
If enoxaparin is used as primary anticoagulant, it should be given as a ____ mg/kg IV bolus.This will typically result in a peak anti-Xa level of >0.5 IU/mL.
0.5 to 0.75 mg/kg IV bolus
_____ is a direct thrombin inhibitor that has been used as an alternative to UFH in patients undergoing PCI.
It generally causes fewer bleeding complications than UFH because of its shorter half-life (25 minutes) and more predictable bioavailability.
Bivalirudin
Dual antithrombotic in patients with recent PCI requiring anticoagulation: ___________
If with high thrombotic risk and with low bleeding risk: _____________
Duration? _____
Preferred P2Y12i ___________
Preferred AC ______________
A. Oral anticoagulant + P2Y12i
B. ASA + Oral anticoagulant + P2Y12i for 30 days
1. Clopidogrel
2. DOAC
Class IB - In patients with atrial fibrillation who are undergoing PCI and are taking oral anticoagulant therapy, it is recommended to discontinue aspirin treatment after 1 to 4 weeks while maintaining P2Y12 inhibitors in addition to a non–vitamin K oral anticoagulant (rivaroxaban, dabigatran, apixaban, or edoxaban) or warfarin to reduce the risk of bleeding
Class IIA - n patients with atrial fibrillation who are undergoing PCI, are taking oral anticoagulant therapy, and are treated with DAPT or a P2Y12 inhibitor monotherapy, it is reasonable to choose a non–vitamin K oral anticoagulant over warfarin to reduce the risk of bleeding
Antiplatelet withdrawal before surgery
Clopidogrel
Ticagrelor
Prasugrel
Clopidogrel - 5 days
Ticagrelor - 5 days
Prasugrel - 7 days
Anticoagulant Dosing during PCI (No previous AC given)
UFH - ___________, target ACT _________ (in Braun _________, target ACT __________)
Enoxaparin - _______________
Bilavirudin - ________________
Argatroban - _______________
UFH - 70–100 U/kg initial bolus to achieve target ACT of 250 - 300 secs (Braun - 50 - 70 IU/kg, ACT 250 - 300sec if no GP IIB/IIIA given, 200-250 secs if with GP IIB/IIIA)
Enoxa-arin - 0.5–0.75 mg/kg IV bolus
Bilavirudin - 0.75 mg/kg bolus, 1.75 mg/kg/h IV infusion
Argatroban - 350 mg/kg, then 15 mg/kg/min IV infusion
Routine use of IV heparin after PCI is no longer indicated. If no closure device has been used, early sheath removal is encouraged when the ACT falls to less than 150 to 180 seconds.
Anticoagulant Dosing during PCI (with previous AC given)
UFH - ______________________
Enoxaparin - _______________
Bilavirudin - ________________
Argatroban - _______________
UFH - Additional UFH as needed (e.g., 2000–5000 U) to achieve an ACT of 250-300 sec
Enoxaparin - if last dose < 8hrs: no additional dose; if 8-12hrs: give 0.3mg/kg IV dose
Bilavirudin - For patients who have received UFH, repeat ACT; f ACT is not in therapeutic range, then give 0.75 mg/kg IV bolus, then 1.75 mg/kg/h IV infusion
Argatroban - 200 mg/kg IV bolus, then 15 mg/kg/min IV infusion
_______________ is not effective in reducing ischemic events in patients undergoing primary PCI for STEMI; has a long half-life of fondaparinux and the need for adjunctive anticoagulation with heparin during PCI to avoid the development of catheter thrombi.
Fondaparinux
Anatomic (or angiographic) success after PCI is defined as attainment of a residual diameter stenosis of ______________, which is generally associated with at least a _____ improvement in diameter stenosis and relief of ischemia.
With the widespread use of coronary stents, the angiographic criterion for success is _________ stenosis when stents are used.
A. less than 50%
B. 20%
C. ≤20%
Anatomic (or angiographic) success after PCI is defined as attainment of a residual stenosis diameter _____.With the widespread use of coronary stents,the angiographic criterion for success is à20% stenosis when stents are used
(1) RSD < 50%
(2) At least a 20% improvement in diameter stenosis
(3) Relief of ischemia
___________________ is defined as angiographic success without the occurrence of major complications (death, MI, or CABG) within 30 days of the procedure.
Clinical success is defined as procedural success without the need for urgent repeated PCI or surgical revascularization within the first __________ of the procedure.
A. Procedural success
B. 30 days
Procedural success is defined as _____.
(1) Angiographic success
(2) No occurrence of major complications (death, MI, or CABG) within 30 days of the procedure.
Clinical success is defined as _____.
(1) Procedural success
(2) No need for urgent repeated PCI or surgical revascularization within the first 30 days of the procedure.
The 2018 Fourth Universal Definition of Myocardial Infarction defines a periprocedural MI as an elevation of cTn values _________________ the 99th percentile upper reference limit (URL) in patients with normal baseline values.
In patients with elevated pre-procedure cTn, in whom the cTn levels are stable or falling, the postprocedure cTn must rise by ____________.
A. more than five times
B. greater than 20%
The absolute postprocedural value must still be at least five times the 99th percentile URL.
At least 1 is required:
New ischemic ECG changes.
Development of new pathologic Q waves
Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
Angiographic findings consistent with a procedural flow-limiting complication such as coronary dissection, occlusion of a major epicardial artery or a side branch occlusion/thrombus, disruption of collateral flow, or distal embolization.
The SCAI definition is more stringent, and defines a clinically relevant MI post-PCI as elevation in:
(1) CK-MB to ≥ 10 × ULN; or
(2) cTn (I orT)to ≥ 70× ULN; or
(3) CK-MB to≥ 5× ULN or cTnto≥ 35×ULN + development of new pathologic Q-waves in2 contiguous leads or LBBB
Periprocedural Myocardial Infarction Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting (Within 48 Hours) Based on ARC-2
MI
* Absolute rise in cTn (from baseline) ≥ 35 x URL
* Plus 1 or more of the following:
New significant Q waves or equivalent
Flow-limiting angiographic complications
New “substantial” loss of myocardium on imaging
Significant periprocedural MI
*Absolute rise in cTn (from baseline) ≥ 70 x URL
Q wave criteria requires the development of new Q waves:
≥ 40 milliseconds in duration
≥ 1 mm deep in voltage
≥ 2 contiguous leads
If coronary dissections that extend deeper into the media or adventitia begin to compromise the _____ of the vessel, clinical ischemia may develop. Even though most intraprocedural dissections can be treated promptly by stenting, significant residual dissections of the treated artery occur in 1.7% of patients.
True lumen
Coronary ____ develops in 0.2% to 0.5% of patients undergoing PCI and is more common with atheroablative devices and hydrophilic wires than with balloon angioplasty or conventional guidewires.
Coronary perforation
Depending on the rate of flow through the vessel perforation, cardiac tamponade and hemodynamic collapse can occur within minutes, thus requiring immediate recognition and treatment of the perforation.
_____ is defined as reduced anterograde perfusion in the absence of a flow-limiting stenosis and occurs in up to 2% to 3% of PCI procedures, typically during interventions on degenerated SVGs, during rotational atherectomy, and during acute MI interventions
No-reflow
No-reflow is probably caused by distal embolization of atheromatous and thrombotic debris dislodged by balloon inflation, atherectomy, or stent implantation.
Once it occurs, no-reflow can cause severe short- and long-term consequences, including a fivefold increased risk for periprocedural MI and a threefold increased risk for death
Lesion-specific factors that increase the likelihood of stent thrombosis include a _____.
(1) Residual dissection at the margin of the stent
(2) Impaired flow into or out of the stent
(3) Small stent diameter (<3 mm)
(4) Long stent length
(5) Treatment of acute MI
Patient noncompliance with DAPT, resistance to the antiplatelet effects of aspirin and clopidogrel, and hypercoagulability may also play important roles in the development of stent thrombosis
Stent Thrombosis
Acute
Subacute
Late
Very Late
The timing of stent thrombosis is defined as:
Acute <24 hrs
Subacute 24 hours to 30 days
Late 30 days to 1 year
Very late >1year
Lesion-specific factors that increase the likelihood of stent thrombosis include a residual dissection at the margin of the stent, impaired flow into or out of the stent, small stent diameter (<3 mm), long stent length, and treatment of acute MI. Patient noncompliance with DAPT, resistance to the antiplatelet effects of aspirin and clopidogrel, and hypercoagulability
The PARIS registry noted a trend towards higher MACE and stent thrombosis rates after DAPT interruption (as for urgent noncardiac surgery) compared with DAPT continuation.
In this registry, patients who stopped DAPT due to noncompliance or bleeding (“disruption”) had the highest MACE and stent thrombosis rates, particularly within the first ____ days
First 7 days
Late Clinical Outcomes post PCI
___________________ requiring repeated target-lesion revascularization occurs in 20% to 30% of patients undergoing balloon angioplasty because of reparative arterial constriction, also known as “negative remodeling.”
___________________ after stent implantation is less common (10% to 20%) and attributable to intimal hyperplasia within the stent.
Progression of __________________ at a site remote from that treated earlier by PCI
Death and MI can also result from ___________________
________________ refers to accumulation of lipid-laden foamy macrophages within the neointima after stent implantation, with or without necrotic core formation and/or calcification
A. Lumen renarrowing
B. Clinical restenosis
C. Coronary atherosclerosis
D. Sudden rupture of a plaque
E. Neoatheroma
Variables associated with Stent Thrombosis
Clinical
Anatomic
Procedural
Clinical Variables
• Acute myocardial infarction
• Clopidogrel noncompliance and discontinuation
• Clopidogrel bioavailability
• Diabetes mellitus
• Renal failure
• Congestive heart failure
• Previous brachytherapy
Anatomic Variables
• Long lesions
• Smaller vessels
• Multivessel disease
• Acute myocardial infarction
• Bifurcation lesions
Procedural Factors
• Stent underexpansion
• Incomplete wall apposition
• Residual inflow and outflow disease
• Margin dissections
• Crush technique
• Overlapping stent
• Polymer materials
Identify the trial
Compared routine versus fractional flow reserve (FFR)-directed percutaneous coronary intervention (PCI) for patients with coronary artery disease (CAD)
Patients admitted for elective PCI of native coronary artery stenosis. FFR-guided conditional PCI vs. routine PCI; PCI was performed with either bare-metal stent or balloon PCI alone.
This is a landmark trial that helped establish the utility of FFR in patients with stable angina. Routine PCI in the setting of an FFR ≥0.75 is not superior to optimal medical therapy for cardiovascular events at 5 years, and at 15 years, appears to be associated with a higher risk of MI than medical management alone. This trial provides long-term data regarding the safety of an FFR-guided approach for the management of CAD. One limitation of this trial is that it enrolled patients with relatively simple lesions from a non-contemporary era (no drug-eluting stent, low use/doses of currently utilized medications for CAD).
DEFER trial
Deferral Versus Performance of PTCA in Patients Without Documented Ischemia
Give components of J CTO score
Evaluated ticagrelor compared with prasugrel among patients with an acute coronary syndrome undergoing planned coronary angiography
Patients with an acute coronary syndrome undergoing planned early invasive therapy were randomized to ticagrelor (n = 2,012) versus prasugrel (n = 2,006)
ISAR REACT 5 (Intracoronary Stenting and Antithrombotic Regimen 5)
In patients across the acute coronary syndrome spectrum undergoing planned coronary angiography, prasugrel was superior to ticagrelor at preventing major adverse ischemic events. Findings were similar among the tested subgroups, including the elderly (≥75 years) and low body weight (<60 kg). Benefit from prasugrel was accomplished without an increase in major bleeding
