SCAI CHAP 19 STEMI intervention COPY Flashcards
What is the rate of reocclusion of an artery after fibrinolytic therapy?
20%
Give three clinical advantages of PCI compared to fibrinolytic therapy?
1 – Lower rate of re-infarction
2 – Lower rate of recurrent ischemia,
3 – Lower rate of intracranial hemorrhage.
By what percentage fibrinolytics decrease mortality in patient with ST elevation myocardial infarction?
Usually buy more than 50%
What procedure carries lower mortality in patients with ST elevation myocardial infarction? PCI or fibrinolytics?
PCI carries lower mortality for patients with ST elevation myocardial infarction compared to lytics.
Give two advantages on coronary angiogram for PCI compared to fibrinolytics?
PCI achieve higher rate rates of Timi grade 3 flow, and higher rates of infarct related artery reperfusion. Whereas with fibrinolysis , there is failure to reperfuse infarct related artery in 1/5 of the cases which is about 20%.
What is the allowable window to give thrombolytics per ACC guidelines ?
Class 1: STEMI within 12 hrs of symptoms onset
Class 2a: STEMI and persistent signs of ischemia within 12-24 hours of symptoms onset and large area of myocardium at risk or hemodynamic instability.
What is the primary benefit of timely fibrinolysis compared to delayed PCI?
Improved outcomes including survival and prevention of major adverse cardiovascular outcomes (MACE)
What was the focus of the 2013 STREAM trial?
To compare primary PCI and fibrinolysis in patients with symptom onset within 3 hours of medical contact who could not undergo primary PCI within 1 hour
How many patients were randomized in the 2013 STREAM trial?
1892 patients
What was the primary endpoint of the STREAM trial? Strategic reperfusion early after myocardial infarction trial.
No significant difference among both groups ( delayed PCI versus fibrinolysis ) in terms of MORTALITY from any cause, including congestive heart failure (CHF), shock, or reinfarction at 30 days.
What significant adverse effect was noted in the fibrinolysis group of the STREAM trial?
Increased intracranial hemorrhage
What conclusion can be drawn from the STREAM trial regarding fibrinolysis?
Prompt fibrinolysis should be administered when primary PCI is not available to be performed in a timely fashion.
Fill in the blank: The STREAM trial randomized patients with symptom onset within ______ hours of medical contact.
3
True or False: The STREAM trial found a significant difference in the primary endpoint between the primary PCI and fibrinolysis groups.
False
What is an absolute contraindication to fibrinolytic therapy in patients presenting with STEMI?
Any prior ICH
Name a known structural cerebral vascular lesion that is a contraindication for fibrinolytic therapy.
AVM (arteriovenous malformation) AVM is a type of vascular malformation in the brain.
What is a fibrinolysis contraindication related to malignant intracranial neoplasm?
Known malignant intracranial neoplasm (primary or metastatic) . This includes any brain tumors that can be either primary or metastatic.
What is the time frame for ischemic stroke as a contraindication for fibrinolytic therapy?
Ischemic stroke within 3 months EXCEPT acute ischemic stroke within 3 hours. This means if the ischemic stroke occurred more than 3 months ago, it is not a contraindication.
True or False: menstrual periods are absolute contraindication for fibrinolytic therapy.
False. Active bleeding or bleeding diathesis (excluding menses) is considered an absolute contraindication.
What significant trauma within 3 months can contraindicate fibrinolytic therapy?
Significant closed head or facial trauma. This refers to serious injuries to the head or face that could lead to complications.
What type of surgery within 2 months is a contraindication for fibrinolytic therapy?
Intracranial or intraspinal surgery . This includes any surgery conducted on the brain or spinal cord.
What level of hypertension is considered a contraindication for fibrinolytic therapy?
Severe uncontrolled hypertension (unresponsive to emergency therapy).
What is a relative contraindication to fibrinolysis related to the history of hypertension?
History of chronic, severe, poorly controlled hypertension. This suggests that past hypertension challenges may affect treatment decisions.
Fill in the blank: For streptokinase, prior treatment within the previous _______ is a contraindication to fibrinolysis.
6 months
What is a relative fibrinolysis contraindication concerning CPR?
Traumatic or prolonged (>10 min) CPR. This refers to extended resuscitation efforts that may pose risks.
What is a contraindication for fibrinolysis related to recent internal bleeding?
Recent (within 2-4 weeks) internal bleeding.
Name a relative fibrinolysis contraindication concerning vascular punctures.
Noncompressible vascular punctures
This refers to punctures that cannot be effectively controlled to stop bleeding.
What is a contraindication regarding pregnancy in the context of fibrinolytic therapy?
Pregnancy 😀. This indicates that therapy may pose risks to both mother and fetus.
What condition related to the gastrointestinal system is a contraindication for fibrinolytic therapy?
Active peptic ulcer
During the first _______ after coronary occlusion, myocardial necrosis is not observed.
15 minutes
At _______ minutes after coronary occlusion, myocardial cell death develops rapidly.
40
After 40 minutes post-occlusion, progression to necrosis is _______.
slowed considerably !
What is the relationship between time of ischemia and myocardial salvage?
The longer the interval from symptom onset to reperfusion, the less myocardium there is to rescue or salvage.
How does the timing of reperfusion therapy affect survival?
Reperfusion therapy offers maximum benefits of myocardial salvage and improvement in survival within the first few hours of therapy.
What happens if reperfusion is delayed?
Delayed reperfusion increases the risk of mortality due to less myocardium available for salvage.
List 6 factors that can influence the time window of successful myocardial salvage.
1- Presence of collateral circulation
2- Intermittent occlusion
3- Myocardial oxygen consumption
4- Ischemic preconditioning
5- Persistence of residual blood flow
6- Hibernation
True or False: The benefits of reperfusion therapy are independent of the time elapsed since symptom onset.
False
What is the recommended systems goal for time from first medical contact to balloon angioplasty?
90 minutes or less.
How are symptom onset to balloon time and door-to-balloon time related to mortality?
They are significantly associated with mortality following primary PCI.
What is the effect of earlier reperfusion on mortality risks?
It reduces mortality risks, especially in patients presenting early after symptom onset (<2 hours).
In which STEMI patient groups do delays in therapy affect mortality benefit more significantly?
High risk groups such as those with large territory of myocardium at risk, anterior infarcts, CHF, advanced age, and renal insufficiency.
What does data from the National Cardiovascular Data Registry (NCDR) reveal about door-to-balloon time?
There is a direct association between door-to-balloon time and in-hospital mortality.
What is the implication of delays even below the 90-minute DTB cutoff?
Any delay can potentially carry an increased risk of mortality.
How do system-related delays affect long-term mortality in STEMI ?
They are independently associated with worse long-term mortality; each hour of delay increases the risk of death.
What percentage of US hospitals are capable of performing primary PCI?
Less than 50%.
What percentage of the population lives within one hour of a PCI capable hospital?
80%.
What is the median door-to-balloon (D2B) time per NCDR Registry 2005 2006?
The median D2B time was 83 minutes.
What is the mortality rate associated with the median D2B time of 83 minutes per NCDR 2006 registry ?
The mortality rate associated with the median D2B time was 4.6%.
How does longer door-to-balloon time affect in-hospital mortality?
Longer door-to-balloon times are associated with a higher adjusted risk of mortality in hospital in a continuous NONLINEAR fashion.
What is the impact on mortality when reducing D2B time from 90 to 60 minutes?
A reduction in door-to-balloon time from 90 to 60 minutes was associated with 0.8% lower mortality.
What is the impact on mortality when reducing D2B time from 60 to 30 minutes?
A reduction from 60 to 30 minutes was associated with a 0.5% lower mortality.
If the patient with STEMI had fibrinolytics, when can he have angiography and revascularization once transferred to a PCI capable facility?
Angiography and revascularization should not be performed within the first 2 to 3 hours after administration of fibrinolytic therapy.
When is PCI considered inappropriate in stemi ?
PCI is considered inappropriate in patients where the risk of revascularization outweighs the benefit, or if the patient or designee does not agree to the procedure.
What is the greatest mortality benefit of primary PCI?
The greatest mortality benefit is in patients who present early or are at the highest risk, such as those with cardiogenic shock complicating their acute myocardial infarction.
What did the SHOCK trial report?
The SHOCK trial reported reduced mortality rates following invasive intervention in patients with cardiogenic shock complicating their acute myocardial infarction.
Is there an indication for primary PCI in asymptomatic STEMI patients?
Yes, there is an indication for primary PCI in asymptomatic patients presenting between 12 and 24 hours after symptom onset as supported by BRAVE 2 trial.
What did the BRAVE-2 trial find?
The BRAVE-2 trial found that PCI reduced infarct size in asymptomatic patients with STEMI and symptom onset between 12 and 48 hours before presentation and recorded a reduction in the 4-year mortality rate compared to conservative strategies.
What do current revascularization guidelines indicate for asymptomatic stable patients who present with STEMI ?
Current revascularization guidelines indicate a Class III (no benefit) for asymptomatic stable patients with STEMI who have a totally occluded infarct artery after symptom onset and have no ischemia.
What percentage of STEMI patients have multivessel disease with significant stenosis in at least one non-IRA?
40%-60%
What are the PCI options for patients with multivessel disease presenting with STEMI?
- Primary PCI of the culprit vessel only, with PCI of nonculprit arteries for HIGH RISK features.
- Multivessel PCI at the time of primary PCI.
- Primary PCI followed by staged PCI of the nonculprit vessels.
What did the CULPRIT SHOCK trial show for high-risk patients with cardiogenic shock concerning culprit-vessel only PCI?
It showed lower rates of mortality and renal dysfunction after a 30-day follow-up when performing PCI ONLY on culprit vessel.
What do recent clinical trials argue regarding nonculprit vessel PCI in patients with cardiogenic shock?
They argue for an attempt to achieve complete revascularization because obstructive nonculprit vessel lesions may lead to incident MACE
What are the indications for Primary PCI and Angiography in Patients With STEMI?
STEMI and ischemic symptoms within 12 h or STEMI with hemodynamic instability and cardiogenic shock irrespective of time delay from MI onset.
What is the protocol for STEMI patients who have failed reperfusion after fibrinolytic therapy?
Angiography is performed within 3-24 h ( not before) of fibrinolytic therapy with the intent to perform PCI.
What is the best management for stable STEMI patients presenting 12-24 h after symptom onset?
They may require intervention if complicated by ongoing ischemia, acute severe heart failure, or life-threatening arrhythmia. This is irrespective of time delay from MI onset.
What should be done in asymptomatic stable STEMI patients with a totally occluded infarct artery?
In asymptomatic stable patients with totally occluded infarct artery after symptom onset and no ischemia, PCI should not be performed - class III indication.
What are the possible candidates for staged PCI of significant non-IRA stenosis according to the 2021 AHA/ACC/SCAI guidelines?
Patients with STEMI and multivessel disease who are hemodynamically stable.
Who are not candidates for PCI of the non-IRA at the same time as primary PCI in STEMI ?
Patients with complications like cardiogenic shock - Class III: harmful.
What factors influence the decision to perform complete revascularization ( perform PCI also to non IRA ) in STEMI patients?
Symptoms, clinical stability, and presence of mechanical complications or cardiogenic shock ( in the latter, do not do all vessels, do only IRA )
In what setting is PCI allowed to be performed in the US without on site surgery ( OSS ) ?
Almost all regions in the US allow PCI to be performed without OSS
What do the 2014 SCAI guidelines Class III recommendations refer to in terms of PCI without OSS ?
Class III refers to PCI being performed in institutions that lack the ability to transport patients to a cardiac surgery hospital or to maintain hemodynamic stability prior to transfer.
What do the SCAI guidelines say about volume-outcome relations and PCI ?
Class I refers to >400 PCIs/y, Class Ila refers to 200 to 400 PCIs/y, and Class III refers to <200 PCIs/y. Hospitals performing <36 PCIs/y do not have PCI capabilities.
What does the most recent SCAI consensus document provide guidance on about PCI without OSS ?
Factors like clinical lesion risk characteristics, operators’ experience, and rescue treatment plan at the performing facility, all affect decision to perform PCI in hospitals without OSS .
What indicates failed reperfusion after thrombolysis on an ECG?
<50% resolution of ST-segment elevation in anterior leads or <70% in inferior leads.
Is chest pain required for diagnosing failed reperfusion after thrombolysis ?
No, chest pain is not a requirement of failed reperfusion.
What is rescue PCI referred to as after fibrinolysis ?
Rescue PCI or rescue angioplasty is immediate PCI when fibrinolytic therapy fails.
What are the benefits of rescue PCI compared to conservative treatments?
Reduced cardiovascular events such as recurrent MIs and repeat revascularization also improved event-free survival.
What are the possible risks associated with rescue PCI?
Increased bleeding and stroke rates.
What is facilitated PCI?
A strategy for patients with STEMI that combines fibrinolytic therapy followed by PCI at hospitals with PCI capabilities within 2 hours of fibrinolysis
Is the term ‘facilitated PCI’ still used in current guidelines?
No, it is no longer used in current guidelines.
What pharmacologic regimens have been studied in facilitated PCI?
Full-dose or reduced-dose fibrinolytic therapy and combinations with GP I/IIa inhibitors.
How does facilitated PCI compare to primary PCI in terms of outcome ?
Facilitated PCI is inferior to primary PCI according to several studies. It is also associated with increased MACE.
What was the outcome of the ASSENT-4 study ( Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction - ASSENT-4 PCI) ?
The study compared upfront full dose tenecteplase followed by PCI ( facilitated) with primary PCI. It was prematurely terminated due to increased in-hospital mortality, CHF, and shock within 3 MONTHS.
What is the current recommendation regarding facilitated PCI?
Facilitated PCI is no longer recommended by clinical practice guidelines.
What is the pharmacoinvasive approach to revascularization?
The pharmacoinvasive approach, also known as delayed PCI, involves a time frame of 2 to 24 hours between thrombolytic therapy and PCI.
How does the pharmacoinvasive approach differ from the facilitated approach?
The facilitated approach has an ideal time of less than 2 hours between thrombolytic therapy and PCI, while the pharmacoinvasive approach allows for 2 to 24 hours. Facilitated PCI is not recommended anymore. Only rescue PCI ( beyond 2 hrs ) is recommended if patient fails thrombolysis.
What do current guidelines recommend for high-risk patients receiving fibrinolytic therapy?
Current guidelines (Class Ia) recommend transferring high-risk patients who receive fibrinolytic therapy at facilities without PCI capabilities to a PCI-capable facility as soon as possible.
What is a Class IIb recommendation regarding patient transfer after fibrinolytic therapy?
It may be considered to transfer all patients, regardless of risk, who receive fibrinolytic therapy at facilities without PCI capabilities to a PCI-capable facility as soon as possible.
What concerns are associated with performing PCI after fibrinolysis?
Bleeding risk is a significant concern when performing PCI after fibrinolysis.
What advancements have improved success rates and reduced bleeding risks in PCI?
Radial access, improvements in equipment, and adjunctive pharmacotherapies have improved success rates while keeping bleeding risks low.
What is Primary PCI?
Primary PCI is used as the primary reperfusion method in patients with STEMI.
What is Rescue Angioplasty?
PCI following the use of fibrinolysis for STEMI, when based on evidence of failed reperfusion by fibrinolysis. Generally requires time for fibrinolysis (60-90 min, almost 2 hrs ) to assess the need for PCI.
What is Facilitated Angioplasty?
A strategy of planned immediate PCI after administration of an initial pharmacologic regimen intended to improve coronary patency before the emergency PCI procedure.
What is Early Routine Angioplasty/Pharmacoinvasive Approach?
Immediate referral for PCI following initial fibrinolytic therapy, performed within several hours after fibrinolytic administration. Applies to patients presenting to hospitals without primary PCI who cannot undergo timely primary PCI.
What is Delayed Angioplasty in STEMI?
The angioplasty is delayed due to transport delays to a PCI facility or the choice of initial fibrinolysis for reperfusion.
What are guidelines recommendation about a totally occluded infarct artery in a stable STEMI patient who presents more than 24 hours after symptoms onset?
No benefits of primary PCI to the infarct related artery.
What is rescue PCI?
Rescue PCI is performed when fibrinolysis fails. It is usually performed within 60 to 90 minutes, almost 2 hours after fibrinolysis , to allow time for reperfusion and assessment of reperfusion to determine the need for PCI.
What is pharmacoinvasive PCI?
Pharmacoinvasive PCI is performed when the time between fibrinolysis and PCI is between 2 and 24 hours, and this approach generally carries favorable outcomes.
What did the Occluded Artery Trial (OAT) test?
The OAT trial tested the hypothesis that ROUTINE PCI for total 100 % occlusion 3 to 28 days after MI would reduce the composite of death, reinfarction, or Class IV HF in otherwise stable patients. The MINIMAL time from symptoms onset to angiogram in patients with a total occlusion of the IRA ( TIMI 0 or 1 ) was just OVER 24 hours.
What were the important exclusion criteria for the OAT trial?
Exclusion criteria included NYHA Class III or IV HF, resting angina, renal impairment, left main or three-vessel disease, clinical instability, or severe inducible ischemia on stress testing.
What did the Total Occlusion Study of Canada (TOSCA-2) demonstrate?
TOSCA-2 is a substudy of OAT trial . It demonstrated high success rates of IRA reperfusion but no significant benefit.
What is the conclusion regarding elective PCI in stable patients after MI based on OAT and TOSCA 2 studies?
Elective PCI of an occluded infarct artery 1 day to 28 days after MI in stable patients with single- or double-vessel disease had no incremental benefit beyond optimal medical therapy, and preventing subsequent MACE and preserving LV function.
What did the DANAMI trial evaluate?
The DANAMI trial evaluated the benefit of angioplasty in patients with INDUCIBLE residual ischemia following fibrinolysis. A total of 1000 patients with inducible ischemia after fibrinolytic therapy for the FIRST acute myocardial function were randomized to conservative care or angiography, followed by revascularization with either balloon angioplasty or bypass surgery.
What were the findings of the DANAMI trial regarding mortality?
At 2.4 years of follow-up, mortality was 4% in both the invasive and conservative treatment groups (P = NS). However, invasive treatment was associated with lower incidence of reinfarction, and lower incidence of admission for chest pain. The primary endpoint ( composite death, reinfarction and admission for unstable angina ) was lower at one year, two years and four years in the invasive group. The study supports the use of delayed PCI or elective PCI in patients after fibrinolysis who do have inducible ischemia or spontaneous ischemia during recovery from STEMI.
In other terms, PCI can be beneficial days or weeks after successful, thrombolysis therapy by reducing unstable angina, reinfarction and long-term mortality (composite).
What was the incidence of reinfarction in the invasive treatment group compared to conservative care in the DANAMI trial?
Invasive treatment was associated with a lower incidence of reinfarction (5.6% vs 10.5%; P = 0.038).
What is the primary endpoint result at 1 year for invasive vs conservative treatment in the DANAMI trial?
The primary endpoint was 15.4% in the invasive group and 29.5% in the conservative group at 1 year (P ≤ 0.001).
What is the benefit of PCI performed after successful fibrinolytic therapy?
PCI can reduce unstable angina, reinfarction, and long-term mortality when performed hours, days, or weeks after successful fibrinolytic therapy, inpatient with documented, inducible, ischemia, or spontaneous ischemia [ DANAMI study ].
What did a large Danish registry find regarding early revascularization in STEMI patients?
STEMI patients after fibrinolysis who have a hemodynamically significant IRA stenosis after 24 hours, provided the infarct artery yet patent , WILL BENEFIT OF A DELAYED PCI. Early revascularization (within 14 days) in individuals with AMI was associated with a substantial reduction in 1-year mortality.
What is a key point about PCI of an occluded vessel in stable patients after MI?
PCI of an OCCLUDED ( 100 % ) infarct artery 1 to 28 days after MI in stable patients with single- or double-vessel disease has no incremental benefit beyond optimal medical therapy.
What were the main results of the OAT trial ?
4 year cumulative negative endpoint was higher in the PCI group and reinfarction rates tend to be higher in the PCI group, which may have attenuated any benefit in left ventricular remodeling.
What are the caveats when considering OAT trial outcomes?
Delayed PCI post 24 hours is STILL INDICATED if the STEMI patient becomes unstable i.e. cardiogenic shock or has postinfarction angina ( excluded from OAT trial ). It is also indicated in patients who did not receive reperfusion therapy, but who demonstrate significant residual ischemia during the same hospitalization ( excluded for randomization in OAT trial )
What is the preferred revascularization approach for patients with significant left main involvement ?
CABG is preferred over PCI for patients with coronary artery disease (CAD) requiring revascularization for significant left main involvement associated with high-complexity (Class I).
When is CABG indicated for patients with STEMI?
CABG is indicated in patients with STEMI who are hemodynamically unstable, suffering from cardiogenic shock (CS), or have certain mechanical complications when PCI is not feasible (Class D).
What are the conditions that may favor the use of CABG over PCI in STEMI patients?
Conditions that may favor CABG include hemodynamic instability, CS, large areas of myocardium at risk when PCI is not feasible, and mechanical complications of myocardial infarction ( VSR, MR or free wall rupture)
What should be avoided when considering CABG contraindications in STEMI patients?
CABG should not be performed when primary PCI has failed with no ischemia or when surgical revascularization is not feasible due to poor distal targets, or there is no reflow (Class III: harm).
What does the 2021 ACC/AHA/SCAI guidelines recommend for multivessel CAD with complex and diffuse CAD?
CABG is preferred over PCI for multivessel CAD with complex and diffuse CAD (SYNTAX score above 33) (Class IIa).
What lesion and patient subsets have higher rates of stent thrombosis ?
STEMI patients, smaller arteries (<2.5 mm diameter), longer lesions, bifurcations, and diabetic vessels have higher rates of thrombosis.
These risk factors predict both stent thrombosis AND restenosis.
When is the greatest risk of stent thrombosis for BMS and DES ?
The greatest risk of stent thrombosis is within the first 30 days for BMS and within the first year for DES.
What is the recommended duration of DAPT after BMS implantation in STEMI?
1 year of DAPT is recommended after BMS implantation in the setting of STEMI. ASA should be continued indefinitely.
What causes the greatest risk of thrombosis with DES?
The greatest risk of thrombosis with DES is due to early discontinuation of DAPT.
What percentage of Premier registry DES treated MI patients stopped thienopyridine within 30 days ?
13.6% of DES treated MI patients stopped their thienopyridine within 30 days.
What are the consequences of stopping thienopyridine by 30 days?
Patients who stopped thienopyridine by 30 days were more likely to die during the next year (7.5% vs 0.7%; P < .0001) or to be re-hospitalized (23% vs 14%; P = 0.08).
How do DESs compare to BMSs in terms of intimal proliferation and restenosis?
DESs significantly reduce intimal proliferation, restenosis, and the need for target vessel revascularization (TVR) more than BMSs.
What is the prevailing consensus on the safety and efficacy of DES in STEMI compared to
BMS?
While DESs did NOT significantly reduce MORTALITY risk compared with BMSs, they mitigate the risk of restenosis, as evidenced by target lesion revascularization (TLR) and TVR. HOWEVER, stent thrombosis, remains a small but significant concern.
What is a concern associated with DES?
Stent thrombosis remains a small but significant concern. Second generation, DES may solve the issue, but not enough evidence yet.
What was the readmission rate for DES compared to BMS in patients with STEMI based on the 2016 Nationwide Readmission Database?
DES had a lower readmission rate of 15.3% compared to 24.3% for BMS.
What were the 6-month mortality rates for DES and BMS patients after STEMI based on the nationwide readmission database in 2016 ?
The mortality rate was 5.5% for DES patients compared to 10.3% for BMS patients.
What did the GRACE registry find regarding mortality rates between BMS and DES in patients with STEMI ?
The GRACE registry showed similar mortality rates between BMS and DES up to 6 months, but higher late postdischarge mortality in DES patients from 6 months to 2 years.
What did the Massachusetts State registry reveal about 2-year risk-adjusted mortality for DES and BMS?
The 2-year risk-adjusted mortality was lower for patients who received a DES (8.5%) than for those who received a BMS (11.6%).
What were the findings of the HORIZONS-AMI study regarding paclitaxel-eluting stents versus BMS?
The study showed that paclitaxel-eluting stents reduced the 1-year rates of ischemia-driven repeat-target lesion and TVR compared to BMS. There was no significant differences in rates of the composite safety endpoint ( stent thrombosis, reinfarction, stroke or death ).
What was the rate of 13-month angiographic binary restenosis for DES compared to BMS in HORIZONS- AMI ?
The rate of 13-month angiographic binary restenosis was significantly decreased by DES (10.0%) compared with BMS (22.9%).
What did the HORIZONS-AMI study demonstrate about patients with risk factors for restenosis?
Patients with risk factors associated with restenosis ( small vessel size below 3 mm, diabetes, long lesion length above 30 mm ) benefited from DES rather than BMS for reducing TVR and angiographic restenosis. Patient without these risk factors had no benefit in terms of TLR at one year.
What was the effect of DES on patients without risk factors for restenosis in HORIZONS-AMI ?
Patients without risk factors for restenosis had no benefit in terms of 1-year TLR with the use of DES compared with BMS.
What is the primary benefit of DESs compared to BMSs in STEMI cases?
The primary benefit of DESs is reducing restenosis and the need for repeat revascularization (target vessel and target lesion).
Based on many trials discussed earlier, do DESs reduce the incidence of death or recurrent MI compared to BMS?
Studies have conflicting results in terms of mortality, however, the answer is likely: No, DESs do not reduce the incidence of death or recurrent MI when compared to BMS. Randomized trials show no mortality benefit with DES over BMS.
Is the risk of stent thrombosis increased with DESs compared to BMSs?
Stent thrombosis does not appear to be increased with DESs over BMSs in randomized trials, but it remains a concern in the real-world setting.
What is the risk of stent thrombosis in STEMI patients compared to elective PCI?
In STEMI patients, there is a higher risk of stent thrombosis with both BMSs and DESs compared to elective PCI.
What do DESs angiographically reduce compared to BMSs?
DESs reduce intimal proliferation, restenosis, and the need for target vessel revascularization (TVR) more than BMSs.
What is the risk associated with discontinuation of DAPT in patients with DES?
Discontinuation of DAPT is considered to lead to the greatest risk of DES thrombosis, which may ultimately increase the risk of mortality and hospitalization.
What did the HORIZONS-AMI study find regarding DESs and BMSs?
The HORIZONS-AMI study indicated lower rates of ischemia-driven repeat target lesion and TVR after 1 and 3 years in DESs compared to BMSs, but NO DIFFERENCE IN RATES of thrombosis, reinfarction, stroke, or death.
Who benefits more from DESs compared to BMSs?
Patients at increased restenosis risks benefit from DESs more than BMSs.
What was the initial recommendation for aspiration thrombectomy in STEMI patients?
Aspiration thrombectomy had a Class Ila recommendation in the 2013 clinical practice guidelines on STEMI.
This was based on the TAPAS study results showing improved outcomes.
What did the TAPAS study demonstrate regarding aspiration thrombectomy?
The TAPAS study in 2008 showed improved TVR, myocardial blush, ST-segment resolution, and lower mortality in patients with with STEMI with better myocardial blush grade and ST-segment resolution.
The study randomized 1071 patients with STEMI.
What change occurred in the recommendation for aspiration thrombectomy based on more recent studies?
Routine aspiration thrombectomy received a Class III recommendation based on the 2021 ACC/AHA/SCAI revascularization guidelines. This change was due to larger studies showing no benefit.
What were the findings of the TASTE trial regarding aspiration thrombectomy?
The TASTE trial randomized 7244 patients and found no difference in 30-day or 1-year outcomes between routine aspiration thrombectomy before primary PCI and primary PCI only. Outcomes include death, hospitalization for recurrent MI, stent thrombosis, TVR or MACE.
What did the TOTAL trial reveal about manual thrombectomy?
The TOTAL trial showed no difference in primary outcomes between manual thrombectomy and PCI alone, but indicated an increased risk of stroke within 30 days, in the thrombectomy group.
It included 10,732 patients.
What does the updated meta-analysis in 2015 conclude about aspiration thrombectomy?
The updated meta-analysis found no significant reduction in death, reinfarction, or stent thrombosis with routine aspiration thrombectomy and a small nonsignificant increase in stroke risk. This included trials like TASTE and TOTAL.
What is the recommendation for selective or bailout thrombectomy?
Selective or bailout thrombectomy has a Class IIb recommendation based on the 2015 ACC/AHA guidelines, but its usefulness is not well established. This indicates it can be considered in certain cases.
What is rheolytic thrombectomy?
A technique to remove thrombus using high-velocity saline jets around the catheter tip that entrain thrombus toward the inflow windows.
Is routine rheolytic thrombectomy ( Angiojet ) recommended for AMI?
No, it has not consistently shown any clinical benefit and its use is not recommended in current guidelines.
What did the JETSTENT trial compare?
It compared rheolytic thrombectomy with stenting to stenting alone.
What were the findings of the JETSTENT trial?
It showed improvement in reperfusion but not in infarct size in the rheolytic thrombectomy group.
What remains the preferential choice for thrombectomy
Aspiration thrombectomy rather than Rheolytic thrombectomy ( AngioJet )
What did the meta-analysis of rheolytic therapy suggest?
Rheolytic thrombectomy was associated with increased mortality risk.
When might selective use of rheolytic thrombectomy be beneficial?
In cases of large thrombus by experienced operators, but this is only in Select cases.
What are the three principal categories of embolic protection devices (EPDs)?
Proximal occlusive devices, distal occlusive devices, and filter-based systems.
What is the effectiveness of EPDs during saphenous vein graft (SVG) interventions?
EPDs have been clearly demonstrated to be advantageous during SVG interventions (Class I).
What is the effectiveness of EPDs during primary PCI in native coronary arteries?
Their effectiveness has not been shown in randomized clinical trials (neutral effect).
What did early trials in 2008 such as TAPAS encourage regarding aspiration thrombectomy?
They encouraged the use of aspiration thrombectomy prior to PCI due to improved TVR, myocardial blush, and ST-segment resolution, as well as lower mortality rates.
What did more recent studies in 2013 like TASTE and TOTAL trials show about aspiration thrombectomy?
They showed no improvement in cardiovascular outcomes with aspiration thrombectomy prior to PCI, leading to a change in classification (Class III according to 2021 guidelines).
What is the recommendation regarding the use of rheolytic thrombectomy and EPD during STEMI?
The use of rheolytic thrombectomy and EPD during STEMI in native coronary circulation are not associated with improved outcomes, and routine use is not recommended.
What are the main parenteral anticoagulants?
The main parenteral anticoagulants include unfractionated heparin (UFH), bivalirudin, enoxaparin, and argatroban.
What is the purpose of anticoagulation in STEMI patients undergoing PCI?
Anticoagulation is needed to prevent thrombotic complications in patients with STEMI undergoing PCI.
Which trials compared bivalirudin with heparin in STEMI patients?
The HERO-14 and HERO-2 trials compared bivalirudin with heparin among STEMI patients receiving aspirin and streptokinase.
What were the findings of the HERO-14 and HERO-2 trials?
Bivalirudin showed higher coronary patency rates at 120 minutes and sustained coronary patency at 3 days compared to heparin.
What was the primary endpoint of the HORIZONS-AMI trial in 2008 ?
The primary endpoint was the composite of major bleeding plus MACE (death, reinfarction, TVR for ischemia, and stroke) within 30 days. This pivotal trial compared UFH/GPIIbIIIa inhibitors with bivalirudin primarily as monotherapy, but also with provisional abciximab or double bolus eptifibatide, among 3600 patients.
What were the major bleeding rates in the HORIZONS-AMI trial?
Major bleeding rates were lower among bivalirudin recipients (5% vs 8.4% at 30 days). The composite endpoint (major bleeding, plus MACE ) was consequently lower in the bivalirudin arm largely because of lower rate of major bleeds, at 30 days and at one year. There was no significant difference in MACE alone.
What was the difference in stent thrombosis rates between bivalirudin and heparin groups in the HORIZONS-AMI trial?
There was a significant absolute 1% increased rate of stent thrombosis only within the first 24 hours with bivalirudin (1.3% vs 0.3%). however, there was no significant difference between the two groups beyond 24 hours.
How did bivalirudin compare to heparin in HORIZONS-AMI trial in terms of cardiac and all-cause mortality?
Bivalirudin had significantly lower rates of cardiac mortality (1.8% vs 2.9%) and all-cause mortality (2.1% vs 3.1%). At 3 years, bivalirudin group had lower rates of all causes mortality, cardiac mortality, reinfarction and major bleeds, without significant differences in TVR, stent thrombosis or MACE.
What were the findings of the HEAT-PPCI trial?
The trial was a randomized study comparing heparin to BIVALIRUDIN group. Both arms also had GP2B3A inhibitors. The HEAT-PPCI trial showed that the primary efficacy outcome ( composite all cause mortality, CVA, REINFARCTION, TVR) occurred in 8.7% in the bivalirudin group and 5.7% in the heparin group. There was more acute STENT THROMBOSIS and reinfarction in the bivalirudin arm. There was no difference in terms of major bleeding.
What were the rates of acute stent thrombosis in the HEAT-PPCI trial?
The rates of acute stent thrombosis were 3.4% in the bivalirudin group versus 0.9% in the heparin group.
Was there a difference in major bleeding rates between bivalirudin and heparin in the HEAT-PPCI trial?
There was no difference in major bleeding rates (3.5% vs 3.1%, P = 0.59).
What is the dosing for UFH with no previous anticoagulant therapy during PCI?
70-100 U/kg bolus goal to achieve therapeutic ACT (250-300 s)
What is the dosing for Bivalirudin with no previous anticoagulant therapy during PCI?
0.75 mg/kg IV bolus, then 1.75 mg/kg/h IV infusion.
What is the dosing for Enoxaparin with no previous anticoagulant therapy during PCI?
0.5-0.75 mg/kg IV bolus
What is the dosing for Argatroban with no previous anticoagulant therapy during PCI?
350 µg/kg, followed by 15 µg/kg/min IV infusion.
What is the dosing for Argatroban with previous anticoagulant therapy during PCI?
200 µg/kg IV bolus, followed by 15 µg/kg/min IV infusion.
What is the dose of bivalirudin if the patient already took heparin during PCI?
Repeat ACT if UFH was administered. If ACT therapeutic range was not achieved then give bivalirudin at the dose of 0.75 mg per kilogram IV bolus followed by 1.75 mg/ kilogram per hour IV infusion.
What is the dose of enoxaparin during PCI if the patient is already on subcutaneous enoxaparin ?
If one SC dose was administered or if the last SC dose was between the last 8 and 12h, give 0.3 mg/kg IV dose.
Nothing is given if last SC dose was given within the last 8 h.
What was the outcome of the MATRIX trial comparing heparin and bivalirudin?
The MATRIX trial demonstrated no significant difference in outcomes or net adverse clinical events between heparin (with discretionary use of GP IIb/IIIa inhibitors) and bivalirudin in 7213 acute coronary syndrome patients. MACE rates as well as NACE ( net adverse clinical events which is composite of major bleeding or MACE ) we were similar among both groups.
What was the rate of definite stent thrombosis in the MATRIX trial?
The rate of definite stent thrombosis was significantly higher in the bivalirudin group compared to the heparin group.
Did post-PCI bivalirudin infusion significantly decrease urgent TVR or NACE in MATRIX trial ?
Post-PCI bivalirudin infusion did not significantly decrease the rate of urgent TVR, definite stent thrombosis, or NACE.
What were the mortality rates associated with bivalirudin compared to heparin in the MATRIX trial ?
Bivalirudin was associated with lower rates of death from any cause, cardiac death and major bleeding. Yet the absolute differences were small.
What did the VALIDATE-SWEDEHEAR trial find regarding bivalirudin and heparin?
The VALIDATE-SWEDEHEAR trial showed no significant difference in outcomes between bivalirudin and heparin in 3005 patients with STEMI.
Death from any cause: 1.9% vs 1.7% (P = 0.21); MI: 0.8% vs 1.1% (P = 0.18); major bleeding: 5.1% vs 5.6% (P = 0.32); stroke: 0.7% vs 0.8% (P = 1.00).
What alternatives to UFH can be used to avoid heparin-induced thrombocytopenia (HIT)?
Bivalirudin and argatroban can be used in place of UFH due to their mechanism of NOT binding platelet factor 4, ‼️ thus avoiding HIT
Can enoxaparin be used instead of UFH during PCI?
Yes, enoxaparin can also be used in place of UFH, as trials have shown no difference in terms of adverse events.
What did the SYNERGY trial reveal about enoxaparin and UFH during PCI?
The SYNERGY trial showed similar rates between enoxaparin and UFH for abrupt closure (1.3% vs 1.7%), threatened abrupt closure (1.1% vs 1.0%), unsuccessful PCI (3.6% vs 3.4%), and emergency CABG (0.3% vs 0.3%).
What do current guidelines recommend regarding the use of UFH and enoxaparin?
Current guidelines recommend avoiding the use of UFH if enoxaparin was administered in the last 12 hours, as stacking both medications increases the risk of bleeding ( class III ) ‼️
What does the activation of phospholipase A2 liberate?
Arachidonic acid (AA) from the cell membrane.
How is thromboxane A2 (TxA2) formed?
AA metabolizes to TxA2 by cyclooxygenase (COX).
TxA2 is a potent platelet agonist and vasoconstrictor.
What inhibits cyclooxygenase (COX)?
Aspirin (AS).
What happens when ADP is released from activated platelets?
It binds to the P2Y12 receptor of circulating platelets, initiating platelet aggregation and amplification.
What drugs irreversibly bind the P2Y12 receptor?
Clopidogrel, prasugrel, and ticlopidine.
What is the mechanism of ticagrelor?
It is a reversible P2Y12 receptor inhibitor.
What is released after the activation of the P2Y12 receptor?
Inosine diphosphate (IP2).
What does IP2 get phosphorylated to?
IP3.
What do the releases of IP3 and diacylglycerol lead to?
Activation of protein kinase C (PKC) and eventual activation of GP IIb/IIIa.
What is the final step in platelet activation and aggregation?
Binding of GP IIb/IIIa to fibrinogen.
What is the P2Y12 receptor?
It is the platelet adenosine diphosphate receptor.
What did the BRAVE-3 trial study?
The BRAVE-3 trial studied 800 patients pretreated with 600 mg of clopidogrel randomly assigned to either abciximab or placebo prior to PCI. At 30 days, there was no significant difference in the composite of death, recurrent MI, stroke, or urgent revascularization of the IRA. There was also no difference in major bleeding.
What were the results of the On-TIME 2 study?
The On-TIME 2 study randomized 491 patients to tirofiban versus placebo prior to primary PCI. All patients received heparin IV, aspirin and 600 mg clopidogrel prior to randomization.
Tirofiban recipients had improved ST-segment resolution, but there were no significant differences in TIMI grade 3 coronary flow, major or minor bleeding rates, or in death, recurrent MI, or urgent TVR.
What did the meta-analysis by Gurm et al compare?
The meta-analysis compared abciximab with small-molecule GP IIb/IIIa inhibitors (eptifibatide or tirofiban).
There were no differences in 30-day mortality or reinfarction rates, and rates of TVR were identical for both groups.
Both major and minor bleeding rates were similar for both groups.
What was the focus of the FINESSE study?
The FINESSE study investigated the timing of GP IIb/IIIa antagonist administration, randomizing 2453 patients to different treatment timings of abciximab. The trial showed no benefit with pre-PCI abciximab compared with abciximab at the time of PCI. Also no difference in mortality.
What conclusion did the guideline writing committee reach regarding GP IIb/IIIa antagonists?
The committee concluded that various GP IIb/IIIa antagonists have similar efficacy and that, in the setting of DAPT, it is reasonable to start treatment with them at the time of primary PCI with or without stenting, in selected patients. Selected patients such as patients with large thrombus burden, no reflow or slow flow.
What was the design of the TRITON-TIMI 38 trial?
The TRITON-TIMI 38 trial was a double-blinded study that randomized 13,600 ACS patients to prasugrel versus clopidogrel for 6 to 15 months.
What were the primary efficacy endpoint results in the TRITON-TIMI 38 trial?
The primary efficacy endpoint of death from cardiovascular causes, nonfatal MI, or nonfatal stroke was seen in 12.1% of clopidogrel patients ( loading dose of 300 mg followed by 75 mg daily ) and in 9.9% of prasugrel patients ( loading dose of 60 mg followed by 10 mg daily ) , for 6 to 12 month, showing a significant benefit of prasugrel. This was also observed with STEMI patients . Sub groups like diabetics and patients receiving GP 2B3A inhibitors also show benefit with prasugrel. Rates of stent thrombosis were also reduced in the prasugrel group.
What safety concerns were associated with prasugrel in the TRITON-TIMI 38 trial?
Major bleeding was seen in 2.4% of prasugrel patients compared with 1.8% in the clopidogrel group, and life-threatening bleeding rates were also higher among prasugrel recipients.
Which groups were found not to have a net clinical benefit from prasugrel?
Patients with a prior TIA or stroke, those weighing <60 kg, and patients aged >75 years were found not to have a net clinical benefit from prasugrel.
What action did the FDA take regarding prasugrel?
The FDA declared prasugrel to be contraindicated in patients with a history of TIA or stroke.
What do current guidelines recommend regarding prasugrel use?
Current ACC/AHA/SCAI guidelines recommend against using prasugrel in patients with a history of TIA or stroke.
What was evaluated in the PLATO trial?
The use of ticagrelor in patients with acute coronary syndrome (ACS).
How many patients were randomized in the PLATO trial?
18,600 patients.
What were the two treatments compared in the PLATO trial?
Clopidogrel and ticagrelor.
What was the loading dose of ticagrelor in the PLATO trial?
180 mg.
What was the daily dose of ticagrelor after the loading dose?
90 mg twice daily.
What percentage of patients in the PLATO trial presented with STEMI?
38%.
What was the primary endpoint of the PLATO trial?
Death from vascular causes, cerebrovascular causes, or unknown causes.
What was the percentage of primary endpoint events in the ticagrelor group?
9.8% in the ticagrelor group versus 11.7% in the clopidogrel group. Primary and point of death from vascular causes or unknown cause.
What was the percentage of primary endpoint events in the clopidogrel group?
11.7%.
What was the significance level of the difference in treatment effect?
P < 0.01.
What was the composite outcome reduced in the ticagrelor group in PLATO trial?
All-cause death, myocardial infarction (MI), or stroke. Rates of Stent thrombosis were also lower in ticagrelor group and rates of major bleeding were similar between clopidogrel and Ticagrelor.
What were the rates of stent thrombosis in the ticagrelor group in PLATO ?
1.3%.
What were the rates of stent thrombosis in the clopidogrel group in PLATO
1.9%.
What was the FDA approval date for ticagrelor based on the PLATO trial?
July 2011.
What do current guidelines recommend for ACS patients undergoing PCI?
Use of ticagrelor or prasugrel in preference to clopidogrel to avoid ischemia and stent thrombosis.
What is recommended for patients older than 75 years regarding P2Y12 inhibitors?
Clopidogrel is preferred over newer P2Y12 inhibitors like ticagrelor or prasugrel because of the increased risk of bleeding.
What dose of aspirin should be used in patients receiving ticagrelor?
Low doses, usually <100 mg.
What do current guidelines recommend for aspirin dosing in patients undergoing PCI?
A loading dose of aspirin followed by a daily dose.
What was the main thienopyridine used before prasugrel and ticagrelor?
Clopidogrel was the main thienopyridine used in practice.
What was the outcome of the CREDO trial regarding clopidogrel 300 mg dose ?
The CREDO trial recorded a 26.9% reduction in the combined risk of death, MI, and stroke a year following PCI.
What is the only P2Y12 inhibitor studied in patients immediately after fibrinolytic therapy?
Clopidogrel is the only P2Y12 inhibitor studied in patients immediately after fibrinolytic therapy.
What was the primary efficacy endpoint in the CLARITY-TIMI 28 trial?
The primary efficacy endpoint was a composite of an occluded IRA on angiography or death or recurrent MI before angiography. Patients below age of 75 years old, undergoing PCI and randomize to Clopidogrel 300 mg versus placebo.
What were the results of the CLARITY-TIMI 28 trial regarding clopidogrel?
The trial showed 15.0% in the clopidogrel group versus 21.7% in the placebo group, representing a 36% reduction in the odds of the endpoint.
What were the primary 30-day outcomes in the clopidogrel group compared to placebo?
The primary 30-day outcome was 3.6% in the clopidogrel group versus 6.2% in the placebo group, composite of cardiovascular death, recurrent MI or stroke.
There was also reduction in/and MI before PCI when patients were pre-treated with clopidogrel.
There was no difference in minor or major bleeding.
What is the current dosing recommendation for clopidogrel?
Current dosing recommendations are a maintenance dose of 75 mg/d, a loading dose of 600 mg, or a loading dose of 300 mg after fibrinolytic therapy.
What did the COMMIT-CCS-2 study find regarding clopidogrel?
The study found a highly significant 9% reduction in death, reinfarction, or stroke with clopidogrel compared to placebo, in patients with acute myocardial infarction when clopidogrel 75 mg daily without loading dose was added to aspirin. There was no difference in terms of major bleeding.
What is the recommendation for the use of cangrelor?
Current revascularization guidelines recommend the use of cangrelor in patients undergoing PCI when they are P2Y12 inhibitor naïve.
Only a few studies, compared, clopidogrel, and cangrelor. Lower rates of mortality, ischemia, and stent thrombosis with cangrelor.
What is the recommendation for DAPT duration in patients with high bleeding risk?
The 2021 ACC/AHA/SCAI revascularization guidelines recommend at least a duration of 1 to 3 months of DAPT before transitioning to P2Y12 monotherapy.
What is the benefit of UFH administration in patients undergoing PCI?
UFH administration is useful in reducing ischemic events.
What alternatives can be used in place of UFH for patients with HIT undergoing PCI?
Bivalirudin and argatroban can be used in place of UFH.
How does Bivalirudin affect bleeding risk in PCI?
Bivalirudin can replace UFH to reduce bleeding risk.
What should be avoided if enoxaparin was administered in the last 12 hours?
Avoid the use of UFH, as stacking both medications increases the risk of bleeding.
What is recommended for patients undergoing PCI regarding aspirin?
A loading dose of aspirin, followed by a daily dose is recommended.
What is recommended for patients with ACS undergoing PCI regarding P2Y12?
A loading dose of P2Y12, followed by a daily dose is recommended.
What is recommended for patients with SIHD undergoing PCI regarding clopidogrel?
A loading dose of clopidogrel, followed by a daily dose is recommended.
What is the recommendation for clopidogrel after fibrinolytic therapy in PCI?
A loading dose of 300 mg clopidogrel after fibrinolytic therapy, followed by a daily dose is recommended.
What is the recommended duration of DAPT in patients undergoing PCI?
A shorter duration (1-3 months) of DAPT is recommended, with transition to P2Y12 monotherapy following.
What alternatives can be used instead of clopidogrel in ACS patients undergoing PCI?
Ticagrelor or prasugrel can be used instead of clopidogrel.
When can Glycoprotein IIb/IIIa be used in ACS patients undergoing PCI?
It can be used in patients with large thrombus burden, no re-flow, or slow flow.
Who can use Ticagrelor as an alternative to clopidogrel in PCI?
Patients who are younger than 75 years can use Ticagrelor.
Who can use Cangrelor in PCI?
Cangrelor can be used in patients who are P2Y12 naïve.
Is Glycoprotein IIb/IIIa recommended for SIHD patients undergoing PCI?
It is not recommended.
Is Prasugrel recommended for patients with a history of TIA or stroke undergoing PCI?
Prasugrel is not recommended.
What is the minimum duration for P2Y12 inhibitor therapy (clopidogrel) in STEMI patients treated with DAPT and fibrinolytic therapy?
A minimum of 14 days is recommended, ideally at least 12 months.
Level of evidence: A for 14 days, C for 12 months.
What is the recommended daily aspirin dose for patients treated with DAPT?
A daily aspirin dose of 81 mg is recommended, with a range of 75-100 mg.
In STEMI patients treated with fibrinolytic therapy, when may continuation of DAPT for longer than 12 months be reasonable?
If the patient has tolerated DAPT without bleeding complications and is not at high bleeding risk ( not on oral and coagulant, no coagulopathy, no prior bleeding on DAPT )
What is the recommended duration for P2Y12 inhibitor therapy in ACS patients treated with DAPT after BMS or DES implantation?
At least 12 months.
What is the preferred P2Y12 inhibitor for maintenance therapy in ACS patients treated with DAPT after coronary stent implantation?
Ticagrelor is preferred over clopidogrel. IIa
When is prasugrel preferred over clopidogrel for maintenance P2Y12 inhibitor therapy in ACS patients?
In patients who are not at high risk for bleeding complications and do not have a history of stroke or TIA.
In ACS patients who have tolerated DAPT without bleeding complications, when may continuation of DAPT for longer than 12 months be reasonable?
If they are not at high bleeding risk.
When may discontinuation of P2Y12 therapy after 6 months be reasonable for ACS patients treated with DAPT after DES implantation?
If they develop a high risk of bleeding, are at high risk of severe bleeding complications, or develop significant overt bleeding ( major, intracranial surgery, started on oral anticoagulant therapy )
Who should not be administered prasugrel?
Patients with a prior history of stroke or TIA.
Elaborate a chart using 2016 guidelines for dual anti platelets therapy recommendations based on bleeding risk.
Elaborate a chart using 2016 guidelines for dual anti platelets therapy recommendations
