Guidelines SCA - Table 9 Flashcards
SHOCK Trial
EARLY REVASCULARIZATION IN ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK
Background The leading cause of death in pa- tients hospitalized for acute myocardial infarction is cardiogenic shock. We conducted a randomized trial to evaluate early revascularization in patients with cardiogenic shock.
Methods Patients with shock due to left ventricular failure complicating myocardial infarction were ran- domly assigned to emergency revascularization (152 patients) or initial medical stabilization (150 patients). Revascularization was accomplished by either coro- nary-artery bypass grafting or angioplasty. Intraaor- tic balloon counterpulsation was performed in 86 percent of the patients in both groups. The primary end point was mortality from all causes at 30 days. Six-month survival was a secondary end point.
Results The mean (±SD) age of the patients was 66±10 years, 32 percent were women, and 55 per- cent had been transferred from other hospitals. The median time to the onset of shock was 5.6 hours after infarction, and most infarcts were anterior in loca- tion. Ninety-seven percent of the patients assigned to revascularization underwent early coronary angiog- raphy, and 87 percent underwent revascularization; only 2.7 percent of the patients assigned to medical therapy crossed over to early revascularization without clinical indication. Overall mortality at 30 days did not differ significantly between the revascularization and medical-therapy groups (46.7 percent and 56.0 per- cent, respectively; difference, ¡9.3 percent; 95 per- cent confidence interval for the difference, ¡20.5 to 1.9 percent; P=0.11). Six-month mortality was lower in the revascularization group than in the medical-ther- apy group (50.3 percent vs. 63.1 percent, P=0.027).
Conclusions In patients with cardiogenic shock, emergency revascularization did not significantly re- duce overall mortality at 30 days. However, after six months there was a significant survival benefit. Early revascularization should be strongly considered for patients with acute myocardial infarction complicated by cardiogenic shock. (N Engl J Med 1999;341:625-34.)
Comparison of Percutaneous Coronary Intervention and
Coronary Artery Bypass Grafting After Acute Myocardial
Infarction Complicated by Cardiogenic Shock
Results From the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) Trial
Background—The Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial demonstrated the survival advantage of emergency revascularization versus initial medical stabilization in patients developing cardiogenic shock after acute myocardial infarction. The relative merits of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with shock have not been defined. The objective of this analysis was to compare the effects of PCI and CABG on 30-day and 1-year survival in the SHOCK trial.
Methods and Results—Of the 302 trial patients, 128 with predominant left ventricular failure had emergency revascularization. The selection of revascularization procedures was individualized. Eighty-one patients (63.3%) had PCI, and 47 (36.7%) had CABG. The median time from randomization to intervention was 0.9 hours (interquartile range [IQR], 0.3 to 2.2 hours) for PCI and 2.7 hours (IQR, 1.3 to 5.5 hours) for CABG. Baseline demographics and hemodynamics were similar, except that there were more diabetics (48.9% versus 26.9%; P0.02), 3-vessel disease (80.4% versus 60.3%; P0.03), and left main coronary disease (41.3% versus 13.0%; P0.001) in the CABG group. In the PCI group, 12.3% had 2-vessel and 2.5% had 3-vessel interventions. In the CABG group, 84.8% received 2 grafts, 52.2% received 3 grafts, and 87.2% were deemed completely revascularized. The survival rates were 55.6% in the PCI group compared with 57.4% in the CABG group at 30 days (P0.86) and 51.9% compared with 46.8%, respectively, at 1 year (P0.71).
Conclusions—Among SHOCK trial patients randomized to emergency revascularization, those treated with CABG had a greater prevalence of diabetes and worse coronary disease than those treated with PCI. However, survival rates were similar. Emergency CABG is an important component of an optimal treatment strategy in patients with cardiogenic shock, and should be considered a complementary treatment option in patients with extensive coronary disease. (Circulation. 2005;112:1992-2001.)
Early Revascularization and Long-term Survival in Cardiogenic Shock Complicating Acute Myocardial Infarction
Context Cardiogenicshockremainsthemajorcauseofdeathforpatientshospital- ized with acute myocardial infarction (MI). Although survival in patients with cardio- genic shock complicating acute MI has been shown to be significantly higher at 1 year in those receiving early revascularization vs initial medical stabilization, data demon- strating long-term survival are lacking.
Objective To determine if early revascularization affects long-term survival of pa- tients with cardiogenic shock complicating acute MI.
Design, Setting, and Patients The Should We Emergently Revascularize Oc- cluded Coronaries for Cardiogenic Shock (SHOCK) trial, an international randomized clinical trial enrolling 302 patients from April 1993 through November 1998 with acute myocardial infarction complicated by cardiogenic shock (mean [SD] age at random- ization, 66 [11] years); long-term follow-up of vital status, conducted annually until 2005, ranged from 1 to 11 years (median for survivors, 6 years).
MainOutcomeMeasures All-causemortalityduringlong-termfollow-up.
Results Thegroupdifferenceinsurvivalof13absolutepercentagepointsat1year favoring those assigned to early revascularization remained stable at 3 and 6 years (13.1% and 13.2%, respectively; hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.57-0.97; log-rank P=.03). At 6 years, overall survival rates were 32.8% and 19.6% in the early revascularization and initial medical stabilization groups, respec- tively. Among the 143 hospital survivors, a group difference in survival also was ob- served (HR, 0.59; 95% CI, 0.36-0.95; P=.03). The 6-year survival rates for the hos- pital survivors were 62.4% vs 44.4% for the early revascularization and initial medical stabilization groups, respectively, with annualized death rates of 8.3% vs 14.3% and, for the 1-year survivors, 8.0% vs 10.7%. There was no significant interaction be- tween any subgroup and treatment effect.
Conclusions In this randomized trial, almost two thirds of hospital survivors with cardiogenic shock who were treated with early revascularization were alive 6 years later. A strategy of early revascularization resulted in a 13.2% absolute and a 67% relative improvement in 6-year survival compared with initial medical stabilization. Early revascularization should be used for patients with acute MI complicated by cardio- genic shock due to left ventricular failure.
Comparison of primary angioplasty and pre-hospital fibrinolysis in acute myocardial infarction (CAPTIM) trial: a 5-year follow-up
Aims The CAPTIM (Comparison of primary Angioplasty and Pre-hospital fibrinolysis In acute Myocardial infarction) study found no evidence that a strategy of primary angioplasty was superior in terms of 30-day outcomes to a strategy of pre-hospital fibrinolysis with transfer to an interventional facility in patients managed early at the acute phase of an
acute myocardial infarction. The present analysis was designed to compare both strategies at 5 years.
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Methods and results
The CAPTIM study included 840 patients managed in a pre-hospital setting within 6 h of an acute ST-segment
elevation myocardial infarction. Patients were randomized to either a primary angioplasty (n 1⁄4 421) or a pre-hospital
fibrinolysis (rt-PA) with immediate transfer to a centre with interventional facilities (n 1⁄4 419). Long-term follow-up
was obtained in blinded fashion from 795 patients (94.6%). Using an intent-to-treat analysis, all-cause mortality at
5 years was 9.7% in the pre-hospital fibrinolysis group when compared with 12.6% in the primary angioplasty
group [HR 0.75 (95% CI, 0.50–1.14); P 1⁄4 0.18]. For patients included within 2 h, 5 year mortality was 5.8% in the
pre-hospital fibrinolysis group when compared with 11.1% in the primary angioplasty group [HR 0.50 (95% CI,
0.25–0.97); P 1⁄4 0.04], whereas it was, respectively, 14.5 and 14.4% in patients included after 2 h [HR 1.02, (95%
CI 0.59–1.75), P 1⁄4 0.92]. ……………………………………………………………………………………………………………………………………………………………….
Conclusion The 5-year follow-up is consistent with the 30-day outcomes of the trial, showing similar mortality for primary per- cutaneous coronary intervention and a policy of pre-hospital lysis followed by transfer to an interventional center. In addition, for patients treated within 2 h of symptom onset, 5-year mortality was lower with pre-hospital lysis.
IABP-SHOCK II Trial
Intraaortic Balloon Support for Myocardial Infarction
with Cardiogenic Shock
Background
In current international guidelines, intraaortic balloon counterpulsation is consid- ered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials.
Methods
In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke.
Results
A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal func- tion. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28).
Conclusions
The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarc- tion for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II
Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial
Background In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results.
Methods The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036.
Findings Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86–1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95–7·10, p=0·05), recurrent revascularisation (0·91, 0·58–1·41, p=0·77), or stroke (1·50, 0·25–8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups.
Interpretation In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality.
STREAM
Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction
Background
It is not known whether prehospital fibrinolysis, coupled with timely coronary an- giography, provides a clinical outcome similar to that with primary percutaneous coronary intervention (PCI) early after acute ST-segment elevation myocardial in- farction (STEMI).
Methods
Among 1892 patients with STEMI who presented within 3 hours after symptom onset and who were unable to undergo primary PCI within 1 hour, patients were randomly assigned to undergo either primary PCI or fibrinolytic therapy with bolus tenecteplase (amended to half dose in patients ≥75 years of age), clopidogrel, and enoxaparin before transport to a PCI-capable hospital. Emergency coronary angiog- raphy was performed if fibrinolysis failed; otherwise, angiography was performed 6 to 24 hours after randomization. The primary end point was a composite of death, shock, congestive heart failure, or reinfarction up to 30 days.
Results
The primary end point occurred in 116 of 939 patients (12.4%) in the fibrinolysis group and in 135 of 943 patients (14.3%) in the primary PCI group (relative risk in the fibrinolysis group, 0.86; 95% confidence interval, 0.68 to 1.09; P=0.21). Emergency angiography was required in 36.3% of patients in the fibrinolysis group, whereas the remainder of patients underwent angiography at a median of 17 hours after random- ization. More intracranial hemorrhages occurred in the fibrinolysis group than in the primary PCI group (1.0% vs. 0.2%, P=0.04; after protocol amendment, 0.5% vs. 0.3%, P=0.45). The rates of nonintracranial bleeding were similar in the two groups.
Conclusions
Prehospital fibrinolysis with timely coronary angiography resulted in effective re- perfusion in patients with early STEMI who could not undergo primary PCI within 1 hour after the first medical contact. However, fibrinolysis was associated with a slightly increased risk of intracranial bleeding.
CULPRIT-SHOCK Investigators
PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock
BACKGROUND
In patients who have acute myocardial infarction with cardiogenic shock, early revascular- ization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel dis- ease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial.
METHODS
In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a compos- ite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke.
RESULTS
At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups.
CONCLUSIONS
Among patients who had multivessel coronary artery disease and acute myocardial infarc- tion with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others;
Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction
Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial
BACKGROUND: The role of intraaortic balloon counterpulsation (IABP)
in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice.
METHODS: The IABP-SHOCK II trial is a multicenter, randomized, open- label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control.
RESULTS: Long-term follow-up was performed 6.2 years (interquartile range 5.6–6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88–1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors’ quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups.
CONCLUSIONS: IABP has no effect on all-cause mortality at 6-year long- term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy.
ECMO CS Trial
Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial
BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used for circulatory support in patients with cardiogenic shock, although the evidence supporting its use in this context remains insufficient. The ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) aimed to compare immediate implementation of VA-ECMO versus an initially conservative therapy (allowing downstream use of VA-ECMO) in patients with rapidly deteriorating or severe cardiogenic shock.
METHODS: This multicenter, randomized, investigator-initiated, academic clinical trial included patients with either rapidly deteriorating or severe cardiogenic shock. Patients were randomly assigned to immediate VA-ECMO or no immediate VA-ECMO. Other diagnostic and therapeutic procedures were performed as per current standards of care. In the early conservative group, VA-ECMO could be used downstream in case of worsening hemodynamic status. The primary end point was the composite of death from any cause, resuscitated circulatory arrest, and implementation of another mechanical circulatory support device at 30 days.
RESULTS: A total of 122 patients were randomized; after excluding 5 patients because of the absence of informed consent, 117 subjects were included in the analysis, of whom 58 were randomized to immediate VA-ECMO and 59 to no immediate VA-ECMO. The composite primary end point occurred in 37 (63.8%) and 42 (71.2%) patients in the immediate VA-ECMO and the no early VA-ECMO groups, respectively (hazard ratio, 0.72 [95% CI, 0.46–1.12]; P=0.21). VA-ECMO was used in 23 (39%) of no early VA-ECMO patients. The 30-day incidence of resuscitated cardiac arrest (10.3.% versus 13.6%; risk difference, –3.2 [95% CI, –15.0 to 8.5]), all-cause mortality (50.0% versus 47.5%; risk difference, 2.5 [95% CI, –15.6 to 20.7]), serious adverse events (60.3% versus 61.0%; risk difference, –0.7 [95% CI, –18.4 to 17.0]), sepsis, pneumonia, stroke, leg ischemia, and bleeding was not statistically different between the immediate VA-ECMO and the no immediate VA-ECMO groups.
CONCLUSIONS: Immediate implementation of VA-ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of VA-ECMO in case of worsening hemodynamic status.
