BACKGROUND: Mortality after ST-elevation myocardial infarction (STEMI) has reduced with reperfusion by primary percutaneous coronary intervention (PCI), which may have impacted on the adverse outcomes of cardiogenic shock (CS) and congestive heart failure (CHF). METHODS AND RESULTS: In the APEX-AMI trial, 5,745 patients with STEMI and planned primary PCI were randomly assigned pexelizumab or matching placebo. Post-randomization CS or CHF was adjudicated by a clinical endpoints committee. Treatment assignment to pexelizumab did not influence either endpoint or mortality rates. Cardiogenic shock developed in 196 patients (3.4%) at a median of 6.0 hours (interquartile range 3.9-28.3) post-randomization, and mortality at 90 days was 54.6%. Congestive heart failure occurred in 254 of patients (4.4%) at a median of 2.6 days (IQR 1.0-16.6), and mortality through 90 days was 10.2%; mortality among those with neither endpoint was 2.1%. Patients with CS or CHF were older, were more often female, and had more hypertension and diabetes, but smoked less compared with non-CS/CHF patients (all P < .05). Independent mortality predictors among those with CS or CHF were hyperlipidemia and a history of angina (interaction P = .011 and .008, respectively); procedural predictors among survivors to PCI were pre-PCI Thrombolysis In Myocardial Infarction (TIMI) flow 0-1 and post-PCI TIMI flow <3 (P = .013 and <.0001, respectively). CONCLUSIONS:Survival after CS remains poor despite aggressive reperfusion. Both CS and CHF remain the major causes of death among STEMI patients undergoing primary PCI. Future studies should examine treatments that aim to reduce mortality in these highest risk patients.
RCT Entities:
BACKGROUND: Mortality after ST-elevation myocardial infarction (STEMI) has reduced with reperfusion by primary percutaneous coronary intervention (PCI), which may have impacted on the adverse outcomes of cardiogenic shock (CS) and congestive heart failure (CHF). METHODS AND RESULTS: In the APEX-AMI trial, 5,745 patients with STEMI and planned primary PCI were randomly assigned pexelizumab or matching placebo. Post-randomization CS or CHF was adjudicated by a clinical endpoints committee. Treatment assignment to pexelizumab did not influence either endpoint or mortality rates. Cardiogenic shock developed in 196 patients (3.4%) at a median of 6.0 hours (interquartile range 3.9-28.3) post-randomization, and mortality at 90 days was 54.6%. Congestive heart failure occurred in 254 of patients (4.4%) at a median of 2.6 days (IQR 1.0-16.6), and mortality through 90 days was 10.2%; mortality among those with neither endpoint was 2.1%. Patients with CS or CHF were older, were more often female, and had more hypertension and diabetes, but smoked less compared with non-CS/CHFpatients (all P < .05). Independent mortality predictors among those with CS or CHF were hyperlipidemia and a history of angina (interaction P = .011 and .008, respectively); procedural predictors among survivors to PCI were pre-PCI Thrombolysis In Myocardial Infarction (TIMI) flow 0-1 and post-PCI TIMI flow <3 (P = .013 and <.0001, respectively). CONCLUSIONS: Survival after CS remains poor despite aggressive reperfusion. Both CS and CHF remain the major causes of death among STEMI patients undergoing primary PCI. Future studies should examine treatments that aim to reduce mortality in these highest risk patients.