학술논문

Myocardial Infarction in the ISCHEMIA Trial
Document Type
article
Source
Circulation. 143(8)
Subject
Clinical Trials and Supportive Activities
Clinical Research
Cost Effectiveness Research
Heart Disease
Cardiovascular
Heart Disease - Coronary Heart Disease
Good Health and Well Being
Aged
Aged
80 and over
Coronary Artery Bypass
Creatine Kinase
MB Form
Female
Follow-Up Studies
Humans
Incidence
Male
Middle Aged
Myocardial Infarction
Myocardial Ischemia
Percutaneous Coronary Intervention
Prognosis
Proportional Hazards Models
Risk Factors
Severity of Illness Index
Survival Analysis
catheterization
drug therapy
myocardial infarction
myocardial ischemia
myocardial revascularization
ISCHEMIA Research Group
Cardiorespiratory Medicine and Haematology
Clinical Sciences
Public Health and Health Services
Cardiovascular System & Hematology
Language
Abstract
BackgroundIn the ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy did not significantly reduce rates of cardiovascular events or all-cause mortality in comparison with a conservative strategy in patients with stable ischemic heart disease and moderate/severe myocardial ischemia. The most frequent component of composite cardiovascular end points was myocardial infarction (MI).MethodsISCHEMIA prespecified that the primary and major secondary composite end points of the trial be analyzed using 2 MI definitions. For procedural MI, the primary MI definition used creatine kinase-MB as the preferred biomarker, whereas the secondary definition used cardiac troponin. Procedural thresholds were >5 times the upper reference level for percutaneous coronary intervention and >10 times for coronary artery bypass grafting. Procedural MI definitions included (1) a category of elevated biomarker only events with much higher biomarker thresholds, (2) new ST-segment depression of ≥1 mm for the primary and ≥0.5 mm for the secondary definition, and (3) new coronary dissections >National Heart, Lung, and Blood Institute grade 3. We compared MI type, frequency, and prognosis by treatment assignment using both MI definitions.ResultsProcedural MIs accounted for 20.1% of all MI events with the primary definition and 40.6% of all MI events with the secondary definition. Four-year MI rates in patients undergoing revascularization were more frequent with the invasive versus conservative strategy using the primary (2.7% versus 1.1%; adjusted hazard ratio [HR], 2.98 [95% CI, 1.87-4.73]) and secondary (8.2% versus 2.0%; adjusted HR, 5.04 [95% CI, 3.64-6.97]) MI definitions. Type 1 MIs were less frequent with the invasive versus conservative strategy using the primary (3.40% versus 6.89%; adjusted HR, 0.53 [95% CI, 0.41-0.69]; P