Coronary Artery DiseaseTiming of and risk factors for myocardial ischemic events after percutaneous coronary intervention (IMPACT-II)☆
Section snippets
Study population
The IMPACT-II trial design, methods, end points, and results have been previously published.1 Briefly, between November 30, 1993, and November 9, 1994, 4,010 patients undergoing elective, urgent, or emergency PCI were enrolled at 85 sites in the United States. Patients were stratified to the “high-risk” group if they had a recent acute myocardial infarction (AMI), unstable angina, or non–Q-wave AMI; all other patients were classified as “low risk.” All patients received oral aspirin before the
Results
The primary end point occurred in 407 patients (10.1%); there were 33 deaths (0.8%) and 288 AMIs (7.2%); 196 patients (4.9%) required unplanned revascularization. Overall, 66% of events occurred within 6 hours. The event rate peaked within 6 hours, lessened between 6 and 9 hours, and was quite low and constant afterward (Figure 1). There was no abrupt increase (“rebound”) in the incidence or risk of events at any point, even after completion of study drug infusion. The risk of ischemic events
Discussion
This study is the first to attempt to characterize the timing of adverse clinical events after PCI. As expected, most adverse outcomes occur early, as a manifestation of periprocedural ischemic events. The risk of complications is highest immediately after PCI and steadily declines over the first 9 hours. After 9 hours, the overall risk is constant and markedly reduced, that is, the hazard function plot is flat. Although the risk of untoward events persists, the hazard function indicates that a
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This study was supported by a grant from COR Therapeutics, Inc., South San Francisco, California. Manuscript received and accepted May 24, 1999; revised manuscript received and accepted September 25, 1999.