Coronary Artery Disease
Timing of and risk factors for myocardial ischemic events after percutaneous coronary intervention (IMPACT-II)

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Abstract

We studied both the time course and risk factors for adverse clinical events after percutaneous coronary intervention (PCI). Such information is critical to clinical decision-making, but scant quantitative data exist to describe the time course of these adverse outcomes. Patients enrolled in the Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis-II (IMPACT-II) trial were analyzed. Patients undergoing elective, urgent, or emergency PCI (n = 4,010) were randomized to receive either placebo or 1 of 2 eptifibatide regimens during intervention. We evaluated the time to the primary end point of the trial, the 30-day composite of death, myocardial infarction, repeat nonelective PCI, nonelective bypass surgery, or stenting for abrupt closure. Adverse events occurred in 407 patients (10.1%). Because the risk of events declined substantially between 6 and 9 hours (66% occurred within 6 hours), events were classified as occurring before or after 6 hours. Independent predictors of “early” events included dissection, pre- and postprocedural coronary blood flow, side-branch occlusion, procedural thrombolytic use, previous bypass, presentation with unstable angina, absence of diabetes, and hyperlipidemia. The predictors of “late” events included lower weight, increased baseline heart rate, coronary dissection, and procedural thrombolytic use. The risk of ischemic events were greatest immediately after PCI and rapidly declined, so that by 9 hours the hazard function plot was flat; 66% of events occurred within 6 hours of PCI. Knowledge of the risk factors for early and late events help risk-stratify patients before and after intervention for myocardial ischemic events.

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.

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