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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Benefit of bolus-only platelet glycoprotein IIb/IIIa inhibition during percutaneous coronary intervention: insights from the very early outcomes in the Evaluation of 7E3 for the Prevention of Ischemic Complications (EPIC) trial.
American Heart Journal 2006 November
BACKGROUND: Platelet glycoprotein IIb/IIIa inhibitors are administered during percutaneous coronary intervention as a bolus followed by infusion. The need for an infusion was established by the Evaluation of 7E3 for the Prevention of Ischemic Complications (EPIC) trial conducted during the percutaneous transluminal coronary balloon angioplasty (PTCA) era, when the threat of acute thrombotic complications prevailed over concerns regarding bleeding, and stenting was considered an adverse event.
METHODS: The EPIC trial randomized high-risk PTCA patients to 3 arms: placebo, abciximab bolus only, and abciximab bolus plus infusion. The present analysis of the EPIC outcomes was done at 6-hour intervals during the first 24 hours after PTCA to identify any early benefit derived from the abciximab bolus-only arm.
RESULTS: At 6 hours after randomization, the primary composite end point of death, myocardial infarction, or urgent intervention was significantly reduced by 46% with abciximab bolus-only compared with placebo (2.9% vs 5.3%; P = .022), which is mainly due to a reduced rate of urgent intervention. There was also a numerical but not statistically significant reduction in myocardial infarction rate using abciximab bolus-only compared with placebo. A lower bleeding rate in the bolus-only arm compared with bolus plus infusion has been reported.
CONCLUSIONS: As stenting and thienopyridine use have become routine, there has been a decrease in the incidence of acute closure and an increasing concern for bleeding complications after percutaneous coronary intervention, which potentially may be addressed by adopting a bolus-only glycoprotein IIb/IIIa inhibitor strategy. The early protective ischemic effect of abciximab bolus-only observed in the EPIC trial may be relevant in this regard.
METHODS: The EPIC trial randomized high-risk PTCA patients to 3 arms: placebo, abciximab bolus only, and abciximab bolus plus infusion. The present analysis of the EPIC outcomes was done at 6-hour intervals during the first 24 hours after PTCA to identify any early benefit derived from the abciximab bolus-only arm.
RESULTS: At 6 hours after randomization, the primary composite end point of death, myocardial infarction, or urgent intervention was significantly reduced by 46% with abciximab bolus-only compared with placebo (2.9% vs 5.3%; P = .022), which is mainly due to a reduced rate of urgent intervention. There was also a numerical but not statistically significant reduction in myocardial infarction rate using abciximab bolus-only compared with placebo. A lower bleeding rate in the bolus-only arm compared with bolus plus infusion has been reported.
CONCLUSIONS: As stenting and thienopyridine use have become routine, there has been a decrease in the incidence of acute closure and an increasing concern for bleeding complications after percutaneous coronary intervention, which potentially may be addressed by adopting a bolus-only glycoprotein IIb/IIIa inhibitor strategy. The early protective ischemic effect of abciximab bolus-only observed in the EPIC trial may be relevant in this regard.
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