A direct comparison of tirofiban and abciximab during percutaneous coronary revascularization and stent placement: rationale and design of the TARGET study.

BACKGROUND

Trials testing intravenous platelet glycoprotein IIb/IIIa antagonists in the setting of percutaneous coronary revascularization and empirically during acute coronary syndromes have consistently demonstrated a reduction in ischemic events. These trials, however, have varied regarding patient population, type, duration and timing of IIb/IIIa therapy, adjunct therapies, and methods for collection and adjudication of end points. All trials were placebo-controlled, and none involved a direct comparison of IIb/IIIa inhibitors. Whether these agents produce a similar clinical outcome in the contemporary practice of coronary interventions is uncertain.

METHODS AND RESULTS

To evaluate the efficacy of tirofiban in patients undergoing percutaneous revascularization with stent placement, a randomized, multicenter, double-blind, double-dummy, abciximab-controlled study is currently underway. All patients will receive preprocedural clopidogrel, weight-adjusted heparin, and aspirin. In 18 countries, 4750 patients undergoing nonemergency percutaneous coronary revascularization will be studied. The primary end point will be the composite 30-day occurrence of death, myocardial infarction, or urgent target vessel revascularization. Secondary end points will include 6-month death, myocardial infarction, or any myocardial revascularization and 1-year death.

CONCLUSION

This is the first large-scale, head-to-head comparison of 2 established IIb/IIIa inhibitors in interventional cardiology. Enrollment is expected to be complete by mid-2000.