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.


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.


CONCLUSIONS
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.
Moliterno
D J
DJ
Department of Cardiology and the Cleveland Clinic Cardiovascular Coordinating Center, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. molited@ccf.org
Topol
E J
EJ
D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D004311:Double-Blind Method; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic / Q000379:methods; D018579:Patient Selection; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D018401:Sample Size; D015607:Stents; D000077466:Tirofiban; D014443:Tyrosine / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D014443:Tyrosine; D000077466:Tirofiban; D000077284:Abciximab