RANDOMIZED TRIAL OF CORONARY INTERVENTION WITH ANTIBODY AGAINST PLATELET IIB IIIA INTEGRIN FOR REDUCTION OF CLINICAL RESTENOSIS - RESULTS AT 6 MONTHS/

Restenosis after coronary angioplasty occurs in at least 30% of patien ts in the first six months and, as yet, there is no known treatment to decrease this event. We tested a monoclonal antibody Feb fragment (c7 E3) directed against the platelet glycoprotein IIb/IIIa integrin, the receptor mediating the final common pathway of platelet aggregation, t o see whether it reduced the frequency of clinical restenosis. Patient s who had unstable angina, recent or evolving myocardial infarction, o r high-risk angiographic morphology, were randomised to receive c7E3 b olus and a 12 hour infusion of c7E3 (708 patients), c7E3 bolus and pla cebo infusion (695 patients), or placebo bolus and placebo infusion (6 96 patients). With maintenance of the double-blind state, patients wer e followed-up for at least 6 months to determine the need for repeat a ngioplasty or surgical coronary revascularisation and the occurrence o f ischaemic events. By 30 days, 12.8% of placebo bolus/placebo infusio n patients had had a major ischaemic event (death, myocardial infarcto n, urgent revascularisation), compared with 8.3% of c7E3 bolus/c7E3 in fusion patients, yielding a 4.5% difference (35% reduction, p = 0.008) . At 6 months, the absolute difference in patients with a major ischae mic event or elective revascularisation was 8.1% between placebo bolus / placebo infusion and c7E3 bolus/c7E3 infusion patients (35.1% vs 27. 0%; 23% reduction p = 0.001). The favourable long-term effect was main ly due to less need for bypass surgery or repeat angioplasty in patien ts with an initial successful procedure, since need for repeat target vessel revascularisation was 26% less for c7E3 bolus/c7E3 infusion tha n for placebo treatment (16.5% vs 22.3%; p = 0.007). The c7E3 bolus/pl acebo infusion group had an intermediate outcome which was not signifi cantly better than that of the placebo bolus/placebo infusion group. T hese results extend the benefit of c7E3 bolus/c7E3 infusion from reduc ing abrupt closure and acute-phase adverse outcomes to a diminished ne ed for subsequent coronary revascularisation procedures. Because this therapy carries a risk of bleeding complications and has been studied only in high-risk angioplasty patients, further evaluation is needed b efore it can be applied to other patient groups.