EVALUATION OF KETANSERIN IN THE PREVENTION OF RESTENOSIS AFTER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY - A MULTICENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Background. Ketanserin is a serotonin S2-receptor antagonist that inhi bits the platelet activation and vasoconstriction induced by serotonin and also inhibits the mitogenic effect of serotonin on vascular smoot h muscle cells. Methods and Results. We conducted a randomized, double blind, placebo-controlled trial to assess the effect of ketanserin in restenosis prevention after percutaneous transluminal coronary angiop lasty (PTCA). Patients received either ketanserin (loading dose, 40 mg 1 hour before PTCA, maintenance dose, 40 mg bid for 6 months) or matc hed placebo. In addition, all patients received aspirin for 6 months. Coronary angiograms before PTCA, after PTCA, and at 6 months were quan titatively analyzed. Six hundred fifty-eight patients were entered int o the intention-to-treat analysis. The primary clinical end point of t he study was the occurrence between PTCA and 6 months of any one of th e following: cardiac death, myocardial infarction, the need for repeat angioplasty, or bypass surgery. It also included the need for revascu larization actuated by findings at 6-month follow-up angiography. The primary clinical end point was reached by 92 (28%) patients in the ket anserin group and 104 (32%) in the placebo group (RR, 0.89; 95% Cl, 0. 70, 1.13; P=.38). Quantitative angiography after PTCA and at follow-up was available in 592 patients (ketanserin, 287; control, 305). The me an difference in minimal lumen diameter between post-PTCA and follow-u p angiogram (primary angiographic end point) was 0.27+/-0.49 mm in the ketanserin group and 0.24+/-0.52 mm in the control group (difference, 0.03 mm; 95% CI, -0.05, 0.11; P=.50). Conclusions. Ketanserin at the dose administered in this trial failed to reduce the loss in minimal l umen diameter during follow-up after PTCA and did not significantly im prove the clinical outcome.