Circulation, Vol 88, 1588-1601, Copyright © 1993 by American Heart Association
PW Serruys, W Klein, JP Tijssen, W Rutsch, GR Heyndrickx, H Emanuelsson, SG Ball, O Decoster, E Schroeder and H Liberman
BACKGROUND. Ketanserin is a serotonin S2-receptor antagonist that inhibits
the platelet activation and vasoconstriction induced by serotonin and also
inhibits the mitogenic effect of serotonin on vascular smooth 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 angioplasty (PTCA).
Patients received either ketanserin (loading dose, 40 mg 1 hour before
PTCA; maintenance dose, 40 mg bid for 6 months) or matched placebo. In
addition, all patients received aspirin for 6 months. Coronary angiograms
before PTCA, after PTCA, and at 6 months were quantitatively analyzed. Six
hundred fifty-eight patients were entered into the intention-to-treat
analysis. The primary clinical end point of the study was the occurrence
between PTCA and 6 months of any one of the following: cardiac death,
myocardial infarction, the need for repeat angioplasty, or bypass surgery.
It also included the need for revascularization actuated by findings at
6-month follow-up angiography. The primary clinical end point was reached
by 92 (28%) patients in the ketanserin group and 104 (32%) in the placebo
group (RR, 0.89; 95% CI, 0.70, 1.13; P = .38). Quantitative angiography
after PTCA and at follow-up was available in 592 patients (ketanserin, 287;
control, 305). The mean difference in minimal lumen diameter between
post-PTCA and follow-up 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 lumen diameter during follow-up after PTCA and did not
significantly improve the clinical outcome.
ARTICLES
Evaluation of ketanserin in the prevention of restenosis after percutaneous transluminal coronary angioplasty. A multicenter randomized double-blind placebo-controlled trial
Catheterization Laboratory, Thoraxcenter, Rotterdam, The Netherlands.
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