Ketanserin prevents early restenosis following percutaneous transluminal coronary angioplasty.

In the treatment of coronary artery stenoses restenosis represents the main problem in 25-35% of cases following successful percutaneous transluminal coronary angioplasty (PTCA). In the present trial the effect of the 5HT2-serotonergic receptor antagonist ketanserin on the rate of restenosis after 24 h ('early restenosis') or 4-9 months ('late restenosis') was investigated. Preliminary studies demonstrated that ketanserin infused at the dose of 0.1 mg/min inhibited platelet aggregation without evidence of side effects. In the restenosis study, 43 patients (37 males, 6 females; mean 55 years) were randomized into two groups. After PTCA, 22 patients were treated with conventional therapy (group A), whereas 21 received additionally ketanserin (0.1 mg/min for 24 h, group B). The angiograms (prior to, after, 24 h after, and 4-9 months after PTCA) were examined in a blind manner using a computer-based quantitative angiographic system. After 24 h, 3 patients of group A, but none of group B showed restenosis (more than 50% decrease in diameter stenosis). In total, the diameter at the site of stenosis prior to PTCA decreased by 11% in the controls, but remained unchanged in the ketanserin-treated patients. After 4-9 months, 26% of group A (5 out of 19 patients examined) and 22% of the controls (4 out of 18 patients examined) developed restenosis of more than 50%; there was no statistical difference in the degree of residual stenosis between both groups. These findings suggest that a 24-hour infusion of ketanserin following PTCA may prevent early restenosis, but does not influence the incidence of late restenosis.

RCT Entities:   Population Interventions Outcomes