Sulotroban during and after coronary angioplasty. A double-blind, placebo controlled study

Sulotroban, a sulphonamide derivative, causes an inhibition of platelet aggregation by blocking thromboxane A2 receptors. We tested the effects of Sulotroban (4 x 800 mg per day) on acute events during and recurrence rate after coronary angioplasty, and compared it with placebo in a double-blind randomized fashion. The follow-up protocol included regular compliance control by pill count, stress testing, and coronary angiography at 6 months. Restenosis was defined as a loss of 50% of the initial gain in luminal diameter. A total of 107 patients were randomized. There were no differences between the groups in terms of age, sex, artery distribution, or left ventricular function. Primary success per vessel was 86% for the Sulotroban group (50/58), and 88% for the placebo group (51/58). Complications occurred in nine patients (8%): five emergency bypass operations and three myocardial infarctions. There were no differences between the centers, or the study groups. The study protocol was completed for 57 patients. There was one death in the placebo group. Restenosis was found in 65% of patients in the Sulotroban group (19/29) and 61% of patients in the placebo group (17/28) (ns). If all patients were included on an intention to treat basis, regardless of primary success and compliance with the protocol, the recurrence rate was 57% in the Sulotroban group (20/35), compared with 56% in the Placebo group (20/36) (ns). This randomized, double-blind study failed to show that Sulotroban is superior to placebo in preventing acute problems during, or restenosis after, coronary angioplasty.