CONTROLLED TRIAL OF HIGH-VERSUS LOW-DOSE ASPIRIN TREATMENT AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN PATIENTS WITH PERIPHERAL VASCULAR-DISEASE

Percutaneous transluminal angioplasty of aortoiliac and femoropoplitea l atherosclerotic lesions can provide long-lasting hemodynamic improve ment. High-dose aspirin is commonly prescribed as reocclusion prophyla xis, but low doses would be preferable because of fewer adverse effect s. We performed a double-blind, randomized, controlled clinical trial in patients with peripheral vascular disease with lesions appropriate for angioplasty. We compared the efficacy and side effects of two dose s of aspirin (50 mg vs. 900 mg daily) during a period of 12 months aft er angioplasty. A total of 359 patients were evaluated: 175 were rando mly assigned to treatment with 900 mg aspirin daily and 184 to 50 mg a spirin a day. Thirty-nine patients developed restenosis at the angiopl asty site; the cumulative percentage of event-free survival after I ye ar (patency rate) was 85% in the 900-mg group and 84% in the 50-mg gro up. An equivalence test showed the two groups equivalent with respect to restenosis rates (P = 0.003 for an equivalence region of <10% diffe rence). Nine patients (5%) in the 900-mg group had serious gastrointes tinal side effects (peptic ulcer, eight; erosive gastritis requiring t ransfusion, one) compared to two (peptic ulcer) in the 50-mg group(P = 0.03). The results of our study show that a dose of 50 mg aspirin a d ay is as effective as one of 900 mg for the prevention of restenoses a fter lower limb angioplasty, and that severe gastrointestinal side eff ects are less frequent.