Usefulness of Nisoldipine for prevention of restenosis after percutaneous transluminal coronary angioplasty (results of the NICOLE study)

The Nlsoldipine in COronary artery disease in LEuven (NICOLE) study investi gates (1) whether nisoldipine, a dihydropyridine calcium antagonist, reduce s the progression of minor coronary arterial lesions in the long term, and (2) whether it reduces the restenosis rate after successful percutaneous tr ansluminal coronary angioplasty (PTCA). The NICOLE study is a single-center , randomized, double-blind trial in 826 patients, who underwent a successfu l PTCA. Nisoldipine 40 mg coat-core or placebo was started the morning afte r the procedure and continued for 3 years. All coronary arterial segments w ere measured on preprocedural angiogram and on the second follow-up angiogr am at 3 years. On the first follow-up angiogram at 6 months only the dilate d segments were measured. Although the study is still ongoing until the pri mary end point is reached, we report in this study the angiographic resteno sis data as well as the clinical events observed at 6-month follow-up. The per-protocol population consisted of 646 patients. Restenosis, defined as a greater than or equal to 50% loss of the initial gain (National Heart, Lun g, and Blood institute criterion IV) occurred in 49% and 55% of the 308 nis oldipine-treated and the 338 placebo-treated patients, respectively (p = NS ). At follow-up, the rates of death and myocardial infarction were low and similar in both groups, but in the nisoldipine group, less patients require d early coronary angiography (18% vs 26%, p = 0.006) and subsequent revascu larization procedures (32% vs 41%, p = 0.057). Thus, nisoldipine did not si gnificantly reduce the angiographic restenosis rate after PTCA, but reduced the number of repeat revascularization procedures, which may be due to its antianginal action. (C) 2001 by Excerpta Medico, Inc.