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Usefulness of Nisoldipine for prevention of restenosis after percutaneous transluminal coronary angioplasty (results of the NICOLE study). NIsoldipine in COronary artery disease in LEuven.
Dens, J A; Desmet, W J; Coussement, P; De Scheerder, I K; Kostopoulos, K; Kerdsinchai, P; Supanantaroek, C; Piessens, J H.
Afiliação
  • Dens JA; Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium. Joseph.Dens@uz.kuleuven.ac.be
Am J Cardiol ; 87(1): 28-33, 2001 Jan 01.
Article em En | MEDLINE | ID: mdl-11137829
ABSTRACT
The NIsoldipine in COronary artery disease in LEuven (NICOLE) study investigates (1) whether nisoldipine, a dihydropyridine calcium antagonist, reduces the progression of minor coronary arterial lesions in the long term, and (2) whether it reduces the restenosis rate after successful percutaneous transluminal coronary angioplasty (PTCA). The NICOLE study is a single-center, randomized, double-blind trial in 826 patients, who underwent a successful PTCA. Nisoldipine 40 mg coat-core or placebo was started the morning after the procedure and continued for 3 years. All coronary arterial segments were measured on preprocedural angiogram and on the second follow-up angiogram at 3 years. On the first follow-up angiogram at 6 months only the dilated segments were measured. Although the study is still ongoing until the primary end point is reached, we report in this study the angiographic restenosis 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 > or =50% loss of the initial gain (National Heart, Lung, and Blood Institute criterion IV) occurred in 49% and 55% of the 308 nisoldipine-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 required early coronary angiography (18% vs 26%, p = 0.006) and subsequent revascularization procedures (32% vs 41%, p = 0.057). Thus, nisoldipine did not significantly reduce the angiographic restenosis rate after PTCA, but reduced the number of repeat revascularization procedures, which may be due to its antianginal action.
Assuntos
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Base de dados: MEDLINE Assunto principal: Bloqueadores dos Canais de Cálcio / Angioplastia Coronária com Balão / Nisoldipino / Doença das Coronárias Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies Limite: Female / Humans / Male / Middle aged Idioma: En Revista: Am J Cardiol Ano de publicação: 2001 Tipo de documento: Article País de afiliação: Bélgica
Buscar no Google
Base de dados: MEDLINE Assunto principal: Bloqueadores dos Canais de Cálcio / Angioplastia Coronária com Balão / Nisoldipino / Doença das Coronárias Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies Limite: Female / Humans / Male / Middle aged Idioma: En Revista: Am J Cardiol Ano de publicação: 2001 Tipo de documento: Article País de afiliação: Bélgica