RT info:eu-repo/semantics/article
T1 Results of the randomized, placebo controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheal arterial disease (CASPAR) trial
A1 Belch, Jill J.F.
A1 Dormandy, John
A1 Caspar Writing Committee
K1 Cardiovascular, Aparato, Efectos de los medicamentos sobre el
K1 Cirugía cardiovascular
AB Objective: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patientswith acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determinewhether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-kneebypass grafting.Methods: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD)were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite ofindex-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safetyendpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occludedcoronary arteries [GUSTO] classification).Results: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151of 426 patients in the placebo (plus ASA) group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.78-1.23). Ina prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graftpatients (HR, 0.65; 95% CI, 0.45-0.95; P   .025) but not in venous graft patients (HR, 1.25; 95% CI, 0.94-1.67, notsignificant [NS]). A significant statistical interaction between treatment effect and graft type was observed (Pinteraction  .008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the ratesof severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1% vs 1.2%).Conclusion: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overallpopulation of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASAconfers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.
PB Universidad de Valladolid. Facultad de Medicina
SN 0741-5214
YR 2010
FD 2010
LK http://uvadoc.uva.es/handle/10324/2925
UL http://uvadoc.uva.es/handle/10324/2925
LA spa
NO Journal of Vascular Surgery, October 2010, vol. 52, n.4. p.825-833
NO Producción Científica
DS UVaDOC
RD 22-dic-2024