on March 20, 2003
Published online before print March 20, 2003, doi: 10.1161/01.STR.0000063141.24491.50
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Submitted on September 12, 2002
From the Service of Neurology, Hospital General Universitario de Alicante, Alicante, Spain (J.M-G.); Department of Neurology, Hospital Santa Maria, Lisbon, Portugal (J.M.F., T.M.); Cerebrovascular Unit, Service of Neurology, Hospital General i Universitari Vall d'Hebron, Barcelona, Spain (J.A-S.); Biostatistics and Epidemiology Laboratory, Autonomous University of Barcelona, Barcelona, Spain (F.T.); Service of Neurology, Hospital Universitario Virgen de Valme, Sevilla, Spain (M.D.J.); and Service of Neurology, Hospital La Fe, Valencia, Spain (A.L.). * To whom correspondence should be addressed. E-mail: matias_jor{at}gva.es.
Background and Purpose--The efficacy of the antiplatelet agent triflusal for prevention of vascular events after stroke has been reported in a pilot study. However, there is a need to confirm those results in a larger study. Methods--We performed a randomized, double-blind, multicenter study to test the efficacy of triflusal (600 mg/d) versus aspirin (325 mg/d) for prevention of vascular events in patients with stroke or transient ischemic attack (Triflusal versus Aspirin in Cerebral Infarction Prevention [TACIP]). We assessed a combined end point (incidence of nonfatal ischemic stroke, nonfatal acute myocardial infarction, or vascular death) as well as the incidence of these events separately and the incidence of major hemorrhage. Results--Of 2113 patients, 1058 received triflusal and 1055 aspirin. The mean follow-up period was 30.1 months. The incidence of combined end point (13.1% for triflusal, 12.4% for aspirin) as well the survival analysis (hazard ratio [HR] for triflusal versus aspirin, 1.09; 95% CI, 0.85 to 1.38) showed no differences between groups. The incidence of nonfatal stroke (HR, 1.09; 95% CI, 0.82 to 1.44), nonfatal acute myocardial infarction (HR, 0.95; 95% CI, 0.46 to 1.98,) and vascular death (HR, 1.22; 95% CI, 0.75 to 1.96) was also similar. A significantly higher incidence of major hemorrhages in the aspirin group was recorded (HR, 0.48; 95% CI, 0.28 to 0.82). The overall incidence of hemorrhage was significantly lower in the triflusal group (16.7% versus 25.2%) (odds ratio, 0.76; 95% CI, 0.67 to 0.86; P<0.001). Conclusions--This study failed to show significantly superior efficacy of triflusal over aspirin in the long-term prevention of vascular events after stroke, but triflusal was associated with a significantly lower rate of hemorrhagic complications.
Accepted on October 22, 2002
Comparison of Triflusal and Aspirin for Prevention of Vascular Events in Patients After Cerebral Infarction. The TACIP Study: A Randomized, Double-Blind, Multicenter Trial
Jordi Matías-Guiu MD*;
Key words: aspirin • cerebral infarction • controlled clinical trials • hemorrhage • salicylates
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