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Triflusal vs aspirin for prevention of cerebral infarction

A randomized stroke study

From the Upstate Medical University (Dr. Culebras), Syracuse, NY; and Servicio de Neurología (Dr. Rotta–Escalante), Policlínico Bancario; Sección Vasculares (Dr. Vila), Servicio de Neurología, Hospital Naval; Servicio de Neurología (Dr. Domínguez), Hospital Sirio Libanés; Sección Vasculares (Drs. Abiusi and Ferrari), Servicio de Neurología, Hospital Eva Perón; Sección Vasculares (Dr. Famulari), Fundación Argentina contra las Enfermedades Neurológicas del Envejecimiento; Sección Vasculares (Dr. Rey), Servicio de Neurología, Hospital Municipal José Ramos Mejía; Servicio de Neurología (Dr. Bauso–Tosselli), Hospital Italiano; Servicio de Neurología (Dr. Gori), Hospital Municipal Teodoro Alvarez; and Servicio de Neurología (Dr. Reich), Hospital Méndez, Buenos Aires, Argentina.

Address correspondence and reprint requests to Dr. A. Culebras, Department of Neurology, Upstate Medical University, 750 E. Adams St., Syracuse, NY 13210; e-mail: aculebras{at}aol.com

Background: Triflusal is an antiplatelet agent that has shown clinical advantages when compared with aspirin in the secondary prevention of vascular events. TAPIRSS (Triflusal versus Aspirin for Prevention of Infarction: a Randomized Stroke Study) explored the efficacy and safety of triflusal in the secondary prevention of stroke in a Latin American homogeneous population with the ultimate aim of preparing for a larger trial in the same setting.

Methods: A double-blind, multicenter, randomized, pilot trial was conducted in Buenos Aires, Argentina, from October 1996 to November 1999. The study sample was 431 patients, randomized to receive aspirin 325 mg daily or triflusal 600 mg daily for a mean of 586 days. All patients had experienced either an ischemic stroke or TIA within 6 months from enrollment. Data from 429 patients were analyzed.

Results: No differences were observed in the primary endpoint that combined the incidence of vascular death, cerebral ischemic infarction, nonfatal myocardial infarction, or major hemorrhage (aspirin 13.9%, triflusal 12.7%; odds ratio [OR] 1.11, 95% CI 0.64 to 1.94) or in the individual analysis of each component of the primary endpoint. In a post hoc analysis, the overall incidence of major and minor hemorrhagic events was significantly lower in triflusal-treated patients (aspirin 8.3%, triflusal 2.8%; OR 3.13, 95% CI 1.22 to 8.06).

Conclusions: This pilot trial has not found differences between triflusal and aspirin in the prevention of vascular complications after TIA or ischemic stroke, although given the wide CI, potentially important group differences could not be ruled out. Triflusal may be associated with a lower risk of hemorrhagic complications. A larger, prospective clinical trial is necessary to verify these results.

Received October 10, 2002. Accepted in final form November 13, 2003.

See also page 1036

*See the Appendix on page 1079 for a list of Group members.

The following authors have lectured with the support of J. Uriach & Cía., S.A.: Antonio Culebras, José Vila, Arturo Famulari, and Raúl O. Domínguez.

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