Triflusal vs aspirin for prevention of cerebral infarction: a randomized stroke study.
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.
Culebras
A
A
Department of Neurology, Upstate Medical University, Syracuse, NY 13210, USA. aculebras@aol.com
Rotta-Escalante
R
R
Vila
J
J
Domínguez
R
R
Abiusi
G
G
Famulari
A
A
Rey
R
R
Bauso-Tosselli
L
L
Gori
H
H
Ferrari
J
J
Reich
E
E
D000368:Aged; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D002544:Cerebral Infarction / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002546:Ischemic Attack, Transient / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012459:Salicylates / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention; D020521:Stroke / Q000517:prevention & control*; D016019:Survival Analysis; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D012459:Salicylates; C016167:triflusal; D001241:Aspirin