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Previous Volume 350:114-124 January 8, 2004 Number 2 Next

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ABSTRACT

Background The use of aspirin for the prevention of thrombotic complications in polycythemia vera is controversial.

Methods We enrolled 518 patients with polycythemia vera, no clear indication for aspirin treatment, and no contraindication to such treatment in a double-blind, placebo-controlled, randomized trial to assess the safety and efficacy of prophylaxis with low-dose aspirin (100 mg daily). The two primary end points were the cumulative rate of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and the cumulative rate of nonfatal myocardial infarction, nonfatal stroke, pulmonary embolism, major venous thrombosis, or death from cardiovascular causes. The mean duration of follow-up was about three years.

Results Treatment with aspirin, as compared with placebo, reduced the risk of the combined end point of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes (relative risk, 0.41; 95 percent confidence interval, 0.15 to 1.15; P=0.09) and the risk of the combined end point of nonfatal myocardial infarction, nonfatal stroke, pulmonary embolism, major venous thrombosis, or death from cardiovascular causes (relative risk, 0.40; 95 percent confidence interval, 0.18 to 0.91; P=0.03). Overall mortality and cardiovascular mortality were not reduced significantly. The incidence of major bleeding episodes was not significantly increased in the aspirin group (relative risk, 1.62; 95 percent confidence interval, 0.27 to 9.71).

Conclusions Low-dose aspirin can safely prevent thrombotic complications in patients with polycythemia vera who have no contraindications to such treatment.

Source Information

From the Catholic University School of Medicine, Rome (R.L.); the Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy (R.M., G.T.); Sahlgrenska Hospital, Göteborg, Sweden (J.K.); the Department of Hematology and Blood Coagulation, University of Vienna, Vienna, Austria (H.G.); the University of Rome La Sapienza, Rome (C.P.); and the Ospedali Riuniti, Bergamo, Italy (T.B.).

Address reprint requests to Dr. Landolfi at the Istituto di Medicina Interna e Geriatria, Università Cattolica, Largo Gemelli 8, 00168 Rome, Italy, or at rlandolfi{at}rm.unicatt.it.

Full Text of this Article

Related Letters:

Low-Dose Aspirin in Polycythemia Vera
Alliot C., Dutrillaux F., Maynadié M., Carli P.-M., Denes A. E., Landolfi R., Marchioli R., Barbui T., Spivak J. L.
Extract | Full Text | PDF  
N Engl J Med 2004; 350:1683-1685, Apr 15, 2004. Correspondence

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