Background Despite the use of warfarin, major systemic embolismremains an important complication in patients with heart-valvereplacement. Although the addition of antiplatelet agents hasthe potential to reduce this complication, their efficacy andsafety when given in combination with warfarin are uncertain.
Methods In a randomized, double-blind, placebo-controlled trial,we assessed the efficacy and safety of adding aspirin (100 mgper day) to warfarin treatment (target international normalizedratio, 3.0 to 4.5) in 370 patients with mechanical heart valvesor with tissue valves plus atrial fibrillation or a historyof thromboembolism.
Results A total of 186 patients were randomly assigned to aspirinand 184 to placebo, and they were followed for up to 4 years(average, 2.5). Major systemic embolism or death from vascularcauses occurred in 6 aspirin-treated patients (1.9 percent peryear) and 24 placebo-treated patients (8.5 percent per year)(risk reduction with aspirin, 77 percent; 95 percent confidenceinterval, 44 to 91 percent; P<0.001). Major systemic embolism,nonfatal intracranial hemorrhage, or death from hemorrhage orvascular causes occurred in 12 patients assigned to aspirin(3.9 percent per year) and 28 patients assigned to placebo (9.9percent per year) (risk reduction, 61 per cent; 95 percent confidenceinterval, 24 to 80 percent; P = 0.005); major systemic embolismor death from any cause occurred in 13 patients (4.2 percent)and 33 patients (11.7 percent), respectively (risk reduction,65 percent; 95 percent confidence interval, 33 to 82 percent;P<0.001); and death from all causes occurred in 9 patients(2.8 percent) and 22 patients (7.4 percent), respectively (riskreduction, 63 percent; 95 percent confidence interval, 19 to83 percent; P = 0.01). Bleeding occurred in 71 patients in theaspirin group (35.0 percent), as compared with 49 patients inthe placebo group (22.0 percent) (increase in risk, 55 percent;95 percent confidence interval, 8 to 124 percent; P = 0.02);major bleeding occurred in 24 and 19 patients, respectively(increase in risk, 27 percent; 95 percent confidence interval,-30 to 132 percent; P = 0.43).
Conclusions In patients with mechanical heart valves and high-riskpatients with prosthetic tissue valves, the addition of aspirinto warfarin therapy reduced mortality, particularly mortalityfrom vascular causes, together with major systemic embolism.Although there was some increase in bleeding, the risk of thecombined treatment was more than offset by the considerablebenefit.
Source Information
From the Departments of Medicine (A.G.G.T., J.H.), Clinical Epidemiology and Biostatistics (M.G., M.K.), and Surgery (J.G.), McMaster University and Hamilton Civic Hospitals Research Centre, Hamilton, Ont.; the Department of Medicine, University of Western Ontario and University Hospital, London, Ont. (A.L.); and the Departments of Medicine (Y.L.) and Surgery (F.B.), Hotel-Dieu Hospital, Montreal -- all in Canada.
Address reprint requests to Dr. Turpie at HGH-McMaster Clinic, Hamilton Civic Hospitals, General Division, 237 Barton St. E., Hamilton, ON L8L 2X2, Canada.
Warfarin and Aspirin after Heart-Valve Replacement
Cannegieter S.C., van der Meer F.J.M., Briet E., Rosendaal F.R., Bussey H. I., Linn W. D., Keimowitz R. M., Fitzgerald D. J., Turpie A.G.G., Gent M., Laupacis A., Hirsh J.
Extract |
Full Text
N Engl J Med 1994;
330:507-509, Feb 17, 1994.
Correspondence
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