(Circulation. 1996;94:2107-2112.)
© 1996 American Heart Association, Inc.
Articles |
AREVA: Multicenter Randomized Comparison of Low-Dose Versus Standard-Dose Anticoagulation in Patients With Mechanical Prosthetic Heart Valves
From the Hopital Tenon, Paris (J.A., B.I., P.L.M.); the Service de Pharmacologie Clinique, Lyon (J.P.B., J.P.T., C.N.); the Hotel-Dieu, Paris (M.M.S.); the Centre Hospitalier Universitaire, Rennes (J.C.P., H.leB.); the Hopital de la Pitie-Salpetriere, Paris (D.T., R.I.); the Hopital Cardiologique, Lyon (G.deG., E.V.); the Hopital Cochin, Paris (A.S.); the Hopital R. Ballanger, Paris (G.H.); the Centre Hospitalier, Gonesse (M.G.); and the Centre Hospitalier Universitaire, Amiens (A.M.), France.
Correspondence to Pr J. Acar, Service de Cardiologie, Hopital Tenon, 4, rue de la Chine, 75020 Paris, France.
Background Moderate anticoagulation may be proposed to reduce the risk of hemorrhage for certain patients with a mechanical prosthesis, but the consequences for risk of thromboembolism are debated.
Methods and Results The purpose of the AREVA trial was to compare moderate oral anticoagulation (international normalized ratio [INR] of 2.0 to 3.0) with the usual regimen (INR of 3.0 to 4.5) after a single-valve replacement with a mechanical prosthesis, either Omnicarbon or St Jude. Patients included were between 18 and 75 years old, in sinus rhythm, and with a left atrial diameter 
50 mm on the time-motion echocardiogram. Patients were randomized for INR after surgery. From 1991 to 1994, 433 patients underwent valve replacement (aortic, 414; mitral, 19) with 353 St Jude and 80 Omnicarbon prostheses; 380 patients were randomized for INR: 188 for INR 2.0 to 3.0 and 192 for INR 3.0 to 4.5. Mean follow-up was 2.2 years (1 to 4 years). Analysis of 18 001 INR samples showed that the mean of the median of INR was 2.74±0.35 in the 2.0 to 3.0 group and 3.21±0.33 in the 3.0 to 4.5 group (P<.0001). Thromboembolic events, as assessed from clinical data and CT brain scans, occurred in 10 patients in the 2.0 to 3.0 INR group and 9 patients in the 3.0 to 4.5 INR group (P=.78). Hemorrhagic events occurred in 34 patients in the 2.0 to 3.0 INR group and 56 patients in the 3.0 to 4.5 INR group (P<.01), with 13 and 19 major hemorrhagic events, respectively (P=.29).
Conclusions In selected patients with mechanical prostheses, moderate anticoagulation prevents thromboembolic events as effectively as conventional anticoagulation and reduces the incidence of hemorrhagic events.
Key Words: anticoagulants • prosthesis • embolism
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