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Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. | LitMetric

AI Article Synopsis

  • The PROACT Mitral trial studied the safety and efficacy of low-dose warfarin (target INR 2.0-2.5) compared to standard-dose warfarin (target INR 2.5-3.5) in patients with an On-X mechanical mitral valve.
  • 401 patients were randomly assigned to either low-dose or standard-dose warfarin after undergoing valve replacement, with a primary focus on events like thromboembolism and bleeding.
  • Results showed that low-dose warfarin did not meet the noninferiority threshold compared to standard-dose, with similar event rates in both groups, indicating low-dose warfarin is not as effective at preventing complications.

Article Abstract

Background: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve.

Methods: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin.

Results: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding.

Conclusions: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

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Source
http://dx.doi.org/10.1016/j.athoracsur.2022.12.031DOI Listing

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