Skip to main content
Journal cover image

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

Publication ,  Journal Article
Chu, MWA; Ruel, M; Graeve, A; Gerdisch, MW; Damiano, RJ; Smith, RL; Keeling, WB; Wait, MA; Hagberg, RC; Quinn, RD; Sethi, GK; Floridia, R ...
Published in: Ann Thorac Surg
April 2023

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).

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Ann Thorac Surg

DOI

EISSN

1552-6259

Publication Date

April 2023

Volume

115

Issue

4

Start / End Page

929 / 938

Location

Netherlands

Related Subject Headings

  • Warfarin
  • Thrombosis
  • Thromboembolism
  • Respiratory System
  • Prospective Studies
  • Mitral Valve
  • Humans
  • Hemorrhage
  • Heart Valve Prosthesis Implantation
  • Anticoagulants
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chu, M. W. A., Ruel, M., Graeve, A., Gerdisch, M. W., Damiano, R. J., Smith, R. L., … PROACT Mitral Investigators, . (2023). Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg, 115(4), 929–938. https://doi.org/10.1016/j.athoracsur.2022.12.031
Chu, Michael W. A., Marc Ruel, Allen Graeve, Marc W. Gerdisch, Ralph J. Damiano, Robert L. Smith, William Brent Keeling, et al. “Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.Ann Thorac Surg 115, no. 4 (April 2023): 929–38. https://doi.org/10.1016/j.athoracsur.2022.12.031.
Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ, Smith RL, et al. Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg. 2023 Apr;115(4):929–38.
Chu, Michael W. A., et al. “Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.Ann Thorac Surg, vol. 115, no. 4, Apr. 2023, pp. 929–38. Pubmed, doi:10.1016/j.athoracsur.2022.12.031.
Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ, Smith RL, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE, DeRose JJ, Lehr EJ, Alexander JH, Puskas JD, PROACT Mitral Investigators. Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg. 2023 Apr;115(4):929–938.
Journal cover image

Published In

Ann Thorac Surg

DOI

EISSN

1552-6259

Publication Date

April 2023

Volume

115

Issue

4

Start / End Page

929 / 938

Location

Netherlands

Related Subject Headings

  • Warfarin
  • Thrombosis
  • Thromboembolism
  • Respiratory System
  • Prospective Studies
  • Mitral Valve
  • Humans
  • Hemorrhage
  • Heart Valve Prosthesis Implantation
  • Anticoagulants