John D Puskas1, Marc Gerdisch2, Dennis Nichols3, Lilibeth Fermin4, Birger Rhenman4, Divya Kapoor4, Jack Copeland5, Reed Quinn6, G Chad Hughes7, Hormoz Azar8, Michael McGrath8, Michael Wait9, Bobby Kong10, Tomas Martin11, E Charles Douville12, Steven Meyer13, Jian Ye14, W R Eric Jamieson15, Lance Landvater16, Robert Hagberg17, Timothy Trotter18, John Armitage19, Jeffrey Askew19, Kevin Accola20, Paul Levy21, David Duncan22, Bobby Yanagawa23, John Ely24, Allen Graeve3. 1. Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: john.puskas@mountsinai.org. 2. Franciscan St. Francis Health, Indianapolis, Indiana. 3. Multicare Tacoma General, Tacoma, Washington. 4. Southern Arizona Veterans Affairs Hospital, Tucson, Arizona. 5. University of Arizona, Tucson, Arizona. 6. Maine Medical, Portland, Maine. 7. Duke University, Durham, North Carolina. 8. Sentara Norfolk General, Norfolk, Virginia. 9. University of Texas Southwestern, Dallas, Texas. 10. St. Joseph Mercy Hospital, Ann Arbor, Michigan. 11. University of Florida, Gainesville, Florida. 12. Providence Portland, Portland, Oregon. 13. University of Alberta, Edmonton, Alberta, Canada. 14. St. Paul's Hospital, Vancouver, British Columbia, Canada. 15. Vancouver General Hospital, Vancouver, British Columbia, Canada. 16. Carolina Cardiovascular, Raleigh, North Carolina. 17. Hartford Hospital, Hartford, Connecticut. 18. Oklahoma City VA, Oklahoma City, Oklahoma. 19. Mary Washington, Fredericksburg, Virginia. 20. Florida Hospital, Orlando, Florida. 21. New Mexico Heart Institute, Albuquerque, New Mexico. 22. Novant Health Forsyth Medical Center, Winston-Salem, North Carolina. 23. St. Michael's Hospital, Toronto, Ontario, Canada. 24. On-X Life Technologies, Austin, Texas.
Abstract
BACKGROUND: The burden oral anticoagulation is a limitation of mechanical valve prostheses. OBJECTIVES: The aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR). METHODS: PROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients≥18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm). RESULTS: The low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality. CONCLUSIONS:DAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (Randomized On-X Anticoagulation Trial [PROACT]; NCT00291525).
RCT Entities:
BACKGROUND: The burden oral anticoagulation is a limitation of mechanical valve prostheses. OBJECTIVES: The aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR). METHODS: PROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients ≥18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm). RESULTS: The low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality. CONCLUSIONS:DAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (Randomized On-X Anticoagulation Trial [PROACT]; NCT00291525).
Authors: Gudrun Lamm; Matthias Hammerer; Uta C Hoppe; Martin Andreas; Rudolf Berger; Ronald K Binder; Nikolaos Bonaros; Georg Delle-Karth; Matthias Frick; Michael Grund; Bernhard Metzler; Thomas Neunteufl; Philipp Pichler; Albrecht Schmidt; Wilfried Wisser; Andreas Zierer; Rainald Seitelberger; Michael Grimm; Alexander Geppert Journal: Wien Klin Wochenschr Date: 2021-03-23 Impact factor: 1.704
Authors: Markus Liebrich; Efstratios I Charitos; Christoph Dingemann; Detlef Roser; Joerg Seeburger; Wolfgang Hemmer; Vladimir Voth Journal: Ann Cardiothorac Surg Date: 2021-07