Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement

PROACT Investigators

Research output: Contribution to journalArticle

13 Citations (Scopus)

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)

Original languageEnglish (US)
Pages (from-to)2717-2726
Number of pages10
JournalJournal of the American College of Cardiology
Volume71
Issue number24
DOIs
StatePublished - Jun 19 2018

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Aortic Valve
Warfarin
Aspirin
International Normalized Ratio
clopidogrel
Thromboembolism
Mortality
Hemorrhage
Group Psychotherapy
Prostheses and Implants
Thrombosis
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement. / PROACT Investigators.

In: Journal of the American College of Cardiology, Vol. 71, No. 24, 19.06.2018, p. 2717-2726.

Research output: Contribution to journalArticle

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title = "Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement",
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)",
author = "{PROACT Investigators} and Puskas, {John D.} and Marc Gerdisch and Dennis Nichols and Lilibeth Fermin and Birger Rhenman and Divya Kapoor and Jack Copeland and Reed Quinn and Hughes, {G. Chad} and Hormoz Azar and Michael McGrath and Michael Wait and Bobby Kong and Tomas Martin and Douville, {E. Charles} and Steven Meyer and Jian Ye and Jamieson, {W. R.Eric} and Lance Landvater and Robert Hagberg and Timothy Trotter and John Armitage and Jeffrey Askew and Kevin Accola and Paul Levy and David Duncan and Bobby Yanagawa and John Ely and Allen Graeve and John Puskas and Marc Gerdisch and Dennis Nichols and Allen Graeve and Lilibeth Fermin and Birger Rhenman and Divya Kapoor and Jack Copeland and Reed Quinn and Hughes, {G. Chad} and Hormoz Azar and Michael McGrath and Michael Wait and Bobby Kong and Tomas Martin and Douville, {E. Charles} and Steven Meyer and Jamieson, {W. R.Eric} and Jian Ye and Lance Landvater and {Sai Sudhakar}, Chittoor",
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TY - JOUR

T1 - Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement

AU - PROACT Investigators

AU - Puskas, John D.

AU - Gerdisch, Marc

AU - Nichols, Dennis

AU - Fermin, Lilibeth

AU - Rhenman, Birger

AU - Kapoor, Divya

AU - Copeland, Jack

AU - Quinn, Reed

AU - Hughes, G. Chad

AU - Azar, Hormoz

AU - McGrath, Michael

AU - Wait, Michael

AU - Kong, Bobby

AU - Martin, Tomas

AU - Douville, E. Charles

AU - Meyer, Steven

AU - Ye, Jian

AU - Jamieson, W. R.Eric

AU - Landvater, Lance

AU - Hagberg, Robert

AU - Trotter, Timothy

AU - Armitage, John

AU - Askew, Jeffrey

AU - Accola, Kevin

AU - Levy, Paul

AU - Duncan, David

AU - Yanagawa, Bobby

AU - Ely, John

AU - Graeve, Allen

AU - Puskas, John

AU - Gerdisch, Marc

AU - Nichols, Dennis

AU - Graeve, Allen

AU - Fermin, Lilibeth

AU - Rhenman, Birger

AU - Kapoor, Divya

AU - Copeland, Jack

AU - Quinn, Reed

AU - Hughes, G. Chad

AU - Azar, Hormoz

AU - McGrath, Michael

AU - Wait, Michael

AU - Kong, Bobby

AU - Martin, Tomas

AU - Douville, E. Charles

AU - Meyer, Steven

AU - Jamieson, W. R.Eric

AU - Ye, Jian

AU - Landvater, Lance

AU - Sai Sudhakar, Chittoor

PY - 2018/6/19

Y1 - 2018/6/19

N2 - 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)

AB - 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)

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DO - 10.1016/j.jacc.2018.03.535

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EP - 2726

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 24

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