Reduced anticoagulation after mechanical aortic valve replacement: Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial

John Puskas, Marc Gerdisch, Dennis Nichols, Reed Quinn, Charles Anderson, Birger Rhenman, Lilibeth Fermin, Michael McGrath, Bobby Kong, Chad Hughes, Gulshan Sethi, Michael Wait, Tomas Martin, Allen Graeve

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Abstract

Objective Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. Methods In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio [INR], 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. Results A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P <.0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P =.047) and minor (1.32% vs 3.41%/pt-yr; P =.021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. Conclusions INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.

Original languageEnglish (US)
JournalJournal of Thoracic and Cardiovascular Surgery
Volume147
Issue number4
DOIs
StatePublished - 2014

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International Normalized Ratio
United States Food and Drug Administration
Aortic Valve
Randomized Controlled Trials
Equipment and Supplies
Thromboembolism
Warfarin
Aspirin
Clinical Trials
Hemorrhage
Aortic Aneurysm
Transient Ischemic Attack
Endocarditis
Coronary Artery Bypass
Nervous System
Prostheses and Implants
Extremities
Stroke
Guidelines
Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

Reduced anticoagulation after mechanical aortic valve replacement : Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial. / Puskas, John; Gerdisch, Marc; Nichols, Dennis; Quinn, Reed; Anderson, Charles; Rhenman, Birger; Fermin, Lilibeth; McGrath, Michael; Kong, Bobby; Hughes, Chad; Sethi, Gulshan; Wait, Michael; Martin, Tomas; Graeve, Allen.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 147, No. 4, 2014.

Research output: Contribution to journalArticle

Puskas, John ; Gerdisch, Marc ; Nichols, Dennis ; Quinn, Reed ; Anderson, Charles ; Rhenman, Birger ; Fermin, Lilibeth ; McGrath, Michael ; Kong, Bobby ; Hughes, Chad ; Sethi, Gulshan ; Wait, Michael ; Martin, Tomas ; Graeve, Allen. / Reduced anticoagulation after mechanical aortic valve replacement : Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial. In: Journal of Thoracic and Cardiovascular Surgery. 2014 ; Vol. 147, No. 4.
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title = "Reduced anticoagulation after mechanical aortic valve replacement: Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial",
abstract = "Objective Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. Methods In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio [INR], 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. Results A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79{\%} were men; and 93{\%} were in sinus rhythm preoperatively. Calcific degeneration was present in 67{\%}; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27{\%}), aortic aneurysm repair (14{\%}), and other (25{\%}). The follow-up duration averaged 3.82 years (755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P <.0001). The test group experienced significantly lower major (1.48{\%} vs 3.26{\%}/pt-yr; P =.047) and minor (1.32{\%} vs 3.41{\%}/pt-yr; P =.021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. Conclusions INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.",
author = "John Puskas and Marc Gerdisch and Dennis Nichols and Reed Quinn and Charles Anderson and Birger Rhenman and Lilibeth Fermin and Michael McGrath and Bobby Kong and Chad Hughes and Gulshan Sethi and Michael Wait and Tomas Martin and Allen Graeve",
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T1 - Reduced anticoagulation after mechanical aortic valve replacement

T2 - Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial

AU - Puskas, John

AU - Gerdisch, Marc

AU - Nichols, Dennis

AU - Quinn, Reed

AU - Anderson, Charles

AU - Rhenman, Birger

AU - Fermin, Lilibeth

AU - McGrath, Michael

AU - Kong, Bobby

AU - Hughes, Chad

AU - Sethi, Gulshan

AU - Wait, Michael

AU - Martin, Tomas

AU - Graeve, Allen

PY - 2014

Y1 - 2014

N2 - Objective Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. Methods In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio [INR], 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. Results A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P <.0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P =.047) and minor (1.32% vs 3.41%/pt-yr; P =.021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. Conclusions INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.

AB - Objective Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. Methods In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio [INR], 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. Results A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P <.0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P =.047) and minor (1.32% vs 3.41%/pt-yr; P =.021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. Conclusions INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.

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