Antithrombotic therapy after bioprosthetic aortic valve implantation: Warfarin versus aspirin, a randomized controlled trial

TY - JOUR

T1 - Antithrombotic therapy after bioprosthetic aortic valve implantation

T2 - Warfarin versus aspirin, a randomized controlled trial

AU - Rafiq, Sulman

AU - Steinbrüchel, Daniel Andreas

AU - Lilleør, Nikolaj Bang

AU - Møller, Christian Holdflod

AU - Lund, Jens T.

AU - Thiis, Jens Juel

AU - Køber, Lars

AU - Olsen, Peter Skov

PY - 2017/2

Y1 - 2017/2

N2 - Background The optimal medical strategy for prevention of thromboembolic events after surgical bioprosthetic aortic valve replacement (BAVR) is still debated. The objective of this study was to compare warfarin therapy (target INR of 2.0 to 3.0) with aspirin 150 mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, major bleeding complications and death. Materials and methods Prospective, single-centre, open-label, randomized controlled trial. 370 patients were enrolled, 328 were available for data analysis. Results At baseline the warfarin and aspirin groups were comparable. Thromboembolic events were comparable between groups 11 (6.6%) vs. 12 (7.5%), p = 0.83. Major bleeding events occurred numerically more often in warfarin patients 9 (5.4%) vs. 3 (1.9%), p = 0.14. Warfarin was in multivariate analysis significantly associated with major bleeding OR 5.18 (CI 1.06–25.43), p = 0.043. 90-day mortality was comparable between groups 8 (4.7%) vs. 6 (3.7%), p = 0.79. Conclusions Our results suggest that aspirin might be equally effective as warfarin in preventing thromboembolic events after BAVR, but with less major bleedings. Although this is numerically the largest trial testing this hypothesis in a prospective randomized trial, further adequately powered studies are warranted.

AB - Background The optimal medical strategy for prevention of thromboembolic events after surgical bioprosthetic aortic valve replacement (BAVR) is still debated. The objective of this study was to compare warfarin therapy (target INR of 2.0 to 3.0) with aspirin 150 mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, major bleeding complications and death. Materials and methods Prospective, single-centre, open-label, randomized controlled trial. 370 patients were enrolled, 328 were available for data analysis. Results At baseline the warfarin and aspirin groups were comparable. Thromboembolic events were comparable between groups 11 (6.6%) vs. 12 (7.5%), p = 0.83. Major bleeding events occurred numerically more often in warfarin patients 9 (5.4%) vs. 3 (1.9%), p = 0.14. Warfarin was in multivariate analysis significantly associated with major bleeding OR 5.18 (CI 1.06–25.43), p = 0.043. 90-day mortality was comparable between groups 8 (4.7%) vs. 6 (3.7%), p = 0.79. Conclusions Our results suggest that aspirin might be equally effective as warfarin in preventing thromboembolic events after BAVR, but with less major bleedings. Although this is numerically the largest trial testing this hypothesis in a prospective randomized trial, further adequately powered studies are warranted.

KW - Anticoagulation

KW - Aspirin

KW - Bioprosthetic valve

KW - Heart valve prosthesis

KW - Thrombosis

U2 - 10.1016/j.thromres.2016.11.021

DO - 10.1016/j.thromres.2016.11.021

M3 - Journal article

C2 - 27914653

AN - SCOPUS:85007415700

SN - 0049-3848

VL - 150

SP - 104

EP - 110

JO - Thrombosis Research

JF - Thrombosis Research

ER -