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 -