Sulman Rafiq1, Daniel Andreas Steinbrüchel2, Nikolaj Bang Lilleør3, Christian Holdflod Møller4, Jens Teglgaard Lund5, Jens Juel Thiis6, Lars Køber7, Peter Skov Olsen8. 1. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: sulman_raf@hotmail.com. 2. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: dastpr@gmail.com. 3. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: thomas.nikolaj.lilleoer@regionh.dk. 4. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: christian.moeller.02@regionh.dk. 5. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: jlund@dadlnet.dk. 6. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: jens.juel.thiis@regionh.dk. 7. Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: lars.koeber.01@regionh.dk. 8. Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen O, Denmark. Electronic address: peter.skov.olsen@regionh.dk.
Abstract
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 150mg 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.
RCT Entities:
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 150mg 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 warfarinpatients 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.
Authors: Joel N Papak; Joseph C Chiovaro; North Noelck; Laura D Healy; Michele Freeman; Jacquelyn A Quin; Robin Paynter; Allison Low; Karli Kondo; Owen J T McCarty; Devan Kansagara Journal: Ann Thorac Surg Date: 2018-11-17 Impact factor: 4.330