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

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@article{6fb014ff23d341f591b3d82c3696d3f2,
title = "Antithrombotic therapy after bioprosthetic aortic valve implantation: Warfarin versus aspirin, a randomized controlled trial",
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.",
keywords = "Aged, Aged, 80 and over, Anticoagulants, Aortic Valve, Aspirin, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Hemorrhage, Humans, Postoperative Complications, Prospective Studies, Thromboembolism, Thrombosis, Warfarin, Journal Article, Randomized Controlled Trial",
author = "Sulman Rafiq and Steinbr{\"u}chel, {Daniel Andreas} and Lille{\o}r, {Nikolaj Bang} and M{\o}ller, {Christian Holdflod} and Lund, {Jens Teglgaard} and Thiis, {Jens Juel} and Lars K{\o}ber and Olsen, {Peter Skov}",
note = "Copyright {\circledC} 2016 Elsevier Ltd. All rights reserved.",
year = "2017",
month = "2",
doi = "10.1016/j.thromres.2016.11.021",
language = "English",
volume = "150",
pages = "104--110",
journal = "Thrombosis Research",
issn = "0049-3848",
publisher = "Pergamon",

}

RIS

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 Teglgaard

AU - Thiis, Jens Juel

AU - Køber, Lars

AU - Olsen, Peter Skov

N1 - Copyright © 2016 Elsevier Ltd. All rights reserved.

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 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.

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 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.

KW - Aged

KW - Aged, 80 and over

KW - Anticoagulants

KW - Aortic Valve

KW - Aspirin

KW - Bioprosthesis

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation

KW - Hemorrhage

KW - Humans

KW - Postoperative Complications

KW - Prospective Studies

KW - Thromboembolism

KW - Thrombosis

KW - Warfarin

KW - Journal Article

KW - Randomized Controlled Trial

U2 - 10.1016/j.thromres.2016.11.021

DO - 10.1016/j.thromres.2016.11.021

M3 - Journal article

VL - 150

SP - 104

EP - 110

JO - Thrombosis Research

JF - Thrombosis Research

SN - 0049-3848

ER -

ID: 52051204