Switching of Oral Anticoagulation Therapy After PCI in Patients With Atrial Fibrillation: The RE-DUAL PCI Trial Subanalysis.


Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
09 12 2019
Historique:
received: 15 04 2019
revised: 23 08 2019
accepted: 27 08 2019
entrez: 7 12 2019
pubmed: 7 12 2019
medline: 21 7 2020
Statut: ppublish

Résumé

The aim of this study was to assess if prior oral anticoagulant agent (OAC) use modifies the lower bleeding risk observed with dabigatran dual therapy (dabigatran twice daily plus a P2Y In the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, the primary outcome of major bleeding or clinically relevant nonmajor bleeding was lower with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation who underwent PCI. A total of 2,725 patients were randomized to dual therapy with dabigatran (110 or 150 mg twice daily) plus clopidogrel or ticagrelor or triple therapy with warfarin plus aspirin and clopidogrel or ticagrelor. Subgroup analysis compared risk for major bleeding or clinically relevant nonmajor bleeding and a composite thromboembolic endpoint in patients with prior OAC use and in those who were OAC treatment naive. Risk for major bleeding or clinically relevant nonmajor bleeding was reduced with both dabigatran dual therapies compared with warfarin triple therapy in both the prior OAC use group (hazard ratios: 0.58 [95% confidence interval (CI): 0.42 to 0.81] and 0.61 [95% CI: 0.41 to 0.92] with 110 and 150 mg dabigatran, respectively) and the OAC-naive group (hazard ratios: 0.49 [95% CI: 0.38 to 0.63] and 0.76 [95% CI: 0.59 to 0.97] with 110 and 150 mg dabigatran) (p for interaction = 0.42 and 0.37, 110 and 150 mg dabigatran, respectively). The risk for thromboembolic events seemed similar with dabigatran dual therapy (both doses) and warfarin triple therapy across subgroups. Bleeding risk was reduced with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation after PCI, regardless of whether they were prior OAC users or OAC treatment naive. These results suggest that it is also safe to switch patients on OAC pre-PCI to dabigatran dual therapy post-PCI.

Sections du résumé

OBJECTIVES
The aim of this study was to assess if prior oral anticoagulant agent (OAC) use modifies the lower bleeding risk observed with dabigatran dual therapy (dabigatran twice daily plus a P2Y
BACKGROUND
In the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, the primary outcome of major bleeding or clinically relevant nonmajor bleeding was lower with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation who underwent PCI.
METHODS
A total of 2,725 patients were randomized to dual therapy with dabigatran (110 or 150 mg twice daily) plus clopidogrel or ticagrelor or triple therapy with warfarin plus aspirin and clopidogrel or ticagrelor. Subgroup analysis compared risk for major bleeding or clinically relevant nonmajor bleeding and a composite thromboembolic endpoint in patients with prior OAC use and in those who were OAC treatment naive.
RESULTS
Risk for major bleeding or clinically relevant nonmajor bleeding was reduced with both dabigatran dual therapies compared with warfarin triple therapy in both the prior OAC use group (hazard ratios: 0.58 [95% confidence interval (CI): 0.42 to 0.81] and 0.61 [95% CI: 0.41 to 0.92] with 110 and 150 mg dabigatran, respectively) and the OAC-naive group (hazard ratios: 0.49 [95% CI: 0.38 to 0.63] and 0.76 [95% CI: 0.59 to 0.97] with 110 and 150 mg dabigatran) (p for interaction = 0.42 and 0.37, 110 and 150 mg dabigatran, respectively). The risk for thromboembolic events seemed similar with dabigatran dual therapy (both doses) and warfarin triple therapy across subgroups.
CONCLUSIONS
Bleeding risk was reduced with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation after PCI, regardless of whether they were prior OAC users or OAC treatment naive. These results suggest that it is also safe to switch patients on OAC pre-PCI to dabigatran dual therapy post-PCI.

Identifiants

pubmed: 31806214
pii: S1936-8798(19)31855-2
doi: 10.1016/j.jcin.2019.08.039
pii:
doi:

Substances chimiques

Anticoagulants 0
Platelet Aggregation Inhibitors 0
Warfarin 5Q7ZVV76EI
Clopidogrel A74586SNO7
Ticagrelor GLH0314RVC
Dabigatran I0VM4M70GC
Aspirin R16CO5Y76E

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2331-2341

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Auteurs

Jurrien M Ten Berg (JM)

St. Antonius Ziekenhuis, Nieuwegein, the Netherlands. Electronic address: jurtenberg@gmail.com.

Anne de Veer (A)

St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.

Jonas Oldgren (J)

Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.

Philippe Gabriel Steg (PG)

French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, Paris, France; Université de Paris, Paris, France; INSERM U-1148, Paris, France; Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.

Dmitry A Zateyshchikov (DA)

Primary Vascular Department, City Clinic Hospital #51, Moscow, Russian Federation.

Petr Jansky (P)

Department of Cardiovascular Surgery, Faculty Hospital Motol, Prague, Czech Republic.

Ki-Bae Seung (KB)

The Catholic University of Korea, Seoul, Korea.

Stefan H Hohnloser (SH)

Johann Wolfgang Goethe University, Frankfurt am Main, Germany.

Gregory Y H Lip (GYH)

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

Matias Nordaby (M)

Boehringer Ingelheim International, Ingelheim, Germany.

Eva Kleine (E)

Boehringer Ingelheim International, Ingelheim, Germany.

Deepak L Bhatt (DL)

Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.

Christopher P Cannon (CP)

Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.

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Classifications MeSH