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Optimal antithrombotic strategy in patients with atrial fibrillation beyond 1 year after drug-eluting stent implantation: Design and rationale of the randomized ADAPT AF-DES trial.
- Source :
-
American heart journal [Am Heart J] 2024 May; Vol. 271, pp. 48-54. Date of Electronic Publication: 2024 Feb 23. - Publication Year :
- 2024
-
Abstract
- Background: Both anticoagulation and antiplatelet therapies are recommended after percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF). Although contemporary guidelines recommend discontinuation of antiplatelet therapy 1 year after drug-eluting stent (DES) implantation due to excessive bleeding risk, supporting randomized trials are still lacking.<br />Methods: The ADAPT AF-DES trial is a multicenter, prospective, open-label, randomized, non-inferiority trial, enrolling 960 patients with AF with a CHA <subscript>2</subscript> DS <subscript>2</subscript> -VASc score > 1, who underwent PCI with DES implantation at least 12 months before enrollment. Eligible patients are randomly assigned to receive either non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy or NOAC plus clopidogrel combination therapy. The primary outcome is net adverse clinical event (NACE) at 1 year after randomization, defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and major or clinically relevant non-major bleeding, as defined by the International Society on Thrombosis and Hemostasis criteria. We hypothesize that NOAC monotherapy would be non-inferior to NOAC plus clopidogrel combination therapy for NACE in patients with AF beyond 12 months after DES implantation.<br />Conclusions: The ADAPT AF-DES trial will evaluate the efficacy and safety of NOAC monotherapy versus NOAC plus clopidogrel combination therapy in patients with AF beyond 12 months after PCI with DES implantation. The ADAPT AF-DES trial will provide robust evidence for an optimal antithrombotic strategy in patients with AF after DES implantation.<br />Clinical Trial Registration: https://www.<br />Clinicaltrials: gov. Unique identifier: NCT04250116.<br />Competing Interests: Disclosure J-SK reported receiving grants from Samjin Pharmaceutical and speaker's fees from Abbott Vascular.<br /> (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Subjects :
- Female
Humans
Male
Drug Therapy, Combination
Hemorrhage chemically induced
Prospective Studies
Stroke prevention & control
Stroke etiology
Time Factors
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Anticoagulants administration & dosage
Anticoagulants therapeutic use
Atrial Fibrillation complications
Atrial Fibrillation drug therapy
Atrial Fibrillation therapy
Clopidogrel administration & dosage
Clopidogrel therapeutic use
Drug-Eluting Stents
Percutaneous Coronary Intervention methods
Platelet Aggregation Inhibitors therapeutic use
Platelet Aggregation Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 271
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 38401647
- Full Text :
- https://doi.org/10.1016/j.ahj.2024.02.014