1. Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.
- Author
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Rodés-Cabau J, Masson JB, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, Al-Qoofi F, Généreux P, Maluenda G, Thoenes M, Paradis JM, Chamandi C, Serra V, Dumont E, and Côté M
- Subjects
- Aged, Aged, 80 and over, Aspirin adverse effects, Canada, Clopidogrel, Drug Therapy, Combination, Early Termination of Clinical Trials, Europe, Female, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced, Humans, Ischemic Attack, Transient etiology, Ischemic Attack, Transient prevention & control, Kaplan-Meier Estimate, Male, Myocardial Infarction etiology, Myocardial Infarction prevention & control, Platelet Aggregation Inhibitors adverse effects, Prosthesis Design, Risk Factors, South America, Stroke etiology, Stroke prevention & control, Thrombosis diagnosis, Thrombosis etiology, Thrombosis mortality, Ticlopidine administration & dosage, Ticlopidine adverse effects, Time Factors, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Treatment Outcome, Aortic Valve surgery, Aspirin administration & dosage, Balloon Valvuloplasty adverse effects, Fibrinolytic Agents administration & dosage, Heart Valve Prosthesis, Platelet Aggregation Inhibitors administration & dosage, Thrombosis prevention & control, Ticlopidine analogs & derivatives, Transcatheter Aortic Valve Replacement instrumentation
- Abstract
Objectives: The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death., Background: Few data exist on the optimal antithrombotic therapy following TAVR., Methods: This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve. The primary endpoint was the occurrence of death, myocardial infarction (MI), stroke or transient ischemic attack, or major or life-threatening bleeding (according to Valve Academic Research Consortium 2 definitions) within the 3 months following the procedure. The trial was prematurely stopped after the inclusion of 74% of the planned study population., Results: A total of 222 patients were included, 111 allocated to DAPT and 111 to SAPT. The composite of death, MI, stroke or transient ischemic attack, or major or life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065). There were no differences between groups in the occurrence of death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), MI (DAPT, 3.6%; SAT, 0.9%; p = 0.18), or stroke or transient ischemic attack (DAPT, 2.7%; SAPT, 0.9%; p = 0.31) at 3 months. DAPT was associated with a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the SAPT group, p = 0.038). There were no differences between groups in valve hemodynamic status post-TAVR., Conclusions: This small trial showed that SAPT (vs. DAPT) tended to reduce the occurrence of major adverse events following TAVR. SAPT reduced the risk for major or life-threatening events while not increasing the risk for MI or stroke. Larger studies are needed to confirm these results. (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation: The ARTE Trial [ARTE], NCT01559298; Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI [ARTE], NCT02640794)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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