Structural
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

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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)

Key Words

aortic stenosis
aspirin
bleeding
clopidogrel
stroke
transcatheter aortic valve replacement

Abbreviations and Acronyms

CI
confidence interval
DAPT
dual antiplatelet therapy
MI
myocardial infarction
OR
odds ratio
SAPT
single-antiplatelet therapy
TAVR
transcatheter aortic valve replacement
TIA
transient ischemic attack

Cited by (0)

This trial was supported by a grant from Edwards Lifesciences and by a grant from the Foundation of the Research Center of the Quebec Heart & Lung Institute. Drs. Rodés-Cabau and Webb have received research grants from Edwards Lifesciences. Dr. Welsh has received research grants and personal fees from AstraZeneca, Amgen, Bayer, Janssen, Bristol-Myers Squibb/Pfizer, and Edwards Lifesciences; and research grants from Boehringer Ingelheim. Drs. Masson and Généreux are consultants for Edwards Lifesciences. Dr. Chamandi has received fellowship grant support from Edwards Lifesciences. Dr. Thoenes is an employee of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.