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

JACC Cardiovasc Interv. 2017 Jul 10;10(13):1357-1365. doi: 10.1016/j.jcin.2017.04.014. Epub 2017 May 17.

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).

Keywords: aortic stenosis; aspirin; bleeding; clopidogrel; stroke; transcatheter aortic valve replacement.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Aspirin / administration & dosage*
  • Aspirin / adverse effects
  • Balloon Valvuloplasty* / adverse effects
  • Canada
  • Clopidogrel
  • Drug Therapy, Combination
  • Early Termination of Clinical Trials
  • Europe
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Heart Valve Prosthesis*
  • 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 / administration & dosage*
  • Platelet Aggregation Inhibitors / adverse effects
  • Prosthesis Design
  • Risk Factors
  • South America
  • Stroke / etiology
  • Stroke / prevention & control
  • Thrombosis / diagnosis
  • Thrombosis / etiology
  • Thrombosis / mortality
  • Thrombosis / prevention & control*
  • Ticlopidine / administration & dosage
  • Ticlopidine / adverse effects
  • Ticlopidine / analogs & derivatives*
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome

Substances

  • Fibrinolytic Agents
  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT01559298
  • ClinicalTrials.gov/NCT02640794