Saturday, October 14, 2017

ARTE Trial

ARTE (Aspirin Versus Aspirin + Clopidogrel Following TAVR) - DAPT vs SAPT

So far all patients who go through transcatheter aortic valve replacement (TAVR), receive dual-antiplatelet therapy (DAPT) per present guidelines, but here is the new development. ARTE trial were presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions by Dr. Josep Rodes-Cabau of Laval University in Quebec City.

ARTE was a multicenter, prospective, international open-label study of 222 TAVR patients who were randomized to 3 months of single-antiplatelet therapy (SAPT) with aspirin at 80-100 mg/day or to DAPT with aspirin at 80-100 mg/day plus clopidogrel at 75 mg/day after a single 300-mg loading dose.  Patients  had a mean Society of Thoracic Surgery Predicted Risk of Mortality score of 6.3%.

Results:

The primary outcome was the 3-month composite of
  • death, 
  • MI, 
  • major or life-threatening bleeding, 
  • stroke or transient ischemic attack. 
Results concluded 15.3% in the DAPT group and 7.2% in the SAPT group. Though study didn't achieve a statistical significance value (P = .065), probably  because of small sample size. But, importantly and most relevantly it showed strong and consistent benefit favoring SAPT,  in major or life-threatening bleeding achieved statistical significance.  Four bleeding events in the SAPT group were vascular in nature, while five of the 12 in the DAPT group were gastrointestinal. All the bleeding events in the SAPT group occurred within 72 hours after TAVR, whereas 5 of 12 in the DAPT recipients occurred later.

Only one patient on SAPT experienced life-threatening bleeding, compared with seven DAPT patients.

Important note: Trial was halted prematurely. The original study was planned to recruit 300 patients with over a year of follow-up. Trial was stopped due to slow enrollment and withdrawal of financial support by the study sponsors.


Reference:

Rod├ęs-Cabau J and et al: - 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. Epub 2017 May 17. 

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