Dual Antiplatelet in TAVR: Is Single Better?

Courtesy of Dr. Agustín Vecchia.

As TAVR is expanded to lower risk patients, complications become more relevant. As regards stroke, the PARTNER 2 and SURTAVI one year outcomes are 8.0% and 8.2% respectively. The mechanisms behind this complication have not yet been clarified and, therefore, neither have guideline recommendations in this regard (as we can tell by the large number of ongoing trials trying out different treatments).

The aim of this study was to compare dual antiplatelet therapy with aspirin and clopidogrel vs. aspirin alone after TAVR with balloon expandable valves to prevent ischemic and bleeding events, and death.  222 patients were randomized to aspirin + clopidogrel (DAPT, N: 111) vs. aspirin alone (SAPT, N: 111). Primary end point was death, AMI, stroke or transient ischemic attack (TIA), or life threatening major bleeding (VARC 2) at 3 months. The study was prematurely interrupted after including 74% of the planned sample population.

Primary end point more frequently occurred (though not significantly) in patients with DAPT: 15.3% vs. 7.2%, p = 0.065. At 3 months there were no differences between the groups as regards death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), AMI (DAPT, 3.6%; SAT, 0.9%; p= 0.18) or stroke/TIA (DAPT, 2.7%; SAPT, 0.9%; p ¼ 0.31). DAPT was associated to a significantly higher rate of life threatening major bleeding: 10.8% vs. 3.6% in the SAPT group, p = 0.038. There were no differences between the groups as regards post TAVR valve hemodynamics.

 Also Read: “How to classify aortic stenosis in TAVR patients”

Authors concluded that even though this is a small study, there is a tendency to lower post TAVR MACE with SAPT, in addition to a significant reduction or life threatening major bleeding events with no increased risk of AMI or stroke.

Editorial Comment

There is a big number of ongoing studies, or studies that have been announced (AVATAR, POPular TAVI, CLOE, AUREA, GALILEO, ATLANTIS, ENVISAGE TAVI…) looking to find the ideal post TAVR antithrombotic strategy. This shows that the physiopathological mechanisms underlying stroke in this population have not yet been elucidated. In addition, there are comorbidities affecting a big part of the population included in these studies (FA, IAM, stents…).

A meta-analyzis of this work and to two prior studies on a small number of patients (Capodanno and Angiolillo), suggest that DAPT has no benefit in preventing 30 day stroke and that there is a tendency to major bleeding. To conclude, there is little evidence to contradict the American guidelines, which recommend 6 month DAPT (Class IIb, Level of Evidence: C) claiming DAPT is actually more damaging than beneficial.

Courtesy of Dr. Agustín Vecchia.

Título original: Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve The ARTE (Aspirin Versus Aspirin þ Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.

Referencia: 10.1016/j.jcin.2017.04.014.

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