Erik Swain , 2025-05-02 13:51:00
Key takeaways:
- Single antiplatelet therapy was tied to lower 6-month mortality risk vs. dual antiplatelet therapy after transcatheter aortic valve replacement.
- The results were consistent by sex and presence of CAD.
In a registry of patients who underwent transcatheter aortic valve replacement, those who had single antiplatelet therapy after their procedure had reduced risk for mortality at 6 months compared with dual antiplatelet therapy.
Francesco Pelliccia, MD, PhD, associate professor of cardiology at Sapienza University in Rome, and colleagues analyzed data from 5,514 patients from the TRITAVI registry who underwent TAVR with femoral access at one of 20 European centers since 2012, who were discharged alive after their procedure, who were not on anticoagulation therapy, who did not have procedural complications and who did not have ACS or PCI within 1 year before the procedure.
“Guideline recommendations state that we should use single antiplatelet treatment unless there is an indication to anticoagulation,” Pelliccia said during a press conference at the Society for Cardiovascular Angiography and Interventions Scientific Sessions. “But in real life, this choice is often not done by the physicians.”
‘There is a reluctance’
Pelliccia told Healio that the guideline recommendations, particularly in the United States, are not strong, “and they tell our cardiologists to feel free to opt for the best therapy for your patient. DAPT was the standard of care in 2010, when TAVR started throughout the world, and it remains that way in the real world, despite growing evidence coming out from randomized controlled trials. There is a reluctance to prescribe single antiplatelet therapy [due to] fear that [it does] not reduce thrombotic risk enough.”
Among the cohort, 3,197 patients had single antiplatelet therapy (SAPT), most often aspirin monotherapy, after their procedure and 2,317 had DAPT, most often aspirin plus clopidogrel, he said.
At 6 months, the DAPT group had elevated risk for all-cause mortality compared with the SAPT group (adjusted HR = 1.65; 95% CI, 1.22-2.23; P = .007; log-rank P < .0001), Pelliccia said during the press conference.
“We did not expect such a huge difference in 6 months,” Pelliccia told Healio. “We now have data for a subset of patients up to 3 years, and we expected a difference in longer follow-up.”
Major bleeding was lower in the SAPT group (0.5% vs. 1.3%; P = .001) and ischemic events trended lower in the SAPT group (0.4% vs. 0.7%; P = .047), he said.
“Bleeding played a major role [in the mortality results], but it is not the only explanation,” Pelliccia told Healio. “[DAPT] was chosen in patients who were judged to be at higher thrombotic risk because they had several comorbidities, for instance, peripheral artery disease and chronic obstructive pulmonary disease. This was a big mistake. Those patients are more frail, so they might suffer more from stronger antithrombotic treatment.”
He said the mortality results did not vary by sex (aHR for DAPT vs. SAPT for men = 2.08; 95% CI, 1.32-3.3; P = .001; log-rank P < .001; aHR for women = 1.53; 95% CI, 1.03-2.29; P = .04) or by presence of CAD (aHR for CAD = 1.83; 95% CI, 1.01-3.35; P = .04; log-rank P < .004; aHR for no CAD = 1.52; 95% CI, 1.04-2.2; P = .03; log-rank P = .005).
The CAD findings were “definitely unexpected,” Pelliccia told Healio.
“We believe these findings are very important,” Pelliccia said during the press conference. “This is one of the first demonstrations in real-life clinical practice that single antiplatelet treatment is associated not only with a decrease in the frequency of bleeds but also with … lower 6-month mortality after the procedure.”
While “one registry cannot make the difference, we can prompt other investigators to look at mortality from antithrombotic treatment,” Pelliccia told Healio. “Several other groups worldwide are looking at the effect on mortality.”
In the future, he said, work needs to be done on determining the optimal single antiplatelet strategy, as historically, clopidogrel has had a better safety profile than aspirin.
‘I am going to change what I do’
In a discussion at the press conference, David A. Cox, MD, MSCAI, interventional cardiologist at Sanger Heart & Vascular Institute in Charlotte, North Carolina, and past president of SCAI, said: “What’s very impressive about this data is that it changes practice. For almost everything, there is benefit to [SAPT], whereas in all these years, patients have gotten DAPT, and these are elderly patients who are going to bleed more if you put them on DAPT. When I take this home, I am going to change what I do.”
For more information:
Francesco Pelliccia, MD, PhD, can be reached at f.pelliccia@mclink.it.
Sources/Disclosures
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Pelliccia F, et al. Featured clinical research. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 1-3, 2025; Washington, D.C.
Disclosures:
Cox and Pelliccia report no relevant financial disclosures.
