Aspirin only post-TAVR reduces bleeding vs. aspirin plus clopidogrel: POPULAR TAVI
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Results from the POPULAR TAVI trial demonstrated that omitting clopidogrel after transcatheter aortic valve replacement may reduce bleeding, and aspirin alone may be sufficient to prevent thromboembolic events, researchers reported.
This study, presented at the virtual European Society of Cardiology Congress, included patients who underwent TAVR but were not already on anticoagulants and had not recently undergone coronary stenting.
“Despite the fact that TAVI procedures are more successful nowadays, the incidence of bleeding and thromboembolic events remains high,” Jorn Brouwer, PhD, clinical researchers in the department of cardiology at St. Antonius Hospital in Nieuwegein, the Netherlands, said during a press conference. “On the other hand, the antithrombotic treatment necessary after TAVI is not completely determined yet. In patients not on oral anticoagulation, the ESC guidelines recommend dual antiplatelet therapy early after TAVI followed by aspirin or clopidogrel alone. However, small studies including these patients suggest that an aspirin-alone strategy without clopidogrel may reduce the rate of bleeding events while not increasing the rate of thromboembolic events.”
For this analysis, simultaneously published in The New England Journal of Medicine, investigators randomly assigned 690 patients who underwent TAVR to receive aspirin plus 3 months of clopidogrel or aspirin alone. The primary outcomes were all bleeding and nonprocedural bleeding.
Among patients who received aspirin and clopidogrel, 26.6% experienced the primary outcome of all bleeding at 1 year compared with 15.1% of the aspirin-alone group (RR = 0.57; 95% CI, 0.42-0.77). Similarly, nonprocedural bleeding occurred in 24.9% of patients assigned to aspirin plus clopidogrel vs. 15.1% of patients assigned to aspirin alone (RR = 0.61; 95% CI, 0.44-0.83).
Moreover, 31.1% of patients assigned aspirin plus clopidogrel experienced the first composite secondary outcome of CV death, MI, stroke or nonprocedural bleeding compared with 23% of those assigned aspirin alone (RR = 0.74; 95% CI, 0.57-0.95; P for noninferiority < .001).
The second composite secondary outcome of CV death, ischemic stroke or MI at 1 year occurred in 9.9% of patients in the aspirin plus clopidogrel group and 9.7% of those in the aspirin-alone group (RR = 0.98; 95% CI, 0.62-1.55; P for noninferiority = .04).
Following the presentation of the POPULAR TAVI results, discussant Anna Sonia Petronio, MD, associate professor and director of the catheterization laboratory in the cardiothoracic department at the University of Pisa, Italy, said the trial showed “that a single antiplatelet therapy can reduce [bleeding] significantly and it is superior to the traditional antiplatelet therapy in patients that don't need anticoagulation. We were able to confirm that aspirin is not inferior to the double treatment if we consider the ischemic events.”
Healio previously reported on a different set of findings from the POPULAR TAVI trial at the American College of Cardiology Scientific Session.
Reference:
Perspective
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Grant Reed, MD, MSc, FACC
POPULAR TAVI was an open label randomized controlled trial designed to answer a common and important question: “Do patients really need DAPT after TAVR, or is aspirin alone enough for most patients?”
In POPULAR TAVI, patients were randomly assigned to aspirin alone or aspirin plus clopidogrel for 3 months after TAVR. The study’s findings are provocative and challenge common practice of DAPT prescription after TAVR. They show that for patients without another reason for DAPT or anticoagulation, aspirin alone is associated with fewer bleeding events than DAPT. The difference was rather dramatic, as aspirin was associated with a nearly threefold reduction in VARC major bleeding at 12 months compared with DAPT (2.4% vs 7.5%). Interestingly, in the study there did not seem to be a significant cost of using aspirin alone, as there was no difference in ischemic events including stroke, MI, or valve thrombosis, and aortic valve function was no different in the aspirin alone or DAPT groups out to 12 months.
These findings are reassuring and suggest that without another indication for antiplatelet therapy or anticoagulation, that aspirin alone is enough, and preferred to DAPT after TAVR.
I do feel that POPULAR TAVI will make a meaningful clinical impact. This study answers an important clinical question and is very relevant to clinical practice. I expect the results will persuade most clinicians to adopt an aspirin-only strategy after TAVR, as now there are data to support this.
The main limitation of POPULAR TAVI is that it is an open-label trial. However, bleeding is an objective clinical endpoint, so I do not view this to be a major issue.
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Brouwer J, et al. Hot Line: POPULAR TAVI. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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