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Aspirin alone best anti-clotting strategy after TAVI

New England Journal of Medicine
ESC 2020
Reuters Health - 04/09/2020 - Results of a new randomized trial challenge current recommendations on antiplatelet therapy after transcatheter aortic valve implantation (TAVI) in patients with no indication for long-term oral anticoagulation.

For these patients, the study showed that aspirin alone, as compared to aspirin plus three months' clopidogrel, "reduces bleeding events significantly and does not increase the rate of thromboembolic events," said lead investigator Dr. Jorn Brouwer in a presentation August 30 to the European Society of Cardiology (ESC) virtual meeting

"Physicians can easily and safely reduce the rate of bleeding by omitting clopidogrel after TAVI. Aspirin alone should be used in patients undergoing TAVI who are not on oral anticoagulation and have not recently undergone coronary stenting," said Dr. Brouwer of St Antonius Hospital, in Nieuwegein, the Netherlands.

Current European guidelines recommend clopidogrel plus aspirin for three to six months after TAVI in patients with no indication for oral anticoagulation.

Yet, "small and exploratory studies" of TAVI patients have not shown a lower incidence of ischemic events with aspirin and clopidogrel than with aspirin alone; however, dual antiplatelet therapy was associated with more bleeding, Dr. Brouwer and colleagues note in their article in The New England Journal of Medicine.

The POPular TAVI (cohort A) study evaluated the optimal antithrombotic strategy in 665 patients without an indication for oral anticoagulation who were randomly allocated to aspirin alone or aspirin with three months of clopidogrel.

Compared to aspirin with clopidogrel, aspirin alone led to significantly lower rates of bleeding at one year, the primary outcome.

The rate of any bleeding was 15.1% with aspirin alone versus 26.6% with aspirin/clopidogrel (risk ratio, 0.57; 95% confidence interval, 0.42 to 0.77; P=0.001). The rate of non-procedural bleeding was 15.1% and 24.9%, respectively (RR, 0.61; 95% CI, 0.44 to 0.83; P=0.005).

The combined secondary outcome of cardiovascular death, non-procedural bleeding, stroke or heart attack, occurred in 23.0% of patients on aspirin alone versus 31.1% of those on dual therapy (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; RR, 0.74; 95% CI for superiority, 0.57 to 0.95; P=0.04).

The other combined secondary outcome of CV death, ischemic stroke and heart attack occurred in 9.7% receiving aspirin alone and 9.9% of those on aspirin and clopidogrel. On this outcome, aspirin was not superior (RR, 0.98; 95% CI, 0.62 to 1.55; P=0.93).

Dr. Ashish Pershad of Banner - University Medicine Heart Institute, in Phoenix, Arizona, told Reuters Health by phone, "Physicians always think about doing no harm, and taking away a medication that potentially could harm somebody, i.e. Plavix, without causing any incremental downside effects like worsening ischemia is an adoption that becomes very easy."

"Even though it's a small study, it's a well conducted study and I think will be very well and quickly embraced by TAVR operators worldwide. Especially for the bread-and-butter TAVR procedures, which account for about 80% of TAVR procedures worldwide," said Dr. Pershad, who was not involved in the study.

The study was funded by the Dutch Organization for Health Research and Development.

By Megan Brooks

SOURCE: https://bit.ly/3jDjo2U New England Journal of Medicine, online August 30, 2020.

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