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In the 1,857-patient SIMPLAAFY trial, aspirin alone and reduced-dose anticoagulants had six-month results at least as good as dual antiplatelet therapy after successful Watchman FLX Pro implantation. The findings support considering simpler regimens for selected patients, but do not settle treatment for all patients or establish what to use beyond the study’s follow-up.
Aspirin alone and reduced-dose oral anticoagulants had six-month outcomes at least as good as dual antiplatelet therapy (DAPT) after successful left atrial appendage closure in the 1,857-patient SIMPLAAFY trial, according to results presented November 4 at the Transcatheter Cardiovascular Therapeutics meeting and published in JAMA. The findings could give clinicians more evidence for choosing post-procedure medication, but apply to a selected group with uncomplicated Watchman FLX Pro implants and do not settle treatment beyond six months.
The trial compared three strategies in people with nonvalvular atrial fibrillation: aspirin 81 to 100 mg daily, DAPT for six months, or reduced-dose non-vitamin K oral anticoagulants (NOACs) for three months followed by aspirin. The NOAC options were apixaban 2.5 mg twice daily or rivaroxaban 10 mg daily. Participants were randomized after successful implantation of a Watchman FLX Pro device.
At six months, the combined rate of all-cause death, stroke, systemic embolism or major bleeding was 3.3% with aspirin, 5.1% with reduced-dose NOACs and 6.9% with DAPT. The reported risk ratio versus DAPT was 0.49 for aspirin (95% confidence interval 0.29-0.82) and 0.75 for reduced-dose NOACs (95% CI 0.48-1.18). The investigators described both monotherapy approaches as at least as good as DAPT on the trial’s primary outcome; the estimates do not establish that one monotherapy is superior to the other.
Secondary results showed no excess stroke at six months in either monotherapy group. The report said bleeding outcomes favored both monotherapy strategies over DAPT. At 45 days, device-related thrombus was reported in 0.9% of patients assigned low-dose NOACs, 2.7% assigned aspirin and 3.4% assigned DAPT. These are separate outcomes and time points from the six-month combined measure. Medication adherence, defined as taking the assigned treatment on at least 80% of days, was 87.9% for aspirin, 85.3% for NOACs and 76.8% for DAPT.
Evidence for Simpler Post-Implant Regimens
After left atrial appendage closure, clinicians must balance the risk of clots forming on or around the device against medication-related bleeding. SIMPLAAFY provides randomized evidence that, among the patients studied, aspirin alone or a limited course of reduced-dose anticoagulation can be considered instead of six months of DAPT without worse results on the measured six-month composite outcome.
The results may be relevant to patients and clinicians weighing medication burden, bleeding risk and adherence after implantation. The trial also found higher adherence in both monotherapy groups than in the DAPT group. But the findings are not a universal instruction to stop DAPT: treatment decisions still depend on the patient’s circumstances, and the study did not include every group at elevated risk.
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Why Post-Closure Medication Varies
Left atrial appendage closure is used for some patients with nonvalvular atrial fibrillation to reduce the risk associated with clots arising in the appendage. Antithrombotic medicines are used after implantation while the device heals and to address clot risk. According to session discussant Mohamad Alkhouli of the Mayo Clinic, practice has varied because clinicians have lacked strong evidence to guide the choice of regimen.
SIMPLAAFY included participants with a mean age of 76; 43% were women. Their mean CHA2DS2-VASc stroke-risk score was 4.2, and mean HAS-BLED bleeding-risk score was 2.6. The findings were presented at the Cardiovascular Research Foundation’s annual TCT conference and published simultaneously in JAMA.
Another trial, ANDES, complicates interpretation of the anticoagulant results. The source report says ANDES found short-term NOACs were no better than DAPT for preventing device-related thrombus at 60 days, and reported more thrombi with NOACs at one year than with DAPT (5.2% versus 2.3%; P=0.154). That difference was not statistically significant by the reported P value. The studies assessed different follow-up points and do not by themselves establish a single preferred regimen.
“These findings support the simplification of antithrombotic management after uncomplicated LAA [closure] and may be individualized according to competing bleeding and device thrombosis risks and patient preferences.”
— Saibal Kar, MD, of Los Robles Hospital and Medical Center
Limits of the Six-Month Findings
The results do not show that DAPT is unnecessary for every patient after device closure. SIMPLAAFY enrolled people whose Watchman FLX Pro implantation was uncomplicated; it excluded some higher-risk groups, including people with severe kidney disease, recent stroke, recent myocardial infarction or major bleeding. The findings may not apply to those patients or to other devices and clinical circumstances.
The study did not prespecify a comparison between aspirin and reduced-dose NOACs, so it cannot establish which monotherapy is better. The primary outcome combined several events, and the reported results are specific to six months. The source report says 12-month findings are still pending, leaving longer-term outcomes and medication plans unresolved.
There is also no settled interpretation of the NOAC strategy: SIMPLAAFY found a low 45-day device-thrombus rate in that group, while ANDES reported different results at later follow-up. Differences in trial design and timing mean the evidence described here does not support a blanket recommendation.
Awaiting One-Year Trial Results
The next key development is SIMPLAAFY’s 12-month follow-up, which may add information about later complications and the medication strategy after the initial treatment period. In the trial, the DAPT group was assigned aspirin after six months, while the reduced-dose NOAC group switched to aspirin after three months; the study protocol therefore does not answer every question about treatment beyond one year.
For now, the presented findings add evidence for clinicians discussing post-closure options with eligible patients, rather than ending the debate over DAPT. Further interpretation will need to account for the trial’s exclusions, the lack of a direct monotherapy comparison and the separate results reported in ANDES.
Key Questions
Does SIMPLAAFY show that DAPT should be stopped after LAA closure?
No. The trial found that aspirin alone and reduced-dose NOACs had six-month outcomes at least as good as DAPT in its selected group, but it does not establish that DAPT should be stopped for everyone. Treatment choices depend on patient risk and clinical circumstances.
Which treatment had the lowest six-month combined event rate?
Aspirin alone had the lowest reported rate of the combined outcome—3.3%, compared with 5.1% for reduced-dose NOACs and 6.9% for DAPT. The trial did not prespecify a direct comparison between the two monotherapy groups.
What did the trial find about device-related thrombus?
At 45 days, device-related thrombus was reported in 0.9% with reduced-dose NOACs, 2.7% with aspirin and 3.4% with DAPT. This secondary outcome does not resolve longer-term questions, and findings from the separate ANDES trial differed at later follow-up.
Who was included in SIMPLAAFY?
The study enrolled 1,857 people with nonvalvular atrial fibrillation after successful Watchman FLX Pro implantation. It excluded some higher-risk patients, including those with severe kidney disease, recent stroke, recent myocardial infarction or major bleeding.
When will longer-term results be available?
The source report says 12-month SIMPLAAFY results are pending. No publication date for those results was provided.
Source: medpagetoday.com
