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The SIMPLAAFY trial found that aspirin alone and reduced-dose oral anticoagulants had 6-month results at least as good as dual antiplatelet therapy after uncomplicated left atrial appendage closure. The findings do not establish a universal replacement for DAPT: 12-month results are pending, and the trial excluded some high-risk patients.
The SIMPLAAFY trial found that aspirin alone and reduced-dose oral anticoagulants had 6-month outcomes at least as good as dual antiplatelet therapy (DAPT) after uncomplicated left atrial appendage closure, challenging the assumption that patients need two antiplatelet drugs after the procedure. The results were presented at the Transcatheter Cardiovascular Therapeutics meeting and published in JAMA, but they do not settle which regimen should be used for every patient.
The trial randomized 1,857 people with nonvalvular atrial fibrillation after successful implantation of a Watchman FLX Pro occluder. Participants received aspirin alone, DAPT for six months, or reduced-dose non-vitamin K oral anticoagulants (NOACs) for three months, followed by aspirin. The anticoagulant regimens were apixaban 2.5 mg twice daily or rivaroxaban 10 mg daily.
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 comparison found aspirin performed better than DAPT (risk ratio 0.49, 95% confidence interval 0.29-0.82); reduced-dose NOACs met the trial’s measure of being at least as good as DAPT (risk ratio 0.75, 95% CI 0.48-1.18). The study did not prespecify a direct comparison between the two monotherapy groups.
Researchers reported no excess stroke at six months in either monotherapy group. Bleeding outcomes favored the single-drug strategies, while device-related thrombus at 45 days was reported in 0.9% of patients on reduced-dose NOACs, compared with 3.4% on DAPT and 2.7% on aspirin. These are separate outcomes at different follow-up points and do not by themselves establish which regimen is best overall.
How the Results Could Change Post-Implant Care
After left atrial appendage closure, clinicians must balance the risk of clot formation on the device against bleeding from antithrombotic drugs. A regimen with fewer medicines may be easier to tolerate and could reduce bleeding, but it must also protect patients while the implanted device heals. SIMPLAAFY provides randomized evidence that aspirin alone, and in this trial reduced-dose NOACs, can be considered in place of six months of DAPT for the studied population.
The results may matter to patients and clinicians because current practice varies and choices can involve different medication burdens and risks. They do not justify stopping or changing medication without a clinician’s direction: the study tested specific regimens in selected patients, and its follow-up does not answer how to manage treatment over the longer term.
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A Treatment Choice With Limited Evidence
Left atrial appendage closure is used for some people with nonvalvular atrial fibrillation to reduce the risk of clots associated with the appendage. Antithrombotic treatment after implantation is intended to manage clotting risk while the device becomes incorporated. The appropriate balance can be difficult, particularly when a patient also has a substantial bleeding risk.
MedPage Today reported that post-procedure drug strategies have varied because clinicians have lacked strong evidence to guide them. Another trial, ANDES, found short-term NOAC treatment was no better than DAPT at preventing device-related thrombus at 60 days; its reported one-year thrombus rates were 5.2% with NOACs and 2.3% with DAPT, a difference that was not statistically significant (P=0.154). That result adds caution against treating SIMPLAAFY as a blanket endorsement of anticoagulants.
“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, presenting SIMPLAAFY
Limits on Applying the Trial Results
SIMPLAAFY enrolled patients whose Watchman FLX Pro implants were uncomplicated. It excluded some high-risk groups, including people with severe kidney disease, recent stroke, recent myocardial infarction or recent major bleeding. The findings may not apply to those patients or to other devices and circumstances not studied.
The trial’s reported comparison was each monotherapy strategy against DAPT, not aspirin directly against reduced-dose NOACs. Follow-up currently reported here is six months for the main combined outcome, with device-thrombus imaging described at 45 days. Twelve-month results are pending, and the source report does not establish a preferred treatment beyond that period or a universal approach to medication after closure.
Awaiting One-Year Follow-Up
The next key development is the release of SIMPLAAFY’s 12-month results, which may clarify whether the observed differences persist and how treatment choices relate to device-related thrombus and bleeding over a longer period. Until then, the evidence supports discussion of options for patients like those enrolled, rather than a blanket switch away from DAPT.
Clinicians will also need to weigh the trial alongside evidence such as ANDES and each patient’s bleeding and clotting risks, procedure details and preferences. The available report does not specify when the one-year findings will be published.
Key Questions
Does SIMPLAAFY show that DAPT is no longer needed after left atrial appendage closure?
No. It found that aspirin alone and reduced-dose NOACs had six-month outcomes at least as good as DAPT in the trial’s selected group. The results do not establish that DAPT should be abandoned for every patient.
Which regimen had the lowest six-month combined event rate?
Aspirin alone had the lowest reported rate at 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% of patients receiving reduced-dose NOACs, 2.7% receiving aspirin and 3.4% receiving DAPT. This finding is one outcome within the study and does not alone determine the best regimen.
Who may not be represented by these findings?
The study included patients with successful, uncomplicated Watchman FLX Pro implantation and excluded some high-risk groups, including people with severe kidney disease, recent stroke, myocardial infarction or major bleeding. Its results may not apply directly to those patients.
When will longer-term results be available?
The source report says 12-month SIMPLAAFY results are pending, but does not give a publication date. The reported findings do not settle what treatment should be used beyond one year.
Source: medpagetoday.com
