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In the 1,857-patient SIMPLAAFY trial, aspirin alone and reduced-dose oral anticoagulants had six-month combined outcomes that were statistically no worse than dual antiplatelet therapy after successful Watchman FLX Pro implantation. The findings support studying simpler drug regimens, but do not settle which approach is best or what patients should take long term; 12-month results are pending.
The SIMPLAAFY trial found that aspirin alone and reduced-dose oral anticoagulants had six-month combined outcomes statistically no worse than dual antiplatelet therapy (DAPT) after successful Watchman FLX Pro implantation for left atrial appendage closure. The findings, presented at the Transcatheter Cardiovascular Therapeutics meeting and published in JAMA, may inform efforts to simplify treatment after the procedure, but they do not establish that DAPT is no longer needed for every patient.
The trial randomized 1,857 people with nonvalvular atrial fibrillation to aspirin alone, 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 had undergone successful implantation of the Watchman FLX Pro device.
At six months, the combined incidence of all-cause death, stroke, systemic embolism or major bleeding was 3.3% with aspirin, 6.9% with DAPT and 5.1% with reduced-dose NOACs. Compared with DAPT, aspirin’s risk ratio was 0.49 (95% CI 0.29-0.82), and the reduced-dose NOAC risk ratio was 0.75 (95% CI 0.48-1.18). The report described both single-drug strategies as at least as good as DAPT in the statistical analysis; the trial did not prespecify a comparison between the two monotherapy groups.
Secondary findings included no excess stroke at six months in either monotherapy group and fewer bleeds with both single-drug strategies than with DAPT, according to the report. At 45 days, device-related thrombus was reported in 0.9% of the reduced-dose NOAC group, 2.7% of the aspirin group and 3.4% of the DAPT group. Medication adherence, defined as taking assigned treatment on at least 80% of days, was 87.9% with aspirin, 76.8% with DAPT and 85.3% with NOACs.
How the Results Could Change Post-Implant Care
After left atrial appendage closure, clinicians must balance the risk of bleeding against the risk of clots forming on the device. The trial’s results offer evidence that some patients with an uncomplicated implant may be able to use a simpler regimen during the early months after the procedure. Fewer medicines may also be easier for some patients to take, though adherence in this trial does not by itself show that one regimen improves outcomes in routine practice.
The data do not amount to a universal recommendation to stop DAPT. Treatment choice still depends on a patient’s bleeding and clotting risks, and the study has limitations that narrow the group to whom its findings apply. In particular, the results cannot settle care for people with complicated procedures or certain serious health conditions excluded from the trial.
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Why Post-Closure Drug Choices Vary
Left atrial appendage closure is used for some people with nonvalvular atrial fibrillation to reduce stroke risk by sealing off the appendage, where blood clots can form. Antithrombotic medicines are used after implantation, but the best regimen and duration have been uncertain. MedPage Today reported that practice varies, in part because clinicians have lacked strong evidence to guide choices.
SIMPLAAFY compared three initial regimens, but the treatment periods differed: DAPT continued for six months, while reduced-dose NOAC treatment lasted three months before aspirin. All participants were assigned aspirin alone, DAPT or NOACs according to the trial plan; the results therefore address those specific strategies and follow-up periods, not every possible drug schedule or device.
“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, the trial’s presenting investigator
Limits on Applying the Six-Month Findings
SIMPLAAFY enrolled only patients with successful, uncomplicated Watchman FLX Pro implants. People with severe kidney disease, recent stroke, recent myocardial infarction or major bleeding were among those excluded, so the trial does not answer how those groups should be treated. The study also did not set out to determine whether aspirin or reduced-dose NOACs are better than each other.
Findings from another study, ANDES, add uncertainty about NOACs: the report said short-term NOACs were no better than DAPT at preventing device-related thrombus at 60 days, and reported thrombus at one year in 5.2% of NOAC recipients versus 2.3% of DAPT recipients (P=0.154). That result does not prove a difference, but it complicates a broad preference for NOACs. SIMPLAAFY’s 12-month outcomes are not yet available, and the best regimen beyond one year is unknown.
Awaiting One-Year Trial Outcomes
The next major update is the 12-month follow-up from SIMPLAAFY, which may add information about longer-term outcomes after the initial treatment periods. Until those data are reported, the current results describe six-month outcomes in a selected group and do not establish a single post-procedure regimen for all patients.
For now, the trial’s investigators and discussants frame treatment as a decision that depends on bleeding risk, device-thrombus risk and patient circumstances. The report does not provide a new blanket guideline. Further evidence will be needed to clarify how the findings apply beyond uncomplicated implants and how best to manage therapy after the first year.
Key Questions
Does SIMPLAAFY show that DAPT is no longer needed after left atrial appendage closure?
No. The trial found aspirin alone and reduced-dose NOACs statistically no worse than DAPT on its six-month combined outcome in the studied population. It does not establish that DAPT should be stopped for all patients.
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 outcomes were included in the main measure?
The combined outcome included all-cause death, stroke, systemic embolism or major bleeding within six months.
Who was included in the trial?
SIMPLAAFY randomized 1,857 people with nonvalvular atrial fibrillation after successful Watchman FLX Pro implantation. The findings may not apply to people with complicated implants or certain excluded conditions, including severe kidney disease or recent major bleeding.
When will longer-term results be available?
The report said 12-month SIMPLAAFY results are pending. It did not provide a publication date for that follow-up.
Source: medpagetoday.com
