TL;DR
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The SIMPLAAFY trial found aspirin alone and reduced-dose oral anticoagulants had six-month outcomes at least as good as dual antiplatelet therapy after successful Watchman FLX Pro implantation. The results may support simpler treatment for some patients, but longer-term findings are pending and the trial does not settle the best regimen for every patient.
The SIMPLAAFY trial found that 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 with a Watchman FLX Pro device. The results, presented at the Transcatheter Cardiovascular Therapeutics conference and published in JAMA, could inform a post-procedure regimen that currently varies among clinicians, but do not establish one approach for every patient.
Among 1,857 patients with nonvalvular atrial fibrillation, the combined rate of all-cause death, stroke, systemic embolism or major bleeding by six months was 3.3% with aspirin, 5.1% with reduced-dose non-vitamin K oral anticoagulants (NOACs), and 6.9% with DAPT. The trial reported that both monotherapy strategies met its statistical comparison with DAPT: the risk ratio was 0.49 for aspirin (95% CI 0.29-0.82) and 0.75 for reduced-dose NOACs (95% CI 0.48-1.18).
The treatment plans differed in duration and medication. Patients assigned to aspirin took 81 to 100 mg daily; those assigned to DAPT received it for six months, then aspirin; and the reduced-dose NOAC group received apixaban 2.5 mg twice daily or rivaroxaban 10 mg daily for three months, then aspirin. The participants’ mean age was 76 years, 43% were women, and the average CHA2DS2-VASc and HAS-BLED scores were 4.2 and 2.6.
Secondary findings included no excess stroke at six months in either monotherapy group. Major bleeding was reported in 0.2% of both the aspirin and reduced-dose NOAC groups, compared with 0.5% with DAPT. At 45 days, device-related thrombus occurred in 0.9% of the NOAC group, 2.7% of the aspirin group and 3.4% of the DAPT group. These secondary results do not mean that one medicine is best for all patients or that all risks have been resolved.
How Post-Closure Therapy Could Change
After left atrial appendage closure, clinicians must weigh the risk of clot formation on the device against bleeding from antithrombotic medication. The SIMPLAAFY findings offer randomized evidence that, in the studied patients, an initial single-drug strategy was not worse than DAPT on the trial’s six-month combined outcome. If supported by longer follow-up and clinical guidance, this may give clinicians more evidence when choosing a less complex regimen.
The findings are not a treatment instruction for individual patients. The trial included people with successful, uncomplicated implants, and the researchers did not prespecify a direct statistical comparison between the aspirin and NOAC groups. The reported outcome combines several events, so its overall rates should be read alongside the separate results for bleeding and device-related thrombus.
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Evidence Behind LAA Closure Regimens
Left atrial appendage closure is used for some people with nonvalvular atrial fibrillation to reduce stroke risk by sealing off the area where clots can form. Antithrombotic treatment after implantation is used during the period when the device is healing. The source report says practice has varied because clinicians have lacked sufficient evidence to guide the choice and duration of therapy.
SIMPLAAFY compared three post-procedure approaches in patients receiving the Watchman FLX Pro. Its results sit alongside evidence from the ANDES trial, which found short-term NOAC treatment was not better than DAPT for preventing device-related thrombus at 60 days; at one year, reported thrombus rates were 5.2% with NOACs and 2.3% with DAPT (P=0.154). The two trials’ results make it difficult to draw a blanket conclusion about 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, SIMPLAAFY investigator
Limits of the Six-Month Findings
SIMPLAAFY’s 12-month results are pending, and the six-month data do not answer how long patients should continue treatment after the studied regimens end. The study also did not prespecify a comparison between aspirin and reduced-dose NOACs, so their reported outcome rates do not establish which monotherapy is superior.
Generalizability is limited: the trial enrolled patients with uncomplicated, successful device implants and excluded some higher-risk groups, including people with severe kidney disease, recent stroke, recent myocardial infarction or major bleeding. The source report also notes the different ANDES results for NOACs and DAPT. Whether the observed differences in device-related thrombus persist, and how findings apply to patients outside SIMPLAAFY’s criteria, remain unresolved.
Awaiting One-Year Trial Results
The next key evidence from SIMPLAAFY is its 12-month follow-up, which could clarify whether the six-month outcome patterns continue and provide more information on treatment after the initial post-implant period. The report does not give a release date for those results.
Until longer-term evidence and clinical recommendations address the remaining questions, treatment choices will need to account for each patient’s bleeding risk, risk of device thrombosis and clinical circumstances. Kar said the trial findings did not give him grounds for a blanket recommendation of NOACs after closure.
Key Questions
Did SIMPLAAFY show that DAPT is no longer needed after LAA closure?
No. The study found aspirin and reduced-dose NOACs had six-month outcomes at least as good as DAPT among patients with uncomplicated Watchman FLX Pro implantation. It does not establish that DAPT should be abandoned for all patients.
Which group had the lowest six-month combined event rate?
The aspirin-alone group had a reported rate of 3.3% for the combined outcome of death, stroke, systemic embolism or major bleeding. The rate was 5.1% with reduced-dose NOACs and 6.9% with DAPT.
Did aspirin or NOAC monotherapy increase stroke risk?
The report says secondary analyses found no excess stroke at six months with either monotherapy approach. The findings apply to the trial population and do not determine an individual patient’s risk.
Who was included in the trial?
SIMPLAAFY enrolled 1,857 people with nonvalvular atrial fibrillation who had a successful Watchman FLX Pro implant. Patients with certain higher-risk conditions, including severe kidney disease and recent stroke, myocardial infarction or major bleeding, were excluded.
When will longer-term results be available?
The report says 12-month results are still pending, but does not provide a publication or presentation date.
Source: medpagetoday.com
