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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Low-dose direct oral anticoagulation vs dual antiplatelet therapy after left atrial appendage occlusion: 1-year
Eduardo Flores-Umanzor1, Ignacio Cruz-González2, Pedro Cepas-Guillén1
1Departamento de Cardiología, Instituto Cardiovascular, Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS), Hospital Clínic, Barcelona, Spain.
Insights
Low-dose direct oral anticoagulation (LD-DOAC) followed by single antiplatelet therapy (SAPT) significantly reduced thromboembolic and bleeding events after left atrial appendage occlusion (LAAO) compared to dual antiplatelet therapy (DAPT). This strategy effectively managed device-related thrombus (DRT) in high-risk patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Thrombosis and Hemostasis
Background:
- Left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulation for stroke prevention in atrial fibrillation.
- Optimal antithrombotic therapy post-LAAO remains debated, with initial studies comparing low-dose direct oral anticoagulation (LD-DOAC) and dual antiplatelet therapy (DAPT).
Purpose of the Study:
- To evaluate the 1-year outcomes of patients undergoing LAAO who were initially treated with LD-DOAC versus DAPT, focusing on efficacy and safety after transitioning to single antiplatelet therapy (SAPT).
Main Methods:
- A multicenter, randomized clinical trial (ADALA) enrolled 91 patients with atrial fibrillation and contraindications to oral anticoagulation.
- Participants received either LD-DOAC or DAPT for 3 months post-LAAO, followed by a mandatory switch to SAPT for all patients.
- The primary endpoint was a composite of thromboembolic events, device-related thrombus (DRT), or major bleeding at 1 year.
Main Results:
- The primary endpoint occurred significantly less frequently in the LD-DOAC group (9.1%) compared to the DAPT group (32.6%) at 1 year (P=.013).
- This reduction was primarily driven by a significant decrease in DRT (0% vs 11.6%; P=.023) in the LD-DOAC arm.
- Major bleeding was numerically lower in the LD-DOAC group (9.1% vs 19.6%; P=.167), and total bleeding events were significantly reduced (13.6% vs 37.0%; P=.013).
Conclusions:
- A 3-month regimen of LD-DOAC followed by SAPT demonstrated superior efficacy and safety compared to DAPT for 1 year post-LAAO, particularly in reducing early DRT.
- The observed reduction in DRT and bleeding events supports the use of LD-DOAC for 3 months followed by SAPT in high-risk patients post-LAAO.
- Complete resolution of DRT without bleeding complications was noted in all cases treated with LD-DOAC.
Introduction And Objectives:
The ADALA trial showed a more favorable efficacy-safety profile with low-dose direct oral anticoagulation (LD-DOAC) vs dual antiplatelet therapy (DAPT) at 3 months after left atrial appendage occlusion (LAAO). However, outcomes after switching both regimens to single antiplatelet therapy (SAPT) remain uncertain. This study reports the 1-year results, focusing on outcomes after the switch to SAPT.
Methods:
The ADALA trial was a multicenter, randomized clinical trial that enrolled 91 patients with atrial fibrillation and contraindications to oral anticoagulation. After successful LAAO, participants were randomized to receive LD-DOAC or DAPT for 3 months, after which all patients transitioned to SAPT. The primary endpoint was a composite of thromboembolic events, device-related thrombus (DRT), or major bleeding at 1-year.
Results:
At 12 months, the primary endpoint was significantly lower in the LD-DOAC group compared with the DAPT group (9.1% vs 32.6%; HR, 0.25; 95%CI, 0.08-0.74; P=.013), mainly driven by a reduction in DRT (0% vs 11.6%; P=.023). Major bleeding was numerically lower with LD-DOAC (9.1% vs 19.6%; P=.167), and total bleeding events were significantly reduced (13.6% vs 37.0%; P=.013). Landmark analysis showed significant differences during the initial 3 months (P <.001) but not from 3 to 12 months (P=.195). All DRT cases treated with LD-DOAC (n=4) resolved completely without bleeding.
Conclusions:
LD-DOAC reduced thromboembolic and bleeding events compared with DAPT during the first year after LAAO, driven by a marked reduction in early DRT. No DRT events occurred after LD-DOAC withdrawal, supporting a strategy of LD-DOAC for 3 months followed by SAPT in this high-risk population.
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