Arrhythmias & electrophysiology

Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion: The ADALA Randomized Clinical Trial

JAMA CardiolPublished Randomised controlled trial

Primary resultResult — go to the resultHazard ratio 0.19 95% CI 0.04–0.88
  • prematurely terminated (60% of estimated sample size)

Authors' conclusion

Results show that use of low-dose DOAC for 3 months after LAAO was associated with a better balance between efficacy and safety compared with DAPT.

Study context

Population
Patients after successful percutaneous left atrial appendage occlusion (LAAO)included in the analysis
Participants
90 patients
Comparison
Low-dose DOAC vs dual antiplatelet therapy (DAPT) for 3 months after LAAO
  • Low-dose DOACn = 44
  • DAPTn = 46reference
Primary endpoint
Composite of:
  • Major bleeding
  • Thromboembolic events (stroke, systemic embolism, device-related thrombosis)
Follow-up
3 months after successful LAAO
Methodological detailsinvestigator-initiated, multicentre, prospective, open-label, 3 European sites
  • Investigator-initiated
  • Multicentre
  • Prospective
  • Open-label
  • 3 European sites

Primary result

As reported in the abstract

3 months

Hazard ratio

0.19

95% CI 0.04–0.88

P = 0.02

Events by treatment group

Low-dose DOAC vs DAPT
HR 0.19 (95% CI 0.04–0.88); P = 0.02

Secondary outcomes

Device-related thrombosis

  • Device-related thrombosis: P = .04

Stroke and systemic embolism

None in the overall population
0

Safety

Major bleeding

  • Major bleeding: P = .17

Original publication

Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion: The ADALA Randomized Clinical Trial. JAMA Cardiol. Published 1 October 2024. doi:10.1001/jamacardio.2024.2335

Summarised from the published abstract; every number is checked against it

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