Lower rate of major bleeding in very high risk patients undergoing left atrial appendage occlusion: A propensity score-matched comparison with direct oral anticoagulant

Heart Rhythm. 2024 Aug;21(8):1267-1276. doi: 10.1016/j.hrthm.2024.01.018. Epub 2024 Jan 20.

Abstract

Background: Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation. However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high TE risk profile.

Objective: The purpose of this study was to compare the safety and efficacy of LAAO vs DOACs in patients with atrial fibrillation at very high stroke risk (CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score ≥ 5).

Methods: Data from patients with CHA2DS2-VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (covariates: CHA2DS2-VASc and HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] scores), which resulted in a matched population of 277 patients per group. The primary end point was a composite of cardiovascular death, TE events, and clinically relevant bleeding during follow-up.

Results: Of 2381 patients, 554 very high risk patients were included in the study (mean age 79 ± 7 years; CHA2DS2-VASc score 5.8 ± 0.9; HAS-BLED score 3.0 ± 0.9). The mean follow-up duration was 25 ± 11 months. A higher incidence of the composite end point was documented with DOACs compared with LAAO (14.9 events per 100 patient-years in the DOAC group vs 9.4 events per 100 patient-years in the LAAO group; P = .03). The annualized clinically relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; P = .04), while the risk of TE events was not different between groups (4.1% vs 3.2%; P = .63).

Conclusion: In high-risk patients, LAAO had a similar stroke prevention efficacy but a significantly lower risk of clinically relevant bleeding when compared with DOACs. The clinical benefit of LAAO became significant after 18 months of follow-up.

Keywords: Atrial fibrillation; Bleeding; Left atrial appendage; Oral anticoagulant; Stroke prevention; Watchman.

Publication types

  • Multicenter Study
  • Comparative Study

MeSH terms

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Anticoagulants* / administration & dosage
  • Anticoagulants* / therapeutic use
  • Atrial Appendage* / surgery
  • Atrial Fibrillation* / complications
  • Atrial Fibrillation* / drug therapy
  • Female
  • Follow-Up Studies
  • Hemorrhage / chemically induced
  • Hemorrhage / epidemiology
  • Humans
  • Incidence
  • Male
  • Propensity Score*
  • Prospective Studies
  • Risk Assessment / methods
  • Risk Factors
  • Stroke / epidemiology
  • Stroke / etiology
  • Stroke / prevention & control
  • Thromboembolism / epidemiology
  • Thromboembolism / etiology
  • Thromboembolism / prevention & control
  • Treatment Outcome

Substances

  • Anticoagulants