Nielsen-Kudsk JE. JACC Cardiovasc Interv. 2021 Jan 11;14(1):69-78.

The pathophysiology is embolization of thrombotic material often deeloped in the left atrial appendage(LAA) to the brain. An anticoagulation is the centrepiece treatment for stroke prevention, and now, direct oral anticoagulants (DOACs) are preferred over warfarin, mainly because of a decreased risk of intracerebral bleeding. A nonpharmacological stroke prevention technology, Transcatheter LAA occlusion (LAAO) which closed the LAA and confined from the heart and circulation. There is very limited data available comparing LAAO with DOACs. Thus, Nielsen-Kudsk JE, et al., conducted a study to analyse clinical outcomes between AF patients having LAAO following enlistment in the Amulet Observational Study versus propensity score–matched AF patients managed using DOACs.

1,088 patients with AF were enlisted in the Amulet Observational Registry. 1,078 patients had successful LAAO with the Amplatzer Amulet device were compared with a propensity score–matched control group of 1,184 incident AF patients managed with DOACs recognised from Danish national patient registries. Propensity score matching was depend on the covariates of the CHA2DS2-VASc score (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) and HAS-BLED score (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) for forecasting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium ≥3), or all-cause mortality, and follow-up was 2 years.

The mean age of patients was 75.1 years, and matching proceed in very similar CHA2DS2-VASc (4.2 vs. 4.3) and HASBLED (3.3 vs. 3.4) scores between the 2 groups (LAAO vs. DOAC). LAAO group showed 256 primary outcome events (ischemic stroke, major bleeding, or all-cause mortality) versus 461 in the DOAC group. Median duration of follow-up was 732.0 (interquartile range: 649.0 to 732.0) days for LAAO and 732.0 (interquartile range: 411.5 to 732.0) days for DOAC. The LAAO group showed substantial reduction in the annualized event rate (14.5; 95% CI: 12.8 to 16.5) as compared to the DOAC cohort (25.7; 95% CI: 22.1 to 30.0). The primary outcome time-to-event curves started to separate following about 1 week and exhibited developing separation in favour of LAAO in the follow-up period of 2 years. The HR (LAAO vs. DOAC) was substantially decreased to 0.57 (95% CI: 0.49 to 0.67), comparable to a relative 43% reduction in risk. Ischemic stroke outcome did not vary substantially among the LAAO and DOAC groups (HR: 1.11; 95% CI: 0.71 to 1.75), although LAAO was correlated with a substantially decreased risk of major bleeding (HR: 0.62;95% CI: 0.49 to 0.79), all-cause mortality (HR: 0.53; 95% CI: 0.43 to 0.64), and cardiovascular mortality (HR: 0.51; 95% CI: 0.37 to 0.70). (Table 1) (Figure 1)

Thus, it was concluded that LAAO showed similar stroke prevention potency in comparison with DOACs however lower risk of major bleeding and mortality between high-risk AF patients.

Table 1: Number of Clinical Outcome Events, Event Rates and Hazard Ratios in Propensity Score–Matched Atrial Fibrillation Patients Treated by LAAO Versus DOAC

Figure 1: Secondary Clinical Outcomes

Cumulative incidence of ischemic stroke, major bleeding, all-cause mortality, and cardiovascular mortality associated with left atrial appendage occlusion (LAAO) versus direct anticoagulation (DOAC) in propensity score–matched atrial fibrillation (AF) patients (Aalen-Johansen estimate). The number of AF patients at risk are given along the time axis. CI = confidence interval.