Among high-risk atrial fibrillation patients (AF), percutaneous left atrial appendage occlusion (LAAO) with the Amplatzer Amulet device showed a similar rate stroke prevention and lower risk of major bleeding and mortality in comparison with direct oral anticoagulants (DOACs), according to a propensity-matched analysis from the Amulet observational and Danish national patient registries released Monday.
Jens Erik Nielsen-Kudsk, MD, DMSc, of Aarhus University Hospital, Denmark and co-authors reported their findings in a manuscript published in the Jan. 11 issue of JACC: Cardiovascular Interventions.
Previous randomized and observational studies have shown that LAAO is noninferior to warfarin for stroke prevention in AF. However, studies comparing LAAO to DOACs are limited. In this analysis, the authors performed a propensity-matched analysis of the Amulet observational registry (n=1,088) and Danish National patient registries (n=1,184) based on covariates of CHA2DS2-VASc and HAS-BLED scores. The primary outcome was a composite of ischemic stroke, major bleeding or all-cause mortality at 2 years.
In the matched analysis, 1,071 patients with LAAO were compared with 1,184 AF patients treated with DOACs. The patients’ mean age was 75 years and both groups had similar CHA2DS2-VASc (4.2 vs. 4.3) and HAS-BLED scores (3.3 vs. 3.4). Revascularization for coronary artery and carotid artery disease were more common in the LAAO cohort, whereas chronic obstructive pulmonary disease was more prevalent in DOAC cohort.
At 2 years, AF patients treated with LAAO had a significantly lower risk of the primary composite outcome than patients treated with DOACs (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.49 to 0.67). The risk of ischemic stroke was similar in both groups (HR, 1.11; 95% CI, 0.71 to 1.75); however, risk of major bleeding (HR, 0.62; 95% CI, 0.49 to 0.79) and all-cause mortality (HR, 0.53; 95% CI, 0.43 to 0.64) were significantly lower in patients treated with LAAO.
The authors noted that although confounding was reduced by propensity matching and sensitivity analysis, there could still unmeasured confounders and noted this as a major limitation.
In an accompanying editorial, Mohmad Alkhouli, MD, of Mayo Clinic School of Medicine, Rochester, Minnesota, noted that large sample size, adjudication of clinical events and use of contemporary LAAO devices are the strengths of the study. However, Alkhouli stated that selection bias, ascertainment of events and majority of patients in DOAC arm discontinuing their medication during the follow-up were the major limitations.
Nielsen-Kudsk and colleagues concluded that among high-risk patients, percutaneous LAAO has similar stroke prevention with a better safety profile in comparison with DOACs. The authors added that larger randomized clinical trials should be performed to confirm the safety and efficacy of LAAO compared to DOACs.
The study was supported by the Novo Nordisk Research Foundation and an unrestricted research grant from Abbott (manufacturer of the Amplatzer Amulet device). Nielsen-Kudsk has served as a proctor and investigator for Abbott and Boston Scientific.
Nielsen-Kudsk JE, Korsholm K, Damgaard D, et al. Clinical outcomes associated with left atrial appendage occlusion versus direct oral anticoagulation in atrial fibrillation. JACC Cardiovasc Interv 2021;14:69–78.
Alkhouli M. Moving the needle forward for more relevant evidence on left atrial appendage occlusion. JACC Cardiovasc Interv 2021;14:79–82.
Image Credit: Abbott