ISSN 2996-8215
International Journal of Cardiology | Vol. 4, No. 9, September 2013 | pp. 65–72
DOI: 10.46882/2013/IJC/000054
Original Research Article
Efficacy and Safety of Left Atrial Appendage Closure versus Direct Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation
Matteo Barbieri¹, Luigi Marini², Francesca Costa¹
¹Department of Cardiology, San Raffaele Hospital, Milan, Italy
²Division of Interventional Cardiology, University Hospital of Bologna, Bologna, Italy
Abstract:
Oral anticoagulation is standard for stroke prevention in non-valvular atrial fibrillation (AF), but compliance can be limited by recurrent bleeding. Percutaneous left atrial appendage closure (LAAC) serves as a mechanical alternative. This prospective observational study evaluated the 2-year efficacy and safety of LAAC using the Watchman device compared with direct oral anticoagulants (DOACs) in patients at high risk of stroke and bleeding. We evaluated 210 patients with non-valvular AF and a HAS-BLED score greater than or equal to 3 who underwent successful LAAC (n = 105) or received standard DOAC therapy (apixaban or rivaroxaban, n = 105). The primary efficacy endpoint was a composite of ischemic stroke, systemic embolism, or cardiovascular mortality at 24 months. The primary safety endpoint was major bleeding according to BARC criteria. At 24 months, the primary efficacy endpoint did not differ significantly between the LAAC and DOAC groups (4.8% vs. 5.7%, hazard ratio: 0.82, 95% CI: 0.25–2.68, p = 0.74). However, the incidence of major bleeding was significantly lower in the LAAC group than in the DOAC cohort after the initial 3-month post-procedural period (2.9% vs. 10.5%, hazard ratio: 0.26, 95% CI: 0.08–0.88, p = 0.02). Device-related thrombus was detected in 3.8% of LAAC patients via transesophageal echocardiography, successfully managed with temporary anticoagulation. Percutaneous left atrial appendage closure provides stroke protection non-inferior to direct oral anticoagulants while significantly reducing long-term major bleeding risks in high-risk atrial fibrillation patients.
Keywords: Atrial fibrillation, Left atrial appendage closure, Direct oral anticoagulants, Ischemic stroke, Major bleeding, Watchman device
Received: June 08, 2013; Revised: July 20, 2013; Accepted: August 12, 2013; Published: September 18, 2013
Citation: International Journal of Cardiology, 2013, Vol. 4, No. 9, pp. 65–72, DOI: 10.46882/2013/IJC/000054
International Journal of Cardiology | Vol. 4, No. 10, October 2013 | pp. 73–80
DOI: 10.46882/2013/