Half-Dose Direct Oral Anticoagulation Versus Standard Antithrombotic Therapy After Left Atrial Appendage Occlusion

Domenico G Della Rocca; Michele Magnocavallo; Luigi Di Biase; Sanghamitra Mohanty; Chintan Trivedi; Nicola Tarantino; Carola Gianni; Carlo Lavalle; Christoffel Johannes Van Niekerk; Jorge Romero; David F Briceño; Mohamed Bassiouny; Amin Al-Ahmad; J David Burkhardt; Veronica N Natale; G Joseph Gallinghouse; Armando Del Prete; Giovanni B Forleo; Javier Sanchez; Dhanunjaya Lakkireddy; Rodney P Horton; Douglas N Gibson; Andrea Natale

doi:10.1016/j.jcin.2021.07.031

Half-Dose Direct Oral Anticoagulation Versus Standard Antithrombotic Therapy After Left Atrial Appendage Occlusion

JACC Cardiovasc Interv. 2021 Nov 8;14(21):2353-2364. doi: 10.1016/j.jcin.2021.07.031. Epub 2021 Oct 13.

Authors

Domenico G Della Rocca¹, Michele Magnocavallo², Luigi Di Biase³, Sanghamitra Mohanty⁴, Chintan Trivedi⁴, Nicola Tarantino⁵, Carola Gianni⁴, Carlo Lavalle⁶, Christoffel Johannes Van Niekerk⁷, Jorge Romero⁵, David F Briceño⁵, Mohamed Bassiouny⁴, Amin Al-Ahmad⁴, J David Burkhardt⁴, Veronica N Natale⁸, G Joseph Gallinghouse⁴, Armando Del Prete⁹, Giovanni B Forleo¹⁰, Javier Sanchez⁴, Dhanunjaya Lakkireddy¹¹, Rodney P Horton⁴, Douglas N Gibson⁷, Andrea Natale¹²

Affiliations

¹ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA. Electronic address: domenicodellarocca@hotmail.it.
² Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
³ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Arrhythmia Services, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA; Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.
⁴ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.
⁵ Arrhythmia Services, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
⁶ Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
⁷ Interventional Electrophysiology, Scripps Clinic, La Jolla, California, USA.
⁸ Charlotte R. Bloomberg Children's Center, Johns Hopkins University, Baltimore, Maryland, USA.
⁹ Division of Cardiology, S. Maria Goretti Hospital, Latina, Italy.
¹⁰ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Department of Cardiology, Azienda Ospedaliera-Universitaria Luigi Sacco, Milano, Italy.
¹¹ Kansas City Heart Rhythm Institute, HCA Midwest Health, Kansas City, Kansas, USA.
¹² Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Interventional Electrophysiology, Scripps Clinic, La Jolla, California, USA; Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

PMID: 34656496
DOI: 10.1016/j.jcin.2021.07.031

Abstract

Objectives: This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation.

Background: No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure.

Methods: After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events.

Results: Overall, 555 patients (mean age 75 ± 8 years, 63% male; median 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 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P = 0.002).

Conclusions: After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.

Keywords: Watchman; antiplatelet therapy; aspirin; left atrial appendage; oral anticoagulation; stroke; thromboembolism.

MeSH terms

Aged
Aged, 80 and over
Anticoagulants / adverse effects
Atrial Appendage* / diagnostic imaging
Atrial Fibrillation* / complications
Atrial Fibrillation* / diagnosis
Atrial Fibrillation* / drug therapy
Female
Fibrinolytic Agents / adverse effects
Humans
Male
Stroke* / diagnosis
Stroke* / etiology
Stroke* / prevention & control
Treatment Outcome

Substances

Anticoagulants
Fibrinolytic Agents