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. 2021 Dec;7(12):1533-1543.
doi: 10.1016/j.jacep.2021.04.012. Epub 2021 Jun 30.

Incidence of Device-Related Thrombosis in Watchman Patients Undergoing a Genotype-Guided Antithrombotic Strategy

Domenico G Della Rocca  1 , Rodney P Horton  2 , Luigi Di Biase  3 , Carola Gianni  2 , Chintan Trivedi  2 , Sanghamitra Mohanty  2 , Alisara Anannab  4 , Michele Magnocavallo  5 , Qiong Chen  6 , Nicola Tarantino  7 , Mohamed Bassiouny  2 , Carlo Lavalle  8 , Veronica N Natale  2 , Giovanni B Forleo  9 , Armando Del Prete  10 , Christoffel Johannes Van Niekerk  11 , Amin Al-Ahmad  2 , J David Burkhardt  2 , G Joseph Gallinghouse  2 , Javier E Sanchez  2 , Dhanunjaya Lakkireddy  12 , Douglas N Gibson  11 , Andrea Natale  13
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Free article

Incidence of Device-Related Thrombosis in Watchman Patients Undergoing a Genotype-Guided Antithrombotic Strategy

Domenico G Della Rocca et al. JACC Clin Electrophysiol. 2021 Dec.
Free article

Abstract

Objectives: This study sought to report the incidence of device-related thrombosis (DRT) and thromboembolic (TE) events when an alternative to clopidogrel is prescribed in loss-of-function (LOF) allele carriers of the cytochrome P450 2C19 (CYP2C19) gene.

Background: LOF polymorphisms of the CYP2C19 gene are associated with reduced hepatic bioactivation of clopidogrel.

Methods: A total of 1,002 Watchman patients were included. Six hundred forty-five patients underwent CYP2C19 genetic testing; among patients with clopidogrel resistance, clopidogrel was replaced by either prasugrel (pilot cohort) or half dose direct oral anticoagulant ([DOAC]/Group 1), both in combination with aspirin. We compared the incidence of DRT/TE events among genotyped patients and a control group which received standard dual antiplatelet therapy (DAPT) (Group 2; n = 357). All reported events occurred during a timeframe between 45- and 180-day follow-up transesophageal echocardiograms, when the 2 different antithrombotic strategies (genotype-guided vs standard DAPT) were adopted.

Results: In the pilot cohort (n = 244), bleeding events occurred in 10.2% of patients who received aspirin plus prasugrel, leading to early discontinuation of the prasugrel-based protocol. DOAC Group 1 patients (n = 401), 25.7% were reduced metabolizers, and clopidogrel was replaced by half dose direct oral anticoagulant. DRT was documented in 1 (0.2%) patient of Group 1 and 7 (1.96%) patients of Group 2 (log-rank P = 0.021). The composite endpoint of DRT/TE events was significantly lower among patients receiving a genotype-guided antithrombotic strategy (0.75% vs 3.10%; log-rank P = 0.017).

Conclusions: In Watchman patients, a genotype-based antithrombotic strategy with aspirin plus half dose DOAC in reduced clopidogrel metabolizers was superior to standard DAPT with respect to DRT/TE events.

Keywords: Watchman; atrial fibrillation; clopidogrel; device-related thrombus; left atrial appendage; stroke.

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Conflict of interest statement

Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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