TCT-177 Direct Oral Anticoagulants Versus Vitamin K Antagonist After Transcatheter Aortic Valve Replacement in Patients With Concomitant Indication for Oral Anticoagulation: A Meta-Analysis

Background Clinical evidence on the safety and effectiveness of using direct oral anticoagulants (DOACs) in patients with atrial fibrillation after transcatheter aortic valve replacement (TAVR) remains limited. The aim of this study was to investigate the trends and outcomes of using DOACs in patients with TAVR and atrial fibrillation. Methods and Results Data from the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry was used to identify patients who underwent successful TAVR with preexisting or incident atrial fibrillation who were discharged on oral anticoagulation between January 2013 and May 2018. Patients with a mechanical valve, valve‐in‐valve procedure, or prior stroke within a year were excluded. The adjusted primary outcome was 1‐year stroke events. The adjusted secondary outcomes included bleeding, intracranial hemorrhage, and death. A total of 21 131 patients were included in the study (13 004 TAVR patients were discharged on a vitamin K antagonist and 8127 were discharged on DOACs.) The use of DOACs increased 5.5‐fold from 2013 to 2018. The 1‐year incidence of stroke was comparable between DOAC‐treated patients and vitamin K antagonist‐treated patients (2.51% versus 2.37%; hazard ratio [HR], 1.00; 95% CI, 0.81–1.23) whereas DOAC‐treated patients had lower 1‐year incidence of any bleeding (11.9% versus 15.0%; HR, 0.81; 95% CI, 0.75–0.89), intracranial hemorrhage (0.33% versus 0.59%; HR, 0.54; 95% CI, 0.33–0.87), and death (15.8% versus 18.2%; HR, 0.92; 95% CI, 0.85–1.00). Conclusions In patients with TAVR and atrial fibrillation, DOAC use, when compared with vitamin K antagonists, was associated with comparable stroke risk and significantly lower risks of bleeding, intracranial hemorrhage, and death at 1 year.

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Antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement. A meta-analysis of randomized controlled trials

Clinical Research in Cardiology ◽

10.1007/s00392-020-01791-x ◽

2020 ◽

Author(s):

Costanza Pellegrini ◽

Erion Xhepa ◽

Gjin Ndrepepa ◽

Hector Alvarez-Covarrubias ◽

Sebastian Kufner ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Confidence Intervals ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Antithrombotic Therapy ◽

Transcatheter Aortic Valve Replacement ◽

Meta Analysis ◽

Transcatheter Aortic Valve ◽

Life Threatening

Abstract Aims To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR). Methods and results This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio—RR = 0.83, 95% Confidence intervals—CI (0.57–1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61–2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27–3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke. Conclusions In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Graphic abstract Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.

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