Dataset Information

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

ABSTRACT:

Background

One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC).

Aims

We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective. Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days.

Results

In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results.

Conclusions

Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.

SUBMITTER: Mangner N

PROVIDER: S-EPMC9909456 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

Mangner Norman N Brinkert Miriam M Keller Lukas S LS Moriyama Noriaki N Hagemeyer Daniel D Haussig Stephan S Crusius Lisa L Kobza Richard R Abdel-Wahab Mohamed M Laine Mika M Stortecky Stefan S Pilgrim Thomas T Nietlispach Fabian F Ruschitzka Frank F Thiele Holger H Toggweiler Stefan S Linke Axel A

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20230206 13

<h4>Background</h4>One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC).<h4>Aims</h4>We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective. Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enro ...[more]

PMID: 36440479

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Project description:BackgroundThe best anticoagulation choice for patients undergoing transcatheter aortic valve replacement (TAVR) with indications of oral anticoagulation (OAC) remains uncertain. We carried out a comprehensive analysis adopting updated evidence that investigated the efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in this population.MethodsA systematic search has been conducted through PubMed, Embase, and Cochrane Library to collect randomized controlled trials (RCTs) and real-world studies comparing the therapy outcomes of DOACs with VKAs in patients undergoing TAVR with indications of OAC up to Dec 2021. Included studies reported all-cause mortality, bleeding, stroke, or composite endpoint. A random-effects model was used and followed a sensitivity analysis based on the heterogeneity. In addition, five scenario analyses were performed to robust our findings.ResultsOur analysis included 11 articles enrolling a total of 8934 patients undergone TAVR with indications of OAC (DOACs group = 3890, VKAs group = 5044). Pooled analysis revealed no significant different risk of all-cause mortality (aHR: 0.95, 95% CI: 0.65-1.39, I2 : 90.6%), stroke (aHR: 0.86, 95% CI: 0.55-1.35, I2 : 44.3%), bleeding (aHR: 0.83, 95% CI: 0.61-1.13, I2 : 76.3%), and composite endpoint (aHR: 1.05, 95% CI: 0.88-1.24, I2 : 11.7%) in the DOACs and VKAs groups. Various forms of death, stroke and bleeding, including cardiovascular death (aHR: 0.92, 95% CI: 0.64-1.33, I2 : 34.1%), hemorrhagic stroke (aHR: 0.63, 95% CI: 0.23-1.75, I2 : 22.7%), ischemic stroke (aHR: 0.79, 95% CI: 0.56-1.15, I2 : 0.0%), transient ischemic attack (aHR: 0.75, 95% CI: 0.40-1.41, I2 : 0.0%), major or life-threatening bleeding (aHR: 0.96, 95% CI: 0.74-1.24, I2 : 27.9%), and minor bleeding (aHR: 0.90, 95% CI: 0.52-1.57, I2 : 54.3%), also showed similar rates among DOACs and VKAs groups. The results based on five scenarios confirmed the said findings.ConclusionsCompared with VKAs, the efficacy and safety of DOACs were comparable for treating TAVR patients combined with anticoagulation indications. Further large-scale RCTs investigating more detailed scenarios are still needed to confirm the optimal anticoagulation strategy.

Project description:ObjectiveTranscatheter aortic valve implantation (TAVI) procedures are increasing rapidly, but the durability of tissue valve and periprocedural complications are not satisfactory. Immune reaction to the galactose-α-1,3 galactose β-1,4-N-acetylglucosamine (α-Gal) and conventional processing protocols of cardiac xenografts lead to calcification. Next-generation TAVI needs to be made with α-Gal-free xenografts by multiple anticalcification therapies to avoid immune rejection and enhance durability, and three-dimensional (3D) printing technology to improve the procedural safety.MethodsPorcine pericardia were decellularized and immunologically modified with α-galactosidase. The pericardia were treated by space filler, crosslinked with glutaraldehyde in organic solvent, and detoxified. The sheep-specific nitinol (nickel-titanium memory alloy) wire backbone was made from a 3D-printed model for ovine aortic root. After it passed the fitting test, we manufactured a self-expandable stented valve with the porcine pericardia mounted on the customized nitinol wire-based stent. After in vitro circulation using customized silicone aortic root, we performed TAVI in 9 sheep and obtained hemodynamic, radiological, immunohistopathological, and biochemical results.ResultsThe valve functioned well, with excellent stent fitting and good coronary flow under in vitro circulation. Sheep were sequentially scheduled to be humanely killed until 238 days after TAVI. Echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the aortic valve. The xenografts were well preserved without α-Gal immune reaction or calcification based on the immunological, radiographic, microscopic, and biochemical examinations.ConclusionsWe proved preclinical safety and efficacy for next-generation α-Gal-free TAVI with multiple anticalcification therapies and 3D-printing technology. A future clinical study is warranted based on these promising preclinical results.

Dataset Information

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

Background

Aims

Results

Conclusions

Publications

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

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