What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Atrial fibrillation post transcatheter aortic valve replacement (TAVR) (n=30388). Intervention: Novel oral anticoagulants (NOACs) vs. Vitamin K antagonists (VKAs). Primary outcome: Composite endpoints of any clinically relevant risk events (RR 1.04, 95% CI 0.94, 1.14, p=0.48).

August 31, 2023Frontiers in Cardiovascular MedicineOpen Access

Post-TAVR patients with atrial fibrillation: are NOACs better than VKAs?—A meta-analysis

Q: What are the key findings of this study?

In post-TAVR patients with atrial fibrillation, NOACs did not significantly reduce composite clinical endpoints compared to VKAs, but significantly reduced major bleeding (RR 0.82) and all-cause mortality (RR 0.83).

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Key result

NOACs fail to reduce composite events vs VKAs post-TAVR with AF but cut major bleeding ~18%.

Why the study?

To compare the efficacy of novel oral anticoagulants with traditional vitamin K antagonists in patients with atrial fibrillation post transcatheter aortic valve replacement.

Do NOACs reduce composite endpoints, stroke, major bleeding, and all-cause mortality compared to VKAs in post-TAVR patients with atrial fibrillation?

Study Design

Type

Meta-Analysis (n=30,388)

Structured PICO

Do NOACs reduce composite endpoints, stroke, major bleeding, and all-cause mortality compared to VKAs in post-TAVR patients with atrial fibrillation?

Population

30,388 adult patients with atrial fibrillation requiring oral anticoagulation after transcatheter aortic valve replacement, included across 13 studies.

Intervention

Novel oral anticoagulants (NOACs) as a class (including rivaroxaban, apixaban, dabigatran, edoxaban)

Comparator

Vitamin K antagonists (VKAs)

Outcome

Four main indexes: composite endpoints composed mainly of any clinically relevant risk events, stroke, major bleeding, and all-cause mortalitycomposite

Main Result

Relative Risk: 1.04 (95% CI 0.94–1.14)

Absolute Event Rate: 6.14% vs 5.85%

p-value: p=0.48

In post-TAVR patients with atrial fibrillation, the use of NOACs is associated with significantly lower rates of major bleeding and all-cause mortality compared to VKAs, with similar rates of stroke.

Limitations

Few randomized controlled studies and most included studies were retrospective
Significant heterogeneity between studies due to differences in country, ethnicity, and type of study
Specific drugs used in the studies were not the same
Some studies included a small sample of patients
Few randomized controlled studies included
Most included studies were retrospective with inherent limitations
Potential lack of power in smaller samples
Potential bias in non-RCTs

Implication

NOACs may lower major bleeding and mortality versus VKAs in post-TAVR AF; leaves open composite endpoint effects pending randomized confirmation.

Abstract

Objective This study aimed to compare the efficacy of novel oral anticoagulants (NOACs) with traditional anticoagulants vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) post transcatheter aortic valve replacement (TAVR). Methods Studies comparing the usage of NOACs and VKAs in AF patients with oral anticoagulant indication post-TAVR were retrieved from PubMed, EMBASE, Medline, and Cochrane databases from their building-up to Jan. 2023. The literature was screened in line of inclusion and exclusion criteria. Risk ratio (RR) or odds ratio (OR),95% confidence interval (CI) and number needed to treat (NNT) were calculated for four main indexes that composite endpoints composed mainly of any clinically relevant risk events, stroke, major bleeding, and all-cause mortality. Subsequently, a meta-analysis was performed using the RevMan5.3 and Stata 16.0 software. Results In the aggregate of thirteen studies, contained 30388 post-TAVR patients with AF, were included in this meta-analysis. Our results indicated that there was no significant difference in stroke between the NOACs group and the VKAs group, and the NOACs group had a numerically but non-significantly higher number of composite endpoint events compared with the other group. Nevertheless, the incidence of major bleeding [11.29% vs. 13.89%, RR 0.82, 95%CI (0.77,0.88), P < 0.00001, I ² = 69%, NNT = 38] and all-cause mortality [14.18% vs. 17.61%, RR 0.83, 95%CI (0.79,0.88), p < 0.00001, I ² = 82%, NNT = 29] were significantly lower in the NOACs group than another group. Conclusion Taken together, our data indicated that the usage of NOACs reduced the incidence of major bleeding and all-cause mortality compared to VKAs in post-TAVR patients with AF.

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Published by Frontiers in Cardiovascular Medicine · CC BY

Cite This Study

Wang et al. (2023) conducted a meta-analysis in Atrial fibrillation post transcatheter aortic valve replacement (TAVR) (n=30,388). Novel oral anticoagulants (NOACs) vs. Vitamin K antagonists (VKAs) was evaluated on Composite endpoints of any clinically relevant risk events (RR 1.04, 95% CI 0.94, 1.14, p=0.48). In post-TAVR patients with atrial fibrillation, NOACs did not significantly reduce composite clinical endpoints compared to VKAs, but significantly reduced major bleeding (RR 0.82) and all-cause mortality (RR 0.83).

synapsesocial.com/papers/6a2aea2f4f8464ef95c7b135 https://doi.org/10.3389/fcvm.2023.1175215