Real-World Anticoagulatory Treatment After Transcatheter Aortic Valve Replacement: A Retrospective, Observational Study on 4,800 Patients

Abstract

Background: Transcatheter aortic valve replacement (TAVR) has developed to the therapy of choice for patients with symptomatic severe aortic stenosis who are unsuitable for surgical aortic valve replacement and elderly patients with intermediate or high operative risk. However, the optimal anticoagulant therapy post-TAVR still remains a matter of debate.Aims: This study sought to investigate current anticoagulant treatment patterns and clinical outcome in patients undergoing TAVR.Methods: In a retrospective study based on anonymized health claims data of approximately seven million Germans with statutory health insurance (InGef database), anticoagulant treatment regimens were assessed using any drug prescription post discharge within the first 90 days after TAVR procedure. Clinical events between 30 days and 6 months were examined by treatment regime.Results: The study population comprised 4,812 patients with TAVR between 2014 and 2018: 29.4% received antiplatelet monotherapy, 17.8% dual antiplatelet therapy, 17.4% oral anticoagulation (OAC) plus antiplatelet therapy, 12.9% OAC monotherapy, 2.2% triple therapy and 19.2% did not receive any anticoagulatory drugs. Sixty-four percentage of patients with OAC received direct oral anticoagulants (DOAC). Hence, 68% of all patients were treated non-adherent to current guidelines. Forty percentage of patients with OAC prior to TAVR did not have any OAC after TAVR. The adjusted risk of all-cause mortality was significantly increased in patients with OAC (HR 1.40, 95% CI 1.03–1.90, p = 0.03) and no anticoagulatory treatment (HR 3.95, 95% CI 2.95–5.27, p < 0.0001) when compared to antiplatelet monotherapy.Conclusions: This large real-world data analysis demonstrates substantial deviations from guideline recommendations and treatment after TAVR. Considering relevant differences in clinical outcome across treatment groups, major effort is warranted to examine underlying causes and improve guideline adherence.

Efficacy and outcomes of antiplatelet therapy versus oral anticoagulants in patients undergoing TAVR: A systematic review and meta-analysis

“…The ACM outcome was reported in eight studies 13 – 15 , 19 , 20 , 22 . No statistically significant difference was found between the APT and OAC groups with respect to ACM [8.35% versus 10.4%; RR:0.67; 95% CI:0.45–1.01; P =0.05; I 2 =76%] (Fig.…”

“…Hohmann et al . 22 studied ACM in similar treatment and control arms and reported that APT is superior. DeBacker et al .…”

New Oral Anticoagulants Versus Vitamin K Antagonists in Patients with Left-Sided Bioprosthetic Heart Valves and Atrial Fibrillation: A Systematic Review and Meta-Analysis

“…VHD and AF are frequently coexisting and both of them lead to an increased risk of death. Generally, AF can cause a 5-fold increase risk of stroke [3] , while transcatheter aortic valve replacement(TAVR) increases stroke risk by 3.95-fold [4] . In patients suffering from aortic stenosis, 40.7% have AF and 6.8% experienced new-onset AF after TAVR [5] .…”