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

2021 ◽  
Vol 8 ◽  
Author(s):  
Christopher Hohmann ◽  
Marion Ludwig ◽  
Jochen Walker ◽  
Hendrik Wienemann ◽  
Stephan Baldus ◽  
...  

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.

Author(s):  
Toshiki Kuno ◽  
Yujiro Yokoyama ◽  
Alexandros Briasoulis ◽  
Makoto Mori ◽  
Masao Iwagami ◽  
...  

Background Although current guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months following transcatheter aortic valve replacement (TAVR), there are no studies directly comparing outcomes of different durations of DAPT following TAVR. Methods and Results PubMed, EMBASE, and Cochrane Database were searched through November 2020 to identify clinical studies that investigated single antiplatelet therapy versus DAPT use following TAVR. Studies using oral anticoagulants and antiplatelet therapy concomitantly were excluded. The DAPT group was subdivided by the duration of DAPT. We extracted the risk ratios (RRs) of major or life‐threatening bleeding, stroke, and all‐cause mortality. Four randomized controlled trials, 2 propensity‐score matched studies, and 1 observational study were identified, yielding a total of 2498 patients who underwent TAVR assigned to the single antiplatelet therapy group (n=1249), 3‐month DAPT group (n=485), or 6‐month DAPT group (n=764). Pooled analyses demonstrated that when compared with the single antiplatelet therapy group, the rates of major or life‐threatening bleeding were significantly higher in the 3‐ and 6‐month DAPT groups (RR [95% CI]=2.13 [1.33–3.40], P =0.016; RR [95% CI]=2.54 [1.49–4.33], P =0.007, respectively) with no difference between the 3‐month DAPT versus 6‐month DAPT groups. The rates of stroke and all‐cause mortality were similar among the 3 groups. Conclusions In this network meta‐analysis of antiplatelet therapy following TAVR, single antiplatelet therapy with aspirin had lower bleeding without increasing stroke or death when compared with either 3‐ or 6‐month DAPT.


2019 ◽  
Vol 57 (5) ◽  
pp. 965-976 ◽  
Author(s):  
Yuexin Zhu ◽  
Ziyuan Zou ◽  
Yusi Huang ◽  
Lei Zhang ◽  
Huiting Chen ◽  
...  

Abstract OBJECTIVES We sought to determine the optimal antithrombotic therapy after transcatheter aortic valve replacement. METHODS Related scientific databases were searched until December 2018. We conducted a pairwise and a network meta-analysis within a frequentist framework, measuring 30-day bleeding, stroke and all-cause mortality. The surface under the cumulative ranking (SUCRA) curve was estimated to rank the therapies. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was performed. The protocol was registered with PROSPERO (CRD42018111163). RESULTS Eight studies comprising 2173 patients were analysed. The risk of 30-day bleeding was higher for dual antiplatelet therapy (DAPT) than single antiplatelet therapy (SAPT) [odds ratio (OR) 1.90 (1.10–3.28); P = 0.02], whereas there was no difference in the risk of 30-day stroke [OR 1.27 (0.38–4.20); P = 0.69] and mortality [OR 1.46 (0.67–3.22); P = 0.34] between DAPT and SAPT. In the network meta-analysis, DAPT + oral anticoagulant (OAC) increased the risk of 30-day bleeding compared with SAPT [OR 6.21 (1.74–22.17); P = 0.005], DAPT [OR 3.27 (1.04–10.32); P = 0.043], SAPT + OAC [OR 4.87 (2.51–9.45); P < 0.001] and OAC [OR 14.4 (1.3–154.7); P = 0.028]. Additionally, patients receiving DAPT + OAC had the highest risks for 30-day bleeding (SUCRA 1.0%). OAC seemed to be superior to SAPT and DAPT in terms of 30-day bleeding (SUCRA OAC: 86.3%, SAPT: 72.3%, DAPT: 32.3%) and stroke (SUCRA 54.2%, 47.4%, 40.5%), but not mortality (SUCRA 69.6%, 74.1%, 43.4%). CONCLUSIONS There is a trend towards less bleeding with the application of SAPT, but no mortality benefit with the application of DAPT is shown. The comparison of SAPT, DAPT and OAC shows that OAC may improve the balance between stroke and bleeding, which can reduce the risk of mortality. In addition, the application of DAPT + OAC was ranked the worst amongst all treatment modalities and should be avoided due to an increased risk of bleeding. Clinical trial registration number PROSPERO (International Prospective Register of Systematic Reviews, CRD42018111163).


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