scholarly journals Rationale and design of the ADAPT-TAVR trial: a randomised comparison of edoxaban and dual antiplatelet therapy for prevention of leaflet thrombosis and cerebral embolisation after transcatheter aortic valve replacement

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042587
Author(s):  
Hanbit Park ◽  
Do-Yoon Kang ◽  
Jung-Min Ahn ◽  
Kyung Won Kim ◽  
Anthony Y T Wong ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Antiplatelet Therapy ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Dual Antiplatelet Therapy ◽  
Medical Center ◽  
Lesion Volume ◽  
Study Drug Administration ◽  
Transcatheter Aortic Valve

IntroductionOptimal antithrombotic strategy following transcatheter aortic valve replacement (TAVR) is still unknown. We hypothesised that the direct factor Xa inhibitor edoxaban can potentially prevent subclinical leaflet thrombosis and cerebral embolisation compared with conventional dual antiplatelet therapy (DAPT) in patients undergoing TAVR.Methods and analysisThe ADAPT-TAVR trial is an international, multicentre, randomised, open-label, superiority trial comparing edoxaban-based strategy and DAPT strategy in patients without an indication for oral anticoagulation who underwent successful TAVR. A total of 220 patients are randomised (1:1 ratio), 1–7 days after successful TAVR, to receive either edoxaban (60 mg daily or 30 mg daily if patients had dose-reduction criteria) or DAPT using aspirin (100 mg daily) plus clopidogrel (75 mg daily) for 6 months. The primary endpoint was an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging at 6 months post-TAVR. The key secondary endpoints were the number of new lesions and new lesion volume on brain diffusion-weighted MRI and the changes in neurological and neurocognitive function assessment between immediate post-TAVR and 6 months of study drug administration. Detailed clinical information on thromboembolic and bleeding events were also assessed.Ethics and disseminationEthic approval has been obtained from the Ethics Committee/Institutional Review Board of Asan Medical Center (approval number: 2017–1317) and this trial is also approved by National Institute of Food and Drug Safety Evaluation of Republic of Korea (approval number: 31511). Results of this study will be disseminated in scientific publication in reputed journals.Trial registration numberNCT03284827.

scholarly journals Aspirin Versus Clopidogrel as Single Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry

2021 ◽  
Vol 14 (5) ◽  
Author(s):  
Yusuke Kobari ◽  
Taku Inohara ◽  
Tetsuya Saito ◽  
Nobuhiro Yoshijima ◽  
Makoto Tanaka ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Propensity Score ◽  
Aortic Valve Replacement ◽  
Propensity Score Matching ◽  
Antiplatelet Therapy ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Events ◽  
Transcatheter Aortic Valve

Background: Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR. Methods: Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR. Results: After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P =0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P =0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P =0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P =0.02) anticoagulation. Conclusions: We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use. Registration: URL: https://upload.umin.ac.jp ; Unique identifier: UMIN000020423.

scholarly journals Single antiplatelet therapy versus dual antiplatelet therapy after transcatheter aortic valve replacement: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G Sayat ◽  
L G Porciuncula ◽  
A Gerodias
Keyword(s):  
Myocardial Infarction ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Antiplatelet Therapy ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Dual Antiplatelet Therapy ◽  
Meta Analysis ◽  
Randomized Controlled ◽  
Transcatheter Aortic Valve

Abstract Background The performance of transcatheter aortic valve replacement (TAVR) has expanded considerably during the past decade. Technological advances and refinement in implantation techniques have resulted in improved procedural outcomes, whereas indications are progressively extending toward lower-risk patients. Ischemic/embolic complications and major bleeding remain important and strongly correlate to mortality. In this regard, the optimal antithrombotic regimen after successful transcatheter aortic valve replacement remains unclear. Purpose To compare the efficacy and safety of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) for post Transcatheter Aortic Valve Replacement. Search strategy Key Terms: transcatheter aortic valve replacement, transcatheter aortic valve implantation, antiplatelet, single antiplatelet therapy, dual antiplatelet therapy. Selection criteria Four randomized, controlled clinical trials comparing single antiplatelet therapy versus dual antiplatelet therapy for post TAVR patients were included in this study. Method Extensive search of PubMed, Medline, Cochrane and Ovid was done for articles published until November 20, 2020. Studies were limited to RCTs comparing SAPT and DAPT among patients who underwent TAVR. Outcome measures include: stroke, myocardial infarction, all-cause mortality and major bleeding. Two reviewers independently reviewed the studies. Results were gathered from published articles, journals and clinical trials. Studies were critically appraised with regards to methods of minimizing bias. All four studies included received a quality scale for meta-analysis overall score of not less than B. Statistical analysis was done using Review manager V5.4. Main results Four RCTs with 1086 patients were included in this meta-analysis. Overall, the risk of stroke (OR 0.94 [0.54 −1.64]), myocardial infarction (OR 0.50 [0.18–1.40]), and overall mortality (OR 1.01 [0.65–1.57]) did not differ significantly between DAPT and SAPT. There was noted increased risk of bleeding noted with DAPT, thus favoring SAPT (OR 0.44 [0.30–0.65]). Author's conclusions Among patients who underwent TAVR, DAPT compared to SAPT had similar rates of stroke, myocardial infarction and death. Due to lower rates of bleeding, we recommend using single antiplatelet therapy after TAVR. FUNDunding Acknowledgement Type of funding sources: None.

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