CBS 2019
CBSMD教育中心
English

Transcatheter Aortic Valve Replacement

科研文章

荐读文献

Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR Predictors of high residual gradient after transcatheter aortic valve replacement in bicuspid aortic valve stenosis Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study Ascending Aortic Length and Risk of Aortic Adverse Events: The Neglected Dimension Low Transvalvular Flow Rate Predicts Mortality in Patients With Low-Gradient Aortic Stenosis Following Aortic Valve Intervention Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial

Clinical TrialJanuary 9, 2020

JOURNAL:N Engl J Med. Article Link

A Controlled Trial of Rivaroxaban After Transcatheter Aortic-Valve Replacement

GD Dangas, JGP Tijssen, the GALILEO Investigators et al. Keywords: antithrombotic strategy vs antiplatelet-based strategy; post TAVR

ABSTRACT


BACKGROUND - Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear.


METHODS - We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns.


RESULTS - After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P=0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P=0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).


CONCLUSIONS - In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.)