Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial.

Van Mieghem, Nicolas M; Popma, Jeffrey J; Deeb, G Michael; Yakubov, Steven J; Serruys, Patrick W; Windecker, Stephan; Søndergaard, Lars; Mumtaz, Mubashir; Gada, Hemal; Chetcuti, Stanley; Kleiman, Neal S; Kodali, Susheel; George, Isaac; Teefy, Patrick; Kiaii, Bob; Oh, Jae K; Kappetein, Arie Pieter; Chang, Yanping; Mugglin, Andrew S and Reardon, Michael J (2020). Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial. JACC. Cardiovascular Interventions, 13(3), pp. 323-331. Elsevier 10.1016/j.jcin.2019.10.043

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OBJECTIVES

The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis.

BACKGROUND

Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated.

METHODS

The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients.

RESULTS

The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference; Bayesian credible interval: -5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences.

CONCLUSIONS

The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1876-7605

Publisher:

Elsevier

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

04 Nov 2020 14:17

Last Modified:

14 Dec 2020 07:56

Publisher DOI:

10.1016/j.jcin.2019.10.043

PubMed ID:

32029248

Additional Information:

Collaborators SURTAVI Trial Investigators: Thierry Carrel

Uncontrolled Keywords:

aortic stenosis randomized clinical trial surgical aortic valve replacement transcatheter aortic valve replacement

BORIS DOI:

10.7892/boris.147262

URI:

https://boris.unibe.ch/id/eprint/147262

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