Author + information
- Received July 9, 2019
- Revision received September 17, 2019
- Accepted October 9, 2019
- Published online February 3, 2020.
- Nicolas M. Van Mieghem, MD, PhDa,∗ (, )
- Jeffrey J. Popma, MDb,
- G. Michael Deeb, MDc,
- Steven J. Yakubov, MDd,
- Patrick W. Serruys, MD, PhDe,
- Stephan Windecker, MDf,
- Lars Søndergaard, MDg,
- Mubashir Mumtaz, MDh,
- Hemal Gada, MDi,
- Stanley Chetcuti, MDj,
- Neal S. Kleiman, MDk,
- Susheel Kodali, MDl,
- Isaac George, MDl,
- Patrick Teefy, MDm,
- Bob Kiaii, MDn,
- Jae K. Oh, MDo,
- Arie Pieter Kappetein, MD, PhDp,
- Yanping Chang, MSq,
- Andrew S. Mugglin, PhDr,
- Michael J. Reardon, MDs,
- for the SURTAVI Trial Investigators
- aDepartment of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, the Netherlands
- bDepartment of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- cCardiac Surgery, University of Michigan, Ann Arbor, Michigan
- dInterventional Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio
- eCardiovascular Science Division of the National Heart and Lung Institute, Imperial College London, London, United Kingdom
- fDepartment of Interventional Cardiology, University Hospital Bern, Bern, Switzerland
- gThe Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- hCardiac Surgery, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania
- iInterventional Cardiology, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania
- jInterventional Cardiology, University of Michigan, Ann Arbor, Michigan
- kCardiology, Methodist DeBakey Heart and Vascular Center, Houston, Texas
- lStructural Heart and Valve Center, Columbia University Medical Center, New York, New York
- mDepartment of Medicine, Cardiology Division, London Health Sciences Centre, University Hospital, London, Ontario, Canada
- nDepartment of Cardiovascular and Thoracic Surgery, London Health Sciences Centre, University Hospital, London, Ontario, Canada
- oEchocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota
- pBaaken Research Center, Medical Affairs, Medtronic, Maastricht, the Netherlands
- qClinical, Medtronic, Mounds View, Minnesota
- rParadigm Biostatistics, Anoka, Minnesota
- sDepartment of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, Texas
- ↵∗Address for correspondence:
Dr. Nicolas M. Van Mieghem, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
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.
- aortic stenosis
- randomized clinical trial
- surgical aortic valve replacement
- transcatheter aortic valve replacement
Medtronic funded the SURTAVI trial. Dr. Van Mieghem has received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr. Popma has received grants from Medtronic, Boston Scientific, Abbott Vascular, and Edwards Lifesciences; and serves on the medical advisory boards of Boston Scientific and Edwards Lifesciences. Dr. Deeb serves on an advisory board and as a proctor for Medtronic; serves as a consultant and research investigator for Edwards Lifesciences; serves as a consultant and proctor for Terumo; and serves as a research investigator for Gore Medical (he receives no personal remunerations). Dr. Yakubov has received institutional research grants from Medtronic and Boston Scientific; and serves on advisory boards for Medtronic and Boston Scientific. Dr. Kodali has received consulting fees from Edwards Lifesciences; has served on the steering committees of Edwards Lifesciences and St. Jude Medical; has served on the Speakers Bureau of Thubrikar Aortic Valve, Inc.. Dr. George has received personal fees from W.L. Gore, MitreMedical, Cardiomech, and Atricure. Dr. Kiaii has received personal fees from Medtronic and Boston Scientific as a proctor, consultant, and speaker; has received consulting and speaking fees from Johnson & Johnson; and has received fees from Edwards Lifesciences as a member of the Canadian advisory board and as a consultant and proctor. Dr. Windecker has received research grant support from Edwards Lifesciences. Medtronic, Boston Scientific, Biotronik, and Abbott. Dr. Søndergaard has received institutional research grants and consultancy fees from Medtronic, Abbott, Boston Scientific, Edwards Lifesciences, and Symetis. Dr. Chetcuti has received grant support and fees for proctoring from Medtronic. Dr. Kappetein and Ms. Chang are employees and shareholders of Medtronic. Dr. Serruys has received personal fees from Biosensors, Micell Technologies, Sino Medical Sciences Technology, Philips/Volcano, Heartflow, and Xeltis. Dr. Reardon serves on an advisory board for Medtronic. Dr. Mugglin has received consultancy fees from Angel Medical Systems, Boston Scientific, SentreHeart, Cardialen, Cardiovascular Systems, Abbott, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 9, 2019.
- Revision received September 17, 2019.
- Accepted October 9, 2019.
- 2020 American College of Cardiology Foundation
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