@article{dce311d248bf4aba84aeb0fcbcb3a1f2,
title = "Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial)",
abstract = "The SURTAVI trial demonstrated the noninferiority of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis at intermediate surgical risk. Most TAVI patients received an early generation device which is no longer commercially available. This analysis compares TAVI outcomes in patients that received the Evolut R valve to those of similar patients randomized to SAVR in the SURTAVI trial. The continued access study of SURTAVI (CAS) enrolled 290 patients. Of them, 252 were implanted with the 23, 26, or 29 mm Evolut R device. Propensity-score matching between this group and SURTAVI SAVR patients with annular diameter of 26 mm or less was based on 22 clinical characteristics, resulting in 197 matched pairs for analysis. The primary end point for comparison was the rate of all-cause mortality or disabling stroke at 1-year. The mean age for TAVI and SAVR patients in the propensity-score matched population was 79.1 years and STS-PROM was 4.0 ± 1.5% for TAVI and 3.9% ± 1.3% for SAVR. The rate of all-cause mortality or disabling stroke at 30-days significantly favored TAVI (0.5% vs 5.1%; p = 0.006). At 1-year TAVI was numerically favored (4.1% vs 8.2%; p = 0.082). In conclusion, compared with SAVR, TAVI using Evolut R had a favorable 30-day safety profile, significantly better hemodynamic performance, and a comparable 1-year rate of all-cause mortality or disabling stroke, suggesting this may be a preferred treatment for patients with severe, symptomatic aortic stenosis at intermediate surgical risk.",
keywords = "Aged, Aged, 80 and over, Aortic Valve Stenosis/surgery, Female, Heart Valve Prosthesis, Humans, Male, Postoperative Complications/mortality, Propensity Score, Risk Assessment, Risk Factors, Transcatheter Aortic Valve Replacement/methods",
author = "Yakubov, {Steven J.} and {Van Mieghem}, {Nicolas M.} and Reardon, {Michael J.} and Serruys, {Patrick W.} and Hemal Gada and Mubashir Mumtaz and Deeb, {G. Michael} and Susheel Kodali and Isaac George and Stephan Windecker and Neal Kleiman and Chetcuti, {Stanley J.} and Carlos Sanchez and Dauerman, {Harold L.} and Shuzhen Li and Popma, {Jeffrey J.}",
note = "Funding Information: Dr. Yakubov has received institutional research grants from Boston Scientific, and Medtronic; Dr. Van Mieghem has received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular; Dr. Reardon has received fees from Medtronic for providing educational services; Prof. Serruys has received fees from Abbott Laboratories, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Societe Europa Digital Publishing, Stentys France, Svelte Medical Systems, Philips/Volcano, St. Jude Medical, Qualimed, and Xeltis; Dr. Chetcuti is a consultant and proctor for Medtronic, and receives research support from Medtronic, Gore, Boston Scientific, Edwards Lifescience, and JenaValve. Dr. Li is an employee and shareholder of Medtronic, plc; Dr. Popma has received institutional research grants from Medtronic, Boston Scientific and has served on a Medical Advisory Board for Boston Scientific, Cordis Corporation and Edwards Lifesciences. Dr. Dauerman is a consultant to Medtronic and Boston Scientific; serves on the Data Safety and Monitoring Board for HCRI, Recor Medical and CRF (multiple trials), and receives research grants from Medtronic and Boston Scientific. Funding Information: Molly Schiltgen, MS, and Colleen Gilbert, PharmD, employees of Medtronic, plc, provided editorial support including drafts of the methods and results sections, creation of tables and figures, and ensured the accuracy of the trial information. Dr. Yakubov has received institutional research grants from Boston Scientific, and Medtronic; Dr. Van Mieghem has received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular; Dr. Reardon has received fees from Medtronic for providing educational services; Prof. Serruys has received fees from Abbott Laboratories, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Societe Europa Digital Publishing, Stentys France, Svelte Medical Systems, Philips/Volcano, St. Jude Medical, Qualimed, and Xeltis; Dr. Chetcuti is a consultant and proctor for Medtronic, and receives research support from Medtronic, Gore, Boston Scientific, Edwards Lifescience, and JenaValve. Dr. Li is an employee and shareholder of Medtronic, plc; Dr. Popma has received institutional research grants from Medtronic, Boston Scientific and has served on a Medical Advisory Board for Boston Scientific, Cordis Corporation and Edwards Lifesciences. Dr. Dauerman is a consultant to Medtronic and Boston Scientific; serves on the Data Safety and Monitoring Board for HCRI, Recor Medical and CRF (multiple trials), and receives research grants from Medtronic and Boston Scientific. Funding: Medtronic (Minneapolis, Minnesota) funded the SURTAVI Trial Publisher Copyright: {\textcopyright} 2020",
year = "2020",
month = sep,
day = "15",
doi = "10.1016/j.amjcard.2020.06.051",
language = "English (US)",
volume = "131",
pages = "82--90",
journal = "American Journal of Cardiology",
issn = "0002-9149",
publisher = "Elsevier",
}