The n e w e ng l a n d j o u r na l of m e dic i n e original article Transcatheter Aortic Valve Replacement with a Self Expanding Prosthesis David H Adams M D Jeffrey J Popma M D Michael J Reardon M D Steven J Yakubov M D Joseph S Coselli M D G Michael Deeb M D Thomas G Gleason M D Maurice Buchbinder M D James Hermiller Jr M D Neal S Kleiman M D Stan Chetcuti M D John Heiser M D William Merhi D O George Zorn M D Peter Tadros M D Newell Robinson M D George Petrossian M D G Chad Hughes M D J Kevin Harrison M D John Conte M D Brijeshwar Maini M D Mubashir Mumtaz M D Sharla Chenoweth M S and Jae K Oh M D for the U S CoreValve Clinical Investigators A BS T R AC T BACKGROUND From Mount Sinai Medical Center New York D H A and St Francis Hospital Roslyn N R G P both in New York Beth Israel Deaconess Medical Center Boston J J P Houston Methodist DeBakey Heart and Vascular Center M J R N S K and Texas Heart Institute at St Luke s Medical Center J S C both in Houston Riverside Methodist Hospital Columbus OH S J Y University of Michigan Medical Center Ann Arbor G M D S Chetcuti and Spectrum Health Hospitals Grand Rapids J H W M both in Michigan University of Pittsburgh Medical Center Pittsburgh T G G Palo Alto Veterans Affairs Medical Center Palo Alto CA M B St Vincent Medical Center Indianapolis J H University of Kansas Hospital Kansas City G Z P T Duke University Medical Center Durham NC G C H J K H Johns Hopkins Hospital Baltimore J C Pinnacle Health Harrisburg PA B M M M and Medtronic Minneapolis S Cheno weth and Mayo Clinical Foundation Rochester J K O both in Minnesota Address reprint requests to Dr Popma at Interventional Cardiology Service Beth Israel Deaconess Medical Center 185 Pilgrim Rd Boston MA 02460 or at jpopma bidmc harvard edu A complete list of the investigators institutions and research organizations participating in the U S CoreValve High Risk Study is provided in the Supplementary Appendix available at NEJM org This article was published on March 29 2014 at NEJM org N Engl J Med 2014 370 1790 8 DOI 10 1056 NEJMoa1400590 Copyright 2014 Massachusetts Medical Society 1790 We compared transcatheter aortic valve replacement TAVR using a self expanding transcatheter aortic valve bioprosthesis with surgical aortic valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors Eligible patients were randomly assigned in a 1 1 ratio to TAVR with the self expanding transcatheter valve TAVR group or to surgical aortic valve replacement surgical group The primary end point was the rate of death from any cause at 1 year evaluated with the use of both noninferiority and superiority testing RESULTS A total of 795 patients underwent randomization at 45 centers in the United States In the as treated analysis the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group 14 2 vs 19 1 with an absolute reduction in risk of 4 9 percentage points upper boundary of the 95 confidence interval 0 4 P 0 001 for noninferiority P 0 04 for superiority The results were similar in the intention to treat analysis In a hierarchical testing procedure TAVR was noninferior with respect to echocardiographic indexes of valve stenosis functional status and quality of life Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk TAVR with a self expanding transcatheter aortic valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic valve replacement Funded by Medtronic U S CoreValve High Risk Study ClinicalTrials gov number NCT01240902 n engl j med 370 19 nejm org may 8 2014 The New England Journal of Medicine Downloaded from nejm org at WEILL CORNELL MEDICAL LIBRARY on September 9 2014 For personal use only No other uses without permission Copyright 2014 Massachusetts Medical Society All rights reserved Tr anscatheter Aortic Valve Replacement A ortic stenosis is a debilitating disease in elderly persons that carries a dismal prognosis after symptom onset 1 Although surgical aortic valve replacement remains the standard treatment for aortic stenosis 2 many patients are not suitable candidates for surgical replacement owing to an increased risk of death during surgery 3 4 Transcatheter aortic valve replacement TAVR with a balloon expandable device improves survival as compared with medical therapy in patients with severe aortic stenosis who cannot undergo surgery 5 Balloon expandable TAVR and surgical aortic valve replacement are associated with similar survival rates at 1 year among patients considered to be at high surgical risk although the frequency of neurologic events is higher among patients treated with balloonexpandable TAVR than among those treated surgically 6 7 An alternative transcatheter bioprosthesis comprising a self expanding nitinol frame and trileaflet porcine pericardial valve CoreValve Medtronic reduced the composite end point of death from any cause or major stroke at 1 year as compared with an objective performance goal of medical management alone in patients with severe aortic stenosis who were considered to be at extreme surgical risk 8 The purpose of the present study was to assess the safety and effectiveness of TAVR with a self expanding prosthesis as compared with surgical valve replacement in patients with severe aortic stenosis who were at increased surgical risk ME THODS STUDY DESIGN This study was a multicenter randomized noninferiority trial performed at 45 clinical sites in the United States Table S1 in the Supplementary Appendix available with the full text of this article at NEJM org Medtronic funded the trial and developed the protocol available at NEJM org in collaboration with the study steering committee Table S2 in the Supplementary Appendix The institutional review board at each site approved the study protocol Medtronic was responsible for the selection of the clinical sites monitoring of the data and management of all source data and statistical analyses The
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