original articleThe new england journal of medicinen engl j med 370;19 nejm.org may 8, 20141790Transcatheter 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*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 De-Bakey 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 Michi-gan Medical Center, Ann Arbor (G.M.D., S. Chetcuti), and Spectrum Health Hos-pitals, Grand Rapids (J.H., W.M.) — both in Michigan; University of Pittsburgh Medi-cal Center, Pittsburgh (T.G.G.); Palo Alto Veterans Affairs Medical Center, Palo Alto, CA (M.B.); St. Vincent Medical Center, In-dianapolis (J.H.); University of Kansas Hos-pital, Kansas City (G.Z., P.T.); Duke Univer-sity Medical Center, Durham, NC (G.C.H., J.K.H.); Johns Hopkins Hospital, Balti-more (J.C.); Pinnacle Health, Harrisburg, PA (B.M., M.M.); and Medtronic, Minne-apolis (S. Cheno weth), and Mayo Clinical Foundation, Rochester (J.K.O.) — both in Minnesota. Address reprint requests to Dr. Popma at Interventional Cardiology Ser-vice, Beth Israel Deaconess Medical Center, 185 Pilgrim Rd., Boston, MA 02460, or at [email protected].* A complete list of the investigators, in-stitutions, and research organizations participating in the U.S. CoreValve High Risk Study is provided in the Supplemen-tary 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/NEJMoa1400590Copyright © 2014 Massachusetts Medical Society.ABSTRACTBACKGROUNDWe 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.METHODSWe 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 aor-tic-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 superior-ity testing.RESULTSA 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 signifi-cantly 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 pro-cedure, 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.CONCLUSIONSIn patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a sig-nificantly 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.)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.Transcatheter Aortic-Valve Replacementn engl j med 370;19 nejm.org may 8, 20141791A ortic stenosis is a debilitating dis-ease in elderly persons that carries a dis-mal prognosis after symptom onset.1 Al-though 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 re-placement (TAVR) with a balloon-expandable device improves survival, as compared with med-ical therapy, in patients with severe aortic steno-sis who cannot undergo surgery.5 Balloon-expand-able 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 balloon-expandable TAVR than among those treated sur-gically.6,7An alternative transcatheter bioprosthesis com-prising a self-expanding nitinol frame and trileaf-let 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 com-pared with surgical valve replacement in patients with severe aortic stenosis who were at increased surgical risk.METHODSSTUDY DESIGNThis study was a multicenter, randomized, non-inferiority 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 de-veloped the
View Full Document
Unlocking...