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N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

Transcatheter versus surgical aortic-valve replacement in high-risk patients.

Collaborators (209)

Leon MB, Smith C, Mack M, Miller DC, Moses J, Svensson L, Tuzcu M, Webb J, Akin JJ, Foley K, Dziem G, Pocock S, Wang D, Anderson WN, Carrozza J, Wechsler A, Carabello B, Peterson E, Lee K, Bartus S, Petersen J, Douglas P, Cohen D, Reynolds M, Lasala J, Damiano R, Zajarias A, Maniar H, Striler K, Zoole J, Lindman BR, Cohn L, Eisenhauer A, Welt F, Davidson M, Charleson T, Gross W, Makkar R, Fontana G, Trento A, Kar S, Gheorghiu M, Doumanian A, Stegic J, Tolstrup K, Siegel R, Tuzcu M, Svensson L, Kapadia S, Roselli E, Bartow R, Gerace C, Rodriguez L, Stewart W, Grim R, Savage R, Alfirevic A, Wallace L, Leon M, Smith C, Moses J, Kodali S, Williams M, Hawkey M, Schnell S, Hahn R, Gillam L, Chiu Wong S, Krieger K, Bergman G, Salemi A, Reynolds D, Devereux R, Block P, Guyton R, Babaliaros V, Thourani V, Tequia E, Carter F, Lerakis S, Martin R, Howell S, Whisenant B, Jones K, Clayson S, Revenaugh J, Miller B, Flores J, Rodes-Cabau J, Doyle D, Dumont, Delarochelliere R, Aube J, Mohr F, Schuler G, Walther T, Ott S, Palacios I, Vlahakes G, Agnihotri A, Inglessis I, Daher M, Passeri J, Holmes D, Sundt T, Rihal C, Greason K, Anderson B, Rolbiecki D, Michelena H, Sarano M, Andrew K, Dewey T, Brown D, Bowers B, Mack M, Brinkman W, McKibben C, Kenady A, Foreman J, Roper K, Gopal D, Horswell J, Michelsen L, Feldman T, Alexander J, Salinger M, Seifert D, Focks C, Smart S, Marymount J, Davidson C, McCarthy P, Beohar N, Malaisrie C, Madden K, DeAngelis M, Mikati I, Ramee S, Parrino G, Collins T, Bates M, Hirstius B, Bienvenu L, Teirstein P, Brewster S, Tyner J, Stinis C, Price M, Clarke S, Buchanan T, Anderson E, Miller DC, Yeung A, Fearon W, Fischbein M, Speight M, McWard C, Liang D, Cohen D, Allen K, Grantham JA, Borkon M, Chhatriwalla A, Hall J, Miller M, Main M, Magalski A, Webb J, Cheung A, Ye J, Lichtenstein S, Zwanenburg E, Thompson C, Kron IL, Lim S, Ailawadi G, Kern J, Ragosta M, Burks S, Gahring K, Dent J, O'Neill W, Williams D, Heldman A, Medina A, Morales S, Bilsker M, Bavaria J, Herrmann HC, Szeto W, Roche L, Walsh L, Riesman M, Verrier E, Aldea G, Dean L, Letterer R, Otto C, Pichard G, Corso P, Boyce S, Satler L, Waksman R, Okubagzi P, Whitman D, Asch F, Goldstein S, Wang Z.

Author information

  • 1Columbia University Medical Center–New York Presbyterian Hospital, New York, NY 10032, USA. crs2@columbia.edu

Abstract

BACKGROUND:

The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.

METHODS:

At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.

RESULTS:

The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.

CONCLUSIONS:

In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).

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PMID:
21639811
[PubMed - indexed for MEDLINE]
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