Document Detail


Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
MedLine Citation:
PMID:  20961243     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.
METHODS: We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.
RESULTS: A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.
CONCLUSIONS: In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Authors:
Martin B Leon; Craig R Smith; Michael Mack; D Craig Miller; Jeffrey W Moses; Lars G Svensson; E Murat Tuzcu; John G Webb; Gregory P Fontana; Raj R Makkar; David L Brown; Peter C Block; Robert A Guyton; Augusto D Pichard; Joseph E Bavaria; Howard C Herrmann; Pamela S Douglas; John L Petersen; Jodi J Akin; William N Anderson; Duolao Wang; Stuart Pocock;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-09-22
Journal Detail:
Title:  The New England journal of medicine     Volume:  363     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-21     Completed Date:  2010-10-28     Revised Date:  2011-09-09    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1597-607     Citation Subset:  AIM; IM    
Affiliation:
Columbia University Medical Center/NewYork–Presbyterian Hospital, New York, NY 10032, USA. ml2398@columbia.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00530894
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Aortic Valve Stenosis / mortality,  surgery,  therapy*
Balloon Dilation
Cardiovascular Diseases / mortality
Echocardiography
Female
Heart Catheterization
Heart Valve Prosthesis Implantation / methods*
Hospitalization
Humans
Kaplan-Meier Estimate
Male
Prospective Studies
Treatment Outcome
Investigator
Investigator/Affiliation:
M B Leon / ; C Smith / ; M Mack / ; D C Miller / ; J Moses / ; L Svensson / ; M Tuzcu / ; J Webb / ; N Cohen / ; G Dziem / ; W N Anderson / ; S Pocock / ; D Wang / ; W N Anderson / ; J Carrozza / ; A Wechsler / ; B Carabello / ; E Peterson / ; K Lee / ; S Bartus / ; J Petersen / ; P Douglas / ; D Cohen / ; M Reynolds / ; J Lasala / ; R Damiano / ; A Zajarias / ; H Maniar / ; K Striler / ; J Zoole / ; A Eisenhauer / ; M Davidson / ; F Welt / ; T Charleson / ; W Gross / ; R Makkar / ; G Fontana / ; A Trento / ; S Kar / ; M Gheorghiu / ; A Doumanian / ; K Tolstrup / ; R Siegel / ; M Tuzcu / ; L Svensson / ; S Kapadia / ; E Roselli / ; R Bartow / ; C Gerace / ; L Rodriguez / ; W Stewart / ; R Grim / ; R Savage / ; M Leon / ; C Smith / ; J Moses / ; S Kodali / ; M Williams / ; M Hawkey / ; S Schnell / ; R Hahn / ; L Gillam / ; S Chiu Wong / ; K Krieger / ; G Bergman / ; A Salemi / ; D Reynolds / ; R Devereux / ; P Block / ; R Guyton / ; V Babaliaros / ; V Thourani / ; E Block / ; E Tequia / ; S Howell / ; F Mohr / ; G Schuler / ; T Walther / ; S Ott / ; B Whisenant / ; K Jones / ; S Clayson / ; J Revenaugh / ; B Miller / ; J Flores / ; J Rodes-Cabau / ; D Doyle / ; Dumont / ; J Aube / ; I Palacios / ; G Vlahakes / ; A Agnihotri / ; I Inglessis / ; M Daher / ; A Jonri / ; D Holmes / ; T Sundt / ; C Rihal / ; K Greason / ; B Anderson / ; D Rolbiecki / ; H Michelena / ; M Sarano / ; K Andrew / ; M Mack / ; D Brown / ; B Bowers / ; T Dewey / ; C McKibben / ; A Kenady / ; D Gopal / ; T Feldman / ; J Alexander / ; M Salinger / ; D Seifert / ; C Focks / ; S Smart / ; J Marymount / ; C Davidson / ; P McCarthy / ; N Beohar / ; C Malaisrie / ; K Madden / ; M DeAngelis / ; I Mikati / ; S Ramee / ; G Parrino / ; T Collins / ; M Bates / ; B Hirstius / ; L Bienvenu / ; P Teirstein / ; S Brewster / ; J Tyner / ; S Clarke / ; T Buchanan / ; E Anderson / ; C Miller / ; A Yeung / ; W Fearon / ; M Fischbein / ; M Speight / ; C McWard / ; D Liang / ; D Cohen / ; K Allen / ; A Grantham / ; J Hall / ; M Miller / ; J Webb / ; A Cheung / ; J Ye / ; S Lichtenstein / ; E Zwanenburg / ; E Horlick / ; C Feindel / ; W O'Neill / ; D Williams / ; A Heldman / ; A Medina / ; S Morales / ; M Bilsker / ; J Bavaria / ; H C Herrmann / ; W Szeto / ; L Roche / ; L Walsh / ; M Riesman / ; E Verrier / ; G Aldea / ; L Dean / ; R Letterer / ; C Otto / ; G Pichard / ; P Corso / ; S Boyce / ; L Satler / ; P Okubagzi / ; F Asch / ; S Goldstein /
Comments/Corrections
Comment In:
Intern Emerg Med. 2011 Apr;6(2):161-2   [PMID:  21380551 ]
N Engl J Med. 2010 Oct 21;363(17):1667-8   [PMID:  20961251 ]
Nat Rev Cardiol. 2010 Dec;7(12):663   [PMID:  21155125 ]
N Engl J Med. 2011 Sep 8;365(10):958-9; author reply 959   [PMID:  21899458 ]
Evid Based Med. 2011 Jun;16(3):74-5   [PMID:  21228050 ]
N Engl J Med. 2011 Jan 13;364(2):179; author reply 180-1   [PMID:  21226588 ]
N Engl J Med. 2011 Jan 13;364(2):180; author reply 180-1   [PMID:  21226586 ]
N Engl J Med. 2011 Jan 13;364(2):179; author reply 180-1   [PMID:  21226587 ]
Kardiol Pol. 2010 Dec;68(12):1412-4   [PMID:  21174307 ]

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