Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years.
Humans
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
/ adverse effects
Postoperative Complications
/ etiology
Risk Factors
Stroke
/ epidemiology
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
Follow-Up Studies
Patient Readmission
Heart Failure
/ etiology
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
23 Nov 2023
23 Nov 2023
Historique:
medline:
23
11
2023
pubmed:
24
10
2023
entrez:
24
10
2023
Statut:
ppublish
Résumé
A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
Sections du résumé
BACKGROUND
BACKGROUND
A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown.
METHODS
METHODS
We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years.
RESULTS
RESULTS
A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group.
CONCLUSIONS
CONCLUSIONS
Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
Identifiants
pubmed: 37874020
doi: 10.1056/NEJMoa2307447
doi:
Banques de données
ClinicalTrials.gov
['NCT02675114']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1949-1960Investigateurs
Mohammad El-Hajjar
(M)
Stephen Bailey
(S)
John Brown
(J)
Robert Kipperman
(R)
Mark Webster
(M)
Frank Zidar
(F)
Faraz Kerendi
(F)
Marvin Eng
(M)
Kenith Fang
(K)
Basil Paulus
(B)
Pinak Shah
(P)
Tsuyoshi Kaneko
(T)
Bassem Chehab
(B)
Brett Grizzell
(B)
Michael Rinaldi
(M)
Eric Skipper
(E)
Raj Makkar
(R)
Alfredo Trento
(A)
Andrew Eisenhauer
(A)
Susheel Kodali
(S)
Isaac George
(I)
Tamim Nazif
(T)
Shing Chiu Wong
(SC)
Arash Salemi
(A)
Stephanie Mick
(S)
James DeVries
(J)
Joseph DeSimone
(J)
Vinod Thourani
(V)
Robert Guyton
(R)
Kendra Grubb
(K)
Vasilis Babaliaros
(V)
Kevin Accola
(K)
Raymond McKay
(R)
Robert Hagberg
(R)
William O'Neill
(W)
Gaetano Paone
(G)
Dimitrios Apostolou
(D)
Jorge Castellanos
(J)
Anthony Caffarelli
(A)
Shahram Yazdani
(S)
Eric Sarin
(E)
Brian Whisenant
(B)
Kent Jones
(K)
Marcos Nores
(M)
Mark Rothenberg
(M)
Edward McNulty
(E)
Richard Richter
(R)
Kentaro Hayashida
(K)
Paul Coady
(P)
Scott Goldman
(S)
David Holmes
(D)
Mohammad Alkhouli
(M)
Kevin Greason
(K)
Bruce Bowers
(B)
Todd Dewey
(T)
David Daniels
(D)
Conrad Vial
(C)
Noah Jones
(N)
Patrick Wells
(P)
Steve Xydas
(S)
Nirat Beohar
(N)
Willis Wu
(W)
Curtis Anderson
(C)
Omar Nass
(O)
Steven Martin
(S)
Mathew Williams
(M)
Mark Russo
(M)
Sergio Waxman
(S)
Bruce Haik
(B)
Justin Levisay
(J)
Hyde Russell
(H)
Chris Malaisrie
(C)
Charles Davidson
(C)
Stephen Ramee
(S)
Jose Tafur
(J)
Patrick Parrino
(P)
Mohammad Ghani
(M)
Mark Bodenhamer
(M)
Yasushi Sakata
(Y)
Jeffrey Christy
(J)
Jeffery Goldstein
(J)
Ethan Korngold
(E)
Jeffrey Swanson
(J)
Joseph Montarello
(J)
Fareed Collado
(F)
Adnan Chhatriwalla
(A)
Evelio Rodriguez
(E)
Andrew Morse
(A)
Paul Mahoney
(P)
Joseph Newton
(J)
John Webb
(J)
Michael Fischebin
(M)
Alan Yeung
(A)
Michael Ingram
(M)
Ken Kozuma
(K)
Dean Kereiakes
(D)
Geoffrey Answini
(G)
Samir Kapadia
(S)
Michael Mack
(M)
Molly Szerlip
(M)
Christian Spies
(C)
Benjamin Plank
(B)
Jeffrey Lau
(J)
Richard Smalling
(R)
Tuyen Tom Nguyen
(TT)
Brad Oldemeyer
(B)
Mark Guadagnoli
(M)
Vijay Iyer
(V)
Gary Grosner
(G)
James Davies
(J)
Richard Shemin
(R)
William Suh
(W)
Thomas Beaver
(T)
David Anderson
(D)
Phillip Horwitz
(P)
Gregory Helmer
(G)
Ranjit John
(R)
Joseph Bavaria
(J)
Howard Herrmann
(H)
Gorav Ailawadi
(G)
Kenan Yount
(K)
James McCabe
(J)
Gabriel Aldea
(G)
Giorgio Gimelli
(G)
Lucian Lozonschi
(L)
Satoru Osaki
(S)
Alan Zajarias
(A)
Hersh Maniar
(H)
Amr Abbas
(A)
Richard Schwartz
(R)
Paul Tolerico
(P)
Mark Burlingame
(M)
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