Title :

Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients

Author(s) :

Popma, Jeffrey J. [Auteur]
Deeb, G Michael [Auteur]
Yakubov, Steven J. [Auteur]
Mumtaz, Mubashir [Auteur]
Gada, Hemal [Auteur]
O''''hair, Daniel [Auteur]
Bajwa, Tanvir [Auteur]
Heiser, John C. [Auteur]
Merhi, William [Auteur]
Kleiman, Neal S. [Auteur]
Askew, Judah [Auteur]
Sorajja, Paul [Auteur]
Rovin, Joshua [Auteur]
Chetcuti, Stanley J. [Auteur]
Adams, David H. [Auteur]
Teirstein, Paul S. [Auteur]
Zorn, George L. [Auteur]
Forrest, John K. [Auteur]
Tchetche, Didier [Auteur]
Resar, Jon [Auteur]
Walton, Antony [Auteur]
Piazza, Nicolo [Auteur]
Ramlawi, Basel [Auteur]
Robinson, Newell [Auteur]
Petrossian, George [Auteur]
Gleason, Thomas G. [Auteur]
Oh, Jae K. [Auteur]
Boulware, Michael J. [Auteur]
Qiao, Hongyan [Auteur]
Mugglin, Andrew S. [Auteur]
Reardon, Michael J. [Auteur]

Journal title :

The New England journal of medicine

Abbreviated title :

N. Engl. J. Med.

Volume number :

380

Pages :

1706-1715

Publication date :

2019-05-02

ISSN :

1533-4406

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. We performed ...
Show more >Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm22 In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
CNRS
Inserm
Université de Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172

Research team(s) :

Troubles cognitifs dégénératifs et vasculaires

Submission date :

2019-11-27T14:32:04Z