Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

Aged Aortic Valve / surgery Aortic Valve Insufficiency / etiology Aortic Valve Stenosis / complications Atrial Fibrillation / etiology Bayes Theorem Bioprosthesis Echocardiography Female Heart Valve Prosthesis Heart Valve Prosthesis Implantation / adverse effects Humans Kaplan-Meier Estimate Length of Stay Male Postoperative Complications / epidemiology Prosthesis Design Risk Factors Stroke / etiology Transcatheter Aortic Valve Replacement / adverse effects

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:
02 05 2019

Historique:

pubmed: 19 3 2019

medline: 29 5 2019

entrez: 19 3 2019

Statut: ppublish

Résumé

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 cm 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.).

Sections du résumé

BACKGROUND

METHODS

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.

RESULTS

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 cm

CONCLUSIONS

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.).

Identifiants

DOI: 10.1056/NEJMoa1816885 PMID: 30883053

pubmed: 30883053

doi: 10.1056/NEJMoa1816885

doi:

Banques de données

ClinicalTrials.gov

['NCT02701283']

Types de publication

Comparative Study Equivalence Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1706-1715

Investigateurs

Judah Askew (J)

Paul Sorajja (P)

Richard Bae (R)

Frazier Eales (F)

Mario Goessl (M)

Thomas Flavin (T)

Desmond Jay (D)

Vibhu Kshettry (V)

John Lesser (J)

Karol Mudy (K)

Anil Poulose (A)

Lynelle Schneider (L)

Benjamin Sun (B)

Karen Meyer (K)

Timothy Byrne (T)

Merick Kirshner (M)

Michael Caskey (M)

Claude Frey (C)

Ayman Jamal (A)

Neal Klein (N)

Peter Maki (P)

Tamara Querry (T)

Lynn Bessette (L)

Tanvir Bajwa (T)

Daniel O'Hair (D)

John Crouch (J)

Suhail Allaqaband (S)

Thomas Barragry (T)

Paul Bernstein (P)

John Crouch (J)

Anthony DeFranco (A)

Francis Downey (F)

Babak Haddadian (B)

Muhammad Fuad Jan (M)

Renuka Jain (R)

Bijoy Khandheria (B)

Jayant Khitha (J)

Louie Kostopoulos (L)

David Kress (D)

Tonga Nfor (T)

Steven Port (S)

Ramagopal Tumuluri (R)

Eric Weiss (E)

Paul Werner (P)

Michelle Bennett (M)

Joseph Coselli (J)

Guilherme Silva (G)

Benjamin Cheong (B)

Kim de la Cruz (K)

Jose Diez (J)

Ourania Preventza (O)

Michele Sartoni (M)

Raymond Stainback (R)

Luis Castro (L)

Robert Hebeler (R)

Robert Stoler (R)

Paul Grayburn (P)

Carl Henry (C)

Ravi Vallabhan (R)

Angela Mendez (A)

Ashequl Islam (A)

Anthony Rousou (A)

Mary Galdauskas (M)

Ali Haider (A)

William Hiser (W)

John Joelson (J)

Evan Lau (E)

Grace LaValley (G)

Annette Scarnici (A)

Kamal Khabbaz (K)

Jeffrey J Popma (JJ)

James Chang (J)

Kimberly Guibone (K)

Roger J Laham (RJ)

David Liu (D)

Warren Manning (W)

Susan Papazian (S)

Duane Pinto (D)

Marilyn Riley (M)

Venkatachalam Senthilnathan (V)

Jenifer Kaufman (J)

Mark Bladergroen (M)

David S Lim (DS)

Christine Browning (C)

Mohammad Chaudhry (M)

Steven Fiser (S)

Susan Fisher (S)

Lindsey Guirgues (L)

Kathryn Johnston (K)

Janet Barrett (J)

Kelly Patterson (K)

Peter Fail (P)

Donald Netherland (D)

Richard Abben (R)

Darrell Solet (D)

Deanna Benoit (D)

Ka Yan Lam (KY)

W A L Tonino (WAL)

Patrick Houthuizen (P)

Johannes Post (J)

Harold J M Helmes (HJM)

Lieke Staaltjens (L)

Francine Steerneman-Geurts (F)

Maria van Eijck (M)

Thomas Modine (T)

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