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

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

doi:10.1056/NEJMoa1816885

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

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

Biostatistics

Research output: Contribution to journal › Article › peer-review

2263 Scopus citations

Abstract

BACKGROUND: 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.

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 2 vs. 2.0 cm 2).

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.).

Original language	English (US)
Pages (from-to)	1706-1715
Number of pages	10
Journal	New England Journal of Medicine
Volume	380
Issue number	18
DOIs	https://doi.org/10.1056/NEJMoa1816885
State	Published - May 2 2019

Bibliographical note

Publisher Copyright:
Copyright © 2019 Massachusetts Medical Society.

Keywords

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

PubMed: MeSH publication types

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

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10.1056/NEJMoa1816885

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Popma, J. J., Michael Deeb, G., Yakubov, S. J., Mumtaz, M., Gada, H., O’Hair, D., Bajwa, T., Heiser, J. C., Merhi, W., Kleiman, N. S., Askew, J., Sorajja, P., Rovin, J., Chetcuti, S. J., Adams, D. H., Teirstein, P. S., Zorn, G. L., Forrest, J. K., Tchétché, D., ... Reardon, M. J. (2019). Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. New England Journal of Medicine, 380(18), 1706-1715. https://doi.org/10.1056/NEJMoa1816885

Popma, JJ, Michael Deeb, G, Yakubov, SJ, Mumtaz, M, Gada, H, O’Hair, D, Bajwa, T, Heiser, JC, Merhi, W, Kleiman, NS, Askew, J, Sorajja, P, Rovin, J, Chetcuti, SJ, Adams, DH, Teirstein, PS, Zorn, GL, Forrest, JK, Tchétché, D, Resar, J, Walton, A, Piazza, N, Ramlawi, B, Robinson, N, Petrossian, G, Gleason, TG, Oh, JK, Boulware, MJ, Qiao, H, Mugglin, AS & Reardon, MJ 2019, 'Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients', New England Journal of Medicine, vol. 380, no. 18, pp. 1706-1715. https://doi.org/10.1056/NEJMoa1816885

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title = "Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients",

abstract = "BACKGROUND: 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.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 2 vs. 2.0 cm 2). 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.).",

keywords = "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",

author = "Popma, {Jeffrey J.} and {Michael Deeb}, G. and Yakubov, {Steven J.} and Mubashir Mumtaz and Hemal Gada and Daniel O{\textquoteright}Hair and Tanvir Bajwa and Heiser, {John C.} and William Merhi and Kleiman, {Neal S.} and Judah Askew and Paul Sorajja and Joshua Rovin and Chetcuti, {Stanley J.} and Adams, {David H.} and Teirstein, {Paul S.} and Zorn, {George L.} and Forrest, {John K.} and Didier Tch{\'e}tch{\'e} and Jon Resar and Antony Walton and Nicolo Piazza and Basel Ramlawi and Newell Robinson and George Petrossian and Gleason, {Thomas G.} and Oh, {Jae K.} and Boulware, {Michael J.} and Hongyan Qiao and Mugglin, {Andrew S} and Reardon, {Michael J.}",

note = "Publisher Copyright: Copyright {\textcopyright} 2019 Massachusetts Medical Society.",

year = "2019",

month = may,

day = "2",

doi = "10.1056/NEJMoa1816885",

language = "English (US)",

volume = "380",

pages = "1706--1715",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "18",

}

TY - JOUR

T1 - Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients

AU - Popma, Jeffrey J.

AU - Michael Deeb, G.

AU - Yakubov, Steven J.

AU - Mumtaz, Mubashir

AU - Gada, Hemal

AU - O’Hair, Daniel

AU - Bajwa, Tanvir

AU - Heiser, John C.

AU - Merhi, William

AU - Kleiman, Neal S.

AU - Askew, Judah

AU - Sorajja, Paul

AU - Rovin, Joshua

AU - Chetcuti, Stanley J.

AU - Adams, David H.

AU - Teirstein, Paul S.

AU - Zorn, George L.

AU - Forrest, John K.

AU - Tchétché, Didier

AU - Resar, Jon

AU - Walton, Antony

AU - Piazza, Nicolo

AU - Ramlawi, Basel

AU - Robinson, Newell

AU - Petrossian, George

AU - Gleason, Thomas G.

AU - Oh, Jae K.

AU - Boulware, Michael J.

AU - Qiao, Hongyan

AU - Mugglin, Andrew S

AU - Reardon, Michael J.

PY - 2019/5/2

Y1 - 2019/5/2

N2 - BACKGROUND: 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.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 2 vs. 2.0 cm 2). 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.).

AB - BACKGROUND: 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.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 2 vs. 2.0 cm 2). 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.).

KW - Aged

KW - Aortic Valve/surgery

KW - Aortic Valve Insufficiency/etiology

KW - Aortic Valve Stenosis/complications

KW - Atrial Fibrillation/etiology

KW - Bayes Theorem

KW - Bioprosthesis

KW - Echocardiography

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Kaplan-Meier Estimate

KW - Length of Stay

KW - Male

KW - Postoperative Complications/epidemiology

KW - Prosthesis Design

KW - Risk Factors

KW - Stroke/etiology

KW - Transcatheter Aortic Valve Replacement/adverse effects

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UR - http://www.scopus.com/inward/citedby.url?scp=85063752928&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1816885

DO - 10.1056/NEJMoa1816885

M3 - Article

C2 - 30883053

AN - SCOPUS:85063752928

SN - 0028-4793

VL - 380

SP - 1706

EP - 1715

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 18

ER -

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

Abstract

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Keywords

PubMed: MeSH publication types

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