Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients

Michael J. Mack, Martin B. Leon, Vinod H. Thourani, Raj Makkar, Susheel K. Kodali, Mark Russo, Samir R. Kapadia, S. Chris Malaisrie, David J. Cohen, Philippe Pibarot, Jonathon Leipsic, Rebecca T. Hahn, Philipp Blanke, Mathew R. Williams, James M. McCabe, David L. Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y. Szeto, Philippe GenereuxAshish Pershad, Stuart J. Pocock, Maria C. Alu, John G. Webb, Craig R. Smith

Research output: Contribution to journalArticle

236 Citations (Scopus)

Abstract

BACKGROUND Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan–Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, −6.6 percentage points; 95% confidence interval [CI], −10.8 to −2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)

Original languageEnglish (US)
Pages (from-to)1695-1705
Number of pages11
JournalNew England Journal of Medicine
Volume380
Issue number18
DOIs
StatePublished - May 2 2019
Externally publishedYes

Fingerprint

Aortic Valve Stenosis
Stroke
Confidence Intervals
Mortality
Random Allocation
Transcatheter Aortic Valve Replacement
Cardiomyopathies
Aortic Valve
Surgical Instruments
Atrial Fibrillation
Blood Vessels
Hospitalization
Population

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Mack, M. J., Leon, M. B., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., ... Smith, C. R. (2019). Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. New England Journal of Medicine, 380(18), 1695-1705. https://doi.org/10.1056/NEJMoa1814052
Mack, Michael J. ; Leon, Martin B. ; Thourani, Vinod H. ; Makkar, Raj ; Kodali, Susheel K. ; Russo, Mark ; Kapadia, Samir R. ; Chris Malaisrie, S. ; Cohen, David J. ; Pibarot, Philippe ; Leipsic, Jonathon ; Hahn, Rebecca T. ; Blanke, Philipp ; Williams, Mathew R. ; McCabe, James M. ; Brown, David L. ; Babaliaros, Vasilis ; Goldman, Scott ; Szeto, Wilson Y. ; Genereux, Philippe ; Pershad, Ashish ; Pocock, Stuart J. ; Alu, Maria C. ; Webb, John G. ; Smith, Craig R. / Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. In: New England Journal of Medicine. 2019 ; Vol. 380, No. 18. pp. 1695-1705.
@article{da0845d2494844be950699d2ceff5585,
title = "Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients",
abstract = "BACKGROUND Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9{\%} (with scores ranging from 0 to 100{\%} and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan–Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5{\%} vs. 15.1{\%}; absolute difference, −6.6 percentage points; 95{\%} confidence interval [CI], −10.8 to −2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95{\%} CI, 0.37 to 0.79; P=0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)",
author = "Mack, {Michael J.} and Leon, {Martin B.} and Thourani, {Vinod H.} and Raj Makkar and Kodali, {Susheel K.} and Mark Russo and Kapadia, {Samir R.} and {Chris Malaisrie}, S. and Cohen, {David J.} and Philippe Pibarot and Jonathon Leipsic and Hahn, {Rebecca T.} and Philipp Blanke and Williams, {Mathew R.} and McCabe, {James M.} and Brown, {David L.} and Vasilis Babaliaros and Scott Goldman and Szeto, {Wilson Y.} and Philippe Genereux and Ashish Pershad and Pocock, {Stuart J.} and Alu, {Maria C.} and Webb, {John G.} and Smith, {Craig R.}",
year = "2019",
month = "5",
day = "2",
doi = "10.1056/NEJMoa1814052",
language = "English (US)",
volume = "380",
pages = "1695--1705",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "18",

}

Mack, MJ, Leon, MB, Thourani, VH, Makkar, R, Kodali, SK, Russo, M, Kapadia, SR, Chris Malaisrie, S, Cohen, DJ, Pibarot, P, Leipsic, J, Hahn, RT, Blanke, P, Williams, MR, McCabe, JM, Brown, DL, Babaliaros, V, Goldman, S, Szeto, WY, Genereux, P, Pershad, A, Pocock, SJ, Alu, MC, Webb, JG & Smith, CR 2019, 'Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients', New England Journal of Medicine, vol. 380, no. 18, pp. 1695-1705. https://doi.org/10.1056/NEJMoa1814052

Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. / Mack, Michael J.; Leon, Martin B.; Thourani, Vinod H.; Makkar, Raj; Kodali, Susheel K.; Russo, Mark; Kapadia, Samir R.; Chris Malaisrie, S.; Cohen, David J.; Pibarot, Philippe; Leipsic, Jonathon; Hahn, Rebecca T.; Blanke, Philipp; Williams, Mathew R.; McCabe, James M.; Brown, David L.; Babaliaros, Vasilis; Goldman, Scott; Szeto, Wilson Y.; Genereux, Philippe; Pershad, Ashish; Pocock, Stuart J.; Alu, Maria C.; Webb, John G.; Smith, Craig R.

In: New England Journal of Medicine, Vol. 380, No. 18, 02.05.2019, p. 1695-1705.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients

AU - Mack, Michael J.

AU - Leon, Martin B.

AU - Thourani, Vinod H.

AU - Makkar, Raj

AU - Kodali, Susheel K.

AU - Russo, Mark

AU - Kapadia, Samir R.

AU - Chris Malaisrie, S.

AU - Cohen, David J.

AU - Pibarot, Philippe

AU - Leipsic, Jonathon

AU - Hahn, Rebecca T.

AU - Blanke, Philipp

AU - Williams, Mathew R.

AU - McCabe, James M.

AU - Brown, David L.

AU - Babaliaros, Vasilis

AU - Goldman, Scott

AU - Szeto, Wilson Y.

AU - Genereux, Philippe

AU - Pershad, Ashish

AU - Pocock, Stuart J.

AU - Alu, Maria C.

AU - Webb, John G.

AU - Smith, Craig R.

PY - 2019/5/2

Y1 - 2019/5/2

N2 - BACKGROUND Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan–Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, −6.6 percentage points; 95% confidence interval [CI], −10.8 to −2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)

AB - BACKGROUND Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan–Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, −6.6 percentage points; 95% confidence interval [CI], −10.8 to −2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)

UR - http://www.scopus.com/inward/record.url?scp=85063743385&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063743385&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1814052

DO - 10.1056/NEJMoa1814052

M3 - Article

C2 - 30883058

AN - SCOPUS:85063743385

VL - 380

SP - 1695

EP - 1705

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 18

ER -