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Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

Publication ,  Journal Article
Mack, MJ; Leon, MB; Thourani, VH; Makkar, R; Kodali, SK; Russo, M; Kapadia, SR; Malaisrie, SC; Cohen, DJ; Pibarot, P; Leipsic, J; Hahn, RT ...
Published in: N Engl J Med
May 2, 2019

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 2, 2019

Volume

380

Issue

18

Start / End Page

1695 / 1705

Location

United States

Related Subject Headings

  • Transcatheter Aortic Valve Replacement
  • Stroke
  • Risk Factors
  • Prosthesis Design
  • Postoperative Complications
  • Patient Readmission
  • Male
  • Length of Stay
  • Kaplan-Meier Estimate
  • Humans
 

Citation

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Mack, M. J., Leon, M. B., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., … PARTNER 3 Investigators, . (2019). Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med, 380(18), 1695–1705. https://doi.org/10.1056/NEJMoa1814052
Mack, Michael J., Martin B. Leon, Vinod H. Thourani, Raj Makkar, Susheel K. Kodali, Mark Russo, Samir R. Kapadia, et al. “Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.N Engl J Med 380, no. 18 (May 2, 2019): 1695–1705. https://doi.org/10.1056/NEJMoa1814052.
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695–705.
Mack, Michael J., et al. “Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.N Engl J Med, vol. 380, no. 18, May 2019, pp. 1695–705. Pubmed, doi:10.1056/NEJMoa1814052.
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, 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, PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695–1705.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 2, 2019

Volume

380

Issue

18

Start / End Page

1695 / 1705

Location

United States

Related Subject Headings

  • Transcatheter Aortic Valve Replacement
  • Stroke
  • Risk Factors
  • Prosthesis Design
  • Postoperative Complications
  • Patient Readmission
  • Male
  • Length of Stay
  • Kaplan-Meier Estimate
  • Humans