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.).

• Authors: 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 Genereux, Ashish Pershad, Stuart J Pocock, Maria C Alu, John G Webb, Craig R Smith, PARTNER 3 Investigators
• Journal: The New England journal of medicine (N Engl J Med) Vol. 380 Issue 18 Pg. 1695-1705 (05 02 2019) ISSN: 1533-4406 [Electronic] United States
• PMID: 30883058 (Publication Type: Comparative Study, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Massachusetts Medical Society.

Topics

• Aged
• Aortic Valve (surgery)
• Aortic Valve Stenosis (complications, mortality, surgery)
• Atrial Fibrillation (etiology)
• Female
• Heart Valve Prosthesis
• Heart Valve Prosthesis Implantation (adverse effects, methods)
• Humans
• Kaplan-Meier Estimate
• Length of Stay
• Male
• Patient Readmission (statistics & numerical data)
• Postoperative Complications (epidemiology)
• Prosthesis Design
• Risk Factors
• Stroke (epidemiology, etiology)
• Transcatheter Aortic Valve Replacement (adverse effects, instrumentation)