Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.
Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.
- 2019
Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present
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. 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.). Copyright (c) 2019 Massachusetts Medical Society. 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.
English
0028-4793
10.1056/NEJMoa1814052 [doi]
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation/mt [Methods]
*Patient Readmission/sn [Statistics & Numerical Data]
*Postoperative Complications/ep [Epidemiology]
*Transcatheter Aortic Valve Replacement/is [Instrumentation]
Aged
Aortic Valve Stenosis/co [Complications]
Aortic Valve Stenosis/mo [Mortality]
Atrial Fibrillation/et [Etiology]
Female
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Humans
Kaplan-Meier Estimate
Length of Stay
Male
Prosthesis Design
Risk Factors
Stroke/ep [Epidemiology]
Stroke/et [Etiology]
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
MedStar Heart & Vascular Institute
Journal Article
Research Support, Non-U.S. Gov't
Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present
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. 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.). Copyright (c) 2019 Massachusetts Medical Society. 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.
English
0028-4793
10.1056/NEJMoa1814052 [doi]
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation/mt [Methods]
*Patient Readmission/sn [Statistics & Numerical Data]
*Postoperative Complications/ep [Epidemiology]
*Transcatheter Aortic Valve Replacement/is [Instrumentation]
Aged
Aortic Valve Stenosis/co [Complications]
Aortic Valve Stenosis/mo [Mortality]
Atrial Fibrillation/et [Etiology]
Female
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Humans
Kaplan-Meier Estimate
Length of Stay
Male
Prosthesis Design
Risk Factors
Stroke/ep [Epidemiology]
Stroke/et [Etiology]
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
MedStar Heart & Vascular Institute
Journal Article
Research Support, Non-U.S. Gov't