Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.

MedStar author(s):
Citation: New England Journal of Medicine. 374(17):1609-20, 2016 Apr 28.PMID: 27040324Institution: MedStar Washington Hospital CenterDepartment: MedStar Heart InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/mt [Methods] | *Transcatheter Aortic Valve Replacement | Aged | Aged, 80 and over | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve Stenosis/us [Ultrasonography] | Female | Heart Valve Prosthesis Implantation/mo [Mortality] | Humans | Kaplan-Meier Estimate | Male | Multivariate Analysis | Postoperative Complications/mo [Mortality] | Risk Factors | Stroke/et [Etiology] | Stroke/mo [Mortality]Year: 2016Local holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - presentISSN:
  • 0028-4793
Name of journal: The New England journal of medicineAbstract: BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.All authors: Alu MC, Anderson WN, Babaliaros V, Brown DL, Cohen DJ, Dewey T, Doshi D, Fearon WF, Greason KL, Hahn RT, Herrmann HC, Hodson RW, Jaber WA, Kapadia S, Kereiakes D, Kodali SK, Leon MB, Mack MJ, Makkar RR, Miller DC, Moses JW, PARTNER 2 Investigators, Pibarot P, Pichard AD, Smith CR, Svensson LG, Szeto WY, Thourani VH, Trento A, Tuzcu EM, Webb JG, Whisenant BK, Williams MR, Zajarias AFiscal year: FY2016Digital Object Identifier: Date added to catalog: 2016-05-24
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 27040324 Available 27040324

Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present

BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.

CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.

RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.

English

Powered by Koha