BACKGROUND: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. METHODS:At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo eithertranscatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. RESULTS: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. CONCLUSIONS: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
RCT Entities:
BACKGROUND: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. RESULTS: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. CONCLUSIONS: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
Authors: Taku Inohara; Pratik Manandhar; Andrzej S Kosinski; Roland A Matsouaka; Shun Kohsaka; Robert J Mentz; Vinod H Thourani; John D Carroll; Ajay J Kirtane; Joseph E Bavaria; David J Cohen; Todd L Kiefer; Jeffrey G Gaca; Samir R Kapadia; Eric D Peterson; Sreekanth Vemulapalli Journal: JAMA Date: 2018-12-04 Impact factor: 56.272
Authors: Ali Hasan; Ebrahim M Kolahdouz; Andinet Enquobahrie; Thomas G Caranasos; John P Vavalle; Boyce E Griffith Journal: Med Eng Phys Date: 2017-08-02 Impact factor: 2.242
Authors: J Matthew Brennan; Laine Thomas; David J Cohen; David Shahian; Alice Wang; Michael J Mack; David R Holmes; Fred H Edwards; Naftali Z Frankel; Suzanne J Baron; John Carroll; Vinod Thourani; E Murat Tuzcu; Suzanne V Arnold; Roberta Cohn; Todd Maser; Brenda Schawe; Susan Strong; Allen Stickfort; Elizabeth Patrick-Lake; Felicia L Graham; Dadi Dai; Fan Li; Roland A Matsouaka; Sean O'Brien; Fan Li; Michael J Pencina; Eric D Peterson Journal: J Am Coll Cardiol Date: 2017-07-25 Impact factor: 24.094
Authors: V Kamperidis; S Hadjimiltiades; S A Mouratoglou; A Ziakas; G Sianos; A Sarafidou; I Ventoulis; G Kazinakis; G Giannakoulas; G K Efthimiadis; G Parcharidis; H Karvounis Journal: Herz Date: 2015-09-17 Impact factor: 1.443
Authors: Brian R Englum; Asvin M Ganapathi; Matthew A Schechter; J Kevin Harrison; Donald D Glower; G Chad Hughes Journal: Ann Thorac Surg Date: 2015-09-16 Impact factor: 4.330