BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. METHODS: We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to eitherSAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894. FINDINGS: We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003). INTERPRETATION: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. FUNDING: Edwards Lifesciences.
RCT Entities:
BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. METHODS: We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894. FINDINGS: We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003). INTERPRETATION: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. FUNDING: Edwards Lifesciences.
Authors: Harun Kundi; Jeffrey J Popma; Kamal R Khabbaz; Louis M Chu; Jordan B Strom; Linda R Valsdottir; Changyu Shen; Robert W Yeh Journal: JAMA Cardiol Date: 2019-01-01 Impact factor: 14.676
Authors: Luise Gaede; Johannes Blumenstein; Christoph Liebetrau; Oliver Dörr; Won-Keun Kim; Holger Nef; Oliver Husser; Jan Gülker; Albrecht Elsässer; Christian W Hamm; Stephan Achenbach; Helge Möllmann Journal: Clin Res Cardiol Date: 2019-06-24 Impact factor: 5.460
Authors: Andrew J Gorton; Eric P Anderson; Jonathan A Reimer; Khaled Abdelhady; Raed Sawaqed; Malek G Massad Journal: Pediatr Cardiol Date: 2021-05-28 Impact factor: 1.655
Authors: Susheel Kodali; Vinod H Thourani; Jonathon White; S Chris Malaisrie; Scott Lim; Kevin L Greason; Mathew Williams; Mayra Guerrero; Andrew C Eisenhauer; Samir Kapadia; Dean J Kereiakes; Howard C Herrmann; Vasilis Babaliaros; Wilson Y Szeto; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; Jonathon Leipsic; Philipp Blanke; Brian K Whisenant; Rakesh M Suri; Raj R Makkar; Girma M Ayele; Lars G Svensson; John G Webb; Michael J Mack; Craig R Smith; Martin B Leon Journal: Eur Heart J Date: 2016-03-31 Impact factor: 29.983