Jeffrey J Popma1, G Michael Deeb1, Steven J Yakubov1, Mubashir Mumtaz1, Hemal Gada1, Daniel O'Hair1, Tanvir Bajwa1, John C Heiser1, William Merhi1, Neal S Kleiman1, Judah Askew1, Paul Sorajja1, Joshua Rovin1, Stanley J Chetcuti1, David H Adams1, Paul S Teirstein1, George L Zorn1, John K Forrest1, Didier Tchétché1, Jon Resar1, Antony Walton1, Nicolo Piazza1, Basel Ramlawi1, Newell Robinson1, George Petrossian1, Thomas G Gleason1, Jae K Oh1, Michael J Boulware1, Hongyan Qiao1, Andrew S Mugglin1, Michael J Reardon1. 1. From Beth Israel Deaconess Medical Center, Boston (J.J.P.); University of Michigan Hospitals, Ann Arbor (G.M.D., S.J.C.), and Spectrum Health Hospitals, Grand Rapids (J.C.H., W.M.) - both in Michigan; Riverside Methodist-Ohio Health, Columbus (S.J.Y.); University of Pittsburgh Medical Center Pinnacle Health, Harrisburg (M.M., H.G.), and the University of Pittsburgh, Pittsburgh (T.G.G.) - both in Pennsylvania; Aurora-Saint Luke's Medical Center, Milwaukee (D.O., T.B.); Houston Methodist Debakey Heart and Vascular Center, Houston (N.S.K., M.J.R.); Abbott Northwestern Hospital (J.A., P.S.) and Medtronic (M.J.B., H.Q.), Minneapolis, Mayo Clinic, Rochester (J.K.O.), and Paradigm Biostatistics, Anoka (A.S.M.) - all in Minnesota; Morton Plant Hospital, Clearwater, FL (J. Rovin); Mount Sinai Health System, New York (D.H.A.), and Saint Francis Hospital, Roslyn (N.R., G.P.) - both in New York; Scripps Clinic and Research Foundation, La Jolla, CA (P.S.T.); University of Kansas Hospital, Kansas City (G.L.Z.); Yale New Haven Hospital, New Haven, CT (J.K.F.); Clinique Pasteur, Toulouse, France (D.T.); Johns Hopkins Hospital, Baltimore (J. Resar); Alfred Hospital, Melbourne, VIC, Australia (A.W.); McGill University Health Centre, Montreal (N.P.); and Winchester Medical Center, Winchester, VA (B.R.).
Abstract
BACKGROUND:Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).
RCT Entities:
BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).
Authors: Molly Szerlip; Deborah Tabachnick; Mohanad Hamandi; LuAnn Caras; Allison T Lanfear; John J Squiers; Katherine Harrington; Srinivasa P Potluri; J Michael DiMaio; Jordan Wooley; Benjamin Pollock; Justin M Schaffer; William T Brinkman; David L Brown; Michael J Mack Journal: Proc (Bayl Univ Med Cent) Date: 2020-09-23
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: Wolfgang von Scheidt; A Welz; M Pauschinger; T Fischlein; V Schächinger; H Treede; R Zahn; M Hennersdorf; J M Albes; R Bekeredjian; M Beyer; J Brachmann; C Butter; L Bruch; H Dörge; W Eichinger; U F W Franke; N Friedel; T Giesler; R Gradaus; R Hambrecht; M Haude; H Hausmann; M P Heintzen; W Jung; S Kerber; H Mudra; T Nordt; L Pizzulli; F-U Sack; S Sack; B Schumacher; G Schymik; U Sechtem; C Stellbrink; C Stumpf; H M Hoffmeister Journal: Clin Res Cardiol Date: 2019-08-13 Impact factor: 5.460
Authors: Dmitry Levin; G Burkhard Mackensen; Mark Reisman; James M McCabe; Danny Dvir; Beth Ripley Journal: Curr Cardiol Rep Date: 2020-02-17 Impact factor: 2.931