William F Fearon1, Susheel Kodali2, Darshan Doshi2, Michael P Fischbein3, Alan C Yeung3, E Murat Tuzcu4, Charanjit S Rihal5, Vasilis Babaliaros6, Alan Zajarias7, Howard C Herrmann8, David L Brown9, Michael Mack10, Paul S Teirstein11, Brian K Whisenant12, Raj Makkar13, Samir Kapadia4, Martin B Leon3. 1. Stanford University School of Medicine, Stanford, California. Electronic address: wfearon@stanford.edu. 2. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York. 3. Stanford University School of Medicine, Stanford, California. 4. Cleveland Clinic Foundation, Cleveland, Ohio. 5. Mayo Clinic, Rochester, Minnesota. 6. Emory University School of Medicine, Atlanta, Georgia. 7. Washington University School of Medicine, St. Louis, Missouri. 8. Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania. 9. Baylor Healthcare System, Plano, Texas. 10. Baylor Scott & White Health, Plano, Texas. 11. Scripps Clinic, La Jolla, California. 12. Intermountain Medical Center, Salt Lake City, Utah. 13. Cedars Sinai Medical Center, Los Angeles, California.
Abstract
OBJECTIVES: This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. BACKGROUND: The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. METHODS: The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. RESULTS: In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were significantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower. CONCLUSIONS: The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
RCT Entities:
OBJECTIVES: This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. BACKGROUND: The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. METHODS: The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. RESULTS: In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were significantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower. CONCLUSIONS: The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
Authors: Pamela S Douglas; Martin B Leon; Michael J Mack; Lars G Svensson; John G Webb; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; D Craig Miller; Samir Kapadia; Howard C Herrmann; Susheel K Kodali; Raj R Makkar; Vinod H Thourani; Stamatios Lerakis; Ashley M Lowry; Jeevanantham Rajeswaran; Matthew T Finn; Maria C Alu; Craig R Smith; Eugene H Blackstone Journal: JAMA Cardiol Date: 2017-11-01 Impact factor: 14.676
Authors: Tarique Al Musa; Akhlaque Uddin; Catherine Loveday; Laura E Dobson; Mark Igra; Fiona Richards; Peter P Swoboda; Anvesha Singh; Pankaj Garg; James R J Foley; Graham J Fent; Anthony J P Goddard; Christopher Malkin; Sven Plein; Daniel J Blackman; Gerald P McCann; John P Greenwood Journal: BMJ Open Date: 2019-01-21 Impact factor: 2.692