Author + information
- Received April 30, 2014
- Accepted May 8, 2014
- Published online November 1, 2014.
- William F. Fearon, MD∗∗ (, )
- Susheel Kodali, MD†,
- Darshan Doshi, MD†,
- Michael P. Fischbein, MD, PhD∗,
- Alan C. Yeung, MD∗,
- E. Murat Tuzcu, MD‡,
- Charanjit S. Rihal, MD§,
- Vasilis Babaliaros, MD‖,
- Alan Zajarias, MD¶,
- Howard C. Herrmann, MD#,
- David L. Brown, MD∗∗,
- Michael Mack, MD††,
- Paul S. Teirstein, MD‡‡,
- Brian K. Whisenant, MD§§,
- Raj Makkar, MD‖‖,
- Samir Kapadia, MD‡,
- Martin B. Leon, MD∗,
- PARTNER Trial Investigators
- ∗Stanford University School of Medicine, Stanford, California
- †Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- ‡Cleveland Clinic Foundation, Cleveland, Ohio
- §Mayo Clinic, Rochester, Minnesota
- ‖Emory University School of Medicine, Atlanta, Georgia
- ¶Washington University School of Medicine, St. Louis, Missouri
- #Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- ∗∗Baylor Healthcare System, Plano, Texas
- ††Baylor Scott & White Health, Plano, Texas
- ‡‡Scripps Clinic, La Jolla, California
- §§Intermountain Medical Center, Salt Lake City, Utah
- ‖‖Cedars Sinai Medical Center, Los Angeles, California
- ↵∗Reprint requests and correspondence:
Dr. William F. Fearon, Stanford University Medical Center, 300 Pasteur Drive, H2103, Stanford, California 94305.
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).
- aortic stenosis
- transcatheter aortic valve implantation
- transcatheter aortic valve replacement
Dr. Fearon has received research support from St. Jude Medical; and serves on the Steering Committee for the PARTNER 2 trial. Dr. Kodali is a consultant for Edwards Lifesciences; and serves on the Scientific Advisory Board of and owns equity in Thubrikar Aortic Valve, Inc. Dr. Yeung receives research support from Abbott Vascular and Medtronic; and is a consultant for Boston Scientific Corporation and Medtronic Cardiovascular. Dr. Tuzcu has received travel reimbursements from Edwards Lifesciences related to his activities as an unpaid member of the PARTNER Trial Executive Committee. Dr. Rihal is an investigator in the PARTNER trial. Dr. Babaliaros is a consultant for Bard Medical, Intervalve, and Direct Flow Medical. Dr. Zajarias is a consultant for Edwards Lifesciences; serves on the Steering Committee for the PARTNER 2 trial; and serves on the Advisory Board of Philips. Dr. Herrmann has received grants/research support from Abbott Vascular, Boston Scientific Corporation, Edwards Lifesciences, Medtronic, Siemens, St. Jude Medical, and W. L. Gore and Associates; and is a consultant for Edwards Lifesciences, St. Jude Medical, and Siemens. Dr. Brown has received grants from Edwards Lifesciences, Medtronic, and St. Jude Medical; and owns equity in The Heart Hospital Baylor Plano and TRG Healthcare. Dr. Mack has received travel reimbursements from Edwards Lifesciences related to his activities as an unpaid member of the PARTNER Trial Executive Committee. Dr. Teirstein is a consultant for Abbott Vascular, Boston Scientific Corporation, and Medtronic Cardiovascular; has received research funding from Edwards Lifesciences and Medtronic; has received speaking fees from Edwards Lifesciences and Medtronic; and holds equity in Shepherd Scientific. Dr. Whisenant is a consultant for Edwards Lifesciences, Boston Scientific, and Medtronic; has received speaking fees from Edwards Lifesciences, Boston Scientific, and Medtronic; holds principal/partnership in Coherex Medical; and has received research support from Gore Medical. Dr. Makkar has received grant support from Edwards Lifesciences and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Dr. Leon has received travel reimbursements from Edwards Lifesciences related to his activities as an unpaid member of the PARTNER Trial Executive Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Fearon and Kodali contributed equally to this study.
- Received April 30, 2014.
- Accepted May 8, 2014.
- American College of Cardiology Foundation