Author + information
- Received March 20, 2015
- Revision received April 21, 2015
- Accepted May 5, 2015
- Published online July 14, 2015.
- Michael J. Reardon, MD∗∗ (, )
- David H. Adams, MD†,
- Neal S. Kleiman, MD∗,
- Steven J. Yakubov, MD‡,
- Joseph S. Coselli, MD§,
- G. Michael Deeb, MD‖,
- Thomas G. Gleason, MD¶,
- Joon Sup Lee, MD¶,
- James B. Hermiller Jr., MD#,
- Stan Chetcuti, MD‖,
- John Heiser, MD∗∗,
- William Merhi, MD∗∗,
- George L. Zorn III, MD††,
- Peter Tadros, MD††,
- Newell Robinson, MD‡‡,
- George Petrossian, MD‡‡,
- G. Chad Hughes, MD§§,
- J. Kevin Harrison, MD§§,
- Brijeshwar Maini, MD‖‖,
- Mubashir Mumtaz, MD‖‖,
- John V. Conte, MD¶¶,
- Jon R. Resar, MD¶¶,
- Vicken Aharonian, MD##,
- Thomas Pfeffer, MD##,
- Jae K. Oh, MD∗∗∗,
- Hongyan Qiao, PhD††† and
- Jeffrey J. Popma, MD‡‡‡
- ∗Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas
- †Mount Sinai Health System, New York, New York
- ‡Riverside Methodist Hospital, Columbus, Ohio
- §Texas Heart Institute at St. Luke’s Medical Center, Houston, Texas
- ‖University of Michigan Medical Center, Ann Arbor, Michigan
- ¶University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- #St. Vincent Medical Center, Indianapolis, Indiana
- ∗∗Spectrum Health System, Grand Rapids, Michigan
- ††The University of Kansas Hospital, Kansas City, Kansas
- ‡‡St. Francis Hospital, Roslyn, New York
- §§Duke University Medical Center, Durham, North Carolina
- ‖‖PinnacleHealth, Wormleysburg, Pennsylvania
- ¶¶The Johns Hopkins Hospital, Baltimore, Maryland
- ##Kaiser Permanente–Los Angeles Medical Center, Los Angeles, California
- ∗∗∗Mayo Clinic, Rochester, Minnesota
- †††Medtronic, Inc., Minneapolis, Minnesota
- ‡‡‡Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Michael J. Reardon, Houston Methodist DeBakey Heart & Vascular Center, 6550 Fannin, Suite 1401, Houston, Texas 77030.
Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis.
Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained.
Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients.
Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01).
Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
This study was sponsored by Medtronic. Dr. Reardon serves on a medical advisory board for Medtronic. Dr. Adams has received institutional grants and institutional royalties for patents with Medtronic; and institutional royalties for patents with Edwards Lifesciences. Dr. Kleiman has received grants from Medtronic outside of the current work. Dr. Yakubov has received institutional research grants from Medtronic, Direct Flow Medical, and Boston Scientific; and serves on a medical advisory board for Medtronic and Boston Scientific. Dr. Coselli has received remuneration and other fees from Medtronic and Edwards Lifesciences outside of the submitted work. Dr. Deeb has received grants from Medtronic; and serves on a medical advisory board and on the screening committees for the reported trial, and the SURTAVI and Evolut R trials, but receives no personal income. Dr. Gleason has received institutional grants from Medtronic. Dr. Hermiller serves on the steering committee for the reported trial and the speakers bureau for Medtronic. Dr. Chetcuti has received grants from Medtronic, Edwards Lifesciences, and Boston Scientific; and personal fees from Medtronic and Edwards Lifesciences outside of the submitted work. Dr. Zorn serves as a consultant to Medtronic and Edwards Lifesciences. Dr. Tadros serves as a consultant to Medtronic and St. Jude Medical outside of the submitted work. Dr. Hughes serves as a consultant and speaker for Medtronic. Dr. Harrison has received institutional grants from Medtronic, Boston Scientific, Direct Flow Medical, St. Jude Medical, and Edwards Lifesciences; serves on a medical advisory board for Direct Flow Medical; and serves on the Data and Safety Monitoring Board for CardiAQ. Dr. Maini serves as a speaker and proctor for Medtronic, Boston Scientific, and Abbott Vascular; and has received institutional research grants from Medtronic, Boston Scientific, Direct Flow Medical, and Abbott Vascular. Dr. Mumtaz has received personal fees from Medtronic outside of the submitted work. Dr. Conte serves on a surgical advisory board for Medtronic and Sorin; and has received research support from Boston Scientific, Medtronic, and St. Jude Medical. Dr. Resar has received institutional research grants from Medtronic, Boston Scientific, and St. Jude Medical; has received proctor fees from Medtronic; and serves on a medical advisory board for Boston Scientific. Dr. Oh has received institutional research grants from Medtronic. Dr. Qiao is an employee and shareholder of Medtronic. Dr. Popma has received institutional research grants from Medtronic, Boston Scientific, and Direct Flow Medical; and serves on a medical advisory board for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 20, 2015.
- Revision received April 21, 2015.
- Accepted May 5, 2015.
- American College of Cardiology Foundation