Author + information
- Received May 22, 2018
- Revision received August 14, 2018
- Accepted August 14, 2018
- Published online November 5, 2018.
- Shmuel Chen, MD, PhDa,∗∗ (, )
- Bjorn Redfors, MD, PhDa,b,∗,
- Ori Ben-Yehuda, MDa,
- Aaron Crowley, MAa,
- Kevin L. Greason, MDc,
- Maria C. Alu, MSd,
- Matthew T. Finn, MDd,
- Torsten P. Vahl, MDd,
- Tamim Nazif, MDd,
- Vinod H. Thourani, MDe,
- Rakesh M. Suri, MD, DPhilf,
- Lars Svensson, MD, PhDf,
- John G. Webb, MDg,
- Susheel K. Kodali, MDd and
- Martin B. Leon, MDa,d
- aCardiovascular Research Foundation, New York, New York
- bDepartment of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
- cDepartment of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota
- dColumbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York
- eMedstar Heart & Vascular Institute, Washington, District of Columbia
- fCleveland Clinic, Cleveland, Ohio
- gSt. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- ↵∗Address for correspondence:
Dr. Shmuel Chen, Cardiovascular Research Foundation, 1700 Broadway, 8th Floor, New York, New York 10019.
Objectives The aim of this study was to further evaluate clinical outcomes in patients with and without PCS.
Background Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear.
Methods In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke.
Results Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (pinteraction <0.0001). A similar interaction was observed for life-threatening or disabling bleeding.
Conclusions In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.
- aortic stenosis
- surgical aortic valve replacement
- transcatheter aortic valve replacement
- transcatheter heart valve
↵∗ Drs. Chen and Redfors contributed equally to this work.
The PARTNER 2 trial was funded by Edwards Lifesciences. Ms. Alu has received consulting fees from Claret Medical. Dr. Nazif has received consulting fees from Edwards Lifesciences. Dr. Thourani is an advisor for Edwards Lifesciences, Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific. Dr. Suri has received research grants from Sorin, Abbott, Edwards Lifesciences, and St. Jude Medical. Dr. Svensson is a member of the PARTNER trial Executive Committee (no direct compensation). Dr. Webb is a consultant for Edwards Lifesciences and a member of the PARTNER trial Executive Committee (no direct compensation). Dr. Kodali has received consulting fees from Abbott Vascular and Claret Medical; serves on the advisory boards of Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical; received honoraria from Abbott Vascular, Claret Medical; and has equity in Dura Biotech, Thubrikar Aortic Valve Inc., and Biotrace Medical. Dr. Leon is a member of the PARTNER trial Executive Committee (no direct compensation). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 22, 2018.
- Revision received August 14, 2018.
- Accepted August 14, 2018.
- 2018 American College of Cardiology Foundation
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