Shmuel Chen1, Bjorn Redfors2, Ori Ben-Yehuda3, Aaron Crowley3, Kevin L Greason4, Maria C Alu5, Matthew T Finn5, Torsten P Vahl5, Tamim Nazif5, Vinod H Thourani6, Rakesh M Suri7, Lars Svensson7, John G Webb8, Susheel K Kodali5, Martin B Leon9. 1. Cardiovascular Research Foundation, New York, New York. Electronic address: schen@crf.org. 2. Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden. 3. Cardiovascular Research Foundation, New York, New York. 4. Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. 5. Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York. 6. Medstar Heart & Vascular Institute, Washington, District of Columbia. 7. Cleveland Clinic, Cleveland, Ohio. 8. St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 9. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Abstract
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 versusTAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.
RCT Entities:
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-PCSpatients 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.