Image courtesy of Medtronic
January 29, 2015 — Medtronic revealed new one-year clinical data showing that transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve System offers advantages in survival and safety compared to surgical aortic valve replacement (SAVR) in high risk aortic stenosis patients who have previously undergone coronary artery bypass grafting (CABG) surgery. This is the first analysis to evaluate a self-expanding valve in prior-CABG patients within a trial of TAVR and SAVR.
Presented at the 2015 Annual Meeting of The Society of Thoracic Surgeons (STS), the post-hoc sub-analysis of the High Risk Study of the CoreValve U.S. Pivotal Trial included 226 prior-CABG patients who were either treated with TAVR (N=115) or SAVR (N=111).
At one year, there was a significant difference favoring TAVR with CoreValve in the combined primary study endpoint of all-cause mortality or major stroke with an incidence of 11.4 percent in the TAVR group versus 21.8 percent in the SAVR group (p=0.04). Additionally, there was a trend towards a survival advantage for patients who received TAVR with CoreValve compared to SAVR (90.4 percent versus 81.9 percent, respectively; p=0.06) and lower rates of cardiovascular mortality (7.0 percent versus 13.8 percent, respectively; p=0.10).
“Prior to now, the treatment of this patient population has been confounded by the lack of data showing clinical benefit of TAVR versus surgical aortic valve replacement for prior-CABG aortic stenosis patients, who may have increased risks of mortality and morbidity with re-operation.,” said John Conte, M.D., professor of surgery at The Johns Hopkins Hospital who presented the data at STS. “The CoreValve System demonstrated important clinical advantages including faster recovery compared to surgical valve replacement offering heart teams an alternative to open heart surgery for this patient population.”
The analysis also showed reduced complications for patients receiving TAVR versus SAVR at one year, including lower rates of acute kidney injury (5.3 percent versus 16.3 percent; p=0.007), life threatening or disabling bleeding (14.0 percent versus 43.5 percent; p<0.001), as well as lower MACCE with the TAVR-treated patients (17.5 percent versus 28.1 percent, respectively; p=0.05). There was no difference in the overall rates of all stroke (10.6 percent versus 14.3 percent, p=<0.40) or major stroke (8.8 percent versus 6.6 percent; p=<0.54) between the two patient groups
The CoreValve System is available for use in the United States, following U.S. Food and Drug Administration (FDA) approval in 2014 for patients at extreme risk and high risk for surgery. Since receiving CE Mark in 2007, the CoreValve System has been implanted in more than 70,000 patients in more than 60 countries.
For more information: www.medtronic.com