Medtronic (NYSE:MDT) today presented five-year clinical data for its CoreValve and Evolut transcatheter aortic valve implantation (TAVI) platforms.
Fridley, Minn.-based Medtronic presented results from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference.
According to a news release, data from the trial demonstrated that the hemodynamic (blood flow) benefits of the CoreValve and Evolut systems were maintained at five years with an excellent safety profile and stable valve performance in patients with symptomatic, severe aortic stenosis who are at intermediate risk for open-heart surgery.
Rates of all-cause mortality were similar between transcatheter aortic valve replacement (TAVR) with the CoreValve/Evolut platform and surgical aortic valve replacement (SAVR). The TAVR arm demonstrated durable valve longevity and valve thrombosis remained low out to five years for both TAVR and SAVR.
“TAVR has revolutionized the treatment of aortic stenosis with more TAVR cases now performed than surgical aortic valve replacement for this disease,” principal investigator Dr. Michael Reardon, a professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, said in the release. “With this shift in treatment, longer-term, randomized data is increasingly important as we strive to better understand the lifetime management of these patients.”
The global, prospective, multi-center, randomized SURTAVI trial evaluated the two different valve generations across a range of sizes in 864 aortic stenosis patients, with patients in the TAVR arm compared to 796 intermediate-risk patients who were randomized to open-heart surgery.
“These longer-term outcomes are remarkably similar after TAVR and surgery in patients with severe aortic stenosis at intermediate operative risk,” added Dr. Nicolas Van Mieghem professor of interventional cardiology, department of cardiology, Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands. “Additionally, results from this study are particularly impressive given the TAVR devices evaluated were first- and second-generation systems.”