FDA Gives Greenlight for Low-Risk TAVR Study With CoreValve
The US Food and Drug Administration has given its blessing yet again to a randomized trial of transcatheter aortic valve replacement in low-risk patients, this time with a self-expanding device.
Medtronic announced today that the new trial will randomize approximately 1,200 low-risk patients with severe aortic stenosis to TAVR with the CoreValve Evolut R system or surgical aortic valve replacement. Patients randomized in the trial will be considered low risk for surgery if, based on an evaluation from a heart team, they have a less than 3% risk of death from valve-replacement surgery.
The primary endpoint of the study, which is scheduled to begin enrolment this spring, is all-cause mortality or disabling stroke at 2 years. The FDA has allowed investigators to analyze the results at 1 year so that Medtronic can submit data to support a low-risk TAVR indication with CoreValve.
The study will include a subset analysis of 400 patients to assess leaflet mobility with the bioprosthetic valve. Unexpected concerns about impaired leaflet motion and possible thrombosis were raised last October when investigators analyzed clinical trial and registry data and observed reduced leaflet motion among TAVR patients screened with computed tomography. The data also suggested a higher risk of stroke/transient ischemic attack in patients with reduced leaflet motion.
The Medtronic announcement coincided with a timely presentation at CRT 2016 entitled Patient Selection and TAVR vs SAVR: Are We Ready for Low-Risk Patients? In his concluding remarks, presenter and cardiothoracic surgeon Michael Reardon, MD, of Houston Methodist Hospital in Texas predicted that it is only a matter of years before the majority of aortic stenosis patients are treated via a transcatheter approach. “We’re no longer going to say, who’s a bad candidate for surgery?” Reardon said. “We’ll be saying, who’s bad for TAVR?”
Last month, Edwards Lifesciences announced FDA permission to move forward with a randomized trial of TAVR in low-risk patients. The PARTNER III study, which uses the Sapien 3 valve, will enroll approximately 1,300 elderly patients at low risk for death should they undergo surgery for aortic valve replacement. Like the Medtronic study, PARTNER III includes a 400-patient substudy to assess leaflet mobility
Medtronic receives FDA approval for expanded indication trial in low-risk aortic stenosis patients. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2141566. Published on: February 22, 2016. Accessed on: February 22, 2016.