Medtronic's CoreValve and CoreValve Evolut R TAVR Systems Evaluated in Real-World Studies
May 16, 2017—Medtronic announced that new data on the company's self-expanding CoreValve platform were presented from the CoreValve ADVANCE and Evolut R FORWARD clinical studies, which are large global registries. The data were presented during late-breaking clinical trial sessions at the EuroPCR 2017 conference in Paris, France.
According to the company, the data from the studies are consistent with those of the clinical trials and reinforce the favorable safety and efficacy results seen with the CoreValve system and the newer CoreValve Evolut R system for the treatment of transcatheter aortic valve replacement (TAVR) in a real-world population with severe aortic stenosis.
Medtronic reported that the 5-year results from 465 patients in the ADVANCE clinical trial demonstrated sustained, longer-term performance with the CoreValve system in a real-world patient population. There was sustained hemodynamic improvement in patients who were available for long-term follow-up (mean gradient at discharge, 9.7 mm Hg; mean gradient at 5 years, 8.8 mm Hg). Additionally, most patients continued to have symptomatic improvements ,with 81% classified as New York Heart Association class I or II.
In a higher-risk patient population, survival is in line with other 5-year TAVR data in similar high-risk patients, stated the company.
Axel Linke, MD, who serves as Principal Investigator of the ADVANCE clinical trial, commented in Medtronic's announcement, "As TAVR continues to be evaluated in lower-risk patients, the ability to demonstrate sustained valve durability over time is of increasing importance. At final 5-year follow-up, we are very pleased with the excellent performance of the first-generation CoreValve device in the ADVANCE study, which is one of the most rigorously designed global TAVR trials to date.” Dr. Linke is Professor of Medicine at the University of Leipzig Heart Center in Leipzig, Germany.
In the Evolut R FORWARD clinical study, results from the full patient cohort (N = 1,038) demonstrated a 98.1% survival rate and a 1.8% rate of disabling stroke at 30 days postimplantation. The FORWARD study is a global, single-arm, prospective study at 53 centers across four continents. Patients enrolled in the study had a mean Society of Thoracic Surgeons predicted risk of mortality estimate of 5.5%.
Co-Principal Investigator Eberhard Grube, MD, commented in Medtronic's press release, “The FORWARD results with a large patient cohort are encouraging, as these data support the clinical safety and effectiveness of the Evolut R system. These initial 30-day outcomes help to further demonstrate the advantages of the recapturable and repositionable capabilities of the Evolut R System in routine clinical practice and we look forward to conducting further follow-up that will provide insights on contemporary TAVR clinical practice.” Prof. Grube is Head of the Center of Innovative Interventions at the University Hospital in Bonn, Germany.
Medtronic noted that the Evolut R FORWARD study showed that the mean aortic valve gradient was significantly reduced from 41.7 ± 16.1 mm Hg at baseline to 8.5 ± 5.6 mm Hg at discharge. Additionally, 98.1% of patients experienced mild or no/trace aortic regurgitation, as well as a low rate of major vascular complications (6.5%). New pacemaker implantations remained low (17.5%), with no reports of valve thrombosis reported at 30 days.