Two-Year ADVANCE Data Presented for Medtronic's CoreValve System

May 21, 2014—Medtronic, Inc. announced that 2-year data from the CoreValve ADVANCE international postmarket study were presented by Prof. Axel Linke, MD; Johan Bosmans, MD; and Ulrich Gerckens, MD, at the EuroPCR 2014 congress being held May 20–23 in Paris, France. The data from this real-world study population show that patients treated with transcatheter aortic valve implantation (TAVI) using the CoreValve system experienced low rates of mortality and stroke through 2 years.

According to Medtronic, 2-year follow-up was reported on 96.8% of 1,015 patients, all of whom had severe aortic stenosis and were treated with the CoreValve system. Patients experienced low rates of all-cause mortality (25.6%), cardiovascular mortality (16.8%), and major stroke (2.9%) at 2 years. These findings are consistent with the positive findings previously reported at 1 month and 1 year, noted the company.

The investigators reported that a majority of patients experienced dramatic improvement in symptoms through 2 years (87% improved to New York Heart Association class I or class II). Overall hemodynamic performance was strong and stable, with mean gradients remaining below 10 mm Hg at each follow-up visit out to 2 years (9.8 mm Hg at discharge, 9.5 mm Hg at 1 year, and 9.4 mm Hg at 2 years).

As summarized by Medtronic, the international ADVANCE study was conducted with experienced TAVI heart teams across 44 centers in 12 countries, with patients receiving CoreValve implants between March 2010 and July 2011. The study calculated clinical endpoints according to Valve Academic Research Consortium standardized definitions. All data were independently monitored, all adverse events related to primary endpoints were adjudicated by an independent Clinical Events Committee consisting of experienced cardiac surgeons and interventional cardiologists, and all cerebrovascular events were adjudicated by an independent neurologist using neuroimaging and systematic NIH Stroke Scale assessments.

A separate analysis comparing patients aged 75 years or younger (n = 182) with older patients (n = 833) in the ADVANCE study showed that both age groups benefited from CoreValve treatment, demonstrating similar and low all-cause mortality rates at 30 days, 12 months, and 2 years (23.6% vs 26%; P = .448 at 2 years). No significant differences were observed between the two age groups for rates of cardiovascular mortality, stroke, myocardial infarction, bleeding, moderate and severe paravalvular leak, or the need for a new permanent pacemaker at either 1 or 2 years. At baseline, patients aged 75 years or younger had considerably higher rates of comorbidities compared to older patients, reported the company.

Medtronic advised that the US Food and Drug Administration approved the CoreValve system in January 2014 for patients considered at extreme risk for surgery; it is an investigational device for other patient groups in the United States. The device received European CE Mark approval in 2007.

In Medtronic’s press release, Prof. Linke commented, “It’s impressive to see that these positive clinical outcomes sustain out to 2 years, affirming the safety and exceptional performance of the CoreValve system. These contemporary real-world data, combined with results from the rigorous randomized trial in the United States, are important in understanding how TAVI performs and help physicians determine which options are best for their patients.”

Prof. Linke serves as principal investigator of the ADVANCE study and is Professor of Medicine at Universitat Leipzig Herzzentrum in Leipzig, Germany. Dr. Bosmans is Professor of Medicine at University Hospital Antwerp, Belgium, and Dr. Gerckens is with the Gemeinschaftskrankenhaus in Bonn, Germany.