Results Published From CoreValve US Pivotal Trial

March 19, 2014—Jeffrey J. Popma, MD, et al published findings from the CoreValve US Pivotal Trial of the self-expanding CoreValve bioprosthesis (Medtronic, Inc., Minneapolis, MN). The study is available online ahead of print in the Journal of the American College of Cardiology.

Dr. Popma first presented the data last October during a late-breaking clinical trial session of the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. On January 17, 2014, Medtronic announced that the CoreValve system received US Food and Drug Administration approval. The device received European CE Mark approval in 2007.

As summarized in the Journal of the American College of Cardiology, the investigators performed a prospective, multicenter, nonrandomized investigation evaluating the CoreValve’s safety and efficacy for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a prespecified objective performance goal.

 Investigators at a total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve device. The rate of all-cause mortality or major stroke at 12 months was 26% (upper two-sided 95% confidence bound = 29.9%) versus the objective performance goal of 43% (P < .0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; P = .004 for paired analysis).

The investigators concluded that TAVR with the CoreValve self-expanding bioprosthesis is safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement.