CoreValve Approved for TAVR in High-Risk Patients

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Key Points:
  • Accelerated approval based on clearly positive data from high-risk cohort of pivotal trial
  • Entire CoreValve platform including 4 valve sizes up to 31 mm gets nod
  • Option makes TAVR available to broader range of patients

By Kim Dalton
Friday, June 13, 2014

The CoreValve transcatheter valve gained accelerated approval on June 12, 2014, from the US Food and Drug Administration for treatment of patients with severe aortic stenosis who are at high risk for surgery.

The decision, which bypassed the need for an independent device advisory panel review, came less than 3 months after presentation of highly favorable results from the High Risk Study of the CoreValve US Pivotal Trial at the American College of Cardiology/i2 Scientific Session. It complements the approval in January of the self-expanding bioprosthesis (Medtronic; Minneapolis, MN) for inoperable patients.

In the randomized trial of 795 high-risk patients, CoreValve was associated with lower 1-year all-cause mortality compared with surgery, the primary endpoint (14.2% vs 19.1%; P = .04 for superiority). At 1 year, the rate of stroke with TAVR was low and equivalent to surgery (8.8% and 12.6%; P = .10). In addition, hemodynamic outcomes were similar between the therapies.

The entire CoreValve platform was approved, including valve sizes of 23 mm, 26 mm, 29 mm, and 31 mm, all delivered via an 18-Fr catheter. The largest available size for the Sapien XT valve (Edwards Lifesciences; Irvine, CA) is 29 mm.

“This rigorous trial has defined a new standard for transcatheter valve performance, with superiority results that give physicians even more confidence in making TAVR treatment decisions,” said co-principal investigator David H. Adams, MD, of Mount Sinai Medical Center (New York, NY), in a press release. “With this approval we can treat more patients due to the broad range of CoreValve sizes, and we have an option compared to surgery that provides a greater chance for a longer life while minimizing the risk of stroke.”

Small Catheter Across a Range of Valve Sizes

In an email with TCTMD, Jeffrey J. Popma, MD, of Beth Israel Deaconess Hospital (Boston, MA), observed that “the recent [CoreValve High Risk] data will provide reassurance to patients and referring physicians that there are real benefits to considering TAVR for high-risk patients.… For a number of clinically relevant endpoints, the results were superior at 1 year with self-expanding TAVR compared with surgery.”

Dr. Popma cited estimates that, compared with the Sapien device, about 50% more patients may be treated with CoreValve via the transfemoral approach. “The small French size across all valve sizes and the ability to treat annular ranges up to 29 mm are the most obvious benefits,” he said.

“We will have to sort out how both the Sapien and CoreValve [bioprostheses] perform in clinical practice. There will clearly be some patients who will be best treated by 1 device or another,” he noted, adding that TAVR centers should have comprehensive experience with both Sapien and CoreValve, as well as other new devices that are coming to the United States.

In its statement, Medtronic said it will “continue to introduce the CoreValve system safely, supporting heart teams through comprehensive training and education, imaging and patient evaluation programs.”

 


Source:
Medtronic. Medtronic CoreValve system receives FDA approval for patients at high risk for surgery [press release]. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1939539&highlight=%20Published%20June%2012,%202014. Published June 12, 2014. Accessed June 13, 2014.

Disclosure:

  • Dr. Popma reports serving as a co-principal investigator for the CoreValve pivotal trials and receiving research grants from Medtronic.

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