Medtronic CoreValve System ‘real-world’ US patient experience data replicates clinical outcomes

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Medtronic has released the first outcomes data for its CoreValve Transcatheter Aortic Valve Replacement (TAVR) System using CoreValve data from The Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The everyday clinical experience of 6,160 patients has been shown to replicate the outcomes achieved in clinical trials. The primary outcomes of all-cause mortality and stroke in the STS/ACC TVT Registry were numerically similar to the findings in the CoreValve US pivotal trial, which demonstrated statistical superiority to surgical aortic valve replacement in high risk patients.

The CoreValve patients in the STS/ACC TVT Registry showed a very low rate of all-cause mortality (5.2%) and all stroke (2.6%) at 30 days, consistent with pivotal trial results (6.9% all-cause mortality and 5% all stroke). The STS/ACC TVT Registry data represents all patients entered into the registry who were implanted with the CoreValve System since FDA approval in January 2014 through to March 2015.  The patients in the STS/ACC TVT Registry were similar to those enrolled in the pivotal trial with an average age 81.1 years (82.9 in the pivotal trial), average STS risk model score of 8.7 (9.2 in the pivotal trial) and similar comorbidity profiles including 83.7% of patients being NYHA class III/IV (89.4% in the pivotal trial).

“It is reassuring to see that the profound clinical results in the US CoreValve pivotal studies were replicated among patients at high or extreme surgical risk in a ’real-world’ clinical setting,” says Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, co-principal investigator of the US CoreValve pivotal trial and presenter of the STS/ACC TVT Registry CoreValve data at the Transcatheter Cardiovascular Therapeutics TCT scientific meeting. “The favourable results from the CoreValve analyses are likely attributable to operator experience, thoughtful patient selection, and effective education and training based on the ’Best Practices’ learned in the U.S. Pivotal Studies, including the use of CT-based sizing. We believe that these results indicate that the CoreValve self-expanding bioprosthesis is safe and effective in patients with severe aortic stenosis unsuitable for surgery across a wide spectrum of US medical centers.”

 
Compared to the CoreValve U.S. pivotal trial, the STS/ACC TVT Registry CoreValve data analyses also demonstrated:

 

  • CoreValve implantation was successful in 98% of cases (96.8% in the pivotal trial) with just 0.7% of cases requiring conversion to surgery (0.2% in the pivotal trial).
  • With the CoreValve System’s low delivery profile, 89.3% of patients were able to be treated via transfemoral access (77.3% in the pivotal trial) with an extremely low rate of major vascular complications (1.1% compared to 7.5% in the pivotal trial).
  • Only 1.5% of patients required valve related readmission (5.9% in the pivotal trial).
  • CoreValve hemodynamic performance was excellent with a single-digit mean gradient (a measure of blood flow through the valve) of 7.7mm±4.2mm Hg at 30 days and 8.1mm±3.9mm at one year.  As in the clinical trial setting, patients experienced dramatic improvements in quality of life (Kansas City Cardiomyopathy Questionnaire reduction from 40.9 to 68.7, the strongest improvements possible via the test), as well as significant reductions in symptoms (from 83.8% NYHA class III/IV to 13.4%) at 30 days. Such results continued in 380 patients followed out to one year with all-cause mortality at 18.8%, while stroke remained low at 2.6%. There were no reports of valve thrombosis through one year.

The CoreValve System is approved by the FDA for patients at extreme risk and high risk for surgery.  Since receiving CE mark in 2007, the CoreValve System, and the recently approved CoreValve Evolut R system have been implanted in more than 80,000 patients in more than 60 countries.