(Reuters) - Medtronic's CoreValve non-invasive aortic valve replacement system led to significantly fewer deaths than open heart surgery after one year in patients who had previously undergone coronary bypass procedures, according to data from a clinical trial.
One year after a diseased valve was replaced using the CoreValve transcatheter aortic valve replacement (TAVR) system, 11.4 percent of high-risk patients had died or suffered a major stroke versus 21.8 percent among those who had the valve replaced surgically.
There was no significant difference in major strokes alone, so most of the benefit seen in the combined data point came from a reduction in all cause mortality, researchers found.
The data came from a sub-analysis of a larger trial of high risk heart patients, and looked only at the 226 who had previously undergone coronary artery bypass grafting surgery, known as CABG.
"The CoreValve System demonstrated important clinical advantages, including faster recovery compared to surgical valve replacement, offering heart teams an alternative to open heart surgery for this patient population," said Dr. John Conte, a professor of surgery at The Johns Hopkins Hospital, who presented the data at the Society of Thoracic Surgeons meeting in San Diego, in a statement.
The analysis also showed significantly reduced complications for TAVR patients after one year, including lower rates of acute kidney injury (5.3 percent vs 16.3 percent) and life threatening or disabling bleeding (14.0 percent vs. 43.5 percent).
TAVR systems are increasingly being used as an alternative to chest-cracking open heart surgery for patients with aortic stenosis. Using a catheter, the valve is threaded through an artery and into place in the heart.
CoreValve competes with the Sapien TAVR system from Edwards Lifesciences Corp. They are considered important growth drivers for the companies.
The TAVR systems are currently approved for use in patients deemed too frail to undergo surgery or those considered to be at high risk. Both companies are testing their systems in moderate risk patients with the aim toward gaining approval to treat a larger portion of the population.
(Reporting by Bill Berkrot; editing by Gunna Dickson)