(Reuters) — Medtronic‘s (NYSE:MDT)’s CoreValve transcatheter aortic valve implant led to significantly fewer deaths than open heart surgery after 1 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 TAVI system, 11.4% of high-risk patients had died or suffered a major stroke, versus 21.8% 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 graft 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," Dr. John Conte of the Johns Hopkins Hospital, who presented the data at the Society of Thoracic Surgeons meeting in San Diego, said in prepared remarks.
The analysis also showed significantly reduced complications for TAVI patients after 1 year, including lower rates of acute kidney injury (5.3% vs. 16.3%) and life-threatening or disabling bleeding (14.0% vs. 43.5%).
TAVI 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 system from Edwards Lifesciences (NYSE:EW). They are considered important growth drivers for the companies. The TAVI 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.