The PARTNER Trial Cohort B results demonstrate widening survival benefit for transcatheter aortic valve implantation (TAVI) patients at two years, with mortality for TAVI at 43.4% compared to 67.6% for medical therapy. Median days alive outside hospital were 699 days for TAVI patients and 355 days for standard therapy patients, a difference of around one year.
The new results were presented by Raj Makkar, associate director of the Cedars-Sinai Heart Institute, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The PARTNER trial (Cohort B) is a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart valve, from Edwards Lifesciences. The device was approved by the FDA on November 2011.
At one year, all-cause mortality was 30.7% for TAVI and 50.7% for standard therapy as published last year in The New England Journal of Medicine. At two years, mortality for patients treated with TAVI remained superior to standard therapy, with the mortality curves diverging further to demonstrate rates of 43.3% vs. 67.6%, respectively. There was a higher neurologic event rate in the transcatheter group as compared to standard therapy.
“The mortality advantage grew significantly at two years. Remarkably, the median days alive outside of the hospital was 699 days in TAVI patients and 355 days for standard therapy patients – a difference of nearly one year. This demonstrates that without the Sapien valve, patients that survived spent significantly more time in the hospital,” said Makkar.
In addition to the clinical advantages, the new data demonstrated that the improvement in haemodynamic performance was sustained at two years.
This trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomised to receive either the Sapien valve or standard therapy.