In explaining the risks to patients, Dr. Makkar said he would tell them that for every four patients treated with TAVI instead of standard therapy, one patient will survive. For every 12-13 patients treated with TAVI instead of standard therapy, 1 will develop a stroke.
Or, as Dr. Samir Kapadia of the Cleveland Clinic phrased it at a press briefing, patients in this population have a 50-50 chance of being alive at 2 years if they’re treated with TAVI and a 1 in 20 chance of having a stroke.
Patients in both treatment groups had a mean age of 83 years.
The hemodynamic effects of the implanted valves appeared to be stable between years 1 and 2, with sustained mean gradients and valve areas. Among patients with paravalvular leaks, 41% in each group died.
Edwards Lifesciences, which markets the Edwards Sapien valve, funded the study and was involved in its design, data collection, and monitoring. Dr. Makkar holds stock in Entourage Technologies, has received fees for consulting, speaking, or honoraria from Abbott Vascular, Medtronic and Abiomed, and has received research funds from Edwards Lifesciences. Dr. Mack and Dr. Kapadia said they have no conflicts of interest.