Medtronic PLC's Evolut transcatheter aortic valve replacement system worked as well as surgery in treating certain heart disease patients, meeting the main goal of a trial.
In the Evolut Low Risk Trial, the Dublin-based company's transcatheter aortic valve replacement, or TAVR, system showed non-inferiority to open-heart surgery in preventing death or disabling stroke in low-risk patients — or those younger and healthier than higher-risk patients — with aortic stenosis.
Aortic stenosis is a disease in which the heart's aortic valve — which facilitates blood circulation — narrows, causing a restriction in blood flow. The disease is one of the most common and most serious valve disorders and causes breathlessness, chest pain, fainting, palpitation and heart murmur.
Medtronic's TAVR system uses a replacement valve, inserted into the aortic valve's place, to facilitate blood movement.
The Evolut Low Risk Trial evaluated three valve generations — CoreValve, Evolut R and Evolut PRO — in more than 1,400 low-risk severe aortic stenosis patients deemed to have a low mortality risk with surgery. The results of the study were presented March 16 at the American College of Cardiology's 68th Annual Scientific Session.
The 30-day safety composite of death, disabling stroke, life-threatening bleeding, major vascular complications or acute kidney injury was also lower for TAVR compared to open-heart surgery. The 30-day composite endpoint of death or disabling stroke was also lower for those treated with TAVR than those who were treated with surgery.
Further, patients treated with TAVR showed lower rates of heart failure hospitalizations and disabling stroke compared to the surgery group after 12 months.
Medtronic's Evolut TAVR system is not yet approved in any geography for treating patients at low-risk of death from surgery.
The Dublin-based company's CoreValve Evolut R System was approved in the U.S. in 2015 for treating severe aortic stenosis patients at a high or extreme risk for surgery. The Evolut R system also received CE Mark in the EU for treating intermediate risk severe aortic stenosis patients in 2016.
In 2017, Medtronic's Evolut PRO TAVR system was given the nod in the U.S. and EU for treating extreme-, high- and intermediate-risk patients with severe aortic stenosis.