Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.
The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.
Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.
Patients, treated between September 22, 2014 and December 24, 2015, were randomized two to one to receive the Lotus valve or CoreValve system at 55 centers spanning North America, Australia and Europe, according to study results.
Main outcomes being explored by researchers were all-cause mortality and all-cause mortality or disabling stroke at two years. Other factors examined included overall stroke, disabling stroke, repeat procedures, rehospitalization, valve thrombosis and pacemaker implantation.
At two years, results indicated similar rates of all-cause mortality, mortality and disabling stroke between the competing valve devices, according to the study results.
All-cause death was reported at 21.3% with the Lotus valve, versus 22.5% with the CoreValve, while rates of all-cause mortality or disabling stroke were 22.8% with the Lotus and 27% with the CoreValve. Rates of overall stroke were 8.4% with Boston Scientific’s Lotus offering, and 11.4% with Medtronic’s CoreValve.
Disabling stroke rates were higher for patients treated with the CoreValve at 8.6% versus a lower 4.7% with the Lotus device, while more Lotus patients were likely to receive pacemakers than those treated with the CoreValve at 41.7% versus 26.1%, according to the results.
“Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm,” research investigators concluded.
Patients in the trial will be followed out to five-years post procedure, investigators said.
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