Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report lowered stroke rates compared to standard treatment.
The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination therapy for patients who require a left ventricular assist device and received improved blood pressure management, the Fridley, Minn.-based company said.
Data from the study was presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Diego.
Medtronic said that the Endurance trial did not meet its primary endpoint of all neurologic events at 12 months, but that secondary results indicated a 76.4% survival rate on the originally implanted device without disabling stroke. The control arm reported a 66.9% rate, comparatively.
“In the Endurance trial, we were concerned about the higher rate of stroke in the HVAD group compared to the control. In the Endurance Supplemental trial, that gap closed and the stroke rates are comparable: there was no statistically significant difference between the HVAD and HeartMate II. We believe the narrowing of those rates was most likely due to blood pressure management,” co-principal investigator Dr. Carmelo Milano of Durham, N.C.’s Duke University Medical Center said in a press release.
Patients in the HVAD arm had a higher rate of stroke and ischemic attacks, reporting 14.7% at 12 months compared to 12.1% for those in the control arm, Medtronic said.
A post-hoc analysis indicated a lower rate of disabling stroke or death of 18.8% among the HVAD arm, compared to 21.6% in the control.
The analysis also reported a 24.7% relative reduction in overall stroke and transient ischemic attack incident, and a 50% relative reduction in hemorrhagic stroke in patients supported by its HVAD system.
“We are pleased with the overall results of the Endurance Supplemental trial, particularly the reduced rates of disabling stroke and the promising effects of optimal blood pressure management. We hope to be able to offer this therapy to the very sick population of patients in the U.S. who are ineligible for a heart transplant and rely upon mechanical circulatory support as long-term destination therapy,” Medtronic heart failure biz GM Dr. David Steinhaus said in a prepared statement.
Medtronic closed its $1.1 billion acquisition of HeartWare, and its HVAD system, last August.