ENDURANCE: Stroke-free survival similar with centrifugal-flow VAD, LVAD
Patients with advanced HF ineligible for heart transplantation who were implanted with a centrifugal-flow ventricular assist device system or an axial-flow left ventricular assist device had similar rates of stroke-free survival at 2 years, according to data from the ENDURANCE trial presented at the International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions.
The prospective, multicenter study included 446 patients with NYHA class IIIb to IV HF symptoms. Patients had ejection fraction ≤ 25% despite optimal medical therapy for at least 45 days or IV inotropes for at least 14 days or an intra-aortic balloon pump for at least 7 days.
Each patient was randomly assigned at a 2:1 ratio to a centrifugal-flow VAD (HeartWare) or an axial-flow LVAD (HeartMate II, Thoratec).
The primary endpoint was stroke-free survival at 2 years, which the researchers defined as alive on the originally implanted device, transplanted or explanted due to patient recovery without disabling stroke, according to the abstract. Secondary endpoints included adverse events, NYHA functional class and 6-minute walk distance, among others.
The primary endpoint was reported in 55.2% of patients assigned the centrifugal-flow VAD compared with 57.4% of those assigned the axial-flow LVAD. Based on these results, noninferiority of the investigational device was established (P = .006), researcher Francis D. Pagani, MD, PhD, of University of Michigan Hospital, said during a presentation at ISHLT 2015. The two devices were also associated with similar event-free survival at 2 years (67.6% axial-flow LVAD group vs. 60.2% centrifugal-flow VAD group; P =.17), sustained improvements to NYHA class and 6-minute walk distance.
The researchers noted that significantly fewer incidences of treatment failure were attributable to device malfunction or failure, urgent transplantation or explant in the centrifugal-flow VAD group vs. the axial-flow LVAD group (8.8% vs. 16.2%; P = .025). However, stroke occurred significantly more frequently in the centrifugal-flow VAD group (28.7% vs. 12.1%; P < .001).
“This trial is very important, as it shows that patients on [mechanical circulatory support] destination therapy have an excellent long-term survival, and that the [HeartWare centrifugal-flow VAD] system can be used in a similar way as the VAD in the control group,” Andreas Zuckermann, MD, scientific program committee chair for ISHLT 2015, said in a press release.
Pagani FD, et al. Late-breaking clinical trial #1. Presented at: International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions; April 15-18, 2015; Nice, France.
Disclosure: Pagani reports receiving a HeartWare research contract managed by the University of Michigan.