NEXT: Biodegradable DES remains noninferior to durable stent at 5 years
A biodegradable-polymer biolimus-eluting stent was noninferior to a durable-polymer everolimus eluting stent at 5 years, according new data from the NEXT trial.
In the large, prospective, multicenter, randomized, open-label trial, Masahiro Natsuaki, MD, from the department of cardiovascular medicine, Saga University, Japan, and colleagues randomly assigned 3,235 patients (mean age, 69 years; 46% with diabetes; 51% with prior PCI) to receive the biolimus-eluting stent (Nobori, Terumo; n = 1,617) or an everolimus-eluting stent (Xience, Abbott Vascular; n = 1,618).
At 5 years, 93.8% of patients were available for follow-up.
The primary safety endpoint of death or MI occurred in 15.1% of patients assigned the biodegradable-polymer stent vs. 16.5% of those assigned the durable-polymer stent at 5 years (HR = 0.91; 95% CI, 0.75-1.11; P for noninferiority < .0001), according to the researchers.
The primary efficacy endpoint of target lesion revascularization occurred in 9.8% of those in the biodegradable group and 9.3% of those in the durable group at 5 years (HR = 1.04; 95% CI, 0.8-1.34; P for noninferiority = .01), they wrote.
Cumulative incidences of death/MI, TLR and definite stent thrombosis between 1 year and 5 years were not different between the groups.
The results were consistent across subgroups, including diabetes status, insulin use, age, hemodialysis and multivessel vs. single-vessel PCI, Natsuaki and colleagues wrote.
“Both the biodegradable polymer and the durable polymer might have achieved the parallel improvements using more biocompatible polymers than those used in first-generation DES,” the researchers wrote. – by Erik Swain
Disclosure: The study was funded by Terumo. Natsuaki reports he received lecture fees from Abbott Vascular Japan and Terumo Japan. Please see the study for a list of the other authors’ relevant financial disclosures.