Final 5-Year SORT OUT V Outcomes Published for Terumo's Biodegradable Nobori DES
December 21, 2017—Online in EuroIntervention, Lars Jakobsen, MD, et al reported the long-term safety and efficacy of the biodegradable polymer-coated biolimus-eluting Nobori stent (Terumo Interventional System) compared to the durable polymer-coated sirolimus-eluting Cypher stent (Cordis, a Cardinal Health Company) in the SORT OUT V trial.
As summarized in EuroIntervention, SORT OUT V randomized 2,468 patients 1:1 to the Nobori (n = 1,229) versus the Cypher stent (n = 1,239). The investigators used clinically driven event detection based on Danish registries.
The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization). The secondary endpoints were individual components of the primary endpoint.
The SORT OUT V investigators reported that at 5-year follow-up, the composite endpoint rate was found to be similar in patients treated with the two study stents (Nobori, 14.8% [182/1,229] vs Cypher, 15.8% [197/1,239]; odds ratio [OR], 0.93; 95% confidence interval [CI], 0.75–1.16; P = .53). The rates of definite stent thrombosis were also found to be similar in patients treated with the two study stents (Nobori, 1.9% [23/1,229] vs Cypher, 1.5% [18/1,239]; OR, 1.31; 95% CI, 0.70–2.47; P = .4), as were the other secondary endpoints.
At 5-year follow-up, the Nobori stent with a biodegradable polymer coating provided a similar safety and efficacy profile when compared to the durable polymer first-generation Cypher stent, concluded the investigators in EuroIntervention.