March 10, 2013

SAN FRANCISCO, California — A biolimus-eluting coronary stent lined with a biodegradable polymer (Nobori, Terumo) was statistically noninferior to an everolimus-eluting stent (Xience V/Promus, Abbott Vascular/Boston Scientific) with regard to the primary end point of target lesion revascularization (TLR) at one year and various angiographic outcomes, including in-segment and in-stent late loss, at eight to 12 months.

Regarding the safety of the novel device, the cumulative incidence of all-cause mortality, MI, and stent thrombosis was equivalent with both stents.

The results of the study, known as the NEXT trial, were presented here today at the American College of Cardiology 2013 Scientific Sessions by Dr Masahiro Natsuaki (Kyoto University Graduate School of Medicine, Japan). In total, 1617 patients were randomized to the biolimus-eluting stent and 1618 randomized to the everolimus-eluting stents. The average patient age was 69 years, and nearly half of the treated patients had diabetes. More than 80% of patients had stable coronary artery disease, 11% had unstable angina, and roughly 5.0% had an acute MI.

The cumulative incidence of TLR was 4.2% in the biolimus-eluting-stent and everolimus-eluting-stent arms, meeting the definition for noninferiority (p<0.0001). The rate of clinically driven TLR was 3.0% in both treatment arms, while the cumulative incidence of target vessel revascularization (TVR) was 6.8% in the biolimus-eluting-stent arm and 6.5% in the everolimus-eluting-stent arm. Regarding the cumulative one-year incidence of death, MI, and stent thrombosis, the rates were 2.6%, 3.3%, and 0.25%, respectively, in patients treated with the biolimus-eluting stent and 2.5%, 3.1%, and 0.06%, respectively, in the everolimus-eluting-stent arm (between-stent differences not statistically significant).

Speaking with the media during a press conference, Dr Cindy Grines (Detroit Medical Center, MI) noted that NEXT patients were relatively high risk, given their advanced age and the presence of diabetes and multivessel disease in both cohorts. "The clinical outcomes were amazing in both groups," said Grines. "At one month, just 3% of patients in both arms needed to have a repeat procedure done, and there are very low rates of stent clotting up to the first year."

In an angiographic substudy of 528 patients, with follow-up data available in 466 patients, in-segment late loss was 0.03 mm in the biolimus-eluting-stent arm and 0.06 mm everolimus-eluting-stent arm (p<0.0001 for noninferiority).

The data from NEXT are in line with data from the COMPARE II study, a randomized "all-comers" study where patients were treated with the Nobori stent or the Xience/Promus devices. At one year, the primary composite end point of cardiac death, MI, or clinically driven TVR was similar, at roughly 5%, in both groups, reaching the prespecified definition of noninferiority for the Nobori. However, the positive NEXT and COMPARE II trials differ from the SORT OUT V study, a study where Nobori did not do well enough to meet the noninferiority end point when compared with a sirolimus-eluting, standard-polymer stent (Cypher Select Plus, Cordis/Johnson & Johnson).

To heartwire , Natsuaki said the biolimus-eluting stent is not currently approved in the US but is used in about 15% of patients treated in Japan. The Nobori stent also has CE Mark approval in Europe.

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