Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial.

Abstract

OBJECTIVES:

NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year.

BACKGROUND:

Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited.

METHODS:

The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618).

RESULTS:

At 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (p for noninferiority <0.0001, and p for superiority = 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% vs. 0.06%, p = 0.18). An angiographic substudy enrolling 528 patients (BES: n = 263, and EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs. 0.06 ± 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 ± 43 days after stent implantation.

CONCLUSIONS:

One-year clinical and angiographic outcome after BES implantation was noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES and EES use was excellent, with a low rate of TLR and extremely low rate of stent thrombosis.

• Authors: Masahiro Natsuaki, Ken Kozuma, Takeshi Morimoto, Kazushige Kadota, Toshiya Muramatsu, Yoshihisa Nakagawa, Takashi Akasaka, Keiichi Igarashi, Kengo Tanabe, Yoshihiro Morino, Tetsuya Ishikawa, Hideo Nishikawa, Masaki Awata, Mitsuru Abe, Hisayuki Okada, Yoshiki Takatsu, Nobuhiko Ogata, Kazuo Kimura, Kazushi Urasawa, Yasuhiro Tarutani, Nobuo Shiode, Takeshi Kimura, NEXT Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 62 Issue 3 Pg. 181-190 (Jul 16 2013) ISSN: 1558-3597 [Electronic] United States
• PMID: 23684673 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Polymers
• Everolimus
• umirolimus
• Sirolimus

Topics

• Absorbable Implants (standards)
• Aged
• Aged, 80 and over
• Coronary Artery Disease (diagnostic imaging, epidemiology, surgery)
• Drug-Eluting Stents (standards)
• Everolimus
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Polymers (administration & dosage)
• Prospective Studies
• Radiography
• Single-Blind Method
• Sirolimus (administration & dosage, analogs & derivatives)
• Treatment Outcome