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Catheter Cardiovasc Interv. 2012 Nov 1;80(5):789-96. doi: 10.1002/ccd.23280. Epub 2011 Oct 17.

Randomized comparison of the Nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries.

Author information

1
Kurashiki Central Hospital, Kurashiki, Japan. k-kadota@lapis.plala.or.jp

Abstract

OBJECTIVES:

The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher).

BACKGROUND:

The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent.

METHODS:

We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months.

RESULTS:

At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient.

CONCLUSIONS:

Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.

Comment in

PMID:
21805606
DOI:
10.1002/ccd.23280
[Indexed for MEDLINE]

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