Key result
The Nobori drug-eluting stent demonstrated 0.0% stent thrombosis versus 3.2% with the TAXUS stent at 5 years (p=0.014), alongside lower target lesion revascularization (6.3% vs 16.0%).
Why the study?
Does the Nobori drug-eluting stent with biodegradable polymer reduce in-stent late loss and improve long-term safety compared to the TAXUS drug-eluting stent in patients with de novo coronary artery lesions?
RCT (n=363)
2:1
Yes
Does the Nobori drug-eluting stent with biodegradable polymer reduce in-stent late loss and improve long-term safety compared to the TAXUS drug-eluting stent in patients with de novo coronary artery lesions?
Answers are grounded in this paper and cite their sources.
At 5-year follow-up, the Nobori biodegradable polymer DES demonstrated very low target lesion revascularization and no stent thrombosis, outperforming the TAXUS permanent polymer DES in these safety metrics.
AIMS: To assess the safety and performance of the Nobori drug-eluting stent with biodegradable polymer versus the TAXUS drug-eluting stent with permanent polymer, in the treatment of patients with de novo coronary artery lesions. METHODS AND RESULTS: NOBORI 1 was a multicentre, randomised (2:1), prospective, controlled, clinical trial which enrolled 363 patients (238 Nobori and 125 TAXUS) with up to two de novo lesions in two epicardial vessels. The primary endpoint was in-stent late loss at nine months, while secondary endpoints included safety and efficacy up to five years. At five years, clinical data were available for 350 patients (96%). There were no differences in the composite of death and myocardial infarction (10.9% vs. 11.2%) and target lesion failure (9.2% and 10.4%), while ischaemia- and non-ischaemia-driven target lesion revascularisations were less frequent in the Nobori (6.3%) than in the TAXUS arm (16.0%). The rates of stent thrombosis (definite and probable according to the ARC definitions) were 0.0% and 3.2%, in the Nobori and TAXUS stents, respectively (p=0.014). CONCLUSIONS: Five years after implantation, the Nobori DES resulted in durable treatment effects with very low TLR and no stent thrombosis. The study was not powered to assess the differences in clinical endpoints. These data are hypothesis-generating.
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Chevalier et al. (2015) conducted an RCT in de novo coronary artery lesions (n=363). Nobori drug-eluting stent vs. TAXUS drug-eluting stent was evaluated on in-stent late loss at nine months. The Nobori drug-eluting stent demonstrated 0.0% stent thrombosis versus 3.2% with the TAXUS stent at 5 years (p=0.014), alongside lower target lesion revascularization (6.3% vs 16.0%).
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