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NOBORI 1: Low TLR, no stent thrombosis with biodegradable polymer DES at 5 years
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Five-year data demonstrate that the Nobori drug-eluting stent with biodegradable polymer was safe and durable in patients with de novo coronary artery lesions.
The randomized, prospective, controlled, multicenter NOBORI 1 trial included 363 patients with up to two de novo lesions in two epicardial vessels who were randomly assigned to the Nobori DES with biodegradable polymer (Terumo; n=238) or the Taxus Express/Liberté DES (Boston Scientific; n=125). Previously reported results from the trial demonstrated that the Nobori DES was associated with a significant reduction of in-segment and in-stent late loss at 9 months after implantation, according to background information in the study.
“The NOBORI 1 clinical trial was not powered to detect differences in clinical outcomes, but considering the relevance of long-term treatment we have decided to report 5-year follow-up findings,” the researchers wrote.
Clinical data were available for 350 patients (96%) at 5 years.
The composite of death and MI was reported in 10.9% of the Nobori DES group vs. 11.2% of the Taxus DES group. When examined alone, the Nobori group exhibited a trend toward lower MI (5.9% vs. 8.8%; P=.38) and Q-wave MI (0.8% vs. 4.8%; P=.02).
Rates of target lesion failure were similar in the Nobori DES and Taxus DES groups (9.2% vs. 10.4%; P=.71).
The rate of both ischemia-driven and non–ischemia-driven target lesion revascularization was lower in the Nobori DES group (6.3% vs. 16%; P=.005). Most non–ischemia-driven TLRs were reported at 9 months.
No incidences of definite or probable stent thromboses were reported in the Nobori DES group compared with four (3.2%) thromboses in the Taxus DES group (P=.014).
The researchers also examined patients with diabetes, in whom the rate of TLF was 10% in the Nobori DES group vs. 12% in the Taxus DES group; the rate of TLR was 0% vs. 8.8%. Two incidences of stent thrombosis were reported in the Taxus DES group compared with none in the Nobori DES group.
“The 5-year clinical follow-up of the NOBORI 1 trial demonstrated the sustained long-term safety and efficacy of the Nobori DES. The low frequency of clinically indicated TLR and the absence of stent thrombosis indicate that the specific design of the Nobori DES, incorporating an antiproliferative limus drug and a biodegradable polymer coated only on the abluminal side, may offer long-term benefits,” the researchers concluded.
Disclosure: Two researchers report financial ties with Terumo.
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