NOBORI 1 - NOBORI 1
The goal of the trial was to evaluate the Nobori stent, a stent that elutes biolimus A9, a rapamycin derivative, compared with paclitaxel-eluting stents (PES) among patients undergoing percutaneous coronary intervention (PCI) for de novo coronary lesions.
Patients Enrolled: 120
Mean Follow Up: 9 months (to date)
Mean Patient Age: Mean age 64 years
Up to two de novo lesions in native coronary vessels with target lesion length <25 mm and reference vessel diameter 2.5-3.5 mm
Allergy to major PCI-related medications or limus-like drugs, left main disease, bifurcation lesion, visible thrombus in the target lesion, stenosis >50% proximal or distal to the target lesion, totally occluded lesions, or planned major surgery within 6 months after the procedure
In-stent late loss at 270 days, evaluated for noninferiority
MACE, defined as cardiac death, MI, or TVR; binary restenosis at 9 months; minimum lumen diameter at 9 months; neointimal hyperplasia at 9 months; and stent thrombosis at 30 days and 9 months
Patients were randomized in a 2:1 manner to PCI with the Nobori stent (n = 85) or PES (n = 35). The drug was eluted via a PLA polymer. Patients underwent angiographic follow-up at 9 months. A subset of 40% of patients also underwent intravascular ultrasound (IVUS) at follow-up.
Lesion location was the left anterior descending in 55% of cases. The mean number of lesions per patient was 1.1 in the Nobori group and 1.2 in the PES group. Mean lesion length was 11 mm and percent diameter stenosis was 60%. Device success was ~98% in each group.
The primary endpoint of late loss at 9-month angiographic follow-up was 0.15 mm in the Nobori group and 0.32 mm in the PES group, meeting the criteria for noninferiority (p = 0.006 for superiority). There was no binary restenosis in either group. Other angiographic parameters did not differ between groups, including minimum lumen diameter (2.40 mm for Nobori vs. 2.23 mm for PES) and diameter stenosis (14% vs. 18%).
Among the subgroup of patients undergoing IVUS, in-stent volume obstruction was smaller in the Nobori group compared with the PES group (2.2% vs. 8.9%, p = 0.017), as was neointima volume (3.8 mm3 vs. 14.6 mm3, p = 0.006).
Major adverse cardiac events (MACE) occurred in 11.7% of the Nobori group and 20.0% of the PES group (p = NS). Among the components of MACE, there were no deaths in either group, myocardial infarction (MI) occurred in 4.7% of the Nobori group and 8.6% of the PES group, and target vessel revascularization (TVR) in 7.0% and 11.4%, respectively. By 9 months, there were no stent thromboses in either group.
Among patients with de novo coronary lesions, treatment with an eluting-stent with the rapamycin derivative biolimus A9 was associated with a reduction in late loss at 9-month angiographic follow-up compared with PES. The present trial was too small to fully evaluate clinical MACE rates.
Phase 2 of the trial is underway and plans are to enroll 240 patients. Phase 1 used the Taxus Express PES while phase 2 will use the Taxus Liberte PES. Much larger trials will be needed to evaluate safety and clinical efficacy.
Chevalier B, Serruys PW, Silber S, et al. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.
Presented by Dr. Bernard Chevalier at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
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