Nobori BES Demonstrates Good Long-term Outcomes with No Stent Thrombosis Beyond 3 Years
PARIS, France—A novel biolimus A9-eluting, biodegradable-polymer stent (BES) shows favorable long-term clinical outcomes and very low rates of device-related adverse events, according to a registry study presented Thursday, May 22, 2014, at EuroPCR. Additionally, no stent thrombosis events were observed between 3 and 5 years.
Gian Battista Danzi, MD, of Santa Corona Hospital (Pietra Ligure, Italy), and colleagues enrolled 3,067 consecutive patients (819 simple and 2,248 complex) implanted with the Nobori BES (Terumo, Tokyo, Japan) at 125 centers in Europe, Asia, and Australia.
At 5 years, the primary endpoint of target lesion failure (TLF; cardiac death, target vessel MI, and TLR) was 8.2% overall and higher in complex vs simple patients (9.1% vs 5.9%; P < .01). “This is one of the lowest [event rates] we’ve seen in the last few years,” Dr. Danzi said.
The same pattern was seen with the patient-oriented composite endpoint (any death, any MI, and any revascularization) for complex vs simple patients (12.8% vs 16.3%; P = .02). The rate of MACE, defined as cardiac death, any MI, and TVR, was 11.1% overall with no significant difference between simple and complex patients.
Subgroup analyses maintained similar rates of the primary endpoint:
- Female sex: 8.3%
- Diabetes: 11.8%
- CTO: 8.3%
- Bifurcation: 7.8%
- Multivessel revascularization: 7.5%
The overall rate of definite/probable stent thrombosis at 5 years was 0.9%, with the majority of events (70%) occurring within the first year and no events occurring after 3 years. Rates of TLR also decreased over time.
At 5 years, complex patients were more likely to be free of angina than simple patients (90.5% vs 85.2%; P = .01). They were also more likely to undergo PCI and non-target lesion TVR (P = .01 for both).
“These long-term results indicate excellent safety and no late catch-up phenomenon [after Nobori BES implantation] and give further reassurance of the benefit of DES with biodegradable polymer and abluminal coating for the treatment of complex patient and lesion subsets,” Dr. Danzi concluded.
Mean patient age was 64 years. More than half of patients had ACS (53.6%) or multivessel disease (53.3%), and about one-third (29.5%) were diabetic. Radial access was used in one-third (37.3%) of cases. Complex patients were more likely to be male, have had a previous MI, and present with ACS.
Danzi GB. Final 5-years results of large multicentre NOBORI 2 study. Presented at: EuroPCR; May 22, 2014; Paris, France.
- Dr. Danzi reports no relevant conflicts of interest.