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DES With Biodegradable Polymer Safe, Durable Through 5 Years

By L.A. McKeown

Compared with a first-generation DES, the biolimus A9-eluting Nobori stent with biodegradable polymer results in less TLR and stent thrombosis over 5 years, according to findings published online December 23, 2014, ahead of print in EuroIntervention. The study, which was not powered to detect differences in clinical endpoints, showed comparable efficacy and perhaps better long-term safety with the newer device.

“These long-term results confirm previous data showing some superiority to first-generation DES coming from both randomized trials and large registries, and support its safe use in daily practice,” write the authors.DES With Biodegradable Polymer Safe, Durable Through 5 Years

For the multicenter NOBORI 1 clinical trial, investigators led by Bernard Chevalier, MD, of Hôpital Privé Jacques Cartier (Massy, France), randomized 363 CAD patients with up to 2 de novo lesions in 2 epicardial vessels to either the Nobori stent (Terumo) or the paclitaxel-eluting Taxus Express or Taxus Liberté stents (both Boston Scientific). The Liberté stent was used after the Express was discontinued in Europe.

Baseline characteristics were similar between the groups with the exception of more type 2 diabetes in the Taxus arm and more type 1 diabetes in the Nobori arm.

Fewer Adverse Events With Nobori

At the 5-year follow-up, there were 12 cardiac deaths in the Nobori group and 3 in the Taxus group, but this difference was not significant (P = .28). Target lesion failure (TLF) and the frequency of a patient-oriented composite endpoint (any death, MI, or coronary revascularization) were similar between groups. The Nobori group had lower rates of Q-wave MI and a trend toward lower MI overall, as well as a reduced total rate of ischemia- and nonischemia-driven TLR. Additionally, while 4 patients in the Taxus group developed ARC-defined definite or probable stent thrombosis, no cases were seen in the Nobori group (table 1).

Table 1. Endpoints at 5 Years

Outcomes in the diabetic subset were comparable to those of the total patient population.

Potential for Long-term Safety Advantage

The study authors say the long-term findings from the NOBORI 1 trial are comparable to the results of other trials of second-generation DES with similar patient populations, including the SPIRIT III trial, which compared Taxus and Xience V (Abbott Vascular). Importantly, however, the 5-year rate of clinically driven TLR was much lower in the Nobori arm of NOBORI 1 than in the Xience and Taxus arms of SPIRIT III (1.3% vs 8.9% and 12.9%, respectively).

Although long-term data on biodegradable-polymer stents are minimal, Dr. Chevalier and colleagues say the NOBORI 1 results demonstrating lower rates of stent thrombosis in the Nobori arm are very similar to those of the LEADERS trial, which compared another biodegradable-polymer biolimus A9-eluting stent (BioMatrix; Biosensors) with Cypher (Cordis).

“These findings indicate better long-term safety of DES with bioresorbable polymer versus first-generation DES,” they write. “The clinical outcomes of randomized studies between DES with biodegradable polymer and new-generation permanent-polymer DES did not show similar differences in the short and medium term, and long-term results of several ongoing large trials are awaited to elucidate the value of biodegradable technology in contemporary PCI practice.”

However, they acknowledge that since NOBORI 1 was powered only for noninferiority for the angiographic endpoint of in-stent late loss at 9 months, the results should be considered hypothesis-generating.

 

Source:
Chevalier B, Wijns W, Silber S, et al. Five-year clinical outcome of the Nobori drug-eluting coronary stent system in the treatment of patients with coronary artery disease: final results of the NOBORI 1 trial. EuroIntervention. 2014;Epub ahead of print.

Disclosures:

  • Dr. Chevalier reports receiving consulting fees from Terumo.

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