Biolimus A9 Phase-1 Trial Shows Noninferiority to Taxus
A reduction of MACE was also achieved in the Nobori 1 trial.
Early returns from the Nobori 1 trial, an investigation of the new biolimus A9 drug-eluting stent (DES) (Terumo Corp.), showed that the stent met its intended primary endpoint of noninferiority compared with the Taxus Express (Boston Scientific). The trial focused on late loss in patients randomized 2:1 to receive the Nobori or Taxus Express DES. In-stent late loss (at nine months) was 0.15 mm in the Nobori group compared with 0.32 mm in the Taxus group
(P = .006).
The data were presented Tuesday by Bernard Chevalier, MD, of the Centre Cardiologie due Nord in St. Denis, France on behalf of the Nobori Clinical Trial Investigators Group.
The secondary endpoint, reduction of major adverse cardiac events, was also achieved. The total MACE rate was 11.7% in the Nobori group and 20% in the Taxus group. The MI (4.7% vs. 8.6%) and TVR (7% vs. 11.4%) rates were lower in the Nobori group.
The Nobori 1 trial was redesigned after the recent launch of the Taxus Liberte stent. The initial clinical results presented yesterday looked at the Nobori stent compared with the Taxus Express; a second phase of the study, comparing the Nobori stent to the Taxus Liberte is ongoing.
Biolimus A9
The Nobori stent is a stainless steel S-stent coated with PLA bioabsorbable polymer that is designed for controlled release of biolimus A9, a potent new sirolimus derivative designed for stent applications (Figure). The trial was designed around the assumption that the Nobori 1 and Taxus Express stents would both have 0.39 mm late loss at nine months.
Patient demographics were similar between the two groups, as were lesion characteristics.
Lesion success (100%) and device success (97%) were identical between the two groups, and procedural success was slightly higher with the Nobori stent (95% vs. 88%), although there were no significant differences between the two groups.
In commenting on the study, J. Eduardo Sousa, MD, PhD, of the Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, noted that IVUS findings in the study showed that the Nobori stent was better at reducing neointimal hyperplasia. He also said that the results were similar to results from the STEALTH trial conducted at his institution last year. In that trial, late loss at nine months was 0.26 mm, and the MACE rate was 5% using a biolimus A9-eluting stent.
The results from these two trials, Sousa said, indicate that the Nobori stent seems to be safe and effective in preventing neointimal formation at 10 months after stent implantation in de novo lesions, and further, larger-scale trials should investigate this hypothesis.
