[TCT2007]Biolimus A9-eluting Stent Noninferior to Taxus Liberte

Angiographic and IVUS evidence also indicated　superiority in phase 2 trial.

Nine-month results from the Nobori 1 phase 2 trial showed that the Nobori biolimus A9-eluting stent was noninferior to the Taxus Liberte paclitaxel-eluting stent. The secondary endpoint of superiority of the Nobori stent also was achieved with regard to late loss, restenosis, andneointimal volume.

Late loss for Nobori (Terumo) was 0.11 mm vs. 0.32 mm for Taxus Liberte (Boston Scientific; P<0.001 for noninferiority, P =0 .001 for superiority). Among the 243 total patients, the rate of cardiac death was 0.7% for Nobori and 1.1% for Taxus Liberte, and the rates of MI were 3.3% and 4.4%, respectively; the overall rate of major adverse cardiac events (MACE) was 3.9% for Nobori and 5.6% for Taxus Liberte. These differences were not statistically significant. The results were presented by Bernard R. Chevalier, MD, of the Centre Cardiologie du Nord in Saint-Denis, France.

Nobori details

The Nobori stent uses a biodegradable polymer coating and elutes biolimus A9; the drug is more lipophilic than related drugs, and it elutes very quickly from the stent. The phase 1 version of the trial compared Nobori with Taxus Express, but in phase 2 switched to the Taxus Liberte.

The trial included patients with up to 2 de novo lesions located in 2 epicardial vessels; the target lesion length was <25 mm and reference vessel diameter was 2.5 mm to 3.5 mm. The main exclusion criteria were allergies to PCI-associated drugs, left main CAD, bifurcation, visible thrombus in the target lesion, stenosis >50% proximally or distally to the target lesion, totally occluded lesions (TIMI of 0 or 1), or planned major surgery within 6 months postprocedure.

Of the 243 patients, 153 were in the Nobori group. There were no significant demographic differences at baseline, with the exception of diabetes: there were more diabetic patients in the Taxus group (27.8% vs. 16.3%; P = .048) and more insulin-dependent diabetic patients in the Nobori group (7.2% vs. 2.2%; P = .008).

Analysis of late loss distribution showed nonsignificant differences with regard to proximal, distal, and in-segment late loss. In-stent late loss, however, was significantly improved in the Nobori group (Figure). Nine-month stenosis was better in the Nobori group vs. the Taxus group as well (14.0% vs. 20.8%; P<0.001), as was the rate of binary restenosis (0.7% vs. 5.4%; P = .049). There were no instances of stent thrombosis in the Nobori group and two in the Taxus group.

Summary

“Angiographic and IVUS results [regarding] late loss, restenosis rate, and neointimal volume showed superiority of the Nobori stent vs. the Taxus Liberte,” Chevalier said. “Nobori confirmed its excellent safety and efficacy profile consistent with the phase 1 trial.”

Ron Waksman, MD, of the Washington Hospital Center in Washington, DC, gave a critical appraisal of the Nobori I study. He said that although the results are clearly promising, “the study was underpowered to detect noninferiority to Taxus for clinical events.” He added that late loss may not be the best surrogate endpoint for this type of stent comparison.

“Clearly it is an interesting stent to look at in the future, and we need more studies to confirm whether Nobori will indeed be a better stent than Taxus or Cypher,” Waksman said.

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