First-in-Man Study of the Low-Dose Paclitaxel Using the COBRA-P Drug-Eluting Coronary Stent System With a Novel Biodegradable Coating in De Novo Coronary Lesions

Objective The aim of this first-in-man trial was to evaluate vessel response of two doses of the balloon expandable Cobra-P drug-eluting coronary stent (DES). Background The Cobra-P DES system consists of a cobalt chromium alloy with bioabsorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel. Methods A total of 60 lesions (54 patients) were sequentially assigned to extremely low-dose (group A: 3.7 µg/18 mm; n = 30, 1/33 dose of the TAXUS Liberte) or low-dose (group B: 8 µg/18 mm; n = 30) arm. Intravascular ultrasound images were obtained at post-procedure and at 4 months. Results Patient and lesion characteristics were matched between the two groups except for the higher prevalence of men in group B. At 4 months, there were no significant differences in neointimal obstruction (13.5 ± 9.5% vs. 10.9 ± 7.8%, P = 0.276), and maximum cross-sectional narrowing (31.2 ± 14.3% vs. 28.6 ± 16.1%, P = 0.523) between the two groups. Late-acquired incomplete stent apposition occurred in four cases in each arm (P = 1.000). Although the volume of late-acquired incomplete stent apposition did not differ between the two groups (1.0 ± 0.6 mm3 vs. 8.6 ± 10.9 mm3, P = 0.200), maximum late-acquired incomplete stent apposition area was significantly smaller in group A than in group B (1.1 ± 0.3 mm2 vs. 2.5 ± 1.4 mm2, P = 0.029). Conclusions In the first-in-man study of the Cobra-P DES, neointimal hyperplasia at 4 months appears to be similar between extremely low-dose and low-dose groups. Although the incidence of late-acquired incomplete stent apposition was similar, the magnitude of the late-acquired gap between the stent and vessel was greater in the low-dose group compared with the extremely low-dose group. © 2013 Wiley Periodicals, Inc.