The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial.

AIMS: To demonstrate the safety, performance and efficacy of the Endeavor Resolute stent in the treatment of patients with multiple-vessel as well as single-vessel coronary artery disease but where only one lesion per patient was treated.

METHODS AND RESULTS: 130 patients were treated with the Endeavor Resolute stent. Of these patients, 30 consented to a 4 month follow-up evaluation by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) measurements, and 100 consented to a 9 month follow-up evaluation by QCA. Only lesions with diameter stenoses > 50% and with lengths > 14 mm and < 27 mm in vessels with reference diameters > 2.5 mm to < 3.5 mm were included. The device success rate as 99.2%, and the procedure success rate was 96.2%. The mean lesion length was 15.56+/-6.27 mm. The overall 30 day incidence of major adverse cardiac events (MACE) was 3.3%, which consisted entirely of 5 cases of peri-procedural non-Q-wave MI. The QCA and IVUS results at 4 months for the 30 patient subgroup showed in-stent late lumen loss was 0.12+/-0.26 mm, and in segment late lumen loss was 0.05+/-0.20 mm.

CONCLUSIONS: The 4 month results in this subset of Endeavor Resolute patients demonstrated excellent procedural and device success when deployed in lesions up to 27 mm of length. The Endeavor Resolute stent, in this subset, was associated with a low in-stent late lumen loss and a minimal amount of neointimal hyperplastic in-growth.