Safety of direct stenting with the Endeavor stent: results of the Endeavor II continued access registry.

Aims: The safety and efficacy of direct stenting with the Endeavor stent is unknown. The acute and 9 month outcome after direct stenting vs. predilatation was tested in a multicentre, prospective, single-arm study.

Methods And Results: 300 patients were treated with the Endeavor stent for a single, previously untreated coronary artery stenosis (vessel diameter 2.25 to 3.75 mm; lesion length 14 to 27 mm). Predilatation was at discretion of the operator for lesions < 20 mm in length but mandatory for lesions > 20 mm. Angiographic follow-up at 8 months was prespecified for the first 150 consecutive patients. Out of 296 patients, 126 (42.6%) underwent direct stenting and 170 (57.4%) predilatation. Patients in the direct stenting group were younger (62.9 years vs 65.3 years, P=0.04) and lesions were predictably more proximally located and shorter (14.29 mm vs 18.16 mm, P<0.0001), with larger pre-procedural minimum lumen diameter. Success rate was 92.9% with direct stenting vs. 95.3% with predilatation (P=0.45). At 8 months, late loss was not significantly different between groups. The rate of MACE at 9 months was 10.6% with direct stenting vs. 10.2% with predilatation (P=1.00). There were no occurrences of stent thrombosis in either group.

Conclusion: Direct stenting with the Endeavor stent as deemed feasible by the operator, was safe and effective, and comparable to the results of implantation following predilatation.