The 6-month safety, efficacy, and dosing study called ELUTES was conducted among patients receiving V-Flex Plus coronary stents with no coating or 1 of 4 dose densities (0.2, 0.7, 1.4 or 2.7 μg/mm²). Paclitaxel was applied to the stainless steel stents without any polymer coating. The primary efficacy endpoints were percent diameter stenosis and decrease in lumen diameter from post-procedure to follow-up (termed "late loss") determined at mean follow-up of 6 months. The primary safety endpoint was major adverse cardiac events a 1 and 6 months. The trial was conducted among patients with single de novo lesions.

Patients (mean age 60 years, 82% male) received 300 mg daily aspirin and 3 months of clopidogrel (75 mg a day). Technical success overall was 99.0% (190/192 patients). At 6-months, quantitative coronary angiography showed a clear dose relationship, with percent diameter stenosis ranging from 34% for the bare stent, to 33%, 26%, 23% and 14% for ascending dose densities of the paclitaxel-coated stents. The difference between the 2.7μg/mm² stent and placebo was significant (p<0.01). Late loss reflected the same pattern with 0.73 mm for controls and 0.10 mm for the highest dose stent (p<0.005).

The binary in-stent restenosis rate for controls was 21%, with 20%, 12%, 14%, and 3% rates for ascending doses. The difference between the highest dose and placebo did not achieve statistical significance (p=0.055).

Safety was equivalent between groups at 1-month. At 6-months, 89% of controls and 89% of the highest dose group were event-free.

Dr. Gershilick concluded that primary endpoints of diameter stenosis and late loss, and the primary safety endpoint of event-free survival were achieved. Paclitaxel eluting stents, he said, will become an important part of everyday stenting.

6-month QCA Results