Comparison of neointimal formation in polymer-free paclitaxel stents versus stainless stents (from the ASPECT and ELUTES randomized clinical trials)

The investigators examined 326 pairs of angiograms from 2 randomized dose-finding (0.2 to 3.1 μg paclitaxel/mm2 of stent surface area) clinical trials of polymer-free paclitaxel-eluting stents in de novo lesions (the ASian Paclitaxel-Eluting stent Clinical Trial [ASPECT] and the European evaLUation of Taxol Eluting Stent [ELUTES]). A dose-dependent effect was observed: the largest dose of paclitaxel in the 2 trials resulted in a significantly larger proportion of lesions at follow-up with <10% diameter stenosis (54% vs 16%, p = 0.00012 in ASPECT; 53% vs 21%, p = 0.013 in ELUTES) and with minimal luminal diameter located outside the stent compared with control stents (62% vs 20% in ASPECT, 48% vs 18% in ELUTES; p <0.05). Also, significantly shorter lesion lengths at 6-month follow-up were observed for the doses of 0.7 to 3.1 μg/mm2 (p <0.03) relative to their respective lengths before the procedure compared with control stents.