A paclitaxel-eluting, polymer-free coronary stent at 2.7 microg/mm2 reduced angiographic percent diameter stenosis at 6 months compared to bare metal stents (14.2% vs 33.9%; P=0.006).
RCT (n=190)
Yes
Does a paclitaxel-eluting, polymer-free coronary stent reduce angiographic percent diameter stenosis at 6 months in patients with de novo coronary lesions compared to a bare stent alone?
A polymer-free paclitaxel-eluting stent at a dose of 2.7 microg/mm2 significantly reduces angiographic in-stent restenosis at 6 months compared to bare metal stents in de novo coronary lesions.
Absolute Event Rate: 14.2% vs 33.9%
p-value: p=0.006
BACKGROUND: The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis. METHODS AND RESULTS: On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 microg/mm2 stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9+/-26.7% in controls (n=34) and 14.2+/-16.6% in the 2.7-microg/mm2 group (n=31; P=0.006). Late loss decreased from 0.73+/-0.73 to 0.11+/-0.50 mm (P=0.002). Binary restenosis (> or =50% at follow-up) decreased from 20.6% to 3.2% (P=0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively (P=NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only. CONCLUSIONS: Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 microg/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.
Gershlick et al. (Tue,) conducted a rct in de novo coronary lesions (n=190). Paclitaxel-eluting, polymer-free coronary stent (V-Flex Plus) vs. Bare stent alone was evaluated on angiographic percent diameter stenosis at 6 months (p=0.006). A paclitaxel-eluting, polymer-free coronary stent at 2.7 microg/mm2 reduced angiographic percent diameter stenosis at 6 months compared to bare metal stents (14.2% vs 33.9%; P=0.006).