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European evaLUation of pacliTaxel Eluting Stent - ELUTES
Description:
The goal of the trial was to evaluate the safety and efficacy of V-Flex Plus coronary stents coated with escalating doses of paclitaxel compared with bare stent alone in patients with single de novo lesions.
Hypothesis:
Percent diameter stenosis at six-month angiographic follow-up will be reduced in the paclitaxel-coated stent arms compared with placebo.
Study Design
Study Design:
Patients Enrolled: 190
Mean Follow Up: 12 months
Mean Patient Age: Mean age 56 to 64 years
Female: 18
Patient Populations:
Single de novo type A or type B1 lesions <15 mm length in a native coronary artery, and candidates for coronary surgery, if required
Exclusions:
Left ventricular ejection fraction <35%; enrolled in another trial; women of childbearing potential; limited life expectancy; hypersensitivity to contrast or current antiplatelet therapy; a history of bleeding, diathesis, or coagulopathy or would refuse blood transfusions; MI <72 hours previously; chronic total occlusions; or unprotected left main stem stenosis
Primary Endpoints:
Angiographic percent diameter stenosis at six months
Secondary Endpoints:
Death, Q-wave myocardial infarction (MI), subacute stent thrombosis (>24 hours post-procedure), non–Q-wave MI, or coronary artery bypass graft or percutaneous transluminal coronary angioplasty required to treat symptomatic target lesion restenosis at 1, 6, and 12 months
Drug/Procedures Used:
Patients were randomized to bare stent (n=39) or V-Flex Plus coronary stents (Cook Inc.) coated with escalating doses of paclitaxel (0.2 µg/mm2, n=37; 0.7 µg/mm2, n=40; 1.4 µg/mm2, n=39; and 2.7 µg/mm2, n=37) applied directly to the abluminal surface of the stent. The paclitaxel was located directly on the stent (i.e., no polymer used to modulate the release of the drug).
Concomitant Medications:
Aspirin, procedural heparin, and glycoprotein IIb/IIIa receptor blocker (58/190) at operator discretion; and aspirin plus clopidogrel for three months
Principal Findings:
The primary endpoint of percent diameter stenosis at six-month angiographic follow-up was greater in the bare stent arm (33.9%) compared with the 2.7 µg/mm2 group (14.2%, p=0.006), but there was no difference between the bare stent arm and the lower dose coated stent groups (32.8% for 0.2 group, 27.5% for 0.7 group, and 23.3% for 1.4 group). Late loss was lower in the bare stent arm versus the 2.7 group (0.73 mm vs. 0.11 mm, p=0.002), but there was no difference between the bare stent arm and the lower dose coated stent groups (0.71 mm for 0.2 group; 0.47 mm for 0.7 and 1.4 groups). Binary restenosis trended lower in the 2.7 group versus the bare stent group (3.2% vs. 20.6%, p=0.056), but again, there were no significant differences in the lower paclitaxel doses (20.6% with 0.2 group, 14.3% with 0.7 group, and 13.5% with 1.4 group).
There was no difference in freedom from major adverse cardiac events at one year for any dose group versus bare stent (82% bare stent vs. 86% for 2.4 group, 90% for 1.4 group, 92% for 0.7 group, and 95% for 0.2 group; p=NS for each vs. bare stent). There was one subacute thrombosis in the highest dose group, and one in the bare stent group.
Interpretation:
Among patients with single de novo lesions, treatment with the 2.7 µg/mm2 paclitaxel-coated stent was associated with a reduction in the primary endpoint of percent diameter stenosis at six-month angiographic follow-up compared with bare stent, but there was no difference in the lower dose coated stent groups. The paclitaxel was located directly on the stent (i.e., no polymer used to modulate the release of the drug).
Data from the ELUTES trial were used to select the dose for the much larger DELIVER I trial, which used the highest ELUTES dose. In the DELIVER trial, there was no difference in angiographic restenosis (16.7% vs. 22.4%, p=0.15) despite lower in-stent late loss for the paclitaxel stent (0.81 vs. 0.98 mm, p=0.003).
It is not clear why the ELUTES trial showed positive results, but the DELIVER trial did not, despite the same paclitaxel dose coating the stent in the same method (nonpolymer). Full results of the DELIVER trial have not yet been published.
References:
Gershlick A, De Scheerder I, Chevalier B, et al. Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent. The European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial. Circulation 2004;109:487-493.
Keywords: Paclitaxel, Coronary Restenosis, Thrombosis, Polymers, Constriction, Pathologic, Coronary Vessels, Stents
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