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PURPOSE : The purpose of our study to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-12 months clinical follow-up results. BACKGROUND: First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes due to late stent thrombosis. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically due to the use of only 6 months clopidogrel and theoretical low possibility of late stent thrombosis. METHODS: We conducted a prospective single centre registry, bioabsorbable-coated, paclitaxel-eluting coronary stent in 26 patients with single or multiple lesions of de novo coronary disease. RESULTS: Major adverse cardiac events occurred in 2 patients within 12 months. First patient ( chronic renal failure on dialysis and 3 vessels disease)had chest pain with no new ECG findings and died after 2 months when she was already on clopidogrel, The other patient had angina stage 2 and control coronary angiography after 5 months cleared the presence of intsent restenosis( LC 2.75 X20 mm). Otherwise there were no late thrombotic events, death, stroke, TLR or surgical revascularization in that period. There were no myocardial infarctions, or suspected restenosis. CONCLUSIONS: Experience obtained in our centre registry of de novo lesions (almost 70% of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 9/12 months. Excellent immediate procedure outcome 100 %( direct stenting or with predilatation) . Good radiopacity , short deflation time and minimal length reduction after deployment. There were also excellent pushability and trackability with high radial force and minimal recoil. 4 cases with primary PCI. Good deployment with minimal support. Excellent results in one case of aggressive instent stenosis and 3 cases of CTO. Preservation of side branch is a clear character. We recommend more number of patients and comparison with nonbioabsorbable polymer coated paclitaxel eluting stent and bare stents to validate our initial positive experience.
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