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Polymer‐based paclitaxel‐eluting stent for treatment of chronic total occlusions of native coronaries: Results of a Taxus CTO registry
Author(s) -
Buellesfeld Lutz,
Gerckens Ulrich,
Mueller Ralf,
Schmidt Thomas,
Grube Eberhard
Publication year - 2005
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.20477
Subject(s) - medicine , restenosis , mace , stent , taxus , paclitaxel , drug eluting stent , lumen (anatomy) , cardiology , clinical endpoint , myocardial infarction , target lesion , surgery , angioplasty , radiology , percutaneous coronary intervention , clinical trial , chemotherapy , botany , biology
Abstract The purpose of this prospective nonrandomized study was to evaluate both safety and efficacy of the polymer‐based paclitaxel‐eluting Taxus stent for treatment of chronic total coronary occlusions. Drug‐eluting stents have been proven safe and efficacious in suppressing neointimal proliferation when used in simple native de novo coronary lesions. However, there are only limited data on safety and efficacy of these stents for treatment of more difficult lesion subsets, especially chronic total occlusions. Forty‐five consecutive symptomatic patients with chronic total coronary occlusions were included in this observational single‐arm study. Only patients with successfully crossed occlusions were enrolled. Primary endpoints were binary restenosis and late lumen loss at 6‐month angiographic follow‐up. Secondary endpoints were MACE at 30‐day and 6‐month follow‐up. The 30‐day MACE rate was 0%. At 6 months, the cumulative MACE‐free survival was 84.4%. There were no deaths, myocardial infarctions, or stent thrombosis up to 6 months poststenting. At angiographic follow‐up, the in‐stent restenosis rate was 13.2% (5/38). There was a total of five in‐stent restenoses, with three focal and two diffuse restenosis patterns. The in‐segment late lumen loss was 0.13 ± 0.58 mm. The stent edge analyses revealed a late loss of 0.21 ± 0.66 proximally and a negative late loss of −0.10 ± 0.67 at the distal edge segment. This study shows safety and indicators of efficacy of implantation of the paclitaxel‐eluting Taxus stent for treatment of chronic total coronary occlusions. The quantitative angiographic analysis revealed beneficial results with respect to the efficacy surrogates binary restenosis rate and late loss. © 2005 Wiley‐Liss, Inc.