Long-term evaluation of paclitaxel-coated stents for treatment of native coronary lesions. First results of both the clinical and angiographic 18 month follow-up of TAXUS I

• Published in: Zeitschrift für Kardiologie Vol. 92; no. 10; pp. 825 - 832
• Main Authors: BIILLESFELD, L, GERCKENS, U, MÜLLER, R, GRUBE, E
• Format: Journal Article
• Language: English
• Published: Darmstadt Steinkopff 01.10.2003
• Subjects: Aged; Angioplasty, Balloon, Coronary - instrumentation; Antineoplastic Agents, Phytogenic; Biological and medical sciences; Cardiology. Vascular system; Coated Materials, Biocompatible; Coronary Angiography; Coronary heart disease; Coronary Restenosis - diagnosis; Coronary Restenosis - prevention & control; Coronary Stenosis - diagnosis; Coronary Stenosis - therapy; Feasibility Studies; Female; Follow-Up Studies; Germany; Heart; Humans; Male; Medical sciences; Middle Aged; Paclitaxel; Stents; Treatment Outcome; Ultrasonography, Interventional; Germany; Antineoplastic agent; Drug; Endoprosthesis; Evaluation; drug-eluting stent; Coronary artery; Instrumentation therapy; Cardiovascular disease; Coronary heart disease; Long term; Stent; Result; Restenosis; Follow up study; Coronary stent; long-term follow-up; Paclitaxel; Lesion; Antimitotic
• ISSN: 0300-5860; 1435-1285
• DOI: 10.1007/s00392-003-0971-y

The development of restenoses due to tissue proliferation within the stented segment is a major limitation of conventional stent implantations. Recently published studies have shown that drug-eluting stents effectively decrease the incidence of stent restenosis at 6 month follow-up as compared to bare metal stents. However, a persistent efficacy of this stent design beyond the 6 month period still needs to be proven. Therefore, in this study, we are demonstrating the first 18 month follow-up results of a Paclitaxel-coated coronary stent, based on the patient population of the TAXUS I study, a multicenter randomized study to evaluate both safety and efficacy of the Paclitaxel-coated NIRx stent as compared to an uncoated, bare metal stent. In this study we evaluated the long-term outcome of NIRx patients of our center, in which 20 out of 31 patients of the TAXUS I study with NIRx stent implantation have been enrolled. A clinical follow-up was available in 20 out of 20 patients (100%) 535 +/- 82 days post stent implantation (17.8 months). An angiographic follow-up was available in 14 out of 20 patients (70%) 580 +/- 77 days post stent implantation (19.1 months). The MACE rate at 18 month follow-up was 0.0%. There was no stent restenosis in the study group up to 18 month post drug-eluting stent implantation. There was one non-clinically driven target vessel revascularization due to a stent edge lumen renarrowing, which was subsequently calculated as a 43% diameter stenosis. Accordingly, this event was not regarded as MACE. The IVUS analysis of the study population has shown a decrease of the mean minimum lumen area from 8.45 mm(2) postinterventional to 6.87 mm(2) at 6 month follow-up with a relative mean maximum plaque area of 16%. At 18 month follow-up, there were no additional significant changes with a mean minimum lumen area of 7.16 mm(2) and a relative mean maximum plaque area of 13.4%. The reported results of the 18 month follow-up of TAXUS I are the first experiences demonstrating a persistent benefit of the Paclitaxel-coated NIRx stent. Therefore, this stent design seems to be safe and effective, even in long-term follow-up.