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.
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.
Büllesfeld
L
L
Abt. für Kardiologie/Angiologie, Krankenhaus and Herzzentrum Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. LBuellesfeld@gmx.de
Gerckens
U
U
Müller
R
R
Grube
E
E
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel