Safety and efficacy of multiple, overlapping polymer-based paclitaxel-eluting stents.
Dawkins KD., Grube E., Guagliumi G., Banning AP., Zmudka K., Colombo A., Thuesen L., Hauptman K., Marco J., Wijns W., Popma JJ., Weissman NJ., Koglin J., Russell ME.
AIMS: To provide insight on the patients with long lesions that received multiple, overlapping stents by reporting clinical outcomes, together with a detailed angiographic and intravascular ultrasound analysis of the overlap zone. METHODS AND RESULTS: TAXUS VI is a prospective, multicentre, double-blind, trial, specifically designed to assess outcomes of paclitaxel-eluting stents in longer lesions by randomising 446 patients (1:1) between a drug-eluting TAXUS Express2 Moderate Release (MR) and an uncoated Express2 control stent. Multiple overlapping stents were implanted in 124 patients (27.8%) and are the subject of this report. Clinical, angiographic and IVUS outcomes at nine months were compared in the overlap group for patients receiving the TAXUS Express2 MR stent and the uncoated Express2 stent. In the overlap group, mean lesion length was 25.1 mm with a mean stent length of 43.6 mm. At nine months, TVR was reduced by 94% from 25.0% to 1.6% in the TAXUS patients compared with control (p=<0.0001); TLR was reduced by 93% from 23.3% to 1.6% (p=0.0002). Binary restenosis in the stented area was reduced by 89% from 45.5% in the control patients to 4.8% in the TAXUS patients (p<0.0001). There was a trend towards a higher 30-day myocardial infarction rate in the TAXUS group (7.9% vs. 1.6%; p=0.21), but by nine months, MACE was significantly reduced by 62.0%, from 25.0% to 9.5% in favour of the TAXUS patients (p=0.0305). Late acquired incomplete apposition on IVUS was infrequent in either group and was not located in the overlap zone, nor was the finding associated with late MACE. No stent thrombosis occurred in either group. CONCLUSIONS: The use of multiple overlapping TAXUS MR stents appears safe and effective in the treatment of long complex coronary artery lesions.