Key result
Fluid paclitaxel cuts late lumen loss by ~0.38 mm vs BMS and matches PES.
Why the study?
Stents eluting antiproliferative drugs reduce the incidence of restenosis but delay healing of the vascular wall, motivating evaluation of catheter-based local delivery of fluid paclitaxel after bare metal stent implantation.
RCT (n=204)
Randomized
Reduces late loss and events after BMS versus BMS alone while meeting noninferiority to PES; supports catheter-based paclitaxel delivery as an alternative strategy.
BACKGROUND: Stents eluting antiproliferative drugs reduce the incidence of restenosis but delay healing of the vascular wall. We assessed the safety and efficacy of catheter-based local delivery of fluid paclitaxel in patients with coronary de novo stenoses after implantation of a bare metal stent. METHODS AND RESULTS: We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (group I) with the implantation of a bare metal stent (group II) and the implantation of a paclitaxel-eluting stent (group III) in 204 patients. The primary end point was in-stent late lumen loss. Secondary end points included binary restenosis rate >50%, minimal lumen diameter, diameter stenosis, and a composite clinical end point (major adverse cardiac events and revascularization of the target lesion) 6 months after intervention. At 6 months, angiography showed an in-stent late lumen loss of 0.61+/-0.44 mm in group I versus 0.99+/-0.72 mm in group II (I versus II, P=0.0006) and 0.44+/-0.48 mm in group III (noninferiority of I versus III, P=0.023). The 1-sided 95% CI for the true difference of the means of in-stent late lumen loss in groups I and III was -infinity to 0.3174188. The cumulative overall rate of major cardiac events was 13.4% in group I, 26.8% in group II, and 14.9% in group III. Target lesion revascularization rate was 13.4% (group I), 22.1% (group II), and 13.4% (group III). CONCLUSIONS: Additional antiproliferative treatment of de novo lesions in native coronary arteries with catheter-based delivery of fluid paclitaxel after bare metal stenting was safe and significantly reduced neointimal proliferation, restenosis, and clinical events compared with bare metal stent implantation alone.
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Herdeg et al. (2009) conducted an RCT in De novo native coronary artery stenoses (n=204). Catheter-based local delivery of fluid paclitaxel after bare metal stent implantation vs. Bare metal stent alone (group II) and paclitaxel-eluting stent (group III) was evaluated on In-stent late lumen loss at 6 months (mm) (95% CI -infinity to 0.3174188 (1-sided for group I vs III), p=0.0006 (vs BMS); 0.023 for noninferiority (vs PES)). Catheter-based fluid paclitaxel after bare-metal stenting reduced late lumen loss vs BMS (0.61 vs 0.99 mm, P=0.0006) and was noninferior to PES (0.44 mm, P=0.023 for noninferiority).
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