RANDOMIZED CONTROLLED TRIAL
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Comparison between catheter-based delivery of paclitaxel after bare-metal stenting and drug-eluting stents in coronary artery disease patients at high risk for in-stent restenosis.

BACKGROUND: Drug eluting stents reduce the risk of in-stent restenosis but delay healing of the vascular wall. Recent data on late and very late stent thrombosis after drug-eluting stent (DES) implantation have raised concerns about the long-term safety. High lipophilicity of paclitaxel promotes rapid cellular uptake and prolongs its action. This makes paclitaxel a very promising candidate for local drug therapy intended to inhibit the proliferative and migratory processes involved in restenosis following PCI.

OBJECTIVES: In a prospective randomized trial, we compared the efficacy of the new catheter based delivery of fluid paclitaxel after bare metal stenting with that of drug eluting stents in patients at high risk for in-stent restenosis.

METHODS AND RESULTS: We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (DDB+BMS group) with the implantation of drug eluting stent (DES group) (1:1) in 68 patients at high risk for in-stent restenosis. The primary end points were in-stent late lumen loss and binary restenosis rate ›50%. Secondary end points were procedure success and composite clinical end points (major adverse cardiac events and revascularization of the target lesion) 6months after intervention. At 6months, follow-up angiography showed an in-stent late lumen loss of 1.0±1.3mm in (DDB+BMS group) versus 0.94±1.3mm in DES group (P=.743) without statistically significant difference in the cumulative overall rate of major cardiac events between both groups. DES subgroup analysis showed in-stent late lumen loss of 0.09±0.3mm in everolimus eluting stent (EES) subgroup patients that was statistically significant in comparison with (DDB+BMS group, n=30) (P=.033) and paclitaxel eluting stent (PES, n=19) subgroup patients (P=.006).Target lesion revascularization was 0% in EES subgoup patients, 36.7% in DDB+BMS group patients and 47.7% in PES subgroup patients (P=.026).

CONCLUSION: Paclitaxel either in fluid form used in drug delivery balloons or in polymerized form used in drug eluting stents was ineffective in reducing neointimal proliferation, in-stent restenosis, and clinical events. EES was superior compared with PES and catheter based delivery of fluid paclitaxel after bare metal stent implantation regarding primary and secondary end points.

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