RESUMO
The one year clinical benefit of various doses and release durations of paclitaxel eluted from an erodablepolymer has not been evaluated so far.Methods and results: Conor paclitaxel-eluting stents have intra-stent wells in which drug and polymer aredeposited. Stents with six different release formulations (dose: 10 μg or 30 μg, duration: 5, 10 or 30 days,direction: mural or bidirectional) were implanted in 6 patient cohorts. Clinical follow-up was conducted at4 and 12 months. Quantitative angiography and IVUS were performed at 4 months, and additional angiographicand IVUS follow-up were performed for groups D5 (10μg/30days/mural) and D6(30μg/30days/mural), as they had shown the most favorable results at 4 months. At one year, the lowestmajor adverse cardiac event rates were observed in the slow release (30 day) group (5.1% in D5 and 6.9%in D6). One-year in-stent late loss was 0.52±0.34 mm in D5 and 0.36±0.50mm in D6 (p=0.20) whileneointimal area was 0.99±0.54 mm2 in D5 and 0.77±0.92 mm2 in D6 (p=0.42). Corresponding in-stentbinary restenosis at one year was 0% and 5.6% respectively (p=0.36).Conclusions: Patients who received the slow release formulation stent had better clinical outcome at oneyear than those who received the fast release formulation. However, the effect on neointimal suppressionrequires investigation in a larger population to determine whether the high dose formulation confers anadditional clinical benefit.
Assuntos
Angiografia , Paclitaxel , StentsRESUMO
The aim of this study was to evaluate th effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia.Conventional paclitaxel-eluting stents use a durable polymer coating as vehicle for drug delivery.The Conor stent (Conor Medsystem, Menlo Park, Califórnia) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmakocinetics.Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent(n=53) or one of six different release formulations that varied in dose (10 or 30yg) and elution release kinetics (first order, zero oder), direction (abluminal, luminal), and duration (5, 10, and 30 days)...