Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo

Herdeg, Christian; Oberhoff, Martin; Baumbach, Andreas; Blattner, Andreas; Axel, Dorothea I.; Schröder, Stephen; Heinle, H.; Karsch, Karl R.

doi:10.1016/s0735-1097(00)00614-8

Cited by 244 publications

(180 citation statements)

References 32 publications

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“…28,29 Results from the ELUTES (European evaLUation of pacliTaxel-Eluting Stent) and ASPECT (A paclitaxel-eluting Stent for the PrEvention of Coronary restenosis Trial) dose-finding studies showed a significant dose-dependent decrease in late loss and restenosis rate with nonpolymeric paclitaxel-coated stents in patients with single de novo coronary lesions. 19,20 The pivotal DELIVER trial demonstrated that the reduction in late loss seen with the paclitaxel-eluting ACHIEVE stent compared with the bare ML PENTA stent did not translate into a meaningful reduction in clinical revascularization or restenosis.…”

Section: Discussionmentioning

confidence: 99%

Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions

et al. 2004

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; for the DELIVER Clinical Trial InvestigatorsBackground-Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non-polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent. Methods and Results-A total of 1043 patients with focal de novo coronary lesions, Ͻ25 mm in length, in 2.5-to 4.0-mm vessels were randomized (ACHIEVE nϭ524; ML PENTA nϭ519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE nϭ228; ML PENTA nϭ214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (Pϭ0.003), stent binary restenosis was 14.9% versus 20.6% (Pϭ0.076), and target-vessel failure was 11.9% versus 14.5% (Pϭ0.12) for ACHIEVE and ML PENTA, respectively. Conclusions-The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.

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Section: Discussionmentioning

confidence: 99%

Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions

et al. 2004

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“…This suggests that in addition to neointimal growth inhibition and arterial wall dilatation, 16 a third component of the mechanism of action of paclitaxel involves the loss of vascular smooth muscle cells from a quiescent, nondividing population in the medial wall. This effect probably represents true necrosis of the medial wall, with perhaps a smaller contribution from apoptosis.…”

Section: Heldman Et Al Paclitaxel Inhibits Neointimal Hyperplasia 2293mentioning

confidence: 99%

Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

et al. 2001

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Background-Despite limiting elastic recoil and late vascular remodeling after angioplasty, coronary stents remain vulnerable to restenosis, caused primarily by neointimal hyperplasia. Paclitaxel, a microtubule-stabilizing drug, has been shown to inhibit vascular smooth muscle cell migration and proliferation contributing to neointimal hyperplasia. We tested whether paclitaxel-coated coronary stents are effective at preventing neointimal proliferation in a porcine model of restenosis. Methods and Results-Palmaz-Schatz stents were dip-coated with paclitaxel (0, 0.2, 15, or 187 g/stent) by immersion in ethanolic paclitaxel and evaporation of the solvent. Stents were deployed with mild oversizing in the left anterior descending coronary artery (LAD) of 41 minipigs. The treatment effect was assessed 4 weeks after stent implantation.

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“…46,47 However, stent thrombosis remains a serious complication following either BMS or DES treatment, and its occurrence is associated with 40%-50% mortality and a composite death/ myocardial infarction rate of 50%-70%. 48,49 Stent thrombosis has been shown to be a multileveled process in which the vasculoprotective reserve is overcome by prothrombotic factors.…”

mentioning

confidence: 99%

Promoting endothelial recovery and reducing neointimal hyperplasia using sequential-like release of acetylsalicylic acid and paclitaxel-loaded biodegradable stents

Lee¹,

Yu²,

Chang³

et al. 2014

IJN

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Introduction This work reports on the development of a biodegradable dual-drug-eluting stent with sequential-like and sustainable drug-release of anti-platelet acetylsalicylic acid and anti-smooth muscle cell (SMC) proliferative paclitaxel. Methods To fabricate the biodegradable stents, poly-L-lactide strips are first cut from a solvent-casted film. They are rolled onto the surface of a metal pin to form spiral stents. The stents are then consecutively covered by acetylsalicylic acid and paclitaxel-loaded polylactide-polyglycolide nanofibers via electrospinning. Results Biodegradable stents exhibit mechanical properties that are superior to those of metallic stents. Biodegradable stents sequentially release high concentrations of acetylsalicylic acid and paclitaxel for more than 30 and 60 days, respectively. In vitro, the eluted drugs promote endothelial cell numbers on days 3 and 7, and reduce the proliferation of SMCs in weeks 2, 4, and 8. The stents markedly inhibit the adhesion of platelets on days 3, 7, and 14 relative to a non-drug-eluting stent. In vivo, the implanted stent is intact, and no stent thrombosis is observed in the stent-implanted vessels without the administration of daily oral acetylsalicylic acid. Promotion of endothelial recovery and inhibition of neointimal hyperplasia are also observed on the stented vessels. Conclusion The work demonstrates the efficiency and safety of the biodegradable dual-drug-eluting stents with sequential and sustainable drug release to diseased arteries.

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Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo

Abstract: Local delivery of paclitaxel resulted in reduced neointimal stenosis and enlargement in vessel size. Both these effects contribute to a preservation of vessel shape and are likely to be caused by a structural alteration of the cytoskeleton.

Cited by 244 publications

References 32 publications

Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions

Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions

Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

Promoting endothelial recovery and reducing neointimal hyperplasia using sequential-like release of acetylsalicylic acid and paclitaxel-loaded biodegradable stents

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