Systemic Nanoparticle Paclitaxel (<i>nab</i>‐Paclitaxel) for In‐stent Restenosis I (SNAPIST‐I): A First‐in‐Human Safety and Dose‐finding Study

Margolis, James R.; McDonald, John R.; Heuser, Richard R.; Klinke, Peter; Waksman, Ron; Virmani, Renu; Desai, Neil; Hilton, David

doi:10.1002/clc.20066

Cited by 77 publications

(47 citation statements)

References 15 publications

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“…Margolis et al 14 reported no relevant side effects ≤50 mg/ patient. A study reporting hematologic analyses after the use of multiple paclitaxel-coated balloon catheters in femoro-popliteal vessels up to a dose of ≈25 mg/patient did neither indicate paclitaxel plasma levels coming close to those known to cause systemic effects nor changes in cell counts which would indicate systemic toxicity.…”

Section: Discussionmentioning

confidence: 96%

Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty

Werk

Albrecht

Meyer

et al. 2012

Circ: Cardiovascular Interventions

325

235

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P ercutaneous revascularization is an established treatment for femoro-popliteal artery disease.1 Yet, restenosis, reocclusion, and ensuing symptom recurrence can occur in as many as 50% of patients undergoing percutaneous transluminal angioplasty (PTA), often requiring repeat percutaneous or surgical intervention.2,3 The superficial femoral artery represents a unique challenging vessel.4 Bare-metal stents reduce restenosis versus PTA and have gained widespread adoption. 5,6 Alternative therapies, such as drug-eluting balloon (DEB), may be valuable and worthwhile considering their promise and evidence to achieve patency outcomes at least similar to stents but with nothing left behind. 7Several studies in coronary artery disease indicate effective restenosis inhibition by DEB in the treatment of in-stent restenosis whereas drug-eluting stent are the preferred medicated devices in most coronary de novo lesions. Two published randomized trials have so far provided favorable data on the usage of DEB versus PTA for the treatment of femoropopliteal arterial disease. 8,9 More recently, the effect of a novel paclitaxel coating formulation with urea excipient, a naturally occurring highly biocompatible hydrophilic component (FreePac, Medtronic, Santa Rosa, CA) was investigated within a multicenter registry in patients affected by femoral-popliteal arterial disease. 10 To reach a more in-depth understanding onBackground-Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention.A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoropopliteal percutaneous transluminal angioplasty. Methods and Results-Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminalangioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0±5.3 and 6.6±5.5cm for DEB and control arm, respectively.

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Section: Discussionmentioning

confidence: 96%

Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty

Werk

Albrecht

Meyer

et al. 2012

Circ: Cardiovascular Interventions

325

235

View full text Add to dashboard Cite

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“…The risk of systemic effects due to paclitaxel was addressed in a clinical study on the pharmacokinetics of paclitaxel released from coated balloons in peripheral arteries [79]. Based on this study and the experience with intravenous administration of paclitaxel [83,84], up to 7 balloon catheters 6.0 × 120 mm may be used in adult patients during one intervention without reaching the dose known to cause systemic adverse effects.…”

Section: Peripheral Trialsmentioning

confidence: 99%

Drug-Coated Balloons for Restenosis Prophylaxis

Speck

Scheller

Hamm

2013

Fortschr Röntgenstr

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Drug-coated balloons for restenosis prophylaxis provide a high local drug concentration with minimal or no systemic adverse effects. Their development was both delayed and facilitated by the introduction of drug-eluting stents: delayed because sustained release kinetics from stent platforms seemed to be essential and facilitated because prior experience with stents allowed selection of testing methods and drugs. Currently, a variety of drug-coated balloons are available, basically consisting of a coating containing paclitaxel at a dose of about 3??g/mm? balloon surface, and different additives influencing the adherence and release of the drug, e.?g., contrast agent, urea, or various amphiphilic compounds. The drug is almost completely released during a single inflation of 30???60 seconds. Studies in animals and several independent randomized clinical trials in coronary and peripheral arteries demonstrate effective reduction of neointimal proliferation, restenosis, and revascularization persisting for at?least 2 years or 5 years according to one study in coronary arteries. Drug-coated balloons are preferably used for treating coronary in-stent restenosis and de novo and restenotic lesions in peripheral vessels. No coating-related adverse events have been observed in clinical trials. Persistent efficacy may be explained by the long residence time of paclitaxel in tissue or inhibition of an essential first step in the chain of events leading to neointimal proliferation. Citation Format: ??Speck U., Scheller B., Hamm B. Drug-Coated Balloons for Restenosis Prophylaxis. Fortschr R?ntgenstr 2014; 186: 348???358

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“…The phase 1 study has been conducted showing 10-30 mg/m 2 doses of the drug are safe for humans 132 . The phase II study is ongoing.…”

Section: Paclitaxel and Its Analoguesmentioning

confidence: 99%