Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease

Dake, Michael D.; Ansel, Gary M.; Jaff, Michael R.; Ohki, Takao; Saxon, Richard R.; Smouse, H. Bob; Zeller, Thomas; Roubin, Gary S.; Burket, Mark W.; Khatib, Yazan; Snyder, Scott A.; Ragheb, Anthony; White, Jennifer; Machan, Lindsay

doi:10.1161/circinterventions.111.962324

Cited by 520 publications

(415 citation statements)

References 34 publications

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“…Drug eluting stents have been employed in the femoral arteries to address the issue of in-stent restenosis by delivering an anti-restenotic drug to the treated area. This approach has been shown to offer improved patency rates compared to PTA in the Zilver PTX trial [20].…”

Section: Introductionmentioning

confidence: 99%

The influence of composition and location on the toughness of human atherosclerotic femoral plaque tissue

et al. 2016

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The toughness of femoral atherosclerotic tissue is of pivotal importance to understanding the mechanism of luminal expansion during cutting balloon angioplasty (CBA) in the peripheral vessels. Furthermore, the ability to relate this parameter to plaque composition, pathological inclusions and location within the femoral vessels would allow for the improvement of existing CBA technology and for the stratification of patient treatment based on the predicted fracture response of the plaque tissue to CBA. Such information may lead to a reduction in clinically observed complications, an improvement in trial results and an increased adoption of the CBA technique to reduce vessel trauma and further endovascular treatment uptake.This study characterises the toughness of atherosclerotic plaque extracted from the femoral arteries of ten patients using a lubricated guillotine cutting test to determine the critical energy release rate. This information is related to the location that the plaque section was removed from within the femoral vessels and the composition of the plaque tissue,

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Section: Introductionmentioning

confidence: 99%

The influence of composition and location on the toughness of human atherosclerotic femoral plaque tissue

et al. 2016

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“…Based on a systematic literature review of clinical measures 17 , 12 publications including registries and clinical trials were used to estimate the TLR rates associated with each endovascular procedure studied [19][20][21][22][23][24][25][26][27][28][29]. More detailed information about TLR probabilities indicated in each study is shown in Table 3.…”

Section: Resultsmentioning

confidence: 99%

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

Micari

Vadalà

Corbo

et al. 2015

ICFJ

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Background: Drug-coated balloons (DCBs) are an alternative for patients with peripheral arterial disease. Costs and re-intervention rates are potentially reduced compared to other technologies. We assessed the economic impact of these endovascular therapies.Methods: An Italian National Healthcare Service-perspective budget impact model with a 5-year horizon was developed to compare relative costs of 4 index procedures (plain old balloon angioplasty (POBA), DCBs, and bare-metal and drug-eluting stents (BMSs, DESs)) based on 1-year repeat-procedure rates (target-lesion revascularization (TLR)). A published systematic review of TLR rates in patients with femoral-popliteal disease undergoing these treatments was used to measure effectiveness. Costs associated with each treatment were derived from diagnosis-related group tariffs. A decision analytic model was developed to estimate 1-year costs for index procedures and possible revascularizations. Results: Pooled TLR rates show clear patient benefits for DCBs (6.9%) compared with POBA (21.6%) and BMSs (14.2%) and non-inferiority vs. DESs (7.3%). One-year payments for index and repeat interventions (by TLR rate) showed that DCBs were the least costly strategy, saving ~€1,000/patient vs. POBA. The potential savings were €8.7M, assuming 5% annual increase in DCB adoption over 5 years. Conclusions: Despite initial higher investment, DCB represent a cost-saving alternative to other technologies.

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“…The technology has not transferred directly to the peripheral arteries, however, because the drug delivery technology used in the coronary arteries has not been suitably tailored to the unique requirements of the SFA. Thus, observed reintervention rates following implantation of drug-eluting stents in the femoropopliteal segment are substantially higher at 10-20% [4][5][6].…”

Section: Overview Of the Marketmentioning

confidence: 99%

“…Paclitaxel, a microtubule stabilizer, was chosen for its demonstrated antirestenotic effect on peripheral arteries [4,14,15]. Although '-limus' drugs (e.g.…”

Section: Antiproliferative Agent and Dosing Strategymentioning

confidence: 99%

“…By 1 year postimplant, only two patients required a revascularization procedure to address blockage of the original target lesion, leaving 96% of patients with patent stents (Figure 3) [18]. For comparison, reported revascularization-free rates at 1 year average approximately 87% for bare metal stents [23][24][25][26][27][28][29][30] and slightly higher at 90% for a drug-coated stent [4,31] Treatment effectiveness with Eluvia ™ is undergoing further verification in the global IMPERIAL study, which is currently enrolling patients (ClinicalTrials.gov identifier NCT02574481). Results of this study will reveal whether the encouraging findings from MAJESTIC bear out in a large (>450 patients) randomized single-blind clinical study.…”

Section: Clinical Profilementioning

confidence: 99%

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Eluvia™ peripheral stent system for the treatment of peripheral lesions above the knee

Müller‐Hülsbeck¹

2016

Expert Opinion on Drug Delivery

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Introduction: Drug-eluting stents promise to reduce restenosis following endovascular treatment of diseased arteries, but technologies used in peripheral arteries of the leg have not yet achieved desired success rates. Areas covered: The rationale behind the development of the Eluvia TM Drug-Eluting Vascular Stent (Boston Scientific, Marlborough, MA) is described and current preclinical and clinical evidence related to use of the stent is reviewed. Expert opinion: Stents remain an important endovascular treatment option for femoropopliteal lesions, especially those that are long, occluded, and calcified. Drug-eluting stent technologies show promise to improve patency rates, potentially shifting the primary treatment preference away from balloon-based treatment. The available preclinical and clinical data on treatment with Eluvia TM suggest that prolonged paclitaxel elution in the femoropopliteal arteries prevents restenosis and may reduce the need for reintervention.

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Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease

Cited by 520 publications

References 34 publications

The influence of composition and location on the toughness of human atherosclerotic femoral plaque tissue

The influence of composition and location on the toughness of human atherosclerotic femoral plaque tissue

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

Eluvia™ peripheral stent system for the treatment of peripheral lesions above the knee

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