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Journal of Vascular Surgery
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License: Elsevier Non-Commercial
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Journal of Vascular Surgery
Article . 2016 . Peer-reviewed
License: Elsevier Non-Commercial
Data sources: Crossref
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Treatment of the femoropopliteal artery with the bioresorbable REMEDY stent

Authors: Bontinck, Jan; Goverde, Peter; Schroë, Herman; Hendriks, Jeroen; Maene, Lieven; Vermassen, Frank;

Treatment of the femoropopliteal artery with the bioresorbable REMEDY stent

Abstract

Bioresorbable stents are an emerging technology in the endovascular treatment of femoropopliteal lesions. They address the issue of leaving permanent stents in the treated arterial segment that are only temporarily needed to treat dissection or recoil. The REMEDY stent (Kyoto Medical Planning Co, Kyoto, Japan) was the first commercially available biodegradable scaffold for peripheral use. We evaluated its performance and safety in the treatment of short femoropopliteal stenosis or occlusion.A prospective, multicenter, observational registry was set up of patients in Rutherford-Becker categories 2 to 5 with femoropopliteal lesions that could be treated with one REMEDY stent. Clinical examination and duplex ultrasound imaging were performed at 1, 6, and 12 months. The primary end point was absence of clinically driven target lesion revascularization at 12 months. Secondary end points were technical and clinical success, primary and secondary patency rate, clinically driven target vessel revascularization, major complications, and Rutherford-Becker classification at 6 and 12 months.The registry enrolled 99 patients between January 2011 and July 2013 in 12 centers in Belgium. Most lesions were determined as TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A (n = 80) and located in the superficial femoral artery (n = 91). There were 19 total occlusions (mean length, 41.3 mm) and 80 stenoses (mean length, 37.5 mm). Technical success was achieved in 96 patients, and clinical success was obtained in 95. Target lesion revascularization, which equalled target vessel revascularization, was 19% at 6 months and rose to 33% at 12 months. Primary patency was 68% at 6 months and 58% at 12 months. Secondary patency was 85% at 6 months and 86% at 12 months. After 12 months, two patients had undergone an amputation.The 1-year follow-up results of the REMEDY stent do not meet current standards set by nitinol stents. Given the significant issues concerning bioresorbable stents in femoropopliteal arteries, their use outside clinical trials should be withheld until improvements are made and better data are available.

Country
Belgium
Keywords

Male, Time Factors, Constriction, Pathologic, Kaplan-Meier Estimate, Prosthesis Design, Femoral Artery, Peripheral Arterial Disease, Treatment Outcome, Belgium, Risk Factors, Absorbable Implants, Retreatment, Humans, Female, Popliteal Artery, Stents, Human medicine, Prospective Studies, Registries, Angioplasty, Balloon, Aged

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    popularity
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    influence
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    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
23
Top 10%
Top 10%
Top 10%
hybrid