Introduction
Randomized and nonrandomized studies on paclitaxel-coated stents and balloons
Market dissemination and evolution of the guideline recommendations
Reference | Participating societies | Recommendations and level of evidence |
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Frank et al. [14] | European Society for Vascular Medicine (ESVM) | Treatment of (longer and more complex) femoropopliteal lesions with drug-eluting balloons after predilatation is recommended as standard of care (II, B) Adequate vessel preparation is recommended for successful drug-eluting balloon or self-expanding stent application (I, B) |
Mills et al. [25] | European Society for Vascular Surgery (ESVS), Society for Vascular Surgery (SVS), World Federation of Vascular Societies (WFVS) | Insufficient evidence! |
Feldman et al. [13] | Society for Cardiovascular Angiography and Interventions (SCAI) | Recommendations for drug-coated balloons as the intended definitive therapy in the femoropopliteal arterial interventions for CFA bifurcation lesion (IIA, C‑EO), Above knee popliteal lesion (I, A), ostial SFA lesion (I, A), focal SFA lesion (I, A), intermediate SFA lesion (I, A), diffuse SFA lesion (I, B‑R), moderate to severe calcified focal lesion (I, C‑LD), moderate to severe calcified intermediate lesion (I, C‑LD), moderate to severe diffuse lesion (I, C‑LD), chronic total occlusion focal lesion (I, B‑R), chronic total occlusion intermediate lesion (I, B‑R), chronic total occlusion diffuse lesion (I, B‑NR), ISR focal lesion (I, B‑R), ISR intermediate lesion (I, B‑R), ISR diffuse lesion (I, B‑R) Recommendations for drug-eluting stents as the intended definitive therapy in the femoropopliteal arterial interventions for CFA bifurcation lesion (IIA, C‑EO), above knee popliteal lesion (I, B‑R), ostial SFA lesion (I, B‑R), focal SFA lesion (I, B‑R), intermediate SFA lesion (I, B‑R), diffuse SFA lesion (I, B‑NR), moderate to severe calcified focal lesion (I, C‑LD), moderate to severe calcified intermediate lesion (I, C‑LD), moderate to severe diffuse lesion (I, C‑EO), chronic total occlusion focal lesion (I, B‑R), chronic total occlusion intermediate lesion (I, B‑R), chronic total occlusion diffuse lesion (I, B‑NR), ISR focal lesion (IIB, C‑LD), ISR intermediate lesion (IIA, C‑LD), ISR diffuse lesion (IIA, C‑LD) |
Aboyans et al. [1] | European Society for Cardiology (ESC), European Society for Vascular Surgery (ESVS) | Drug-eluting balloons may be considered in short (i.e. <25 cm) lesions (class IIb, level A) Drug-eluting stents may be considered for short (i.e. <25 cm) lesions (class IIb, level B) Drug-eluting balloons may be considered for the treatment of in-stent restenosis (class IIb, level B) |
Gerhard-Herman et al. [15] | American College of Cardiology (ACC), American Heart Association (AHA) | Insufficient evidence! |
Lawall et al. [3] | Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V., AWMF), German Society for Angiology/Vascular Medicine (Deutsche Gesellschaft für Angiologie e. V., DGA) | The clinical significance of drug-eluting stents cannot be sufficiently assessed at present (consensus recommendation). If a reduced risk of restenosis and reintervention following angioplasty is considered essential in a clinical angiology context during the endovascular treatment of femoropopliteal lesions, paclitaxel-coated balloons should be used for angioplasty (II, B). The significance of drug-coated balloons in angioplasty for infrapopliteal arteries cannot be sufficiently assessed (consensus recommendation) |
Meta-analyses of safety outcomes for paclitaxel-coated stents and balloons
Real-world evidence on paclitaxel-coated stents and balloons and the treatment reality in Germany
Debate
Conclusions for professional practice
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Around 15 balloons and 2 stents with a paclitaxel coating have been used in clinical practice since European market access (CE) was granted in 2009.
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Around half of all procedures to treat atherosclerotic lesions below the knee are now performed using coated balloons or stents.
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In a meta-analysis of the use of paclitaxel-coated balloons and stents in femoropopliteal arteries and a further meta-analysis on the use of coated balloons in arteries below the knee, increased all-cause mortality or less favorable amputation-free survival in the long-term could be proven following the use of these coated medical devices. These findings were confirmed in patient-level analyses and independent analyses by the US Food and Drug Administration (FDA).
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In matched or weighted analyses of population-based routinely collected data and register data from the USA, Germany, Great Britain and Greece, no indications of a safety issue with coated medical devices could be discerned. Most of the trials were even able to prove lower mortality following the use of paclitaxel-coated products.
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The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) calls on users of paclitaxel-coated medical devices to provide affected patients with appropriate information until the long-term safety has been confirmed.
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Numerous confounders, bias and diverse conflicts of interest affect insufficiently powered randomized and non-randomized trials alike and limit their generalizability and conclusiveness.
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Currently, the secondary use of longitudinal routinely collected data from social insurance institutions offers the only possibility to evaluate comprehensive long-term data, while case-related or procedure-related datasets are subject to significant bias due to the frequent reinterventions performed on the target population.