Benefit and Risk from Paclitaxel-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Klumb, Christof; Aschenbach, René; Eckardt, Niklas; Teichgräber, Ulf

doi:10.2139/ssrn.3405574

Cited by 13 publications

(22 citation statements)

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“…Although no significant difference between DEB and UCB for target lesion thrombosis, and amputation was found, these results still needed further verification due to the occurrence of smaller events and hence a long-term follow-up of the study is warranted. Finally, no significant difference between DEB and UCB for the risk of all-cause mortality was detected, which was inconsistent with prior meta-analyses [ 38 , 39 ]. An important individual patient data meta-analysis also found that paclitaxel-containing devices yielded an absolute of 4.6% increased mortality risk for patients with patients with symptomatic femoropopliteal peripheral artery disease [ 43 ].…”

Section: Discussioncontrasting

confidence: 93%

“…A meta-analysis conducted by Klumb et al have shown association of DEB with increased incidence of freedom from TLR at 12 and 24 months. Moreover, DEB significantly increased the risk of 2-year mortality [ 39 ]. However, whether the treatment effects between DEB and UCB differed according to the patients’ characteristics were not illustrated.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis

Feng

Chen

Guo

et al. 2020

BMC Cardiovasc Disord

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Background: This quantitative meta-analysis was conducted to evaluate the efficacy and safety of drug-eluting balloon (DEB) vs. uncoated balloon (UCB) in patients with femoropopliteal arterial occlusive disease. Methods: Electronic databases were searched to identify randomized controlled trials (RCTs) that compared DEB and UCB till November 2018. The random-effects model was used for conducting pooled analyses. Results: Seventeen RCTs with 2706 patients were included in the final meta-analysis. Patients who received DEB had higher levels of minimal luminal diameter (MLD) at 6

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Section: Discussioncontrasting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis

Feng

Chen

Guo

et al. 2020

BMC Cardiovasc Disord

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“…A hypothesis to explain restenosis after DCB and DES treatments is involuntary particle detachment outside the target lesion due to difficult device delivery, leading to non-uniform drug distribution at the target site 4,10 . The coating of paclitaxel DCB for targeted drug delivery is subject to an inherent conflict of objectives.…”

mentioning

confidence: 99%

Systematic evaluation of particle loss during handling in the percutaneous transluminal angioplasty for eight different drug-coated balloons

Heinrich

Engler

Güttler

et al. 2020

Sci Rep

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Paclitaxel drug coated balloons (DCBs) should provide optimal drug transfer exclusively to the target tissue. The aim of this study was to evaluate the particle loss by handling during angioplasty. A robotic arm was developed for systematic and reproducible drug abrasion experiments. The contact force on eight different commercially available DCB types was gradually increased, and high-resolution microscopic images of the deflated and inflated balloons were recorded. Three types of DCBs were classified: no abrasion of the drug in both statuses (deflated and inflated), significant abrasion only in the inflated status, and significant abrasion in both statuses. Quantitative measurements via image processing confirmed the qualitative classification and showed changes of the drug area between 2.25 and 45.73% (13.28 ± 14.29%) in the deflated status, and between 1.66 and 40.41% (21.43 ± 16.48%) in the inflated status. The structures and compositions of the DCBs are different, some are significantly more susceptible to drug loss. Particle loss by handling during angioplasty leads to different paclitaxel doses in the target regions for same DCB types. Susceptibility to involuntary drug loss may cause side effects, such as varying effective paclitaxel doses, which may explain variations in studies regarding the therapeutic outcome.

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“…Each DCB differs in drug density and drug-coating [ 43 ]. Although data for DCBs show superiority in reducing restenosis events in the femoropopliteal region, currently no DCB has an FDA indication for IPOD in the United States.…”

Section: Introductionmentioning

confidence: 99%

Infrapopliteal Artery Occlusive Disease: An Overview of Vessel Preparation and Treatment Options

Tummala

Amin

Mehta

2020

JCM

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Critical limb ischemia (CLI) is defined as chronic rest pain and/or the presence of tissue loss (ulcers or gangrene) in the lower extremities secondary to ischemia. CLI is a limb and potentially life-threatening disease associated with a poor prognosis with only 50% of patients being able to preserve both limbs within 12 months of diagnosis. CLI related to diabetes is often more extensive with multi-level long segmental arterial disease resulting in a 5–30-fold increased rate of amputation. As the incidence and prevalence of diabetes mellitus increases within our aging society, the rate of infrapopliteal artery occlusive disease (IPOD) and the need for intervention rises with it. The aim of this manuscript is to provide the reader with an overview of the various devices available for vessel preparation (VP) and treatment of IPOD in order to optimize patency rates, symptom resolution, healing of wounds, and minimize complications.

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Benefit and Risk from Paclitaxel-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Cited by 13 publications

References 0 publications

Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis

Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis

Systematic evaluation of particle loss during handling in the percutaneous transluminal angioplasty for eight different drug-coated balloons

Infrapopliteal Artery Occlusive Disease: An Overview of Vessel Preparation and Treatment Options

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