Drug-Coated Balloon Angioplasty in Clinical Practice for Below-the-Knee, Popliteal, and Crural Artery Lesions Causing Critical Limb Ischemia: 1-Year Results from the Spanish Luminor Registry

Riambau, Vicente; Aciń, Francisco; Blas, Mariano Juan de; Alonso, Mercedes; Giménez-Gaibar, Antonio; Domínguez, Cristina Cañibano; Guisasola, Ignacio Michel; Yugueros, Xavier; Mestres, Gaspar; Artal, S. Rioja; Cañas, Elías; Fernández, Ignacio; Dopazo, Rebeca Vázquez; Encalada, Carol Padrón; Gómez, Ignacio Agúndez; Bernabé, Mónica Herrero; García, Ricardo Asensio; Ochoa, Eguzkine; García, Ainhoa; Egaña, José María; Apodaka, Ana; Monteiro, Ederi Mikelarena

doi:10.1016/j.avsg.2019.06.035

Cited by 8 publications

(11 citation statements)

References 23 publications

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“…Twenty-six studies, 12 retrospective and 14 prospective, fulfilled the inclusion criteria (Table 1). 9,10,35–58 A total of 2108 CLTI patients (mean age 71.3±4.4 years; 67% men) who were treated with DCB for peripheral atherosclerotic lesions were analyzed. Major risk factors were hypertension (91%, 1339/1478), diabetes (69%, 1138/1642), dyslipidemia (63%, 1101/1756), smoking (46%, 799/1754), coronary artery disease (41%, 602/1,468), and end-stage renal disease (26%, 389/1490).…”

Section: Resultsmentioning

confidence: 99%

“…In 10 studies 9,10,35,49,50,52,53,55,56,58 of the 16 studies reporting on DCB use in the femoropopliteal segment, the pooled success rate was 98% (95% CI 96% to 100%; I 2 =70.9%); bailout stenting was necessary in 15% (95% CI 9% to 23%; I 2 =86.5%) of the cases. 9,10,35,37,41,49,52,53,56,58 During 12-month follow-up in 11 studies, 9,35,37,40,41,49,50,53,55,56,58 82% (95% CI 76% to 87%; I 2 =73.7%) of the lesions remained patent, while the pooled TLR rate was 11% (95% CI 7% to 15%; I 2 =57.8%) in 12 studies. 9,10,35,40–42,50,52,53,55,56,58 The pooled incidences of all-cause mortality in 12 studies 9,10,36,41,42,47,49,50,52,53,56,58 and major amputation in 13 studies 9,10,37,40–…”

Section: Resultsmentioning

confidence: 99%

“…9,10,35,37,41,49,52,53,56,58 During 12-month follow-up in 11 studies, 9,35,37,40,41,49,50,53,55,56,58 82% (95% CI 76% to 87%; I 2 =73.7%) of the lesions remained patent, while the pooled TLR rate was 11% (95% CI 7% to 15%; I 2 =57.8%) in 12 studies. 9,10,35,40–42,50,52,53,55,56,58 The pooled incidences of all-cause mortality in 12 studies 9,10,36,41,42,47,49,50,52,53,56,58 and major amputation in 13 studies 9,10,37,40–42,47,49,50,52,53,56,58 at the end of follow-up were 8% (95% CI 5% to 13%; I 2 =75.9%) and 7% (95% CI 3% to 14%; I 2 =89.6%), respectively. Three studies 40,41,49 reported complete wound healing and ulcer reg...…”

Section: Resultsmentioning

confidence: 99%

“…For 16 studies 9,10,[35][36][37][40][41][42]44,49,50,52,53,55,56,58 the primary target lesion was in the femoropopliteal segment (n=1315), while the other 10 studies 38,39,43,[45][46][47][48]51,54,57 involved the infrapopliteal arteries (n=793). In 11 studies with data about inflow/outflow disease, these nontarget lesions were treated at the discretion of the operator using standard techniques.…”

Section: Characteristics Of the Eligible Studiesmentioning

confidence: 99%

“…For the 19 studies 9,10,38,39,[41][42][43][44][45][46][48][49][50][51][52][53][56][57][58] reporting death rates, the 12-month all-cause pooled mortality was 9% (95% CI 6% to 13%; I 2 =76.6%), while 5% (95% CI 2% to 8%; I 2 =84.7%) of the patients underwent major amputation within 1 year after the procedure in 22 studies. 9,10,[35][36][37][38][39][40][41][43][44][45][46][48][49][50][51][52][53][56][57][58] Details regarding the late-term outcomes are illustrated in Supplementary Table 3 and Supplementary Figure 2 (available in the online version of the article).…”

Section: One-year Mortality and Amputation In Cltimentioning

confidence: 99%

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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

et al. 2020

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Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Characteristics Of the Eligible Studiesmentioning

confidence: 99%

Section: One-year Mortality and Amputation In Cltimentioning

confidence: 99%

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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

et al. 2020

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Contemporary treatment of below‐the‐knee peripheral arterial disease in patients with chronic limb threatening ischemia: Observations from the Vascular Quality Initiative

Singh

Ding

Magee

et al. 2022

Cathet Cardio Intervent

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Objective We sought to determine trends in percutaneous transluminal angioplasty (PTA) versus non‐PTA interventions over time, as well as factors that influence the decision for non‐PTA intervention. Background Although the optimal strategy for revascularization in patients with below‐the‐knee (BTK) chronic limb‐threatening ischemia (CLTI) remains under investigation, PTA has been the preferred endovascular approach. Recently, there has been an increase in the use of non‐PTA approaches for revascularization. Methods We performed a retrospective analysis of the Vascular Quality Initiative. Between 2011 and 2020, a total of 23,850 procedures corresponding to 33,098 arteries in 19,404 patients with CLTI were included. After application of exclusion criteria and removal of missing variables, 18,644 arteries were included in the study cohort. The primary analysis was factors associated with receiving non‐PTA intervention. Secondary analysis included trends in PTA versus non‐PTA intervention over time. Results Throughout the study period, the majority of interventions (72%) were PTA alone. The percentage of non‐PTA interventions, on a per‐artery basis, increased over the study period from 18% to 33%, p < 0.01. Advanced age, increasing TransAtlantic Inter‐Society Consensus classification, and concomitant above‐the‐knee disease were associated with an increased likelihood for non‐PTA intervention. In contrast, longer lesion length, insulin‐dependent diabetes mellitus, bilateral disease, and discharge to location other than home were associated with an increased likelihood of PTA. Conclusions We observed a significant increase in the percentage of non‐PTA interventions for patients with CLTI requiring BTK interventions over the last decade, with lesion‐ and patient‐specific characteristics associated with the type of endovascular approach.

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A Bibliometric Analysis on Adherence to Reporting Standards for Endovascular Treatment of Chronic Lower Extremity Peripheral Artery Disease

Modi,

Timmer,

Taylor

et al. 2024

Annals of Vascular Surgery

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Drug-Coated Balloon Angioplasty in Clinical Practice for Below-the-Knee, Popliteal, and Crural Artery Lesions Causing Critical Limb Ischemia: 1-Year Results from the Spanish Luminor Registry

Cited by 8 publications

References 23 publications

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Contemporary treatment of below‐the‐knee peripheral arterial disease in patients with chronic limb threatening ischemia: Observations from the Vascular Quality Initiative

A Bibliometric Analysis on Adherence to Reporting Standards for Endovascular Treatment of Chronic Lower Extremity Peripheral Artery Disease

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