1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease

Micari, Antonio; Vadalà, G; Castriota, Fausto; Liso, Armando; Grattoni, Chiara; Russo, Paolo; Marchese, Alfredo; Pantaleo, Paolo; Roscitano, Giuseppe; Cesana, Bruno Mario; Cremonesi, Alberto

doi:10.1016/j.jcin.2016.02.014

Cited by 73 publications

(58 citation statements)

References 21 publications

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“…In 104 patients (110 lesions) with a mean lesion length for DCB of 94 ± 60 vs. 96 ± 69 mm for PTA, the primary endpoint (1‐year restenosis) was lower in the DCB group (17% vs. 47.3%); P = 0.008). Registry data supports the effectiveness of DCBs in long femoral‐popliteal disease (> 15 cm) reporting that 105 consecutive patients with RC 2 to 4 and a treated lesion length of 25 ± 7 cm obtained a 1‐year patency rate of 83.2% with only 11% requiring bailout stents .…”

Section: Methodssupporting

confidence: 57%

SCAI appropriate use criteria for peripheral arterial interventions: An update

Klein

Jaff

Gray

et al. 2017

Cathet Cardio Intervent

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Section: Methodssupporting

confidence: 57%

SCAI appropriate use criteria for peripheral arterial interventions: An update

Klein

Jaff

Gray

et al. 2017

Cathet Cardio Intervent

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“…39 The rates of provisional stenting among DCB treated FP lesions range from 4.1% to 27% in clinical trials and from 11% to 23.3% in two real-world studies from Italy and Germany respectively. 33,38,[40][41][42] Bail-out stenting was 14.2% in our DCB treated FP lesions, while the total rate of adjunctive stenting (bail-out or planned) was 31%. These rates are higher than those reported by the clinical trials.…”

Section: Discussionmentioning

confidence: 76%

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

et al. 2018

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With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

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“…Both of these trials included patients with moderate length (e.g., <15cm) lesions, but recent observational data suggest that DCB angioplasty is also effective in longer, more complex femoropopliteal lesions. In a study of 105 patients with TASC type C and D lesions, DCB angioplasty demonstrated a primary patency rate of 83% at 1 year . These findings are superior to rates of primary patency reported for drug‐eluting stents (78%), nitinol stents (49%), and covered self‐expanding stents (67%) in similar femoropopliteal lesions .…”

Section: Discussionmentioning

confidence: 86%

Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease

Foley

Cotter

Kokkinidis

et al. 2017

Cathet Cardio Intervent

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In this single-center analysis of patients undergoing DCB angioplasty for claudication or CLI, OA was most often used for the treatment of severely calcified lesions. These lesions were more likely to be treated with scoring balloons and less likely to require bailout stenting. At 1 year, target lesion revascularization and primary patency was similar in patients treated with and without adjunctive OA, despite the higher lesion complexity among those receiving the combination procedure. © 2017 Wiley Periodicals, Inc.

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1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease

Cited by 73 publications

References 21 publications

SCAI appropriate use criteria for peripheral arterial interventions: An update

SCAI appropriate use criteria for peripheral arterial interventions: An update

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease

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