Drug-coated balloon angioplasty for the management of recurring infrapopliteal disease in diabetic patients with critical limb ischemia

Palena, Luis Mariano; Díaz‐Sandoval, Larry J.; Gomez-Jaballera, Efren; Peypoch-Perez, Olga; Sultato, Enrico; Brigato, Cesare; Brocco, Enrico; Manzi, Marco

doi:10.1016/j.carrev.2017.06.006

Cited by 10 publications

(14 citation statements)

References 13 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%

“…9,35,[37][38][39]41,[43][44][45]48,49 Adjunctive devices were sometimes used for vessel preparation prior to DCB angioplasty. 9,37,39,40,43,44 Among lesions located in the femoropopliteal segment, the mean lesion length was 120.6±43.7 mm, with 48% (402/846) and 33% (249/763) of the lesions being occlusions and severely calcified, respectively. In comparison, lesions located at the infrapopliteal segment had a mean length of 135.4±53.5 mm; 48% were occlusions (385/798) and 20% were severely calcified (74/361).…”

Section: Characteristics Of the Eligible Studiesmentioning

confidence: 99%

“…The overall procedural success of DCB angioplasty was 98% (95% CI 95% to 100%; I 2 =87.7%) based on data from 16 studies. 9,10,35,38,39,[47][48][49][50][51][52][53][55][56][57][58] In 13 studies (918 patients) reporting adverse event data, 9,10,35,41,42,45,47,49,[51][52][53]56,58 DCB angioplasty was complicated by thrombosis/distal embolization in 1.2% (n=11), local hematoma in 5.9% (n=54), and residual dissection in 24% (n=220) of the cases. An iatrogenic perforation (n=3) and pseudoaneurysms at the access site with extravasation of contrast (n=3) were also observed.…”

Section: Procedural Outcomesmentioning

confidence: 99%

“…39,[43][44][45]47,48,51,57 Major amputation was necessary in 2% (9 studies; 95% CI 1% to 4%; I 2 =42.1%) and the incidence of all-cause mortality over 1 year was 10% (8 studies; 95% CI 5% to 1%; I 2 =76.9%). Five studies 38,39,43,45,51 demonstrated wound healing in 82% (95% CI 76% to 87%; I 2 =32.5%) of the patients during follow-up. Only the In.PACT DEEP RCT by Zeller et al 64 reported long-term follow-up, with 40% mortality at 5 years.…”

Section: Outcomes By Lesion Location In Clti Patientsmentioning

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: Characteristics Of the Eligible Studiesmentioning

confidence: 99%

Section: Procedural Outcomesmentioning

confidence: 99%

Section: Outcomes By Lesion Location In Clti Patientsmentioning

confidence: 99%

See 2 more Smart Citations

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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“…Thus, use of Lutonix Ò DEB was safe and effective for recurring infrapopliteal disease. It outperformed the objective performance goals (OPG) for CLI patients with clinical and anatomical high-risk features [348]. The significance of drug-eluting balloons in angioplasty for infrapopliteal arteries have not yet been sufficiently assessed.…”

Section: Paclitaxel-coated Balloonsmentioning

confidence: 99%