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

Abstract

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.

Below Knee Angioplasty Using Drug-Eluting Balloons in Patients with Critical Limb Ischemia with Six Months Follow-Up: Single-Center Experience at Tertiary Care Hospital

“…The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. 17 18…”

“…The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. 17,18 In this prospective observational study, we have evaluated the safety and efficacy in terms of 6 monthly primary patency rates of DEB in BTK arterial disease presented with CLI. The results showed that DEB achieved promising clinical outcomes with successful performance in IP arteries in the short-term follow-up with a substantial primary patency rate (76%) that is much better as compared to standard percutaneous transluminal angioplasty (38%).…”

Sirolimus-freisetzende Ballonangioplastie bei komplexen Tibialisverschlüssen

“…nach PCB weniger erneute Revaskularisierungen nötig als nach POBA. Frühere randomisierte Studien konnten dagegen keinen Vorteil von PCB hinsichtlich primärer Offenheit, erneuter Revaskularisierung, Amputationsrate und Mortalität zeigen [4]. Darüber hinaus zeigte eine Metaanalyse von acht randomisierten Studien, dass ein Jahr nach Behandlung mit PCB weniger Patienten ohne Amputation überlebt hatten als nach POBA [5].…”

Expansion of Bypass as a Revascularization Option for Patients With Chronic Limb-Threatening Ischemia

“…3 In the BEST-CLI, the endovascular techniques applied to CLTI patients included the use of atherectomy (15%), drug-coated balloons (25%) and drugeluting stents (22%). 1 With wider application of advanced endovascular techniques, [4][5][6][7] the outcomes of patients offered endovascular treatment are expected to improve. Thus, the BEST-CLI results may become outdated.…”