Advances in below-the-knee drug-eluting balloons
R Ferraresi1, M Centola, G Biondi-Zoccai
1Cardiovascular Interventional Unit, Istituto Clinico Città Studi, Milan, Italy. robertoferraresi@fastwebnet.it
Insights
Drug-eluting balloons offer a promising advancement for critical limb ischemia management in below-the-knee disease. These devices show favorable results, potentially improving outcomes compared to traditional methods.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Critical limb ischemia (CLI) from below-the-knee (BTK) disease presents management challenges due to patient comorbidities and diffuse vascular involvement.
- The BASIL study indicated equivalence between bypass surgery and angioplasty, but percutaneous techniques have since evolved significantly.
- Drug-eluting balloons (DEBs) represent a major advancement, offering theoretical advantages over standard balloons and metallic stents for BTK lesions.
Purpose of the Study:
- To discuss the rationale for employing drug-eluting balloons in the complex treatment of BTK critical limb ischemia.
- To review the findings of recent clinical trials evaluating DEBs for BTK lesions.
Main Methods:
- Review of existing literature and clinical trial data on drug-eluting balloons for below-the-knee critical limb ischemia.
- Discussion of the theoretical advantages of DEBs compared to conventional angioplasty and stenting.
Main Results:
- Two clinical trials reported favorable outcomes using the In.Pact Amphirion paclitaxel-eluting balloon for BTK lesions.
- DEBs present potential benefits for infra-popliteal lesions, addressing restenosis and disease progression.
Conclusions:
- Drug-eluting balloons are a significant development in managing below-the-knee critical limb ischemia.
- Evidence suggests DEBs, like the paclitaxel-eluting balloon, offer promising results in this challenging patient population.
Abstract:
The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, and high rates of restenosis and disease progression. The BASIL study has established the substantial equivalence between bypass surgery and percutaneous transluminal angioplasty in this setting, at least at mid-term follow-up, but percutaneous techniques and devices have seen major developments since the publication of this pivotal trial in 2005. A major breakthrough has indeed been the introduction of drug-eluting balloons, which have several theoretical advantages in comparison to standard balloons and metallic stents for infra-popliteal lesions. Two clinical trials have already been reported with favorable results for the In.Pact Amphirion paclitaxel-eluting balloon, when employed for below-the-knee lesions. We hereby discuss the rationale for the use of drug-eluting balloons in this complex setting and the main findings of the study by Schmidt et al. and the DEBATE-BTK trial.
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