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"Evolution of Drug-Coated Devices for the Treatment of Chronic Limb Threatening Ischemia"
Thomas Creeden1, Douglas W Jones1
1Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, UMass Medical Center, Worcester, MA.
Insights
Drug-coated devices improve outcomes for Chronic Limb Threatening Ischemia (CLTI) patients undergoing femoropopliteal interventions. However, paclitaxel-based therapies show limited benefit below the knee, with newer agents showing promise.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Chronic Limb Threatening Ischemia (CLTI) management often involves endovascular revascularization for limb preservation.
- Balloon angioplasty alone has high failure rates in CLTI patients.
- Drug-coated devices (DCDs) were developed to reduce restenosis, initially studied in claudication, but recent data address their efficacy in CLTI.
Purpose of the Study:
- To review the historical development and current evidence for DCDs in peripheral arterial disease (PAD), particularly in CLTI.
- To evaluate the safety and efficacy of paclitaxel-based therapies in CLTI patients.
- To explore emerging antiproliferative agents and delivery systems for below-the-knee (BTK) interventions.
Main Methods:
- Historical narrative review of DCD development and use in PAD.
- Analysis of major clinical trials investigating DCDs in CLTI and PAD.
- Review of emerging data on newer antiproliferative agents and delivery systems for BTK interventions.
Main Results:
- Paclitaxel-based therapies for PAD do not increase mortality risk compared to non-drug-coated devices.
- In CLTI patients with femoropopliteal disease, paclitaxel-based balloons and stents show superior patency and reduced reintervention rates versus non-DCDs.
- Paclitaxel-based therapies have not demonstrated clinically meaningful outcomes for below-the-knee (BTK) interventions compared to non-drug-based therapies.
Conclusions:
- Paclitaxel-DCDs are effective for femoropopliteal disease in CLTI patients, offering improved patency and reduced reintervention.
- Current evidence does not support paclitaxel-based therapies for BTK interventions in CLTI.
- Newer antiproliferative agents (Sirolimus, Everolimus) and bioabsorbable scaffolds show potential for improved BTK outcomes, including reduced amputation rates.
Abstract:
For patients with Chronic Limb Threatening Ischemia (CLTI), endovascular approaches to revascularization are often employed as a component of multimodality care aimed at limb preservation. However, patients with CLTI are also prone to treatment failure, particularly following balloon angioplasty alone. Drug-coated devices utilizing Paclitaxel were developed to decrease restenosis but have been primarily studied in patients presenting with claudication. In recent years, data have emerged which describe the efficacy of drug-coated devices in the treatment of patients with CLTI. Concurrently, there has been major controversy surrounding the use of drug-coated devices in peripheral arterial disease. A historical narrative of the development and use of drug-coated devices for peripheral arterial disease is presented, along with discussion of major trials. Evidence argues that paclitaxel-based therapies for peripheral arterial disease (PAD) do not increase mortality risk compared to nondrug-coated devices. In CLTI patients, paclitaxel-based balloons and stents provide superior patency and freedom reintervention compared to nondrug-coated devices when treating femoropopliteal disease. However, the use of Paclitaxel-based therapies for below-the-knee (BTK) interventions has not been shown to provide clinically meaningful outcomes compared to nondrug-based therapies. Newer generation antiproliferative agents (Sirolimus, Everolimus) and delivery systems (bioabsorbable scaffolds) hold promise for BTK interventions with early data suggesting decreased rates of major amputation or major adverse limb events.
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