Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date.
A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required.
Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK.
Mohamed
M
Barkat
Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK.
Francesco
F
Torella
Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK.
George A
GA
Antoniou
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D012307:Risk Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible
angioplasty; drug-coated balloon; drug-eluting balloon; peripheral arterial disease