Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs

Abstract

Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.

Comparison of drug eluting balloon angioplasty to infrapopliteal artery critical lesions with or without additional pedal artery angioplasty in patients with diabetes mellitus and critical limb ischemia

“…Therefore the cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its complications are prevented or postponed. DEB angioplasty demonstrated superior outcomes compared to PTA in infrainguinal lesions in many studies especially in DM patients . We also preferred DEB angioplasty for treatment in both BTK and BTA lesions in this study.…”

“…Another important issue is that after a follow-up of 12 months, RBC was decreased significantly more in BTA group compared to BTK Primary, secondary patency, and mortality analysis with Kaplan Meier Curves many studies especially in DM patients. [9][10][11][12] We also preferred DEB angioplasty for treatment in both BTK and BTA lesions in this study.…”

Percutaneous transluminal angioplasty/stent treatment of totally occlusive iliofemoral artery with limb ischemia: Experience of surgical team

“…Commercially available drug-eluting stents may give hope in future; however, its common use is limited because of current cost-effective perspective. [23,24] Due to the complexity and diversity of the patients in our series, it was impossible to make up a control group for a randomized study. That was the limitation of this study.…”

A universal drug delivery catheter for the treatment of infrapopliteal arterial disease: Results from the multi‐center first‐in‐human study

“…Historically, balloon angioplasty provided poor patency outcomes in these vessels with restenosis rates as high as 70% at 1 year [12]. The advent of DCB was seen as a better alternative to balloon angioplasty, however, early clinical results have been limited, and to date, long-term benefit of DCB as compared to balloon angioplasty for treatment of atherosclerotic disease below-the-knee remains unknown [8][9][10]. Although our clinical study was not designed to compare with previous studies due to our small cohort, our reported TLR was greater coating embolization as shown in pre-clinical animal studies [15].…”

“…The BIOLUX P-II trial also showed similar patency loss between DCB and balloon angioplasty at 12 months in CLI patients [9]. Overall, DCB have not demonstrated clinical or angiographic advantage at 1 year follow-up as compared to balloon angioplasty [10].…”