Drug-eluting balloon angioplasty versus uncoated balloon angioplasty in patients with femoropopliteal arterial occlusive disease

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The optimal percutaneous treatment for femoropopliteal arterial occlusive disease has yet to be assessed. This systematic review and meta-analysis assessed the efficacy of drug-eluting balloons (DEBs) compared with uncoated balloons (UCBs) for the treatment of femoropopliteal arterial occlusive disease.


We used Preferred Reporting Items for Systematic Reviews and Meta-Analysis Statement (PRISMA) standards to systematically search the electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for trials comparing DEBs vs UCBs in the femoropopliteal arteries. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. All data were systematically pooled, and meta-analysis was performed on binary restenosis, late lumen loss (LLL), target lesion revascularization (TLR), major amputation, mortality, and changes in the ankle-brachial index and the Rutherford-Baker classification.


From 364 screened articles, we included nine trials, all of which had a low risk of bias. We found a significant reduction of binary restenosis at 6 months (14.3% vs 40.1%; P < .0001), binary restenosis at 1 year (26.6% vs 47.4%; P = .008), LLL at 6 months (−0.80 mm; P < .00001), TLR at 1 year (10.4% vs 26.9; P = .0008), and TLR at 2 years (13.8% vs 40.7%; P = .0003) after DEB angioplasty compared with UCB angioplasty. The difference in amputation rate and mortality was not significant. Definitions on changes in ankle-brachial index and Rutherford classifications were heterogeneous and, therefore, could not be pooled in sufficient numbers.


Compared with UCB angioplasty, the use of DEBs increases the durability of the treatment effect in femoropopliteal arterial disease, expressed by a significant decrease of binary restenosis, LLL, and TLR at short-term and midterm follow-up.

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