Introduction: Restenosis by myointimal hyperplasia after peripheral arterial angioplasty or stenting often limits long term patency. Drug-eluting balloons (DEBs) which inhibit the proliferation of neo-intimal growth of vascular smooth muscle cells may prevent restenosis. The aim of this paper was to examine the evidence in published literature on the use of DEBs in the treatment of peripheral arterial in-stent restenosis (ISR).
Evidence acquisition: A systematic literature review was undertaken of all published literature on the treatment of peripheral ISR with drug eluting balloon using Medline and cross-referenced. All published papers on the use of DEBs in peripheral arterial disease (PAD) were used. Cochrane Central Register of Controlled Trials and electronic databases were also searched for on-going studies.
Evidence synthesis: There were no level 1 or 2 evidence published on this subject. The number of high-quality publications is few, and consequently a sufficient analysis is not possible. Recently data from non-randomized cohort studies showed encouraging results with DEB as treatment modality for ISR, whether used alone or as combined strategies.
Conclusions: Evidence from the published literature suggests that DEBs are safe in preventing peripheral ISR. Despite strong corporate pressure for the use of DEBs, there is only circumstantial evidence that this is a useful modality for ISR. Results from on-going studies may allow further meta-analysis for efficiency and cost-effectiveness.