Drug-Eluting Balloon: An Overview of Clinical Evidences on Safety and Effectiveness

Background: Recent advances in the intravascular diseases have led to the entrance of drug-eluting balloon (DEB) technology. The DEB is a relatively new and easier way to treat vascular stenosis. In this study as part of rapid health technology assessment, we aimed to assess this technology in comparison with drug-eluting stent (DES), uncoated balloon and bare-metal stent in terms of efficacy and safety in common indications by reviewing available clinical evidences. Methods: In order to evaluate the safety and effectiveness of DEB, a non-systematic review on electronic databases including Cochrane, PubMed, INAHTA, CRD, Scopus, Medline, Trip database, and Google Scholar was conducted by keywords: “balloon angioplasty," “drug eluting balloon," “drug eluting stent." Results: DEBs could be suggested as a more effective and safe intervention compared with uncoated balloon angioplasty in patients with in-stent restenosis and peripheral vascular disease however there were not adequate evidences supporting the superiority of DEB compared with DES. There were not also adequate evidences comparing DEB with uncoated balloons or DES for decision making about de novo lesion and small vessel arteries. Conclusion: Conducting an economic evaluation to assess the cost effectiveness of this technology has to be also taken into account for more adequate decision making.