Efficacy of Drug-Eluting Balloons for Patients With In-Stent Restenosis: A Meta-Analysis of 8 Randomized Controlled Trials.

The optimal treatment for in-stent restenosis (ISR) of both bare-metal stent (BMS) and drug-eluting stent (DES) is currently unclear. The aim of this meta-analysis was to assess the role of drug-eluting balloon (DEB) as an optional treatment for ISR. We searched PubMed, MEDLINE, EMBASE, BIOS, and Web of Science from 2005 to July 2014. Eight studies, enrolling 1413 patients were included. Main end points were late lumen loss (LLL), binary in-segment restenosis (BR), major adverse cardiac events (MACEs), target lesion revascularization (TLR), death, myocardial infarction (MI), and stent thrombosis (ST). When compared to plain old balloon angioplasty (POBA), DEB treatment significantly reduced the risk of MACE (risk rato [RR] 0.37, P < .01), death (RR 0.44, P = .04), TLR (RR 0.27, P < .01), BR (RR [95% CI]: 0.23[0.12 to 0.43], P < .01) and associated with better outcomes of LLL ( 0.50 [ 0.65 to 0.35] mm, P < .01). However, the differences were not significant between DEB treatment and DES treatment in all primary and secondary end points. The DEB was a better option to treat ISR when compared to POBA. However, it had similar effects as DES.