Comparison of drug-eluting balloon versus drug-eluting stent treatment of drug-eluting stent in-stent restenosis: A meta-analysis of available evidence.

Background: In-stent restenosis (ISR) remains an important concern despite the recent advances in the drug-eluting stent (DES) technology. The introduction of drug-eluting balloons (DEB) offers a good solution to such problem.

Objectives: We performed a meta-analysis to assess the clinical efficiency and safety of DEB compared with DES in patients with DES-ISR.

Methods: A systematic search was conducted and all randomized and observational studies which compared DEB with DES in patients with DES-ISR were included. The primary outcome measure-major adverse cardiovascular events (MACE)-as well as individual events as target lesion revascularization (TLR), stent thrombosis (ST), myocardial infarction (MI), cardiac death (CD) and all-cause mortality, were analyzed.

Results: Three randomized and 4 observational studies were included with a total of 2052 patients. MACE (relative risk [RR]=1.00, 95% confidence interval (CI) 0.68 to 1.46, P=0.99), TLR (RR=1.15 [CI 0.79 to 1.68], P=0.44), ST (RR=0.37[0.10 to 1.34], P=0.13), MI (RR=0.97 [0.49 to 1.91], P=0.93) and CD (RR=0.73 [0.22 to 2.45], P=0.61) were not different between patients treated with DEB and with DES. However, all-cause mortality was lower in patients treated with DEB (RR=0.45 [0.23 to 0.87, P=0.019) and in particular when compared to only first generation DES (RR 0.33 [0.15-0.74], P=0.007). There was no statistical evidence for publication bias.

Conclusions: The results of this meta-analysis showed that DEB and DES have similar efficacy and safety for the treatment of DES-ISR.