Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

OBJECTIVE: This study aimed to compare the effectiveness of drug-coated balloons (DCB) with everolimus-eluting stents (EES) in the treatment of in-stent restenosis (ISR) and the differential relative effect of DCB in patients with drug-eluting stents (DES)-ISR and bare metal stents (BMS)-ISR. BACKGROUND: The efficiency and safety of DCB and EES need to be assessed for the treatment of ISR. METHODS: A systematic literature search was conducted using PubMed and EMBASE to identify all relevant studies. Angiographic results and clinical events were separately assessed. Subgroup meta-analyses were performed according to the type of restenosed stent. RESULTS: Six randomized trials with 1134 patients were included. The overall pooled outcomes indicated that DCB was associated with lower minimum lumen diameter (mean difference (MD) = −0.17, 95% CI = −0.29 to −0.05, P = 0.006) and higher target lesion revascularization (risk ratio (RR) = 2.38, 95% CI = 1.36 to 4.18, P = 0.002) than EES. However, the subgroup meta-analyses showed that DCB was inferior to EES only in DES-ISR patients, with lower minimum lumen diameter (MD = −0.25, 95% CI = −0.37 to −0.14, P < 0.001), higher percent diameter stenosis (MD = 5.37, 95% CI = 1.33 to 9.42, P = 0.009), more binary restenosis (RR = 2.07, 95% CI = 1.20 to 3.58, P = 0.009), and higher incidence of target vessel revascularization (RR = 2.07, 95% CI = 1.22 to 3.50, P = 0.007) and target lesion revascularization (RR = 2.43, 95% CI = 1.28 to 4.22, P = 0.002). No differences in angiographic results and clinical events were found between DCB and EES in BMS-ISR patients. CONCLUSIONS: DCB was inferior to EES in DES-ISR and comparable in BMS-ISR in terms of angiographic results and clinical events.