Drug-eluting balloons versus drug-eluting stents for the management of in-stent restenosis: A meta-analysis of randomized and observational studies.

OBJECTIVES: The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) with drug-eluting stents (DES) in patients with in-stent restenosis (ISR).

BACKGROUND: DES implantation and DEB were available strategies in percutaneous coronary intervention (PCI) for ISR, but the optimal management for ISR lesions remains controversial.

METHODS: Electronic databases were searched for randomized controlled trials and observational cohort studies which reported the clinical outcomes of using DEB comparing with DES implantation in patients with ISR. Clinical endpoints such as major adverse cardiovascular events (MACE), death, and myocardial infarction were assessed.

RESULTS: Five randomized controlled trials and five observational cohort studies with 962 patients in the DEB group and 908 patients in the DES group met inclusion criteria. There was no significant difference between DEB and DES in major clinical outcomes, such as MACE (OR 1.01; 95% CI: 0.64-1.58; p=0.97; I2 =0%), all-cause death (OR 1.04; 95% CI: 0.54-1.98; p=0.91; I2 =0%), cardiovascular death (OR 1.44; 95% CI: 0.57-3.65; p=0.44; I2 =0%), stent thrombosis (OR 0.61; 95% CI: 0.16-2.33; p=0.47; I2 =0%), and myocardial infarction (OR 1.02; 95% CI: 0.53-1.94; p=0.96; I2 =0%). DEB was associated with a significant increase in target lesion revascularization (OR 1.54; 95% CI: 1.10-2.15; p=0.01; I2 =57%).

CONCLUSION: Treatment of ISR using DEB led to comparable clinical outcomes with DES implantation.