Abstract Introduction Drug-coated balloon angioplasty with paclitaxel-eluting devices (PCB) is an established treatment for coronary in-stent restenosis (ISR). Using a new biolimus-coated balloon (BCB) or sirolimus-coated balloon (SCB) may be non-inferior to using a standard PCB. This study aimed to do a meta-analysis comparing outcomes in patients undergoing treatment for ISR with BCB or SCB vs PCB. Methods Pubmed, SCOPUS and Cochrane Central were searched for cohort studies and randomized controlled trials (RCTs) that directly compared "-limus" coated balloons (BCB or SCB) to PCB for the treatment of in-stent restenosis. Outcomes of interest were: target lesion revascularization (TLR), stent thrombosis, late lumen loss (LLL), minimal lumen diameter (MLD), myocardial infarction (MI), major adverse cardiovascular events (MACE) and diameter stenosis. The results were expressed in risk ratio (RR) or mean difference (MD). Statistical analysis was performed using Review Manager and heterogeneity was assessed with I2 statistics. Results We included 1000 patients from six studies, of which five were randomised controlled trials. BCB or SCB were used to treat ISR in 534 (53.4%) patients. The follow-up period ranged from 6 to 12 months. TLR (RR 1.36; CI 0.74, 2.50; P = 0.32), stent thrombosis (RR 0.33; CI 0.05, 2.07; P = 0.24), MI (OR 1.06; CI 0.27, 4.15; P = 0.94), MACE (RR 1.10; CI 0.50, 2.39; P = 0.81) and diameter stenosis (MD 3.55; CI -1.91, 9.02; P = 0.20) showed no significant differences between treatment groups. LLL (MD -0.02; CI -0.10, 0.06; P = 0.57) and MLD (MD -0.03; CI -0.13, 0.08; P = 0.61) also did not show any relevant differences between the two treatments. Conclusions In patients treated with a drug-coated balloon for ISR, the use of a Biolimus-coated balloon or Sirolimus-coated balloon did not show any significant difference regarding the risk of TLR, stent thrombosis, MI, MACE, diameter stenosis, LLL or MLD when compared to a Paclitaxel-coated balloon. Further research is needed to fully unveil the potential benefits of these novel devices, since our study did not achieve statistical significance for non-inferiority.
Lecchi et al. (Sat,) studied this question.