Abstract Body (Do not enter title and authors here): Introduction: The potential benefits and risks of paclitaxel-coated balloon (PCB) angioplasty over uncoated balloon (UB) angioplasty in the management of coronary in-stent restenosis (ISR) is not well established.

Hypothesis/Aims: This study aims to determine whether PCB angioplasty is superior to UB angioplasty in patients with coronary ISR in terms of target lesion revascularization (TLR), myocardial infarction (MI), and all-cause mortality rates.

Methods: PubMed, Embase and Cochrane Central databases were systematically searched for randomized clinical trials (RCT) comparing PCB with UB angioplasty in patients with coronary ISR. Statistical analyses were performed using Review Manager version 5.4.1. Risk Ratios (RR) with 95% confidence intervals (CI) for dichotomous endpoints were computed with the use of a Mantel-Haenszel random effects model.

Results: A total of 1,407 patients from 7 randomized clinical trials were included. Follow-up periods in the included studies ranged from 6 months to 1 year. PCB angioplasty significantly reduced TLR (RR 0.28; 95% CI 0.16-0.48; p<0.001) and MI (RR 0.57; 95% CI 0.36-0.92; p=0.02). However, there were no significant differences in all-cause mortality (RR 0.75; 95% CI 0.38-1.50; p=0.42).

Conclusion: In the management of coronary ISR, PCB angioplasty reduced TLR and MI compared with UB angioplasty. Nevertheless, PCB did not have a significant impact on all-cause mortality in comparison with UB. Further studies with extended follow-up are necessary to determine long-term mortality effects.