Abstract Body (Do not enter title and authors here): Background: Drug-coated balloons present a potentially advantageous therapeutic approach for managing coronary in-stent restenosis. However, the comparative benefits of paclitaxel-coated balloons (PCBs) over uncoated balloons (UCBs) in coronary interventions remain unclear. Therefore, we conducted a systematic review and meta-analysis with trial sequential analysis (TSA) to evaluate the clinical outcomes of patients treated with PCBs compared to those treated with UCBs for coronary in-stent restenosis.
Methods: We searched PubMed, Embase and Cochrane databases for randomized clinical trials (RCTs) comparing the use of PCBs and UCBs in the treatment of coronary in-stent restenosis. A random-effects model was employed to pool odds ratios (ORs) and their 95% confidence intervals (CIs). Statistical analyses were performed using Review Manager version 5.4.1. and TSA version 0.9.5.10 beta.
Results: We included 7 RCTs with a total of 1,344 patients, of whom 834 underwent percutaneous coronary intervention (PCI) with PCBs. In our pooled analysis, patients treated with PCBs had lower odds of target lesion revascularization (OR 0.21; 95% CI 0.11 – 0.40; P<0.01; Figure 1A), target vessel revascularization (OR 0.43; 95% CI 0.32 – 0.59; P<0.01), major adverse cardiac events (MACE) (OR 0.15; 95% CI 0.09 – 0.27; P<0.01; Figure 1B), and myocardial infarction (OR 0.56; 95% CI 0.33 – 0.94; P=0.03). However, there were no significant differences between groups in the odds of all-cause mortality (OR 0.56; 95% CI 0.18–1.77; P=0.33), cardiac death (OR 0.81; 95% CI 0.12 – 5.27; P= 0.82) and stent thrombosis (OR 0.20; 95% CI 0.03 – 1.36; P=0.10). TSA indicates that the observed effect on the primary outcome of TLR can be deemed conclusive, with a low risk of type 1 error.
Conclusions: These findings suggest that PCBs are superior to UCBs regarding the occurrence of target lesion revascularization, target vessel revascularization, MACE, and myocardial infarction. Nonetheless, there were no significant differences in the odds of all-cause mortality, cardiac death, and stent thrombosis.