Abstract Body (Do not enter title and authors here): Introduction
Coronary in-stent restenosis (ISR) remains challenging despite stent technology advancements. Paclitaxel-coated balloons (PCB) offer a promising non-implant approach to deliver antiproliferative agents directly to the vessel wall. This meta-analysis aims to evaluate the comparative effectiveness of PCB versus uncoated balloons (UCB) in managing coronary ISR to address emerging safety concerns.
Methodology
Medline, Scopus and Embase were searched until April 2024 for randomized controlled trials (RCTs) comparing PCB versus UCB in patients undergoing coronary ISR. Primary outcomes were in-segment late lumen loss (LLL), binary restenosis, target lesion revascularization (TLR), major adverse cardiac events (MACE), and mortality. Secondary outcomes included in-stent LLL, in-stent binary restenosis, myocardial infarction (MI), cardiac death, target vessel MI, and target vessel revascularization (TVR).
Results
This meta-analysis includes seven RCTs with 1,408 patients (PCB = 864, UCB = 544). PCB significantly reduced in-segment LLL (MD= -0.50, 95% CI [-0.67, -0.33]; P < 0.00001), in-segment binary restenosis (RR= 0.25, 95% CI [0.14, 0.45]; P < 0.00001), target lesion revascularization (RR= 0.43, 95% CI [0.32, 0.58]; P < 0.00001), mortality (RR=0.56, 95% CI [0.39, 0.80]; P=0.001), and MACE (RR= 0.36, 95% CI [0.25, 0.51]; P < 0.00001). PCB also significantly decreased in-stent LLL (MD= -0.52, 95% CI [-0.72, -0.32]; P < 0.00001), in-stent binary restenosis (RR = 0.19, 95% CI [0.11, 0.35]; P < 0.00001), and TVR (RR = 0.45, 95% CI [0.29, 0.70]; P = 0.0003). PCB showed a short-term reduction in MACE and target lesion revascularization at 6 months, 1 year and 3 years of followup. No difference was observed in MI, cardiac death, or target vessel MI.
Conclusion
In patients with coronary ISR, PCB are associated with reduced in-segment LLL, in-segment binary restenosis events, target lesion revascularization, mortality, MACE, in-stent LLL, in-stent binary restenosis and target vessel revascularization.