Abstract

Background: The clinical efficacy of paclitaxel-coated balloon (PCB) and statin therapy have been proven in the treatment of instent restenosis (ISR). However, there are no data with clinical follow-ups to support statin therapy in ISR patients treated after PCB. The aim of this study was to investigate the impact of statin therapy in ISR patients treated after PCB.

Methods: A retrospective study was performed of patients who underwent PCB for ISR from 2012 to 2014. A total of 102 patients (mean age: 70.9; 70% men; 69.5% with statin therapy) with 131 lesions [(bare-metal stent restenosis (BMS-ISR); 90 lesions, drug-eluting stent restenosis (DES-ISR); 41 lesions)] were analyzed in this study. The mean of follow-up days is 786.03 ± 350.80 days.

Result: DES-ISR has higher target lesion revascularization (TLR) [14 vs. 9, p < 0.001] and major adverse coronary events (MACE) [16 vs. 16, p < 0.01] than BMS-ISR. Statin therapy was associated with a significant reduction in the occurrence of TLR [11 vs. 12, p = 0.01] and MACE [15 vs. 17, p < 0.001]. DES-ISR (AOR: 3.43, CI: 1.30 to 9.04, p = 0.01) and statin therapy (AOR: 0.33, CI: 0.10 to 0.96, p = 0.04) were independent predictors of TLR. DES-ISR (AOR: 2.46, CI: 1.08 to 5.58, p = 0.03) and statin therapy (AOR: 0.31, CI: 0.13 to 0.77, p = 0.01) also were independent predictors of MACE.

Conclusion: It was the first time that statin therapy had proven to improve clinical cardiac outcome in ISR patients treated after PCB.