FX minirail balloon angioplasty for the treatment of patients with in-stent restenosis: a matched comparison of 6 months' outcome with conventional balloon angioplasty.

The optimal treatment for in-stent restenosis (ISR) is a subject of controversy. Recently, FX minirail balloon angioplasty (BA) has emerged as a management tool for ISR. We assessed the hypothesis that the FX minirail BA has advantages over conventional percutaneous transluminal balloon angioplasty (PTCA) in the treatment of ISR. FX minirail BA or PTCA were applied to 116 patients with ISR (145 lesions) at our institution. Using a computer algorithm, an attempt was made to match each lesion in the FX minirail BA group with a corresponding lesion in the PTCA group. The lesion pairs should match with respect to the patients' age and sex, type of target vessel and stent, reference vessel diameter, and baseline minimal lumen diameter (MLD). Following the matching process, 46 ISR lesion pairs were identified. Baseline patient characteristics were similar among the groups (P=not significant). There was no difference in the in-hospital major adverse cardiac events (MACE) between the groups, whereas MACE at follow-up were significantly lower in the FX minirail BA group than in the PTCA group (19.6% vs 41.3%, P <0.05). The recurrent ISR rate was significantly lower in the FX minirail BA group than in the PTCA group (19.6% vs 39.1%, P <0.05). Also, a diffuse pattern of recurrence was more common in lesions treated with PTCA, whereas the focal pattern of recurrence was more common in the FX minirail BA group (22.2% vs 50%, P <0.05). The MLD at follow-up, the acute gain, and net gain were significantly higher in the group of lesions treated with the FX minirail BA than in the PTCA group. In addition, a significantly higher late loss and loss index at follow-up were observed in the PTCA group compared in the FX minirail BA group. The FX minirail BA has advantages over PTCA in the treatment of patients with ISR, with better immediate and follow-up angiographic outcomes, and a better clinical outcome on follow-up.