Introduction: Conventional percutaneous coronary intervention for the treatment of in-stent restenosis (ISR) has shown a high rate of ISR (30-55%). Considering the need for both extrusion of hyperplastic intima and additional stent expansion, a cutting balloon might be more effective for the treatment of ISR.
Methods: We prospectively assessed the immediate and 8-month outcome of balloon angioplasty using the Barath Cutting Balloon in 100 consecutive patients (mean age: 60.5 +/- 10.8 years, 71% male).
Results: In 73 lesions (73%), a good result was reached with the cutting balloon only. In 21 lesions (21%) postdilatation and in 6 lesions (6%) predilatation with a conventional balloon was necessary. The mean inflation pressure was 8.7 +/- 2.0 (range: 6.0-18.0) atm. Before the procedure the mean minimal luminal diameter (MLD) was 0.95 +/- 0.45 mm. Quantitative coronary analysis showed a mean diameter stenosis of 65%+/- 16%. Immediately after the procedure the mean MLD was 2.42 +/- 0.54 mm with a mean diameter stenosis of 19%+/- 13%. Two patients died during the follow-up period (1 stroke, 1 nonvascular). At 8-month follow-up 26 patients (26%) reported to have anginal complaints CCS class II-IV of whom 16 (16%) needed target lesion revascularization.
Conclusion: Treatment of ISR using the Barath Cutting Balloon can be performed safely with good immediate results and a relatively low need for repeated target lesion revascularization at 8-month follow-up.