Acute outcome with the flexicut directional coronary atherectomy catheter for the treatment of coronary in-stent restenosis.

In-stent restenosis (ISR) is a growing problem that is without a practical, efficacious treatment strategy. The purpose of this study was to determine the acute outcome of 17 patients with coronary ISR who were treated with the new 8 French (Fr), guide-catheter compatible Flexicut directional atherectomy catheter (Guidant Corporation, Santa Clara, California). Failure to deliver the device occurred in 2/17 ISR lesions. The remaining 15 ISR lesions were successfully debulked (e.g., minimum lumen diameter pre-procedure: 0.30 +/- 0.16 mm; post-atherectomy plus adjuvant therapy: 2.16 +/- 0.57 mm). Of note, the reference vessel diameter was only 2.62 +/- 0.63 mm. In 11/15 tissue specimens, macroscopic or microscopic particles consistent with stent material were found. There was an absence of acute closure or elevations of creatinine phosphokinase levels. Apart from 1 patient who developed recurrent restenosis, all other patients demonstrated either clinical improvement or lack of restenosis during early clinical follow-up (mean, 5 months). We conclude that use of the Flexicut catheter provides satisfactory debulking and early clinical outcomes in patients with ISR. Long-term follow-up of these and additional patients will be helpful in determining the efficacy of the Flexicut atherectomy catheter for the treatment of ISR.