Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries.

PURPOSE

Paclitaxel-coated balloon catheters inhibit restenosis after coronary and peripheral angioplasty (PCI,PTA). The aim of this study was to investigate paclitaxel plasma levels and laboratory parameters following PTA with paclitaxel-coated balloons (PCB) in peripheral arteries.

MATERIALS AND METHODS

This single treatment arm, multicenter study included 14 patients with Rutherford stage 1 - 5 with occlusions of up to 5 cm or ≥ 70 % diameter stenosis of the superficial femoral or popliteal arteries (SFA, PA). PTA was performed using up to three PCB catheters. The paclitaxel plasma levels and safety laboratory parameters were determined by collecting blood samples pre-intervention, immediately post-intervention, at 0.5, 1, 2, 4, 8, 24 hours and 1 and 4 weeks post-intervention (p. i.). Vital signs were monitored to assess clinical safety.

RESULTS

PTA was performed successfully in all patients. Paclitaxel plasma levels were always below a level and duration known to cause systemic side effects. A mean peak paclitaxel plasma level (40 ng/ml) was reached immediately p. i. and decreased rapidly below detectable levels in more than half of the patients already 2 hours p. i. The paclitaxel plasma concentrations returned to values below detectable levels at 24 hours p. i. in all patients. Laboratory parameters and vital signs did not give any reason for safety concerns. No adverse events associated with balloon coating were observed.

CONCLUSION

The results of 14 patients with peripheral arterial occlusive disease show no systemic bioavailability of paclitaxel > 24 hours after PTA with one or more PCB catheters, indicating that the PCB catheter is safe with regard to possible systemic effects.