Failure of prolonged dilation to improve long-term patency of femoropopliteal artery angioplasty: results of a prospective trial.

PURPOSE

To determine long-term patency of femoropopliteal artery percutaneous transluminal angioplasty (PTA) in a prospective trial during which prolonged balloon inflation was used for optimization of initial results.

MATERIALS AND METHODS

Femoropopliteal PTA was performed in 112 limbs of 97 patients. The mean total length of the treated segments was 7.2 cm (95% CI: 5.99-8.46; median: 5.5 cm). In cases of unsatisfactory primary results after standard dilation for 1-3 minutes, the procedure was continued with prolonged dilation (93 limbs; mean balloon inflation time: 31 min; 95% CI: 24.2-37.7; median: 15 min) with use of the same balloon catheter (77 limbs) or a perfusion balloon catheter (35 limbs). Thirty-four proximal infrapopliteal artery stenoses were treated to improve peripheral runoff and 12 short stents were placed because of flow-limiting dissections.

RESULTS

Primary hemodynamic success established by Doppler ultrasound (US) criteria was achieved in 92.9% (104 of 112) of the limbs. Three major complications were encountered; none were related to prolonged balloon inflation. The primary patency rate according to Kaplan-Meier analysis was 42% (+/-5% SE) at 1 year and 39% (+/-5%) at 2 and 3 years. The corresponding secondary patency rates were 51% (+/-5%) and 47% (+/-5%). Large numbers of diseased vessels in the treated limb (four to 10 instead of one to three), eccentric lesions (as opposed to concentric morphology), and additional treated segments (instead of only femoropopliteal lesions) were associated with poorer long-term patency. The duration of balloon dilation was not a determinant of long-term patency.

CONCLUSION

Although prolonged dilation is safe and feasible in femoropopliteal artery PTA, its routine use is not warranted because it does not result in superior long-term patency rates.