E. Minar et al., Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty - Results of a prospective randomized study, CIRCULATION, 102(22), 2000, pp. 2694-2699
Citations number
21
Categorie Soggetti
Cardiovascular & Respiratory Systems","Cardiovascular & Hematology Research
Background-inasmuch as endovascular brachytherapy (BT) has gained recent in
terest because of its inhibitory effect on mechanisms leading to restenosis
after percutaneous transluminal angioplasty (PTA), we performed this rando
mized study to determine its efficacy for prophylaxis of restenosis after f
emoropopliteal PTA.
Methods and Results-One hundred thirteen patients (63 men, 50 women; mean a
ge 71 years) with de novo or recurrent femoropopliteal lesions were include
d in this randomized trial comparing the restenosis rate after PTA plus BT
(57 patients, PTA+BT group) versus PTA (56 patients, PTA group) without ste
nt implantation. The mean treated length was 16.7 cm (PTA+BT group) versus
14.8 cm (PTA group). In patients randomized to PTA plus BT,a dose of 12 Cy
was applied by an Ir-192 source 3 mm from the source axis. Follow-up examin
ations included measurement of the ankle-brachial index, color-flow duplex
sonography, and angiography. The primary end point of the study was patency
after 6 months. The overall recurrence rate after 6 months was 15 (28.3%)
of 53 in the PTA+BT group versus 29 (53.7%) of 54 in the PTA group (chi (2)
test, P<0.05). The cumulative patency rates at 12 months of fellow-up were
63.6% in the PTA+BT group and 35.3% in the PTA group (log-rank test, P<0.0
05).
Conclusions-This is the first randomized study to demonstrate the efficacy
of endovascular BT for prophylaxis of restenosis after femoropopliteal PTA.
The value of this approach should now be improved by modification of the B
T procedure and by combination with stent implantation.