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(Circulation. 2000;102:2694.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Endovascular Brachytherapy for Prophylaxis of Restenosis After Femoropopliteal Angioplasty
Results of a Prospective Randomized Study
From the Department of Angiology (E.M., T.M., R.A., R.W.), the Department of Radiotherapy and Radiobiology (B.P., C.F., W.S., R.P.), and the Department of Medical Computer Sciences (M.M.), University of Vienna, General Hospital Vienna, Vienna, Austria.
Correspondence to Prof Erich Minar, Department of Angiology, University of Vienna, General Hospital Vienna, A-1097 Vienna, Austria. E-mail erich.minar{at}akh-wien.ac.at
Background—Inasmuch as endovascular brachytherapy (BT) has gained recent interest because of its inhibitory effect on mechanisms leading to restenosis after percutaneous transluminal angioplasty (PTA), we performed this randomized study to determine its efficacy for prophylaxis of restenosis after femoropopliteal PTA.
Methods and Results—One
hundred thirteen patients (63 men, 50 women; mean age 71 years) with de
novo or recurrent femoropopliteal lesions were included in this
randomized trial comparing the restenosis rate after PTA plus BT (57
patients, PTA+BT group) versus PTA (56 patients, PTA group) without
stent 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 Gy was applied by an 192Ir source
3 mm from the source axis. Follow-up examinations 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
(
2 test, P<0.05). The
cumulative patency rates at 12 months of follow-up were 63.6% in the
PTA+BT group and 35.3% in the PTA group (log-rank test,
P<0.005).
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 BT procedure and by combination with stent implantation.
Key Words: peripheral vascular disease • angioplasty • restenosis • radioisotopes
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