Endovascular brachytherapy after percutaneous transluminal angioplasty of recurrent femoropopliteal obstructions.
OBJECTIVE
To test the preventive effect of endovascular brachytherapy (EVBT) on restenosis following secondary angioplasty in patients with presumed neointimal restenosis in the femoropopliteal segment.


METHODS
From March 1997 through May 2000, 100 patients (58 men; mean age 70 years, range 45-87) with postangioplasty femoropopliteal segment restenoses were enrolled and randomized to treatment with repeat angioplasty and EVBT (n=51) or to angioplasty alone (n=49) as control. The groups were similar with regard to demographics and lesion characteristics. High-dose-rate EVBT was performed with (192)Ir irradiation without a centering device (12 Gy for a reference vessel radius of 3 mm and a 2-mm reference depth). Primary endpoint in the 1-year follow-up was recurrent obstruction >50% documented by duplex ultrasound; the secondary endpoint was clinical improvement.


RESULTS
Only 44 (86%) of 51 patients received adequate EVBT due to technical failure, so the 7 failures were included with the controls in the per-protocol adherence analysis. At 1 year, the patients receiving EVBT had a restenosis rate of 23% (10/44), which differed significantly (p<0.028) from the 42% (23/56) rate in controls. Clinical results tended to be better with EVBT, but differences did not achieve statistical significance.


CONCLUSIONS
EVBT without a centering device reduced restenosis significantly in patients with recurrent stenosis after angioplasty, which confirms previous results in primary long-segment femoropopliteal obstructions.
Zehnder
Thomas
T
Cardiovascular Department, Division of Angiology, University Hospital (Inselspital), Bern, Switzerland.
von Briel
Christian
C
Baumgartner
Iris
I
Triller
Jürgen
J
Greiner
Richard
R
Mahler
Felix
F
Do
Dai-Do
DD
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D001918:Brachytherapy; D003131:Combined Modality Therapy; D005260:Female; D005263:Femoral Artery / Q000528:radiation effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D011150:Popliteal Artery / Q000528:radiation effects*; D011446:Prospective Studies; D019233:Retreatment; D055502:Secondary Prevention