A Phase II study of external-beam radiotherapy and endovascular brachytherapy with PTA and stenting for femoropopliteal artery restenosis.
OBJECTIVE
To assess the safety and seek evidence of efficacy of combined external-beam radiotherapy (EBRT) and endovascular brachytherapy in the treatment of stenotic vascular lesions.


METHODS
Seventeen patients with high risk for restenosis of femoropopliteal arteries were enrolled in this study from February 2000 to August 2002. The external beam radiotherapy regimen consisted of 10 Gy in 5 fractions of 2 Gy, starting on Day 0. This was followed on Day 6 by angiography, stent placement, and intraluminal brachytherapy to a dose of 10 Gy at 1.2 mm from stent surface. The EBRT was continued from the same day to another 10 Gy in 2 Gy daily fractions for 5 days.


RESULTS
The follow up ranged from 33 months to 60 months. At the time of analysis 15 of 17 patients were alive with patent stents. Of these, 10 were symptom-free. Two patients died of unrelated causes.


CONCLUSIONS
The combination of EBRT and endovascular brachytherapy provided adequate dose distribution without any geographical miss or "candy wrapper" restenosis. No incidence of aneurysmal dilation of radiated vascular segment was observed. The treatment was feasible, well tolerated, and achieved 88% stenosis free survival.
Narayan
Kailash
K
Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. kailash.narayan@petermac.org
Denton
Michael
M
Das
Ram
R
Bernshaw
David
D
Rolfo
Aldo
A
van Dyk
Sylvia
S
Mirakian
Alex
A
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000379:methods*; D001157:Arterial Occlusive Diseases / Q000532:radiotherapy / Q000628:therapy*; D001918:Brachytherapy / Q000379:methods; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011879:Radiotherapy Dosage; D015607:Stents