External beam radiotherapy fails to prevent restenosis after iliac or femoropopliteal percutaneous transluminal angioplasty: results of a prospective randomized double-blind study.
OBJECTIVE
Early restenosis is one of the major complications after successful percutaneous transluminal angioplasty (PTA), in main, as well as peripheral, arteries. The effectiveness of hypofractionated external beam radiotherapy (EBRT) as a prophylaxis for restenosis was examined in a prospective, randomized, double-blind, clinical trial.


METHODS
Forty-eight patients underwent sham RT and 47 were treated with daily RT in 3-Gy fractions, to a total dose of 21 Gy. The follow-up lasted for 12 months, and the examinations included pressure measurements and calculations of the ankle-brachial index or duplex sonography ("peak velocity ratio"). If restenosis was suspected, additional angiography was performed.


RESULTS
No statistically significant difference was found between the treatment groups: sham RT 16 failures (33.3%) and EBRT group 21 failures (45.7%; p = 0.292). EBRT also showed no substantial effects on subgroups classified by the specific length of the lesion or in diabetic patients.


CONCLUSIONS
External beam radiotherapy does not prevent restenosis. A reduction in the failure rate >8% using fractionated EBRT with doses aimed at keloid prevention can be ruled out with a probability of 97.5%. Endovascular brachytherapy remains the preferred therapeutic method for achieving restenosis prophylaxis through RT.
Fritz
Peter
P
Department of Radiotherapy, University of Heidelberg, Heidelberg, Germany. P.H.Fritz@t-online.de
Stein
Uwe
U
Hasslacher
Christoph
C
Zierhut
Dietmar
D
Wannenmacher
Michael
M
Pritsch
Maria
M
D000368:Aged; D000800:Angioplasty, Balloon; D003251:Constriction, Pathologic / Q000517:prevention & control / Q000532:radiotherapy; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery; D006801:Humans; D007083:Iliac Artery; D008297:Male; D016491:Peripheral Vascular Diseases / Q000517:prevention & control* / Q000532:radiotherapy / Q000628:therapy; D011150:Popliteal Artery; D011446:Prospective Studies; D055502:Secondary Prevention