De novo femoropopliteal stenoses: endovascular gamma irradiation following angioplasty--angiographic and clinical follow-up in a prospective randomized controlled trial.
OBJECTIVE
To assess and report the follow-up results of a randomized controlled trial on centered endovascular gamma irradiation performed after percutaneous transluminal angioplasty (PTA) for de novo femoropopliteal stenoses.


METHODS
Thirty patients who underwent PTA for de novo femoropopliteal stenoses were randomly assigned to undergo 14-Gy centered endovascular irradiation (irradiation group, n = 15) or no irradiation (control group, n = 15). Intraarterial angiography was performed 6, 12, and 24 months after treatment; duplex ultrasonography (US), the day before and after PTA and 1, 3, 6, 9, 12, 18, and 24 months later. Treadmill tests and interviews were performed the day before PTA and 1, 3, 6, 9, 12, 18, and 24 months later. Results of angiography, duplex US, treadmill tests, and interviews were evaluated with the nonpaired t or the Fisher exact test.


RESULTS
Baseline characteristics did not differ significantly between the two groups. Mean absolute individual changes in degree of stenosis, compared with the degrees of stenosis shortly after PTA, in the irradiation group versus in the control group were -10.6% +/- 22.3 versus 39.6% +/- 24.6 (P <.001) at 6 months, -2.0% +/- 34.2 versus 40.6% +/- 32.6 (P =.002) at 12 months, and 7.4% +/- 43.2 versus 37.7% +/- 34.5 (P =.043) at 24 months. The rates of target lesion restenosis at 6 (P =.006) and 12 (P =.042) months were significantly lower in the irradiation group. The numbers of target lesion re-treatments were similar between the groups, but target vessel re-treatments were more frequent in the irradiation group. There were no significant differences in interview or treadmill test results between the two groups at t test analysis.


CONCLUSIONS
The degree of stenosis was significantly reduced 6, 12, and 24 months after angioplasty of de novo femoropopliteal stenoses in the patients who underwent endovascular irradiation.
Krueger
Karsten
K
Department of Radiology, Universityof Cologne, Joseph-Stelzmann-Str, D-50924 Cologne, Germany. karsten.krueger@uni-koeln.de
Zaehringer
Markus
M
Bendel
Mark
M
Stuetzer
Hartmut
H
Strohe
David
D
Nolte
Monika
M
Wittig
Daniele
D
Mueller
Rolf-Peter
RP
Lackner
Klaus
K
D000368:Aged; D000792:Angiography; D017130:Angioplasty; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000532:radiotherapy* / Q000601:surgery*; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011446:Prospective Studies