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Endovascular Gamma Irradiation of Femoropopliteal de Novo Stenoses Immediately after PTA: Interim Results of Prospective Randomized Controlled Trial¹

¹ From the Departments of Radiology (K.K., P.L., M.Z., G.W., A.G., K.L.), Radiooncology (M.B., M.N., R.B., R.P.M.), and the Institute for Medical Statistics, Informatics and Epidemiology (H.S.), University of Cologne, Joseph-Stelzmann-Strasse, D-50924 Cologne, Germany. From the 2001 RSNA scientific assembly. Received May 4, 2001; revision requested June 28; revision received October 9; accepted December 10. Supported by grant 1/98 from Cologne Fortune, a research program of the University of Cologne. Address correspondence to K.K. (e-mail: karsten.krueger@uni-koeln.de).

PURPOSE: To report an interim analysis of whether centered endovascular irradiation with the iridium 192 (¹⁹²Ir) source immediately after percutaneous transluminal angioplasty (PTA) of de novo femoropopliteal stenoses lowers the restenosis rate.

MATERIALS AND METHODS: Thirty patients undergoing PTA to treat femoropopliteal stenoses were randomized for prophylaxis against restenosis with centered endovascular irradiation with a ¹⁹²Ir source (a dose of 14 Gy 2 mm deep to the vessel wall, irradiation group) or no irradiation (control group). Angiographic follow-up was available for 22 patients at 6 months (irradiation group, n = 10) and 12 patients at 12 months (irradiation group, n = 6). Duplex sonography, treadmill testing, and interviews were performed the day before and the day after PTA and after 1, 3, 6, 9, and 12 months. Results of angiography, duplex sonography, treadmill testing, and interviews were evaluated with a t test and multivariate analysis of variance (clinical characteristics, ² test).

RESULTS: Baseline characteristics were comparable in the two groups. Interim analysis of the 6-month follow-up data revealed a trend toward a significantly lower restenosis rate in the irradiation group. The change in the degree of stenosis compared with that after PTA was -14.7% ± 20.8 (mean ± SD) in the irradiation group versus 37.7% ± 27.3 in the control group (P = .001) and became even more marked at 12 months (-9.5% ± 34.5 vs 45.5% ± 40.7 [P = .03], respectively). The follow-up results of treadmill testing and interviews showed a nonsignificant benefit for the irradiation group. One thromboembolic complication occurred during irradiation. No side effects were observed during follow-up.

CONCLUSION: Endovascular irradiation with a centered ¹⁹²Ir source immediately after PTA of de novo femoropopliteal stenoses reduces the restenosis rate.

© RSNA, 2002

Index terms: Arteries, radiation • Arteries, restenosis, 92.44 • Arteries, stenosis or obstruction, 92.72, 92.721 • Arteries, transluminal angioplasty, 92.1281, 92.1286, 92.454 • Iridium, radioactive

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