Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis: Results of the Paris feasibility clinical trial

R. Waksman, J. R. Laird, C. T. Jurkovitz, A. J. Lansky, F. Gerrits, A. S. Kosinski, N. Murrah, W. S. Weintraub

Research output: Contribution to journalArticle

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Abstract

PURPOSE: To conduct a feasibility study to assess the feasibility, safety, and outcome of endoluminal gamma radiation therapy after balloon angioplasty of superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: Forty patients with claudication were enrolled in the study and underwent percutaneous transluminal angioplasty (PTA) of SFA lesions with a mean lesion length of 9.8 cm ± 3.0 and a mean reference vessel diameter of 5.2 mm ± 3.1. After successful PTA, a segmented centering balloon catheter was positioned to cover the PTA site. The patients were then transported to the radiation oncology suite and treated with a microSelectron HDR afterloader with use of an Ir-192 source with a prescribed dose of 14 Gy, 2 mm into the vessel wall. Ankle-brachial index (ABI) and Rutherford score were evaluated at 1, 6, and 12 months after the procedure and angiographic follow-up was conducted at 6 months. RESULTS: Radiation was delivered successfully to 35 of 40 patients. There were no procedural complications. Exercise and rest ABI were higher at 1 year (0.72 ± 0.26 and 0.89 ± 0.18, respectively) compared to baseline (0.51 ± 0.25 and 0.67 ± 0.17, respectively). Maximum walking time on a treadmill increased from 3.41 min ± 2.41 to 4.43 min ± 2.49 at 30 days and was 4.04 min ± 2.8 at 12 months. The angiographic binary restenosis rate at 6 months was 17.2% and the clinical restenosis rate at 12 months was 13.3%. There were no angiographic or clinical adverse events related to the radiation therapy. CONCLUSIONS: Intraarterial radiation after PTA of SFA lesions with use of high-dose rate gamma radiation is feasible and safe. The angiographic and clinical improvements are sustainable at 1 year and represent a potent antirestenotic therapy for the treatment of narrowed peripheral arteries.

Original languageEnglish (US)
Pages (from-to)915-921
Number of pages7
JournalJournal of Vascular and Interventional Radiology
Volume12
Issue number8
StatePublished - 2001
Externally publishedYes

Fingerprint

Balloon Angioplasty
Paris
Angioplasty
Radiotherapy
Femoral Artery
Arteries
Clinical Trials
Ankle Brachial Index
Gamma Rays
Radiation
Radiation Oncology
Feasibility Studies
Walking
Catheters
Exercise
Safety
Therapeutics

Keywords

  • Angioplasty
  • Arteries, femoropopliteal
  • Radiation therapy
  • Restenosis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis : Results of the Paris feasibility clinical trial. / Waksman, R.; Laird, J. R.; Jurkovitz, C. T.; Lansky, A. J.; Gerrits, F.; Kosinski, A. S.; Murrah, N.; Weintraub, W. S.

In: Journal of Vascular and Interventional Radiology, Vol. 12, No. 8, 2001, p. 915-921.

Research output: Contribution to journalArticle

Waksman, R, Laird, JR, Jurkovitz, CT, Lansky, AJ, Gerrits, F, Kosinski, AS, Murrah, N & Weintraub, WS 2001, 'Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis: Results of the Paris feasibility clinical trial', Journal of Vascular and Interventional Radiology, vol. 12, no. 8, pp. 915-921.
Waksman, R. ; Laird, J. R. ; Jurkovitz, C. T. ; Lansky, A. J. ; Gerrits, F. ; Kosinski, A. S. ; Murrah, N. ; Weintraub, W. S. / Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis : Results of the Paris feasibility clinical trial. In: Journal of Vascular and Interventional Radiology. 2001 ; Vol. 12, No. 8. pp. 915-921.
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abstract = "PURPOSE: To conduct a feasibility study to assess the feasibility, safety, and outcome of endoluminal gamma radiation therapy after balloon angioplasty of superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: Forty patients with claudication were enrolled in the study and underwent percutaneous transluminal angioplasty (PTA) of SFA lesions with a mean lesion length of 9.8 cm ± 3.0 and a mean reference vessel diameter of 5.2 mm ± 3.1. After successful PTA, a segmented centering balloon catheter was positioned to cover the PTA site. The patients were then transported to the radiation oncology suite and treated with a microSelectron HDR afterloader with use of an Ir-192 source with a prescribed dose of 14 Gy, 2 mm into the vessel wall. Ankle-brachial index (ABI) and Rutherford score were evaluated at 1, 6, and 12 months after the procedure and angiographic follow-up was conducted at 6 months. RESULTS: Radiation was delivered successfully to 35 of 40 patients. There were no procedural complications. Exercise and rest ABI were higher at 1 year (0.72 ± 0.26 and 0.89 ± 0.18, respectively) compared to baseline (0.51 ± 0.25 and 0.67 ± 0.17, respectively). Maximum walking time on a treadmill increased from 3.41 min ± 2.41 to 4.43 min ± 2.49 at 30 days and was 4.04 min ± 2.8 at 12 months. The angiographic binary restenosis rate at 6 months was 17.2{\%} and the clinical restenosis rate at 12 months was 13.3{\%}. There were no angiographic or clinical adverse events related to the radiation therapy. CONCLUSIONS: Intraarterial radiation after PTA of SFA lesions with use of high-dose rate gamma radiation is feasible and safe. The angiographic and clinical improvements are sustainable at 1 year and represent a potent antirestenotic therapy for the treatment of narrowed peripheral arteries.",
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T1 - Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis

T2 - Results of the Paris feasibility clinical trial

AU - Waksman, R.

AU - Laird, J. R.

AU - Jurkovitz, C. T.

AU - Lansky, A. J.

AU - Gerrits, F.

AU - Kosinski, A. S.

AU - Murrah, N.

AU - Weintraub, W. S.

PY - 2001

Y1 - 2001

N2 - PURPOSE: To conduct a feasibility study to assess the feasibility, safety, and outcome of endoluminal gamma radiation therapy after balloon angioplasty of superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: Forty patients with claudication were enrolled in the study and underwent percutaneous transluminal angioplasty (PTA) of SFA lesions with a mean lesion length of 9.8 cm ± 3.0 and a mean reference vessel diameter of 5.2 mm ± 3.1. After successful PTA, a segmented centering balloon catheter was positioned to cover the PTA site. The patients were then transported to the radiation oncology suite and treated with a microSelectron HDR afterloader with use of an Ir-192 source with a prescribed dose of 14 Gy, 2 mm into the vessel wall. Ankle-brachial index (ABI) and Rutherford score were evaluated at 1, 6, and 12 months after the procedure and angiographic follow-up was conducted at 6 months. RESULTS: Radiation was delivered successfully to 35 of 40 patients. There were no procedural complications. Exercise and rest ABI were higher at 1 year (0.72 ± 0.26 and 0.89 ± 0.18, respectively) compared to baseline (0.51 ± 0.25 and 0.67 ± 0.17, respectively). Maximum walking time on a treadmill increased from 3.41 min ± 2.41 to 4.43 min ± 2.49 at 30 days and was 4.04 min ± 2.8 at 12 months. The angiographic binary restenosis rate at 6 months was 17.2% and the clinical restenosis rate at 12 months was 13.3%. There were no angiographic or clinical adverse events related to the radiation therapy. CONCLUSIONS: Intraarterial radiation after PTA of SFA lesions with use of high-dose rate gamma radiation is feasible and safe. The angiographic and clinical improvements are sustainable at 1 year and represent a potent antirestenotic therapy for the treatment of narrowed peripheral arteries.

AB - PURPOSE: To conduct a feasibility study to assess the feasibility, safety, and outcome of endoluminal gamma radiation therapy after balloon angioplasty of superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: Forty patients with claudication were enrolled in the study and underwent percutaneous transluminal angioplasty (PTA) of SFA lesions with a mean lesion length of 9.8 cm ± 3.0 and a mean reference vessel diameter of 5.2 mm ± 3.1. After successful PTA, a segmented centering balloon catheter was positioned to cover the PTA site. The patients were then transported to the radiation oncology suite and treated with a microSelectron HDR afterloader with use of an Ir-192 source with a prescribed dose of 14 Gy, 2 mm into the vessel wall. Ankle-brachial index (ABI) and Rutherford score were evaluated at 1, 6, and 12 months after the procedure and angiographic follow-up was conducted at 6 months. RESULTS: Radiation was delivered successfully to 35 of 40 patients. There were no procedural complications. Exercise and rest ABI were higher at 1 year (0.72 ± 0.26 and 0.89 ± 0.18, respectively) compared to baseline (0.51 ± 0.25 and 0.67 ± 0.17, respectively). Maximum walking time on a treadmill increased from 3.41 min ± 2.41 to 4.43 min ± 2.49 at 30 days and was 4.04 min ± 2.8 at 12 months. The angiographic binary restenosis rate at 6 months was 17.2% and the clinical restenosis rate at 12 months was 13.3%. There were no angiographic or clinical adverse events related to the radiation therapy. CONCLUSIONS: Intraarterial radiation after PTA of SFA lesions with use of high-dose rate gamma radiation is feasible and safe. The angiographic and clinical improvements are sustainable at 1 year and represent a potent antirestenotic therapy for the treatment of narrowed peripheral arteries.

KW - Angioplasty

KW - Arteries, femoropopliteal

KW - Radiation therapy

KW - Restenosis

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