De Novo Femoropopliteal Stenoses: Endovascular Gamma Irradiation Following Angioplasty—Angiographic and Clinical Follow-up in a Prospective Randomized Controlled Trial

Krueger, Karsten; Zaehringer, Markus; Bendel, Mark; Stuetzer, Hartmut; Strohe, David; Nolte, M.; Wittig, Daniele; Mueller, Rolf‐Peter; Lackner, K.

doi:10.1148/radiol.2312030421

Cited by 39 publications

(35 citation statements)

References 34 publications

(35 reference statements)

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“…Only rarely did controlled randomized trials indicate advantages of new methods over standard treatment. [15][16][17] In the present study, the efficacy of a novel drug-coated balloon catheter for the prevention of restenosis after treatment of atherosclerotic femoropopliteal lesions was investigated. The study design included a control group treated with conventional balloon PTA, which is considered the standard therapy.…”

Section: Discussionmentioning

confidence: 99%

Inhibition of Restenosis in Femoropopliteal Arteries

Langner²,

et al. 2008

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Background— The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. The aim of the present pilot study was to evaluate a novel method of local drug delivery. Methods and Results— This randomized multicenter study with blinded reading enrolled 87 patients in Rutherford class 1 to 4 with occlusion or hemodynamically relevant stenosis, restenosis, or in-stent restenosis of femoropopliteal arteries. Treatment was performed by either conventional uncoated or paclitaxel-coated balloon catheters. The primary end point was late lumen loss at 6 months. Secondary end points included restenosis rate, ankle brachial index, Rutherford class, target lesion revascularization, and tolerance up to >18 months. Before intervention, there were no significant differences in lesion characteristics such as reference diameter (5.3±1.1 versus 5.2±1.0 mm), degree of stenosis (84±11% versus 84±16%), proportion of restenotic lesions (36% versus 33%), and mean lesion length (5.7 cm [0.8 to 22.6 cm] versus 6.1 cm [0.9 to 19.3 cm]) between treatment groups. The 6-month follow-up angiography performed in 31 of 45 and 34 of 42 patients showed less late lumen loss in the coated balloon group (0.5±1.1 versus 1.0±1.1 mm; P =0.031). The number of target lesion revascularizations was lower in the paclitaxel-coated balloon group than in control subjects (3 of 45 versus 14 of 42 patients; P =0.002). Improvement in Rutherford class was greater in the coated balloon group ( P =0.045), whereas the improvement in ankle brachial index was not different. The difference in target lesion revascularizations between treatment groups was maintained up to >18 months. No adverse events were assessed as related to balloon coating. Conclusions— In this pilot trial, paclitaxel balloon coating caused no obvious adverse events and reduced restenosis in patients undergoing angioplasty of femoropopliteal arteries.

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Section: Discussionmentioning

confidence: 99%

Inhibition of Restenosis in Femoropopliteal Arteries

Langner²,

et al. 2008

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“…Actually, there are several authors pointing out the beneficial effect of endovascular brachytherapy on restenosis reduction in the SFA. Krueger et al [29] reported a significant reduction of restenosis following PTA of de novo lesions in the femoropopliteal area in the brachytherapy group compared to the control group. Gallino et al [15] also stressed the beneficial effect of endovascular brachytherapy in fighting restenosis (17% restenosis rates in the brachytherapy group vs. 35% in the patients without brachytherapy; p < 0.001).…”

Section: Discussionmentioning

confidence: 99%

Früheffekte einer Rhenium-188-Behandlung auf Proliferation, Migration und Matrixsynthese humaner aortaler glatter Muskelzellen in vitro

Kehlbach¹,

Dittmann

Schmid³

et al. 2006

Strahlenther Onkol

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“…[1][2][3][4][5][6] Few controlled trials have been performed with brachytherapy in peripheral arterial obstructive disease. 9,[11][12][13][14] Although most of these studies reported a reduction of restenosis, a multicenter trial 14 did not demonstrate significant benefit, whereas another found no difference in restenosis with the intention-to-treat analysis approach. 13 The limitations of endovascular brachytherapy include the fact that it is sometimes technically impossible to deliver the radiation, 13 that the required vascular manipulations are cumbersome, and that they may also be associated with thromboembolic events.…”

Section: Discussionmentioning

confidence: 99%

External Beam Radiation to Prevent Restenosis After Superficial Femoral Artery Balloon Angioplasty

et al. 2005

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Background— Femoropopliteal percutaneous transluminal angioplasty (PTA) remains limited by restenosis. Although vascular brachytherapy may be effective in reducing restenosis, external beam radiation would be more practical to administer after PTA. Methods and Results— After femoropopliteal PTA without stent placement, 99 patients were randomly assigned to 0 Gy (placebo; n=24), 7 Gy (n=24), 10.5 Gy (n=26), or 14 Gy (n=25) of external beam radiation of the PTA site (with a 3-cm margin at both extremities) in 1 session 24 hours after PTA. The primary end point was minimum lumen diameter on quantitative angiography 1 year after PTA. One year after PTA, the mean minimum lumen diameter was 1.92, 1.64, 1.92, and 2.91 mm, respectively, for the 0-, 7-, 10.5-, and 14-Gy groups ( P =0.0072 for 0 versus 14 Gy). Mean luminal loss was 1.14, 1.27, 1.08, and 0.14 mm, respectively, for the 4 groups ( P =0.0072 for 0 versus 14 Gy). Restenosis >50% was present in 50%, 65%, 48%, and 25% of patients, respectively, for the 0-, 7-, 10.5-, and 14-Gy groups ( P =0.072). At 18 months, repeated revascularizations were required in 25% of patients in the 0-Gy group versus 12% of patients in the 14-Gy group ( P =0.24). Conclusions— A single session of external beam radiation of 14 Gy of the femoropopliteal angioplasty site significantly reduces restenosis at 1 year.

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De Novo Femoropopliteal Stenoses: Endovascular Gamma Irradiation Following Angioplasty—Angiographic and Clinical Follow-up in a Prospective Randomized Controlled Trial

Abstract: 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.

Cited by 39 publications

References 34 publications

Inhibition of Restenosis in Femoropopliteal Arteries

Inhibition of Restenosis in Femoropopliteal Arteries

Früheffekte einer Rhenium-188-Behandlung auf Proliferation, Migration und Matrixsynthese humaner aortaler glatter Muskelzellen in vitro

External Beam Radiation to Prevent Restenosis After Superficial Femoral Artery Balloon Angioplasty

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