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THE JOURNAL OF CARDIOVASCULAR SURGERY
A Journal on Cardiac, Vascular and Thoracic Surgery
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,632
The Journal of Cardiovascular Surgery 2005 August;46(4):437-43
Endovascular brachytherapy for the prevention of restenosis after femoropopliteal angioplasty. Results of the VARA Trial
van Tongeren R. B. 1,2, van Sambeek M. R. H. M. 3, van Overhagen H. 4, Coen V. L. 5,6, Schmitz P. I. 7, Gescher F. M. 8, Wittens C. H. 9, Vernhout R. M. 10, van Urk H. 3, Levendag P. C. 6, Bruijninckx C. M. 2
1 Department of Surgery Leiden University Medical Center, Leiden, The Netherlands
2 Department of Surgery Leyenburg Hospital, The Hague, The Netherlands
3 Department of Surgery Erasmus MC, Rotterdam, The Netherlands
4 Department of Radiology Leyenburg Hospital, The Hague, The Netherlands
5 Department of Radiotherapy Institution for Radiotherapy Zeeland Vlissingen, The Netherlands
6 Department of Radiotherapy Erasmus MC-Daniel den Hoed Cancer Center Rotterdam, The Netherlands
7 Department of Medical Statistics Erasmus MC-Daniel den Hoed Cancer Center Rotterdam, The Netherlands
8 Department of Radiotherapy Leyenburg Hospital, The Hague, The Netherlands
9 Department of Surgery Hospital St. Franciscus Gasthuis Rotterdam, The Netherlands
10 Trial Office, Erasmus MC-Daniel den Hoed Cancer Center Rotterdam, The Netherlands
Aim. Endovascular brachytherapy (EBT) has been proposed as a method to prevent restenosis. We performed a prospective randomised multicenter study to determine its efficacy for prophylaxis of restenosis after femoropopliteal percutaneous transluminal angioplasty (PTA).
Methods. Patients with symptomatic stenotic or totally occluding lesions in the femoropopliteal artery were randomised to be treated with PTA plus EBT or PTA alone. In case of EBT, 14 Gy was applied by an 192Ir source to the vessel wall. Clinical examination, ankle-brachial pressure index (ABPI) and duplex ultrasound were planned after 6 and 12 months. The primary endpoint was significant restenosis of the treated segment at duplex ultrasound after 12 months.
Results. Fifty-three of the 60 patients who eventually met the inclusion criteria could be studied. After 12 months, restenosis rates were 44% (12/27) in the PTA group versus 35% (8/23) in the PTA + EBT group (χ2 test, P=0.51). There was no difference in mandatory reintervention between the 2 groups. Overall, EBT resulted in an absolute risk reduction of significant restenosis of 9%, yet in patients with totally occlusive disease this reduction was 32%.
Conclusion. This study suggests an effect of EBT on the occurrence of restenosis only after PTA of occluded femoropopliteal lesions. Due to a too small number of patients analysed this difference is not statistically significant.