Effect of Vascular BRAchytherapy using HolmiuM-166 Liquid Balloon System afterCutting Balloon Angioplasty in Patients with Stent Restenosis(BRAHMS Study)

Background and Objectives：Vascular brachytherapy for stent restenosis has been demonstrated to reduce restenosis and major adverse cardiac events (MACE). However, the angiographic and clinical outcomes after β-radiation, using a 166Holmium (Ho)-DTPA filled balloon, has not been sufficiently evaluated. Subjects and Methods：Between March 2002 and August 2003, 78 consecutive patients (mean age 50 yrs, 53 male) with in-stent restenosis were randomly enrolled for either cutting balloon angioplasty only (control group, n=38) or in combination with vascular brachytherapy using a 166Ho-DTPA filled balloon (brachytherapy group, n=40). The radiation dose applied was 18 Gy, at a depth of 1.0 mm from the vascular lumen. Results：The treated vessels comprised of 50 left anterior descending arteries (64.1%), 23 right coronary arteries (29.5%) and 5 circumflex arteries. The mean radiation dose and time were 375±67.8 mCi/ml and 191±76 seconds, respectively. Six cases were fractionated.The mean lesion length was 18.2±7.9 mm, with no difference between the 2 groups. Eight month follow-up coronary angiography revealed a restenosis rate of 17.1% (6/35) in the brachytherapy group vs. 39.3% (11/27) in the control group(p=0.042). However, there was no difference in the 1 year MACE. Conclusion：In patients with in-stent restenosis, vascular brachytherapy, using a 166Ho-DTPA filled balloon, showed favorable angiographic outcomes at the 8 month follow-up compared to the control groupope