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

ABSTRACT

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 beta-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 group.