Debulking does not benefit patients undergoing intracoronary beta-radiation therapy for in-stent restenosis: Insights from the START trial

Intracoronary brachytherapy has become the current treatment of choice for patients with in-stent restenosis (ISR). The aim of the present study was to determine whether plaque extraction using debulking techniques prior to brachytherapy would improve the outcomes of patients with ISR. Patients enrolled into the START (n = 476) and START-40 (n = 205) trials were divided into four subgroups according to their treatment assignments: debulking-radiation, debulking-placebo, balloon angioplasty (BA) radiation, and BA placebo. Patients were further divided according to their ISR lesion length: all lesions, > 15 mm, and > 19 mm. Restenosis rates were higher in placebo, nonradiated lesions undergoing debulking (52.7%) vs. BA alone (38.5%; P = 0.04). Postprocedural minimal lumen diameter (MLD) was similar among the subgroups. Outcomes were similar between debulking and BA within each therapeutic arm. MLD after debulking radiation was greater in patients with ISR > 15 mm (post-MLD was 1.9 vs. 1.7 mm; P = 0.06) but not in the placebo. Debulking radiation patients had greater MLD at follow-up, but restenosis (23.5% after debulking vs. 32.7% BA alone) and late loss (0.3 mm in both subgroups) were not statistically different. There was a trend toward higher mortality among debulked patients (3.7%) compared to BA alone (0.8%). In patients with ISR > 19 mm, four patients died following debulking radiation as compared to no death after BA (P = 0.05). Our results do not support the strategy of plaque extraction prior to intracoronary beta-radiation for ISR. Cathet Cardiovasc Intervent 2003;58:331–335. © 2003 Wiley-Liss, Inc.