ABSTRACT
We sought to determine the correlates of failure following intracoronary radiation therapy (IRT) with Sr-90 using the Novoste Beta-Cath system for the treatment of in-stent restenosis (ISR) in a broad range of patients. IRT has been shown to be more efficacious compared to placebo for the treatment of ISR in large randomized trials. However, even in patients treated with IRT, major adverse cardiac events occur in approximately 20% of cases on follow-up. This trial sought to elucidate the correlates of failure following successful IRT for ISR. To determine the correlates of IRT failure, we retrospectively compared the demographics, lesion characteristics, and clinical outcomes of 102 consecutive patients with ISR treated with Sr-90 from September 1998 to July 2001. IRT failure was defined as death, myocardial infarction (MI), or target vessel revascularization (TVR) due to repeat ISR on follow-up. A comparison of the clinical and angiographic profile of IRT failures (n = 16) vs. IRT successes (n = 86) revealed that a history of smoking (75% vs. 40%; P = 0.012), current use of calcium channel blockers (84% vs. 45%; P = 0.013), ostial location of target lesion (44% vs. 16%; P = 0.020), and mean posttreatment minimal luminal diameter (MLD; 1.64 +/- 0.19 vs. 2.21 +/- 0.29 mm; P < 0.001), respectively, were correlated with failure using univariate analysis. After multivariate regression analysis, the correlates of failure that remained significant were treatment of an ostial lesion (OR = 31.2; 95% CI = 2.6-382.7; P = 0.007) and final posttreatment MLD (P < 0.001). Ostial location of target lesion and smaller posttreatment MLD are correlated with subsequent death, MI, and TVR following therapy with Sr-90 for ISR.
Subject(s)
Coronary Restenosis/radiotherapy , Stents , Aged , Beta Particles/therapeutic use , Blood Vessel Prosthesis Implantation , Brachytherapy , Coronary Angiography , Coronary Artery Disease/complications , Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Coronary Restenosis/epidemiology , Coronary Restenosis/etiology , Endpoint Determination , Female , Follow-Up Studies , Humans , Illinois/epidemiology , Incidence , Male , Middle Aged , Multivariate Analysis , Randomized Controlled Trials as Topic , Retrospective Studies , Severity of Illness Index , Statistics as Topic , Strontium Radioisotopes/therapeutic use , Treatment FailureABSTRACT
BACKGROUND: The cutting balloon (CB) is an emerging therapy for the treatment of instent restenosis (ISR), but its impact on the clinical outcomes of patients treated with intracoronary radiation therapy (IRT) with Sr-90 compared with conventional PTCA and IRT is not clearly defined. METHODS: We compared the baseline demographics, angiographic characteristics and clinical outcomes of 102 consecutive patients with ISR treated either with CB+IRT (n=45) or with conventional PTCA+IRT (n=57). The combined endpoint was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI) or target vessel revascularization (TVR) at 6 months. RESULTS: The CB+IRT group had a shorter mean lesion length (14.3+/-6.5 vs. 21.1+/-15.7, P=.009), and greater utilization of glycoprotein IIb/IIIa inhibitors during the procedure (48.9% vs. 26.3%, P=.02) compared to the PTCA+IRT group. There were no significant differences in the baseline demographics, angiographic and procedural results, or subsequent MACE at 6 months between the two groups. CONCLUSION: The strategy of CB+IRT using Sr-90 for ISR is associated with similar procedural and clinical outcomes compared to conventional PTCA+IRT. Further study is warranted to determine which patient subgroups would derive the most benefit from this approach.
