OBJECTIVES: The purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabetic patients with in-stent restenosis (ISR). BACKGROUND:Diabetic patients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR. METHODS: The study group consisted of 749 consecutive patients with ISR who were treated with eitherIRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51placebo) were compared with nondiabetic patients (371 radiation and 75 placebo). RESULTS: In-hospital outcomes were similar between diabetic and nondiabetic patients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabetic patients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabetic patients. In contrast, diabetic and nondiabetic patients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates. CONCLUSIONS: In diabetic patients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabetic patients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabetic patients with ISR.
RCT Entities:
OBJECTIVES: The purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabeticpatients with in-stent restenosis (ISR). BACKGROUND:Diabeticpatients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR. METHODS: The study group consisted of 749 consecutive patients with ISR who were treated with either IRT or placebo in randomized trials and registries at our center. Diabeticpatients (252 radiation and 51 placebo) were compared with nondiabeticpatients (371 radiation and 75 placebo). RESULTS: In-hospital outcomes were similar between diabetic and nondiabeticpatients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabeticpatients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabeticpatients. In contrast, diabetic and nondiabeticpatients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates. CONCLUSIONS: In diabeticpatients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabeticpatients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabeticpatients with ISR.
Authors: Gordon E Pate; May Lee; Karin Humphries; Eric Cohen; Robert Lowe; Rebecca S Fox; Robert Teskey; Christopher E Buller Journal: Can J Cardiol Date: 2006-12 Impact factor: 5.223