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CLINICAL STUDY

The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with diabetes mellitus

Luis Gruberg, MD^**, Ron Waksman, MD, FACC^**,*, Andrew E. Ajani, MD^**, Han-Soo Kim, MD^**, R. Lawrence White, MD, Ellen E. Pinnow, MS^**, Lowell F. Satler, MD, FACC^**, Augusto D. Pichard, MD, FACC^**, Kenneth M. Kent, MD, PhD, FACC^** and Joseph Lindsay, Jr, MD, FACC^**

^* Cardiovascular Research Institute, Washington Hospital Center, Washington, DC, USA
Washington Cancer Center, Washington Hospital Center, Washington, DC, USA

Manuscript received August 13, 2001; revised manuscript received March 5, 2002, accepted March 27, 2002.

^* Reprint requests and correspondence: Dr. Ron Waksman, Washington Hospital Center, 110 Irving Street, NW, Suite 4B-1, Washington, DC 20010.
ron.waksman{at}medstar.net

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 either IRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51 placebo) 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.

Abbreviations and Acronyms   CABG   coronary artery bypass graft surgery   CI   confidence interval   DM   diabetes mellitus   ITDM   insulin-treated diabetes mellitus   IRT   intracoronary radiation therapy   ISR   in-stent restenosis   NITDM   noninsulin-treated diabetes mellitus   PCI   percutaneous coronary interventions   TLR   target lesion revascularization   TVR   target vessel revascularization   WRIST   Washington Radiation for In-Stent restenosis Trial

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