The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with diabetes mellitus.
OBJECTIVE
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.
Gruberg
Luis
L
Cardiovascular Research Institute, Washington Hospital Center, Washington, DC 20010, USA.
Waksman
Ron
R
Ajani
Andrew E
AE
Kim
Han-Soo
HS
White
R Lawrence
RL
Pinnow
Ellen E
EE
Satler
Lowell F
LF
Pichard
Augusto D
AD
Kent
Kenneth M
KM
Lindsay
Joseph
J
D000368:Aged; D001918:Brachytherapy; D023903:Coronary Restenosis / Q000517:prevention & control / Q000532:radiotherapy*; D003331:Coronary Vessels / Q000528:radiation effects*; D003925:Diabetic Angiopathies / Q000532:radiotherapy* / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012189:Retrospective Studies; D015607:Stents; D016896:Treatment Outcome