Localized Intracoronary Gamma-Radiation Therapy to Inhibit the Recurrence of Restenosis after Stenting
Key result
Intracoronary radiation therapy with iridium-192 reduced the composite of death, MI, and target lesion revascularization compared to placebo (28.2% vs 43.8%, P=0.02).
Why the study?
Does an indwelling intracoronary ribbon containing iridium-192 reduce the composite of death, myocardial infarction, and target lesion revascularization in patients with in-stent restenosis?
Population
252 patients with in-stent restenosis
Comparison
Indwelling intracoronary ribbon containing a… vs Similar-appearing nonradioactive ribbon (placebo)
Design
RCT, randomly assigned, double-blind
Follow-up
nine months
Authors
Discussion
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Implication
Supports intracoronary iridium-192 for in-stent restenosis; confirms composite endpoint benefit in RCT.
Study Design
Type
RCT (n=252)
Blinding
Double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does an indwelling intracoronary ribbon containing iridium-192 reduce the composite of death, myocardial infarction, and target lesion revascularization in patients with in-stent restenosis?
P
Population
252 patients with in-stent restenosis
I
Intervention
Indwelling intracoronary ribbon containing a sealed source of iridium-192
C
Comparator
Similar-appearing nonradioactive ribbon (placebo)
O
Outcome
Composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-upcomposite
Main Result
Absolute Event Rate: 28.2% vs 43.8%
p-value: p=0.02
Intracoronary gamma-radiation therapy with iridium-192 reduces clinical restenosis and target lesion revascularization but increases the risk of late thrombosis and myocardial infarction.
Limitations
- Associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction.
Cite This Study
Leon et al. (2001) conducted an RCT in in-stent restenosis (n=252). Intracoronary radiation therapy (iridium-192 ribbon) vs. Nonradioactive ribbon (placebo) was evaluated on Composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion (p=0.02). Intracoronary radiation therapy with iridium-192 reduced the composite of death, MI, and target lesion revascularization compared to placebo (28.2% vs 43.8%, P=0.02).