Safety of Intracoronary γ-Radiation on Uninjured Reference Segments During the First 6 Months After Treatment of In-Stent Restenosis
Key result
In 38 patients, intracoronary gamma-irradiation showed no evidence of a deleterious effect on angiographically normal uninjured reference segments at 6 months compared to placebo.
Why the study?
Does intracoronary gamma-irradiation cause deleterious effects on uninjured reference segments in patients treated for in-stent restenosis?
Population
38 patients with in-stent restenosis treated with conventional catheter-based techniques where radiation or…
Comparison
Intracoronary gamma-irradiation (192Ir) vs Placebo (dummy seeds)
Design
RCT, randomized, blinded
Follow-up
6 months
Authors
Discussion
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Implication
Supports safety of gamma-irradiation for in-stent restenosis without reference segment harm; extends RCT evidence on vascular remodeling.
Study Design
Type
RCT (n=38)
Blinding
blinded
Randomization
randomized
Structured PICO
Does intracoronary gamma-irradiation cause deleterious effects on uninjured reference segments in patients treated for in-stent restenosis?
P
Population
38 patients with in-stent restenosis treated with conventional catheter-based techniques, followed for 6 months.
I
Intervention
Intracoronary gamma-irradiation (192Ir)
C
Comparator
Placebo (dummy seeds)
O
Outcome
Changes in external elastic membrane (EEM), lumen, and plaque and media areas in uninjured reference segments measured by intravascular ultrasoundsurrogate
Intracoronary gamma-irradiation for in-stent restenosis does not negatively impact adjacent uninjured reference segments at 6 months, as it induces positive remodeling (increased EEM area) that preserves lumen area.
Cite This Study
Ahmed et al. (2000) conducted an RCT in in-stent restenosis (n=38). gamma-irradiation (192Ir) vs. placebo (dummy seeds) was evaluated on Changes in external elastic membrane, lumen, and plaque and media areas in uninjured reference segments. In 38 patients, intracoronary gamma-irradiation showed no evidence of a deleterious effect on angiographically normal uninjured reference segments at 6 months compared to placebo.