Effect of Intracoronary γ-Radiation Therapy on In-Stent Restenosis
Key result
Intracoronary γ-radiation therapy with (192)Ir significantly reduced the decrease in stented segment lumen volume compared to placebo (-25±34 mm³ vs -48±42 mm³; P=0.0225).
Why the study?
Does intracoronary gamma-radiation therapy reduce recurrent in-stent restenosis in patients after successful reintervention?
Population
70 patients with recurrent in-stent restenosis who underwent successful reintervention
Comparison
Intracoronary gamma-radiation therapy usingIr vs Placebo
Design
RCT, Randomized to receive either (192)Ir or placebo
Follow-up
8 months
Authors
Discussion
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Implication
Supports γ-radiation after reintervention for in-stent restenosis; confirms neointimal inhibition in RCT.
Study Design
Type
RCT (n=70)
Randomization
randomized
Structured PICO
Does intracoronary gamma-radiation therapy reduce recurrent in-stent restenosis in patients after successful reintervention?
P
Population
70 patients with in-stent restenosis evaluated with intravascular ultrasound immediately after successful reintervention and at 8-month follow-up.
I
Intervention
Intracoronary gamma-radiation therapy using (192)Ir
C
Comparator
Placebo
O
Outcome
Volumetric intravascular ultrasound measurements of the stented segment and reference segments (including lumen volume and intimal hyperplasia volume) at 8-month follow-upsurrogate
Main Result
Absolute Event Rate: -25% vs -48%
p-value: p=0.0225
Intracoronary gamma-radiation therapy effectively inhibits neointimal formation and prevents recurrent in-stent restenosis as assessed by serial volumetric IVUS.
Cite This Study
Mintz et al. (2000) conducted an RCT in In-stent restenosis (n=70). Intracoronary γ-Radiation Therapy ((192)Ir) vs. Placebo was evaluated on Decrease in stented segment lumen volume (p=0.0225). Intracoronary γ-radiation therapy with (192)Ir significantly reduced the decrease in stented segment lumen volume compared to placebo (-25±34 mm³ vs -48±42 mm³; P=0.0225).