Key result
192Ir radiation achieves ~79% undetectable neointima vs placebo, though repeat stenting lacks long-term advantage.
Why the study?
Does (192)Ir radiation and/or re-stenting improve lumen volume index and reduce intimal hyperplasia in in-stent restenosis lesions?
RCT (n=70)
Does (192)Ir radiation and/or re-stenting improve lumen volume index and reduce intimal hyperplasia in in-stent restenosis lesions?
Repeat stenting for in-stent restenosis provides little long-term advantage due to exaggerated neointimal proliferation, even with supplementary intravascular brachytherapy.
Repeat stenting conferred no sustained lumen benefit in in-stent restenosis; leaves open the adjunctive role of (192)Ir radiation.
BACKGROUND: Re-stenting of in-stent restenosis (ISR) improves acute angiographic results. Methods and Results- Volumetric intravascular ultrasound analysis was performed in 70 ISR lesions that received either placebo (n=36) or (192)Ir radiation (n=34). ISR lesions treated by re-stenting were divided into 3 groups: old stent not re-stented (A), old/new stent overlap (B), and new stent only (C). ISR lesions treated without re-stenting were categorized as D. In placebo patients, postintervention lumen volume index (LVI) was significantly greater in re-stented segments B and C than in non-re-stented segment A (P<0.05).At follow-up, however, LVI was similar in all 4 segments secondary to the increased intimal hyperplasia (IH) reaccumulation within the re-stented segments. In patients treated with (192)Ir radiation, LVI was maintained from baseline to follow-up only in non-re-stented segments A and D. Conversely, there was a significant decrease in LVI in re-stented segments B and C (P<0.05). Qualitatively, 79% of patients in the irradiated group had stent struts with undetectable neointimal versus only 27% in the placebo group (P<0.001). Coefficient of variation of IH reaccumulation was greater in re-stented segments of (192)Ir patients (B=57.3% and C=58.9%) than in re-stented segments in placebo patients (B=27.3% and C 26.8%) and non-re-stented segments in irradiated patients. CONCLUSIONS: Additional lumen gain from re-stenting ISR lesions is counteracted by exaggerated neointimal proliferation in placebo patients. Maximum effectiveness and safety of radiation can be achieved for ISR lesions when treated without re-stenting. Thus, regardless of supplementary intravascular brachytherapy, repeat stenting strategies provided little long-term advantage.
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Morino et al. (2002) conducted an RCT in In-stent restenosis (n=70). (192)Ir radiation vs. Placebo was evaluated on Stent struts with undetectable neointima (p=<0.001). (192)Ir radiation resulted in more patients with undetectable neointima on stent struts compared to placebo (79% vs 27%, P<0.001), though repeat stenting provided little long-term advantage.
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