Safety of Intracoronary γ-Radiation on Uninjured Reference Segments During the First 6 Months After Treatment of In-Stent Restenosis

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Abstract
Background—The effects of endovascular irradiation on uninjured reference segments during the treatment of in-stent restenosis are unknown. Methods and Results—In the Washington Radiation for In-Stent restenosis Trial (WRIST), patients with in-stent restenosis were first treated with conventional catheter-based techniques and then randomized (blinded) to receive either γ-irradiation (192Ir) or a placebo (dummy seeds). We identified all patients in whom the active (n=19) or dummy seeds (n=19) extended >10 mm proximal and distal to the in-stent restenosis lesion. Serial (postirradiation and follow-up) external elastic membrane (EEM), lumen, and plaque and media (EEM−lumen) areas were measured (using intravascular ultrasound) every 1 mm over 5-mm-long reference segments that were 6 to 10 mm proximal and distal to the in-stent restenosis lesion. During follow-up, a similar small increase occurred in the plaque and media area in the proximal and distal reference segments in both 192Ir and placebo patients. How...