Why the study?
Does an 18 Gy dose of intracoronary gamma-radiation therapy reduce TLR and MACE compared to 15 Gy or placebo in patients with recurrent in-stent restenosis?
Does an 18 Gy dose of intracoronary gamma-radiation therapy reduce TLR and MACE compared to 15 Gy or placebo in patients with recurrent in-stent restenosis?
A higher dose of 18 Gy intracoronary gamma-radiation therapy improves 3-year clinical outcomes compared to 15 Gy or placebo in patients with recurrent in-stent restenosis.
Supports 18 Gy intracoronary gamma-radiation for recurrent in-stent restenosis; extends evidence to sustained 3-year MACE reduction.
To determine the safety and efficacy, including the impact, on the late recurrence rate of an incremental gamma-radiation dose from 15 to 18 Gy, we report the 3-year clinical outcome of Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST). One hundred eighty patients with recurrent in-stent restenosis (ISR) were enrolled in the Long WRIST series and treated with (192)Ir with 1 month of antiplatelet therapy. Between 6 months and 3 years, the need for repeat revascularization was low and similar among the three groups. At 3 years, target lesion revascularization (TLR) and major adverse cardiac events (MACE) were less frequent in the 18 Gy group than in the 15 Gy group (P = 0.12 for TLR, P < 0.05 for MACE) and less frequent in the 15 Gy group as compared to the placebo group (P < 0.05 for TLR and MACE). At 3 years, a higher dose of 18 Gy with (192)Ir continues to improve the outcome of patients treated for ISR when compared to patients treated with 15 Gy or placebo.
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Cheneau et al. (2004) studied this question.
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