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Three-year follow-up after intracoronary gamma radiation therapy for in-stent restenosis

2001; Elsevier BV; Volume: 2; Issue: 4 Linguagem: Inglês

10.1016/s1522-1865(02)00105-1

1878-5727

Andrew E. Ajani, Ron Waksman, Arvind Sharma, Dong‐Hun Cha, Édouard Cheneau, R. Larry White, Daniel Caños, Augusto D. Pichard, Lowell F. Satler, Kenneth M. Kent, Ellen Pinnow, Joseph Lindsay,

Cerebrovascular and Carotid Artery Diseases

Background: The Washington Radiation for In-Stent Restenosis Trial (WRIST) is a double-blinded randomized study evaluating the effects of intracoronary radiation therapy (IRT) in patients with in-stent restenosis (ISR). Methods: One hundred and thirty patients with ISR (100 native coronary and 30 vein grafts) underwent PTCA, laser ablation, rotational atherectomy, and/or additional stenting (36% of lesions). Patients were randomized to either Iridium-192 IRT or placebo, with a prescribed dose of 15 Gy to a 2-mm radial distance from the center of the source. Results: Angiographic restenosis (27% vs. 56%, P=.002) and target vessel revascularization (TVR; 26% vs. 66%, P<.001) were dramatically reduced at 6 months in IRT patients. Between 6 and 36 months, IRT compared to placebo patients had more target lesion revascularization (TLR; IRT=17% vs. placebo=2%, P=.002) and TVR (IRT=17% vs. placebo=3%, P=.009). At 3 years, the major adverse cardiac event (MACE) rate was significantly reduced with IRT (39% vs. 65%, P=.003). Conclusions: In WRIST, patients with ISR treated with IRT using 192Ir had a marked reduction in the need for repeat target lesion and vessel revascularization at 6 months, with the clinical benefit maintained at 3 years.