Intracoronary radiation for patients with refractory in-stent restenosis: an analysis from the WRIST-Crossover Trial. Washington Radiation for In-stent Restenosis Trial.

BACKGROUND: In-stent restenosis (ISR) is a limitation of intracoronary stent implantation. In animal models and clinical trials, ionizing radiation has been shown to decrease in-stent neointimal formation. METHODS AND MATERIALS: 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 to gamma irradiation (l92Ir, 15 Gy at 2 mm from the source) or placebo. Patients randomized to placebo that developed recurrent ISR and presented with anginal symptoms were crossed-over to active therapy. We compared the clinical and angiographic outcomes of 39 patients in the crossover group with 65 patients treated primarily with radiation. The primary clinical endpoints were mortality, morbidity, and repeat target lesion revascularization (TLR) at 6 months.
RESULTS: Procedural success was 100%. In-hospital and 30-day complications were minimal. At 6 months, the rate for any multiple adverse cardiac events (MACE: death, MI, or TLR) was 25.6% in the crossover group vs. 29.2% in the primary treatment group (p = 0.86). Three patients in the crossover group and four in the primary treatment group died (p = NS). There were no Q-wave myocardial infarction. Ten (9.6%) of the patients presented with late thrombosis and total occlusion: 6.2% (4/65) in the primary treatment group vs. 15.4% (6/39) in the crossover group (p = 0.13).
CONCLUSIONS: Patients who fail conventional catheter-based intervention without radiation can be treated with 192Ir with results similar to those who initially receive brachytherapy. This is of specific importance with respect to patients initially assigned to the placebo arm of randomized clinical trials.

RCT Entities:   Population Interventions Outcomes