Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation

OBJECTIVES The study was done to investigate the relationship between clinical restenosis and the relative angiographic location of the recurrent restenotic lesion, after treatment of in-stent restenosis with vascular brachytherapy in the Washington Radiation for In-Stent Restenosis Trial (WRIST). BACKGROUND Intracoronary radiation therapy reduces recurrence of in-stent restenosis. We investigated the above objective in patients enrolled in WRIST. METHODS The WRIST study randomized 130 patients to double-blinded therapy with gamma irradiation (iridium-192 [Ir-192]) versus placebo after interventional treatment of diffuse in-stent restenosis. After the intervention and at follow-up, three vessel segments were individually analyzed with quantitative coronary angiography: 1) the "stent," 2) the "radiation ribbon," and 3) the "ribbon+margin" segment (including 5 mm on either end of the injured or radiation-ribbon segment). Receiver operator curves (ROC) were used to assess the value of the follow-up percent diameter stenosis (DS) for each of the three analyzed segments in predicting target vessel revascularization (TVR). RESULTS Ir-192 reduced recurrent restenosis (23.7% vs. 60.7%, p < 0.001) and the length of recurrent restenosis (8.99 +/- 4.34 mm. vs. 17.54 +/- 10.48 mm, p < 0.001) at follow-up compared to placebo. Isolated stent edge (3.4%) and ribbon edge (1.7%) restenoses were infrequent in both groups. The best angiographic surrogate of TVR was the 50% follow-up DS obtained from the ribbon+margin analysis (ROC area 0.806). CONCLUSIONS In WRIST, not only was Ir-192 therapy effective in reducing restenosis, but it also reduced the lesion length of treatment failures by 50%, and it was not associated with edge proliferation. The restenosis rate obtained from the vessel segment inclusive of the dose fall-off zones was the best correlate of TVR and should become a standard analysis site in all vascular brachytherapy trials. (C) 2002 by the American College of Cardiology.