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CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY

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

Alexandra J. Lansky, MD^*,*, George Dangas, MD, FACC^*, Roxana Mehran, MD, FACC^*, Kartik J. Desai, MD^*, Gary S. Mintz, MD, FACC, Hongsheng Wu, PhD, Martin Fahy, MSc, Gregg W. Stone, MD, FACC^*, Ron Waksman, MD, FACC and Martin B. Leon, MD, FACC^*

^* Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, New York, USA
Departments of Internal Medicine (Cardiology Divisions) of the Washington Hospital Center, Washington, D.C., USA

Manuscript received December 14, 2000; revised manuscript received October 4, 2001, accepted October 26, 2001.

^* Reprint requests and correspondence: Dr. Alexandra J. Lansky, Cardiovascular Research Foundation, 55 East 59th St., 6th Floor, New York, NY 10022, USA.
alansky{at}crf.org

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 [¹⁹²Ir]) 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: ¹⁹²Ir 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 ¹⁹²Ir 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.

Abbreviations and Acronyms   DS   diameter stenosis   192Ir   iridium-192   MLD   minimal lumen diameter   RD   reference diameter   ROC   receiver operator curve   TVR   target vessel revascularization   WRIST   Washington Radiation for In-Stent Restenosis Trial

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