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CLINICAL RESEARCH

Intravascular brachytherapy for native coronary ostial in-stent restenotic lesions

Costantino O. Costantini, MD^*, Alexandra J. Lansky, MD^*,*, Gary S. Mintz, MD, FACC^*, Kazuyuki Shirai, MD^*, George Dangas, MD, FACC^*, Roxana Mehran, MD, FACC^*, Martin Fahy, PhD^*, Steven Slack, MS^*, Maria Coral, MD^*, Paul S. Teirstein, MD, FACC^*, Ron Waksman, MD, FACC, Gregg Stone, MD, FACC^*, Jeffrey Moses, MD, FACC^* and Martin B. Leon, MD, FACC^*

^* Cardiovascular Research Foundation, Lenox Hill Hospital, New York, New York, USA
Department of Internal Medicine (Cardiology Division) from the Washington Hospital Center, Washington, DC, USA

Manuscript received September 4, 2002; revised manuscript received January 21, 2003, accepted January 30, 2003.

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

OBJECTIVES: We analyzed the effects of vascular brachytherapy (VBT) on ostial in-stent restenosis (ISR).

BACKGROUND: In-stent restenosis has a high recurrence rate after percutaneous reintervention. The recurrence rate of ostial ISR lesions and the impact of VBT remain unknown.

METHODS: We evaluated 133 patients with native coronary ostial ISR from a pooled database of 990 patients enrolled in randomized VBT trials. Independent quantitative angiography was performed at baseline and follow-up in 45 gamma, 27 beta, and 61 placebo patients.

RESULTS: Binary restenosis was significantly higher in placebo than radiated patients (75.4% vs. 17.8% in gamma vs. 22.2% in beta, p < 0.0001). The treatment effect of both gamma (odds ratio [OR] 0.06; 95% confidence interval [CI] 0.02 to 0.17) and beta VBT (OR 0.10; 95% CI 0.03 to 0.31) was maintained after controlling for differences in baseline lesion length. Proximal and distal radiation edge restenosis rates were similar among the groups. Vascular brachytherapy of true aorto-ostial lesions (n = 34) was similarly beneficial: restenosis rates of placebo versus gamma or beta patients of 83.3% versus 6.7% versus 28.6%, p = 0.0002.

CONCLUSIONS: Conventional treatment of ostial ISR is associated with a recurrence rate of over 75%. Vascular brachytherapy with either gamma or beta sources results in significant and similar reductions in restenosis compared with placebo. Similar benefits after VBT prevail in true aorto-ostial lesions.

Abbreviations and Acronyms   CI   confidence interval   DS   diameter stenosis   GM   geographic miss   92Ir   iridium 92   ISR   in-stent restenosis   MLD   minimal lumen diameter   OR   odds ratio   PCI   percutaneous coronary intervention   QCA   quantitative coronary angiography   RD   reference diameter   90Sr/90Y   strontium 90/yttrium 90   VBT   vascular brachytherapy