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(Circulation. 2002;106:2334.)
© 2002 American Heart Association, Inc.

Clinical Investigation and Reports

Delivered Dose and Vascular Response After ß-Radiation for In-Stent Restenosis

Retrospective Dosimetry and Volumetric Intravascular Ultrasound Analysis

Yoshihiro Morino, MD; Hideaki Kaneda, MD; Tim Fox, PhD; Atsushi Takagi, MD; Ali H.M. Hassan, MD; Raoul Bonan, MD; Ian Crocker, MD; Alexandra J. Lansky, MD; Warren K. Laskey, MD; Mohan Suntharalingam, MD; Heidi N. Bonneau, RN, MS; Paul G. Yock, MD; Yasuhiro Honda, MD; Peter J. Fitzgerald, MD, PhD

From the Center for Research in Cardiovascular Interventions, Stanford University Medical Center, Stanford, Calif (Y.M., H.K., A.T., A.H.M.H., P.G.Y., Y.H., P.J.F.); Emory University, Atlanta, Ga (T.F., I.C.); Institut de Cardiologie de Montreal, Montreal, Canada (R.B.); Cardiovascular Research Foundation, New York, NY (A.J.L.); University of Maryland Medical System, Baltimore, Md (W.K.L., M.S.); and Highland Consulting Inc, San Jose, Calif (H.N.B.).

Correspondence to Peter J. Fitzgerald, MD, PhD, Center for Research in Cardiovascular Interventions, Stanford University Medical Center, 300 Pasteur Dr, H3554, Stanford, CA 94305-5637. E-mail ivus{at}crci.stanford.edu

Background— Observations from previous intracoronary radiation therapy trials noted a considerable discrepancy between the prescribed radiation dose and the dose actually delivered. The aims of this study were to investigate the effect of actual delivered dose on vascular changes and to test the appropriateness of the current dose prescription.

Methods and Results— Serial volumetric intravascular ultrasound (IVUS) analysis was performed in 30 in-stent restenosis cases treated with a 40-mm ⁹⁰Sr/Y source train. The fixed dose was prescribed at 2 mm from the centerline of the source train (18.4 Gy at 2 mm for reference diameter 3.35 mm and 23 Gy for diameter 3.36 mm). Only stent segments with full radiation coverage and device injury were enrolled and divided into 2-mm-long subsegments (n=202). D_S90EEM (the minimum dose absorbed by 90% of the external elastic membrane surface) was calculated as the delivered dose corresponding to each segment, assuming that the radiation catheter occupied the same position in the vessel as the IVUS catheter. Mean D_S90EEM of 23.5±5.82 Gy (range 12.3 to 41.7 Gy) was delivered to these subsegments. Overall, intimal hyperplasia volume remained constant from postintervention to follow-up (2.23±1.10 to 2.32±1.09 mm³/m; P=NS). Regression analysis revealed there was no correlation between delivered dose intensity and changes in intimal hyperplasia volume. No particular dose-dependent complications were appreciated in this delivered dose range.

Conclusions— The current dose-prescription protocol of ⁹⁰Sr/Y radiation to native in-stent restenosis lesions may provide substantial inhibition of neointimal reproliferation regardless of the actual delivered dose intensity.

Key Words: restenosis • radioisotopes • stents • coronary disease

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