Circulation. 2002;106:1090-1096
Published online before print August 12, 2002, doi: 10.1161/01.CIR.0000027814.96651.72
Published online before print August 12, 2002, doi: 10.1161/01.CIR.0000027814.96651.72
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(Circulation. 2002;106:1090.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Trial of 90Sr/90Y ß-Radiation Versus Placebo Control for Treatment of In-Stent Restenosis
From Brigham and Women’s Hospital (J.J.P., R.E.K.), Boston, Mass; University of Maryland (M.S.), Baltimore, Md; Lenox Hill Hospital (A.J.L.), New York, NY; Phoenix Heart Center (R.R.H., B.S.), Phoenix, Ariz; Scripps Clinic (P.S.T., V.M.), La Jolla, Calif; University of Florida (T.B., R.H.), Jacksonville; Dr. Mueller Hospital (S.S., P.v.R.), Munich, Germany; Montreal Heart Institute (R.B.), Montreal, Canada; Beth Israel Deaconess Medical Center (K.K.L.H.), Boston, Mass; and Harvard Clinical Research Institute (J.J.P., A.O., R.E.K.), Boston, Mass.
Correspondence to Jeffrey J. Popma, MD, Director, Interventional Cardiology, Brigham and Women’s Hospital, 75 Francis St, L-2 Catheterization Laboratory, Boston, MA 02115. E-mail jpopma{at}partners.org
Background— After conventional treatment of in-stent restenosis, the incidence of recurrent clinical restenosis may approach 40%. We report the first multicenter, blinded, and randomized trial of intracoronary radiation with the use of a 90Sr/90Y ß-source for the treatment of in-stent restenosis.
Methods and Results— After successful catheter-based treatment of in-stent restenosis, 476 patients were randomly assigned to receive an intracoronary catheter containing either 90Sr/90Y (n=244) or placebo (n=232) sources. The prescribed dose 2 mm from the center of the source was 18.4 Gy for vessels between 2.70 and 3.35 mm in diameter and 23.0 Gy for vessels between 3.36 and 4.0 mm. The primary end point, ie, clinically driven target-vessel revascularization by 8 months, was observed in 56 (26.8%) of the patients assigned to placebo and 39 (17.0%) of the patients assigned to radiation (P=0.015). The incidence of the composite including death, myocardial infarction, and target-vessel revascularization was observed in 60 (28.7%) of the patients assigned to placebo and 44 (19.1%) of the patients assigned to radiation (P=0.024). Binary 8-month angiographic restenosis (
50% diameter stenosis) within the entire segment treated with radiation was reduced from 45.2% in the placebo-treated patients to 28.8% in the 90Sr/90Y-treated patients (P=0.001). Stent thromboses occurred in 1 patient assigned to placebo <24 hours after the procedure and in 1 patient assigned to 90Sr/90Y at day 244.
Conclusions— The results of this study demonstrated that ß-radiation using 90Sr/90Y is both safe and effective for preventing recurrence in patients with in-stent restenosis.
Key Words: restenosis • stents • angioplasty • trials
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|
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|
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|
|
|
|
|
|
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|
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|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
 G Sianos, A Hoye, F Saia, W van der Giessen, P Lemos, P J de Feyter, P C Levendag, R van Domburg, and P W Serruys Long term outcome after intracoronary {beta} radiation therapy Heart, July 1, 2005; 91(7): 942 - 947. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
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|
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
R. Waksman Vascular brachytherapy and coronary stenting for de novo lesions: Love on the rocks J. Am. Coll. Cardiol., August 4, 2004; 44(3): 538 - 540. [Full Text] [PDF]
|
|
|
|
|
|
J. R Sindermann, V. Verin, J. W Hopewell, H. P. Rodemann, and J. H Hendry Biological aspects of radiation and drug-eluting stents for the prevention of restenosis Cardiovasc Res, July 1, 2004; 63(1): 22 - 30. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Waksman, R. Lew, A. E. Ajani, A. D. Pichard, L. F. Satler, K. M. Kent, R. Chan, R. L. White, W. O. Suddath, E. Pinnow, et al. Repeat Intracoronary Radiation for Recurrent In-Stent Restenosis in Patients Who Failed Intracoronary Radiation Circulation, August 12, 2003; 108(6): 654 - 656. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
M. Hoher, J. Wohrle, M. Wohlfrom, J. Kamenz, T. Nusser, O. C. Grebe, H. Hanke, M. Kochs, S. N. Reske, V. Hombach, et al. Intracoronary {beta}-Irradiation With a Rhenium-188-Filled Balloon Catheter: A Randomized Trial in Patients With De Novo and Restenotic Lesions Circulation, June 24, 2003; 107(24): 3022 - 3027. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. B. King III Why Have Stents Replaced Balloons? Underwhelming Evidence Ann Intern Med, May 20, 2003; 138(10): 842 - 843. [Full Text] [PDF]
|
|
|
|
|
|
P. S. Brara, M. Moussavian, M. A. Grise, J. P. Reilly, M. Fernandez, R. A. Schatz, and P. S. Teirstein Pilot Trial of Oral Rapamycin for Recalcitrant Restenosis Circulation, April 8, 2003; 107(13): 1722 - 1724. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Waksman, E. Cheneau, A. E. Ajani, R. L. White, E. Pinnow, R. Torguson, R. Deible, L. F. Satler, A. D. Pichard, K. M. Kent, et al. Intracoronary Radiation Therapy Improves the Clinical and Angiographic Outcomes of Diffuse In-Stent Restenotic Lesions: Results of the Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST) Studies Circulation, April 8, 2003; 107(13): 1744 - 1749. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R Seabra-Gomes In-stent restenosis: intracoronary {beta}-radiation at the crossroads Eur. Heart J., April 1, 2003; 24(7): 583 - 585. [Full Text] [PDF]
|
|