(Circulation. 2000;101:2165.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Intracoronary 
-Radiation Therapy After Angioplasty Inhibits Recurrence in Patients With In-Stent Restenosis
From the Cardiology Research Foundation, Division of Cardiology (R.W., G.S.M., R.M., A.J.L., M.B.L., L.F.S., L.G., B.B., K.M.K., A.D.P.), and the Washington Cancer Institute (R.L.W., R.C.C., B.G.B.), Washington Hospital Center, Washington DC; The Interventional Cardiology Department Thoraxcenter (P.W.S.), Erasmus University, Rotterdam, the Netherlands; and the Intravascular Ultrasound Core Laboratories (P.F.), Stanford University, Calif.
Background—Treatment of in-stent
restenosis presents a critical limitation of
intracoronary stent implantation. Ionizing radiation has been
shown to decrease neointimal formation within stents in
animal models and in initial clinical trials. We studied the effects of
intracoronary 
-radiation therapy versus placebo on the
clinical and angiographic outcomes of patients with in-stent
restenosis.
Methods and Results—One hundred thirty patients with in-stent
restenosis underwent successful coronary intervention
and were then blindly randomized to receive either
intracoronary -radiation with 192Ir (15 Gy) or
placebo. Four independent core laboratories blinded to the treatment
protocol analyzed the angiographic and intravascular ultrasound
end points of restenosis. Procedural success and in-hospital
and 30-day complications were similar among the groups. At 6 months,
patients assigned to radiation therapy required less target lesion
revascularization and target vessel
revascularization (9 [13.8%] and 17 [26.2%],
respectively) compared with patients assigned to placebo (41 [63.1%,
P=0.0001] and 44 [67.7%, P=0.0001],
respectively). Binary angiographic restenosis was lower in the
irradiated group (19% versus 58% for placebo,
P=0.001). Freedom from major cardiac events was lower in
the radiation group (29.2% versus 67.7% for placebo,
P<0.001).
Conclusions—Intracoronary -radiation used as adjunct
therapy for patients with in-stent restenosis significantly
reduces both angiographic and clinical restenosis.
Key Words: restenosis • angioplasty • revascularization • radioisotopes
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R. Waksman, A. E. Ajani, E. Pinnow, E. Cheneau, L. Leborgne, R. Dieble, A. B. Bui, L. F. Satler, A. D. Pichard, K. K. Kent, et al. Twelve Versus Six Months of Clopidogrel to Reduce Major Cardiac Events in Patients Undergoing {gamma}-Radiation Therapy for In-Stent Restenosis: Washington Radiation for In-Stent restenosis Trial (WRIST) 12 Versus WRIST PLUS Circulation, August 13, 2002; 106(7): 776 - 778. [Abstract] [Full Text] [PDF]
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D. E. Kandzari and D. B. Mark Intracoronary Brachytherapy: Time to Sell Short? Circulation, August 6, 2002; 106(6): 646 - 648. [Full Text] [PDF]
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D. J. Cohen, R. S. Cosgrove, R. H. Berezin, P. S. Teirstein, M. B. Leon, R. E. Kuntz, and on behalf of the Gamma-1 Investigators Cost-Effectiveness of Gamma Radiation for Treatment of In-Stent Restenosis: Results From the Gamma-1 Trial Circulation, August 6, 2002; 106(6): 691 - 697. [Abstract] [Full Text] [PDF]
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M. Apple, R. Waksman, R. C. Chan, Y. Vodovotz, J. Fournadjiev, and B. G. Bass Radioactive 133-Xenon Gas-Filled Balloon to Prevent Restenosis: Dosimetry, Efficacy, and Safety Considerations Circulation, August 6, 2002; 106(6): 725 - 729. [Abstract] [Full Text] [PDF]
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K. Krueger, P. Landwehr, M. Bendel, M. Nolte, H. Stuetzer, R. Bongartz, M. Zaehringer, G. Winnekendonk, A. Gossmann, R.-P. Mueller, et al. Endovascular Gamma Irradiation of Femoropopliteal de Novo Stenoses Immediately after PTA: Interim Results of Prospective Randomized Controlled Trial Radiology, August 1, 2002; 224(2): 519 - 528. [Abstract] [Full Text] [PDF]
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C. di Mario and K. Toutouzas No room for radiant dreams in the real world Eur. Heart J., July 1, 2002; 23(13): 999 - 1001. [Full Text] [PDF]
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E. Regar, K. Kozuma, G. Sianos, V.L.M.A. Coen, W.J. van der Giessen, D. Foley, P. de Feyter, B. Rensing, P. Smits, J. Vos, et al. Routine intracoronary beta-irradiation. Acute and one year outcome in patients at high risk for recurrence of stenosis Eur. Heart J., July 1, 2002; 23(13): 1038 - 1044. [Abstract] [Full Text] [PDF]
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A. Maehara, N. S. Patel, L. B. Harrison, N. J. Weissman, A. B. Bui, H.-S. Kim, A. E. Ajani, M. T. Castagna, T. L. McMillan, N. Yang, et al. Dose heterogeneity may not affect the neointimal proliferation after gamma radiation for in-stent restenosis: A volumetric intravascular ultrasound dosimetric study J. Am. Coll. Cardiol., June 19, 2002; 39(12): 1937 - 1942. [Abstract] [Full Text] [PDF]
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D. O. Williams Intracoronary Brachytherapy: Past, Present, and Future Circulation, June 11, 2002; 105(23): 2699 - 2700. [Full Text] [PDF]
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M. A. Grise, V. Massullo, S. Jani, J. J. Popma, R. J. Russo, R. A. Schatz, E. M. Guarneri, S. Steuterman, D. A. Cloutier, M. B. Leon, et al. Five-Year Clinical Follow-Up After Intracoronary Radiation: Results of a Randomized Clinical Trial Circulation, June 11, 2002; 105(23): 2737 - 2740. [Abstract] [Full Text] [PDF]
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Y. Morino, T. Limpijankit, Y. Honda, A. J. Lansky, R. Waksman, H. N. Bonneau, P. G. Yock, G. S. Mintz, and P. J. Fitzgerald Late Vascular Response to Repeat Stenting for In-Stent Restenosis With and Without Radiation: An Intravascular Ultrasound Volumetric Analysis Circulation, May 28, 2002; 105(21): 2465 - 2468. [Abstract] [Full Text] [PDF]
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C. Hanefeld, S. Amirie, D. Borchardt, P. Grewe, K.-M. Muller, M. Kissler, and A. Mugge Dosimetric Measurements in Isolated Human Coronary Arteries: Comparison of Commercially Available Iridium192 With Strontium/Yttrium90 Emitters Circulation, May 28, 2002; 105(21): 2493 - 2496. [Abstract] [Full Text] [PDF]
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R. Waksman, A. E. Ajani, R. L. White, R. C. Chan, L. F. Satler, K. M. Kent, A. D. Pichard, E. E. Pinnow, A. B. Bui, S. Ramee, et al. Intravascular Gamma Radiation for In-Stent Restenosis in Saphenous-Vein Bypass Grafts N. Engl. J. Med., April 18, 2002; 346(16): 1194 - 1199. [Abstract] [Full Text] [PDF]
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A. E. Ajani, R. Waksman, D.-H. Cha, L. Gruberg, L. F. Satler, A. D. Pichard, and K. M. Kent The impact of lesion length and reference vessel diameter on angiographic restenosis and target vessel revascularization in treating in-stent restenosis with radiation J. Am. Coll. Cardiol., April 17, 2002; 39(8): 1290 - 1296. [Abstract] [Full Text] [PDF]
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K. Kozuma, M.A. Costa, W.J. van der Giessen, M. Sabate, J.M.R. Ligthart, V.L.M.A. Coen, I.P. Kay, A.J. Wardeh, A.H.M. Knook, P.J de Feyter, et al. Initial observation regarding changes in vessel dimensions after balloon angioplasty and stenting followed by catheter-based {beta}-radiation. Is stenting necessary in the setting of catheter-based radiotherapy? Eur. Heart J., April 2, 2002; 23(8): 641 - 649. [Abstract] [Full Text] [PDF]
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 S. Scott, M. O'Sullivan, S. Hafizi, L. M. Shapiro, and M. R. Bennett Human Vascular Smooth Muscle Cells From Restenosis or In-Stent Stenosis Sites Demonstrate Enhanced Responses to p53: Implications for Brachytherapy and Drug Treatment for Restenosis Circ. Res., March 8, 2002; 90(4): 398 - 404. [Abstract] [Full Text] [PDF]
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J. vom Dahl, U. Dietz, P. K. Haager, S. Silber, L. Niccoli, H. J. Buettner, F. Schiele, M. Thomas, P. Commeau, D. R. Ramsdale, et al. Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis: Results of the Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis Trial (ARTIST) Circulation, February 5, 2002; 105(5): 583 - 588. [Abstract] [Full Text] [PDF]
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S. Meiners, M. Laule, W. Rother, C. Guenther, I. Prauka, P. Muschick, G. Baumann, P.-M. Kloetzel, and K. Stangl Ubiquitin-Proteasome Pathway as a New Target for the Prevention of Restenosis Circulation, January 29, 2002; 105(4): 483 - 489. [Abstract] [Full Text] [PDF]
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H. C. Lowe, S. N. Oesterle, and L. M. Khachigian Coronary in-stent restenosis: Current status and future strategies J. Am. Coll. Cardiol., January 16, 2002; 39(2): 183 - 193. [Abstract] [Full Text] [PDF]
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A. J. Lansky, G. Dangas, R. Mehran, K. J. Desai, G. S. Mintz, H. Wu, M. Fahy, G. W. Stone, R. Waksman, and M. B. Leon Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation J. Am. Coll. Cardiol., January 16, 2002; 39(2): 274 - 280. [Abstract] [Full Text] [PDF]
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M. T. Castagna, G. S. Mintz, R. Waksman, J. M. Ahmed, A. Maehara, A. E. Ajani, A. B. Bui, L. F. Satler, W. O. Suddath, K. M. Kent, et al. Comparative Efficacy of {gamma}-Irradiation for Treatment of In-Stent Restenosis in Saphenous Vein Graft Versus Native Coronary Artery In-Stent Restenosis: An Intravascular Ultrasound Study Circulation, December 18, 2001; 104(25): 3020 - 3022. [Abstract] [Full Text] [PDF]
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P. S. Teirstein and R. E. Kuntz New Frontiers in Interventional Cardiology: Intravascular Radiation to Prevent Restenosis Circulation, November 20, 2001; 104(21): 2620 - 2626. [Full Text] [PDF]
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G. S. Mintz, N. J. Weissman, and P. J. Fitzgerald Intravascular Ultrasound Assessment of the Mechanisms and Results of Brachytherapy Circulation, September 11, 2001; 104(11): 1320 - 1325. [Full Text] [PDF]
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S.-W. Park, M.-K. Hong, D. H. Moon, S. J. Oh, C. W. Lee, J.-J. Kim, and S.-J. Park Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon J. Am. Coll. Cardiol., September 1, 2001; 38(3): 631 - 637. [Abstract] [Full Text] [PDF]
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R. M. Wolfram, B. Pokrajac, R. Ahmadi, C. Fellner, M. Gyongyosi, M. Haumer, R. Bucek, R. Potter, and E. Minar Endovascular Brachytherapy for Prophylaxis against Restenosis after Long-Segment Femoropopliteal Placement of Stents: Initial Results Radiology, September 1, 2001; 220(3): 724 - 729. [Abstract] [Full Text] [PDF]
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J. M. Ahmed, G. S. Mintz, R. Waksman, R. Mehran, B. Leiboff, A. D. Pichard, L. F. Satler, K. M. Kent, and N. J. Weissman Serial Intravascular Ultrasound Assessment of the Efficacy of Intracoronary {gamma}-Radiation Therapy for Preventing Recurrence in Very Long, Diffuse, In-Stent Restenosis Lesions Circulation, August 21, 2001; 104(8): 856 - 859. [Abstract] [Full Text] [PDF]
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G. Tepe, L. M. Dinkelborg, U. Brehme, P. Muschick, B. Noll, T. Dietrich, A. Greschniok, A. Baumbach, C. D. Claussen, and S. H. Duda Prophylaxis of Restenosis With 186Re-Labeled Stents in a Rabbit Model Circulation, August 6, 2001; 104(4): 480 - 485. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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M. T. Metzdorff, W. Sapirstein, B. Zuckerman, J. Dillard, M. J. Eisenberg, R. Sheppard, M. B. Leon, P. S. Teirstein, and J. W. Moses Intracoronary Radiotherapy for Restenosis N. Engl. J. Med., June 7, 2001; 344(23): 1796 - 1797. [Full Text] [PDF]
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R. Waksman, A. E. Ajani, R. L. White, E. Pinnow, R. Dieble, A. B. Bui, M. Taaffe, L. Gruberg, G. S. Mintz, L. F. Satler, et al. Prolonged Antiplatelet Therapy to Prevent Late Thrombosis After Intracoronary {{gamma}}-Radiation in Patients With In-Stent Restenosis : Washington Radiation for In-Stent Restenosis Trial Plus 6 Months of Clopidogrel (WRIST PLUS) Circulation, May 15, 2001; 103(19): 2332 - 2335. [Abstract] [Full Text] [PDF]
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G. L. Kaluza, A. E. Raizner, W. Mazur, D. G. Schulz, J. M. Buergler, L. F. Fajardo, F. O. Tio, and N. M. Ali Long-Term Effects of Intracoronary {beta}-Radiation in Balloon- and Stent-Injured Porcine Coronary Arteries Circulation, April 24, 2001; 103(16): 2108 - 2113. [Abstract] [Full Text] [PDF]
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A. Farb, S. Shroff, M. John, W. Sweet, and R. Virmani Late Arterial Responses (6 and 12 Months) After 32P {beta}-Emitting Stent Placement : Sustained Intimal Suppression With Incomplete Healing Circulation, April 10, 2001; 103(14): 1912 - 1919. [Abstract] [Full Text] [PDF]
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R. Seabra-Gomes Radioactive stents to reduce restenosis: time for an epitaph? Eur. Heart J., April 2, 2001; 22(8): 621 - 623. [PDF]
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H.-S. Kim, R. Waksman, Y. Cottin, M. Kollum, B. Bhargava, R. Mehran, R. C. Chan, and G. S. Mintz Edge stenosis and geographical miss following intracoronary gamma radiation therapy for in-stent restenosis J. Am. Coll. Cardiol., March 15, 2001; 37(4): 1026 - 1030. [Abstract] [Full Text] [PDF]
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