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Netherlands Heart Journal logoLink to Netherlands Heart Journal
. 2004 Sep;12(9):389–393.

BEta versus Gamma Utrecht Trial-Cypher (BEGUT-CYPHER)

Is intracoronary brachytherapy still superior to drug-eluting stents?

PR Stella, P de Jaegere, JJ Battermann, P Bouma, MA Moerland, PA Doevendans
PMCID: PMC2497171  PMID: 25696369

Abstract

Design

Prospective, randomised single-centre pilot study comparing a beta with a gamma source and a sirolimus-eluting stent in patients with an estimated high risk of restenosis (40 to 50%).

Purpose

Although the majority of patients referred for revascularisation are now being treated with percutaneous coronary intervention (PCI) combined with stenting, a small number still suffer from recurrent restenosis which can be invalidating for the patient and frustrating for the cardiologist due to repeated PCIs.

In this prospective single-centre pilot study we will test the hypothesis of three different treatment strategies to use in this special patient subset, to determine if we can find a positive 'trend' in one arm, in order to either make a selection for one of the treatment strategies, or to provide a base to expand the study into a larger multicentre randomised study.

Time course and enrollment

A total of 120 patients will be included, 40 in each treatment arm. All patients with either in-stent and/or native restenosis and/or diabetics and/or type C lesions (ACC/AHA) are eligible. The usual exclusion criteria for intracoronary brachytherapy and prolonged antiplatelet therapy are applied. All lesions <44 mm in length and with a vessel diameter 2.4>4.0 mm are suitable. Angiographic, intravascular ultrasound imaging and clinical follow-up at one year will become available in the first quarter of 2005.

Keywords: brachytherapy, drug-eluting stents, PTCA, restenosis

Full text

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Ahmed J. M., Mintz G. S., Waksman R., Weissman N. J., Mehran R., Pichard A. D., Satler L. F., Kent K. M., Leon M. B. Safety of intracoronary gamma-radiation on uninjured reference segments during the first 6 months after treatment of in-stent restenosis: a serial intravascular ultrasound study. Circulation. 2000 May 16;101(19):2227–2230. doi: 10.1161/01.cir.101.19.2227. [DOI] [PubMed] [Google Scholar]
  2. Baim D. S., Levine M. J., Leon M. B., Levine S., Ellis S. G., Schatz R. A. Management of restenosis within the Palmaz-Schatz coronary stent (the U.S. multicenter experience. The U.S. Palmaz-Schatz Stent Investigators. Am J Cardiol. 1993 Feb 1;71(4):364–366. doi: 10.1016/0002-9149(93)90813-r. [DOI] [PubMed] [Google Scholar]
  3. Condado J. A., Waksman R., Gurdiel O., Espinosa R., Gonzalez J., Burger B., Villoria G., Acquatella H., Crocker I. R., Seung K. B. Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans. Circulation. 1997 Aug 5;96(3):727–732. doi: 10.1161/01.cir.96.3.727. [DOI] [PubMed] [Google Scholar]
  4. Costa M. A., Sabaté M., van der Giessen W. J., Kay I. P., Cervinka P., Ligthart J. M., Serrano P., Coen V. L., Levendag P. C., Serruys P. W. Late coronary occlusion after intracoronary brachytherapy. Circulation. 1999 Aug 24;100(8):789–792. doi: 10.1161/01.cir.100.8.789. [DOI] [PubMed] [Google Scholar]
  5. Di Mario C., Hermans W. R., Rensing B. J., Serruys P. W. Calibration using angiographic catheters as scaling devices--importance of filming the catheters not filled with contrast medium. Am J Cardiol. 1992 May 15;69(16):1377–1378. doi: 10.1016/0002-9149(92)91243-w. [DOI] [PubMed] [Google Scholar]
  6. Fareh J., Martel R., Kermani P., Leclerc G. Cellular effects of beta-particle delivery on vascular smooth muscle cells and endothelial cells: a dose-response study. Circulation. 1999 Mar 23;99(11):1477–1484. doi: 10.1161/01.cir.99.11.1477. [DOI] [PubMed] [Google Scholar]
  7. Faxon D. P. Predicting restenosis: bigger is better but not best. Circulation. 2000 Mar 7;101(9):946–947. doi: 10.1161/01.cir.101.9.946. [DOI] [PubMed] [Google Scholar]
  8. Fischman D. L., Leon M. B., Baim D. S., Schatz R. A., Savage M. P., Penn I., Detre K., Veltri L., Ricci D., Nobuyoshi M. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496–501. doi: 10.1056/NEJM199408253310802. [DOI] [PubMed] [Google Scholar]
  9. Fuessl R. T., Mintz G. S., Pichard A. D., Kent K. M., Satler L. F., Popma J. J., Leon M. B. In vivo validation of intravascular ultrasound length measurements using a motorized transducer pullback system. Am J Cardiol. 1996 May 15;77(12):1115–1118. doi: 10.1016/s0002-9149(96)00145-2. [DOI] [PubMed] [Google Scholar]
  10. King S. B., 3rd Radiation for restenosis: watchful waiting. Circulation. 1999 Jan 19;99(2):192–194. doi: 10.1161/01.cir.99.2.192. [DOI] [PubMed] [Google Scholar]
  11. King S. B., 3rd, Williams D. O., Chougule P., Klein J. L., Waksman R., Hilstead R., Macdonald J., Anderberg K., Crocker I. R. Endovascular beta-radiation to reduce restenosis after coronary balloon angioplasty: results of the beta energy restenosis trial (BERT). Circulation. 1998 May 26;97(20):2025–2030. doi: 10.1161/01.cir.97.20.2025. [DOI] [PubMed] [Google Scholar]
  12. Kuntz R. E., Baim D. S. Prevention of coronary restenosis : the evolving evidence base for radiation therapy. Circulation. 2000 May 9;101(18):2130–2133. doi: 10.1161/01.cir.101.18.2130. [DOI] [PubMed] [Google Scholar]
  13. Kuntz R. E., Gibson C. M., Nobuyoshi M., Baim D. S. Generalized model of restenosis after conventional balloon angioplasty, stenting and directional atherectomy. J Am Coll Cardiol. 1993 Jan;21(1):15–25. doi: 10.1016/0735-1097(93)90712-a. [DOI] [PubMed] [Google Scholar]
  14. Meerkin D., Tardif J. C., Crocker I. R., Arsenault A., Joyal M., Lucier G., King S. B., 3rd, Williams D. O., Serruys P. W., Bonan R. Effects of intracoronary beta-radiation therapy after coronary angioplasty: an intravascular ultrasound study. Circulation. 1999 Apr 6;99(13):1660–1665. doi: 10.1161/01.cir.99.13.1660. [DOI] [PubMed] [Google Scholar]
  15. Peters R. J., Kok W. E., Di Mario C., Serruys P. W., Bär F. W., Pasterkamp G., Borst C., Kamp O., Bronzwaer J. G., Visser C. A. Prediction of restenosis after coronary balloon angioplasty. Results of PICTURE (Post-IntraCoronary Treatment Ultrasound Result Evaluation), a prospective multicenter intracoronary ultrasound imaging study. Circulation. 1997 May 6;95(9):2254–2261. doi: 10.1161/01.cir.95.9.2254. [DOI] [PubMed] [Google Scholar]
  16. Sabaté M., Costa M. A., Kozuma K., Kay I. P., van der Giessen W. J., Coen V. L., Ligthart J. M., Serrano P., Levendag P. C., Serruys P. W. Geographic miss: a cause of treatment failure in radio-oncology applied to intracoronary radiation therapy. Circulation. 2000 May 30;101(21):2467–2471. doi: 10.1161/01.cir.101.21.2467. [DOI] [PubMed] [Google Scholar]
  17. Sabaté M., Marijnissen J. P., Carlier S. G., Kay I. P., van der Giessen W. J., Coen V. L., Ligthart J. M., Boersma E., Costa M. A., Levendag P. C. Residual plaque burden, delivered dose, and tissue composition predict 6-month outcome after balloon angioplasty and beta-radiation therapy. Circulation. 2000 May 30;101(21):2472–2477. doi: 10.1161/01.cir.101.21.2472. [DOI] [PubMed] [Google Scholar]
  18. Serruys P. W., Luijten H. E., Beatt K. J., Geuskens R., de Feyter P. J., van den Brand M., Reiber J. H., ten Katen H. J., van Es G. A., Hugenholtz P. G. Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months. Circulation. 1988 Feb;77(2):361–371. doi: 10.1161/01.cir.77.2.361. [DOI] [PubMed] [Google Scholar]
  19. Serruys P. W., de Jaegere P., Kiemeneij F., Macaya C., Rutsch W., Heyndrickx G., Emanuelsson H., Marco J., Legrand V., Materne P. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489–495. doi: 10.1056/NEJM199408253310801. [DOI] [PubMed] [Google Scholar]
  20. Sharma S. K., Duvvuri S., Dangas G., Kini A., Vidhun R., Venu K., Ambrose J. A., Marmur J. D. Rotational atherectomy for in-stent restenosis: acute and long-term results of the first 100 cases. J Am Coll Cardiol. 1998 Nov;32(5):1358–1365. doi: 10.1016/s0735-1097(98)00382-9. [DOI] [PubMed] [Google Scholar]
  21. Teirstein P. S., Massullo V., Jani S., Popma J. J., Mintz G. S., Russo R. J., Schatz R. A., Guarneri E. M., Steuterman S., Morris N. B. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med. 1997 Jun 12;336(24):1697–1703. doi: 10.1056/NEJM199706123362402. [DOI] [PubMed] [Google Scholar]
  22. Teirstein P. S., Massullo V., Jani S., Popma J. J., Russo R. J., Schatz R. A., Guarneri E. M., Steuterman S., Sirkin K., Cloutier D. A. Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial. Circulation. 2000 Feb 1;101(4):360–365. doi: 10.1161/01.cir.101.4.360. [DOI] [PubMed] [Google Scholar]
  23. VAN DEN BRENK H. A., MINTY C. C. Radiation in the management of keloids and hypertrophic scars. Br J Surg. 1960 May;47:595–605. doi: 10.1002/bjs.18004720603. [DOI] [PubMed] [Google Scholar]
  24. Van Belle E., Abolmaali K., Bauters C., McFadden E. P., Lablanche J. M., Bertrand M. E. Restenosis, late vessel occlusion and left ventricular function six months after balloon angioplasty in diabetic patients. J Am Coll Cardiol. 1999 Aug;34(2):476–485. doi: 10.1016/s0735-1097(99)00202-8. [DOI] [PubMed] [Google Scholar]
  25. Verin V., Urban P., Popowski Y., Schwager M., Nouet P., Dorsaz P. A., Chatelain P., Kurtz J. M., Rutishauser W. Feasibility of intracoronary beta-irradiation to reduce restenosis after balloon angioplasty. A clinical pilot study. Circulation. 1997 Mar 4;95(5):1138–1144. doi: 10.1161/01.cir.95.5.1138. [DOI] [PubMed] [Google Scholar]
  26. Waksman R., Bhargava B., White L., Chan R. C., Mehran R., Lansky A. J., Mintz G. S., Satler L. F., Pichard A. D., Leon M. B. Intracoronary beta-radiation therapy inhibits recurrence of in-stent restenosis. Circulation. 2000 Apr 25;101(16):1895–1898. doi: 10.1161/01.cir.101.16.1895. [DOI] [PubMed] [Google Scholar]
  27. Waksman R. Late thrombosis after radiation. Sitting on a time bomb. Circulation. 1999 Aug 24;100(8):780–782. doi: 10.1161/01.cir.100.8.780. [DOI] [PubMed] [Google Scholar]
  28. Waksman R., White R. L., Chan R. C., Bass B. G., Geirlach L., Mintz G. S., Satler L. F., Mehran R., Serruys P. W., Lansky A. J. Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. Circulation. 2000 May 9;101(18):2165–2171. doi: 10.1161/01.cir.101.18.2165. [DOI] [PubMed] [Google Scholar]
  29. Williams D. O., Sharaf B. L. Intracoronary radiation : it keeps on glowing. Circulation. 2000 Feb 1;101(4):350–351. doi: 10.1161/01.cir.101.4.350. [DOI] [PubMed] [Google Scholar]

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