Abstract
Background
Treatment of restenosis following intracoronary brachytherapy (ICB) is still a challenging problem. Implantation of sirolimus-eluting stents (SES) in this setting may be an option to be evaluated.
Methods and results
We analysed the prospective multicentre SES registry, the German Cypher Stent Registry. 7,445 patients treated with an SES during percutaneous coronary intervention (PCI) were registered. Out of these patients, 61 (0.8%) were treated for restenosis after ICB: 56 patients with completed follow-up could be evaluated. Median age was 65 years, with 80% male patients. 48% of patients had a prior myocardial infarction and 25% had already coronary bypass surgery (CABG). Type B2 lesion was present in 40% and type C lesion in 22.4%. Event rates from SES implantation until 6.6 months follow-up were death 0%, myocardial infarction 3.6%, stroke 2.1%. Target vessel revascularization rate (TVR) was 16.4%, and major adverse cardiovascular or cerebral events (MACCE) or TVR occurred in 17.9% of patients. This TVR rate was higher compared with that of other patients treated with an SES: 8.4% (P = 0.04). During 65 months follow-up MACCE or TVR occurred in 44.6% of patients.
Conclusions
The treatment of lesions after ICB occurred in 0.8% out of all patients treated with an SES. Clinical event rates during early follow-up were low. However, the TVR rate was 16.4%, which was significantly higher when compared with other SES-treated patients (8.4%, P = 0.04). The treatment of restenosis after ICB with SES seems to be safe and reasonably effective; however, there might be a late catch-up phenomenon.
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References
Chu WW, Torguson R, Pichard AD, Satler LF, Chan R, Porrazzo M, Kent KM, Suddath WO, Waksman R (2005) Drug-eluting stents versus repeat vascular brachytherapy for patients with recurrent in-stent restenosis after failed intracoronary radiation. J Invasive Cardiol 17:659–662
Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME (2003) Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 108:788–794
Cremers B, Biedermann M, Mahnkopf D, Bohm M, Scheller B (2009) Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol 98:325–330
Degertekin M, Regar E, Tanabe K, Smits PC, van der Giessen WJ, Carlier SG, de Feyter P, Vos J, Foley DP, Ligthart JM, Popma JJ, Serruys PW (2003) Sirolimus-eluting stent for treatment of complex in-stent restenosis. The first clinical experience. J Am Coll Cardiol 41:184–189
Dibra A, Kastrati A, Alfonso F, Seyfarth M, Perez-Vizcayno MJ, Mehilli J, Schomig A (2007) Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol 49:616–623
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M (1994) 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 331:496–501
Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME (2003) TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 107:38–42
Hoffmann R, Hamm C, Nienaber C, Levenson B, Bonzel T, Sabin G, Senges J, Zahn R, Tebbe U, Pfannebecker T, Richardt G, Schneider S, Kelm M, for the German Cypher Stent Registry (2007) Implantation of sirolimus-eluting stents in sapheneous vein grafts. Clinical follow-up results from the German Cypher Stent Registry. Coron Artery Dis 18:559–564
Holmes DR Jr, Teirstein P, Satler L, Sketch M, O’Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA (2006) Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA 295:1264–1273
Hong MK, Mintz GS, Lee CW, Song JM, Han KH, Kang DH, Song JK, Kim JJ, Weissman NJ, Fearnot NE, Park SW, Park SJ (2003) Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries: a serial volumetric intravascular ultrasound analysis from the ASian Paclitaxel-Eluting Stent Clinical Trial (ASPECT). Circulation 107:517–520
Iakovou I, Sangiorgi GM, Stankovic G, Corvaja N, Michev I, Chieffo A, Rogacka R, Vitrella G, Airoldi F, Colombo A (2004) Effectiveness of sirolimus-eluting stent implantation for treatment of in-stent restenosis after brachytherapy failure. Am J Cardiol 94:351–354
Iofina E, Gorchstein V, Radke P, Schubert D, Franke A, Langenberg R, Hanrath P, vom Dahl J, Hoffmann R (2007) Advantage of sirolimus-eluting stents compared to intracoronary radiation therapy 30 months after treatment of in-stent restenosis. EuroInterv 2:467–473
Jeremias A, Sylvia B, Bridges J, Kirtane AJ, Bigelow B, Pinto DS, Ho KK, Cohen DJ, Garcia LA, Cutlip DE, Carrozza JP Jr (2004) Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation 109:1930–1932
Leon MB, Teirstein PS, Moses JW, Tripuraneni P, Lansky AJ, Jani S, Wong SC, Fish D, Ellis S, Holmes DR, Kerieakes D, Kuntz RE (2001) Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. N Engl J Med 344:250–256
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW (2004) Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 364:1519–1521
Möllmann H, Elsasser A, Nef H, Schneider S, Nienaber CA, Richardt G, Weber M, Kelm M, Levenson B, Bonzel T, Tebbe U, Sabin G, Pfannebecker T, Senges J, Hamm CW (2008) Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry. Clin Res Cardiol 97:432–440
Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban HE, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346:1773–1780
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323
Park SJ, Shim WH, Ho DS, Raizner AE, Park SW, Hong MK, Lee CW, Choi D, Jang Y, Lam R, Weissman NJ, Mintz GS (2003) A paclitaxel-eluting stent for the prevention of coronary restenosis. N Engl J Med 348:1537–1545
Park SW, Lee SW, Koo BK, Park DW, Lee SW, Kim YH, Lee CW, Hong MK, Kim JJ, Mori K, Lansky AJ, Mintz GS, Lee MM, Park SJ (2008) Treatment of diffuse in-stent restenosis with drug-eluting stents vs. intracoronary beta-radiation therapy: INDEED Study. Int J Cardiol 131:70–77
Popma JJ, Suntharalingam M, Lansky AJ, Heuser RR, Speiser B, Teirstein PS, Massullo V, Bass T, Henderson R, Silber S, von Rottkav P, Bonan R, Ho KK, Osattin A, Kuntz RE (2002) Randomized trial of 90Sr/90Y beta-radiation versus placebo control for treatment of in-stent restenosis. Circulation 106:1090–1096
Price MJ, Giap H, Teirstein PS (2007) Intracoronary radiation therapy for multi-drug resistant in-stent restenosis: initial clinical experience. Catheter Cardiovasc Interv 69:132–134
Radke PW, Kaiser A, Frost C, Sigwart U (2003) Outcome after treatment of coronary in-stent restenosis; results from a systematic review using meta-analysis techniques. Eur Heart J 24:266–273
Saia F, Lemos PA, Sianos G, Degertekin M, Lee CH, Arampatzis CA, Hoye A, Tanabe K, Regar E, van der Giessen WJ, Smits PC, de Feyter P, Ligthart J, van Domburg RT, Serruys PW (2003) Effectiveness of sirolimus-eluting stent implantation for recurrent in-stent restenosis after brachytherapy. Am J Cardiol 92:200–203
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U (2008) Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 97:773–781
Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G (2004) Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 110:810–814
Schiele TM, Rieber J, Konig A, Leibig M, Erhard I, Theisen K, Siebert U, Klauss V (2004) Comparison of acute and long-term results and underlying mechanisms from sirolimus-eluting stent implantation for the treatment of in-stent restenosis and recurrent in-stent restenosis in patients in whom intracoronary radiation failed as assessed by intravascular ultrasound. Am J Cardiol 94:917–921
Schofer J, Schlüter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G (2003) Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 362:1093–1099
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P (1994) A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 331:489–495
Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W (2005) Guidelines for percutaneous coronary interventions: the task force for percutaneous coronary interventions of the European society of cardiology. Eur Heart J 26:804–847
Silber S, Borggrefe M, Bohm M, Hoffmeister HM, Dietz R, Ertl G, Heusch G (2008) Drug-eluting coronary stents and drug eluting balloon catheters: summary of the position papers of the DGK. Clin Res Cardiol 97:548–563
Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW (2001) Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 103:192–195
Sousa JE, Costa MA, Abizaid A, Sousa AG, Feres F, Mattos LA, Centemero M, Maldonado G, Abizaid AS, Pinto I, Falotico R, Jaeger J, Popma JJ, Serruys PW (2003) Sirolimus-eluting stent for the treatment of in-stent restenosis: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 107:24–27
Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P (2007) Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 370:937–948
Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350:221–231
Stone GW, Ellis SG, O’Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME (2006) Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA 295:1253–1263
Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, Staberock M, de Feyter P, Muller R, Regar E, Degertekin M, Ligthart JM, Disco C, Backx B, Russell ME (2003) TAXUS III trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation 107:559–564
Teirstein PS, Massullo V, Jani S, Popma JJ, Mintz GS, Russo RJ, Schatz RA, Guarneri EM, Steuterman S, Morris NB, Leon MB, Tripuraneni P (1997) Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med 336:1697–1703
Torguson R, Sabate M, Deible R, Smith K, Chu WW, Kent KM, Pichard AD, Suddath WO, Satler LF, Waksman R (2006) Intravascular brachytherapy versus drug-eluting stents for the treatment of patients with drug-eluting stent restenosis. Am J Cardiol 98:1340–1344
Waksman R, Ajani AE, White RL, Chan RC, Satler LF, Kent KM, Pichard AD, Pinnow EE, Bui AB, Ramee S, Teirstein P, Lindsay J (2002) Intravascular gamma radiation for in-stent restenosis in saphenous-vein bypass grafts. N Engl J Med 346:1194–1199
Waksman R, Lew R, Ajani AE, Pichard AD, Satler LF, Kent KM, Chan R, White RL, Suddath WO, Pinnow E, Torguson R, Dilcher C, Wolfram R, Lindsay J (2003) Repeat intracoronary radiation for recurrent in-stent restenosis in patients who failed intracoronary radiation. Circulation 108:654–656
Waksman R, White RL, Chan RC, Bass BG, Geirlach L, Mintz GS, Satler LF, Mehran R, Serruys PW, Lansky AJ, Fitzgerald P, Bhargava B, Kent KM, Pichard AD, Leon MB (2000) Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. Circulation 101:2165–2171
Wöhrle J, Krause BJ, Nusser T, Kochs M, Hoher M (2006) Repeat intracoronary beta-brachytherapy using a rhenium-188-filled balloon catheter for recurrent restenosis in patients who failed intracoronary radiation therapy. Cardiovasc Revasc Med 7:2–6
Zahn R, Hamm CW, Schneider S, Zeymer U, Nienaber CA, Richardt G, Kelm M, Levenson B, Bonzel T, Tebbe U, Sabin G, Senges J (2005) Incidence and predictors of target vessel revascularization and clinical event rates of the Sirolimus-eluting coronary stent (results from the prospective multicenter German Cypher Stent Registry). Am J Cardiol 95:1302–1308
Zahn R, Hamm CW, Zeymer U, Schneider S, Nienaber CA, Richardt G, Kelm M, Levenson B, Bonzel T, Tebbe U, Schobel WA, Sabin G, Senges J (2004) “Real life” use of sirolimus-eluting coronary stents in Germany. Results from the prospective multi-centre German Cypher Registry. Z Kardiol 93:287–294
Zahn R, Hamm CW, Zeymer U, Schneider S, Nienaber CA, Richardt G, Kelm M, Levenson B, Bonzel T, Tebbe U, Schobel WA, Sabin G, Senges J (2004) Safety and current indications during “Real Life” use of sirolimus-eluting coronary stents in Germany. Results from the prospective multicenter German Cypher Stent Registry. Herz 29:181–186
Acknowledgments
The design of the German Cypher Stent Registry as well as the collection, analysis and interpretation of the data were all independent of Cordis Corporation, a Johnson & Johnson Company, Langenfeld, Germany, who supported the study.
Conflict of interest statement
All authors, with the exception of Dr. Zeymer, have received travel expenses and/or payment for taking part at meetings of the steering committee of the Cypher registry from Cordis. Mr. Pfannebecker is an employee of Cordis.
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For the German Cypher Stent Registry (see Appendix).
Appendix
Appendix
Organization of the German Cypher Stent Registry
Members of the Steering Committee
Christian W. Hamm (Chairman), Tassilo Bonzel, Malte Kelm, Benny Levenson, Christoph A. Nienaber, Gert Richardt, Georg Sabin, Jochen Senges, Ulrich Tebbe, Thomas Pfannebecker (Cordis)
Internet data acquisition (Institute of Clinical Research of the German Cardiac Society)
Thomas Fetsch, Petra Kremer
Statistical analysis (Institut für Herzinfarktforschung, Heart Centre Ludwigshafen)
Steffen Schneider
Study coordination
Thomas Fetsch
The participating centres are reported elsewhere (45).
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Zahn, R., Hamm, C.W., Zeymer, U. et al. Coronary stenting with the sirolimus-eluting stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry. Clin Res Cardiol 99, 99–106 (2010). https://doi.org/10.1007/s00392-009-0088-z
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DOI: https://doi.org/10.1007/s00392-009-0088-z