Abstract
Background
Drugeluting coronary stents (DES) are increasingly used during percutaneous coronary interventions (PCI). Due to limited budgets in Germany, no special reimbursement has been given for their use and therefore they were mainly used in selected patients.
Methods
In order to determine the change in indications in patients treated with a Sirolimus-eluting stent (SES) in daily clinical practice between 2002 and 2005, we analysed data from a prospective multi-centre DES registry, the German Cypher Stent Registry.
Results
From April 2002 until September 2005, 11 507 patients at 132 hospitals, who received at least one SES during their PCI, were included. Between 2002 and 2005, the median age of patients increased from 63 years to 66 years (p for trend <0.0001), whereas the prevalence of prior coronary bypass surgery (p<0.0001) and prior PCI (p<0.001) significantly decreased. Initial presentation of patients was stable over time, with a small increase of patients treated for non-ST elevation myocardial infarction (p=0.05). We found a significant increase in the treatment of complex stenoses (p<0.0001) as well as an increase in the proportion of chronic total occlusions (p<0.01). There was a steady increase in the proportion of patients treated for de novo lesions (p<0.0001), which was accompanied by a relative decrease in the proportion of patients treated for in-stent restenosis (p<0.0001). Concerning interventional characteristics a significant increase in the length of SES implanted per lesion, the numbers of SES implanted per lesion as well as an increase of the proportion of patients treated for more than one stenosis during one intervention could be observed (all p<0.0001). There was a significant decrease in the use of glycoprotein II b/IIIa antagonists during the PCI (2002: 26.5 to 14.2% in 2005, p<0.0001). MACE rates until hospital discharge did not change significantly over time.
Conclusions
Between 2002 and 2005 there were two trends in the use of SES: a) a significant increase in the use of SES for de novo lesions and b) a significant trend to use SES for longer lesions, smaller arteries, more complex lesions and more SES per lesion. In summary these findings indicate that still SES are mainly used in patients with lesions that are at high risk for restenosis.
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References
Bauters C, Hubert E, Prat A, Bougrimi K, Van Belle E, McFadden EP, Amouyel P, Lablanche JM, Bertrand M (1998) Predictors of restenosis after coronary stent implantation. J Am Coll Cardiol 31:1291–1298
Bruckenberger E (2006) Herzbericht 2005 mit Transplantationschirurgie. 18. Bericht, Sektorenübergreifende Gesundtheitsberichterstattung zur Kardiologie und Herzchirurgie in Deutschland. Mit vergleichenden Daten aus Österreich und anderen europäischen Staaten. Hannover
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
de Feyter PJ, Kay P, Disco C, Serruys PW (1999) Reference chart derived from post-stent-implantation intravascular ultrasound predictors of 6- month expected restenosis on quantitative coronary angiography. Circulation 100:1777–1783
Degertekin M, Arampatzis CA, Lemos PA, Saia F, Hoye A, Daemen J, Tanabe K, Lee CH, Hofma SJ, Sianos G, McFadden E, Van der GW, Smits PC, de Feyter PJ, van Domburg RT, Serruys PW (2004) Very long sirolimuseluting stent implantation for de novo coronary lesions. Am J Cardiol 93:826–829
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
Ge L, Iakovou I, Sangiorgi GM, Chieffo A, Melzi G, Cosgrave J, Montorfano M, Michev I, Airoldi F, Carlino M, Corvaja N, Colombo A (2005) Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome. J Am Coll Cardiol 45:989–994
Gitt AK, Seabra-Gomes R, Bassand JP et al (2003) Verwendung der Drugeluting Stents seit der Zulassung in Europa: Ergebnisse des internationalen SHAKESPEARE Registers. Z Kardiol 92 (Suppl1):1
Goy JJ, Stauffer JC, Siegenthaler M, Benoit A, Seydoux C (2005) A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology The TAXi trial. J Am Coll Cardiol 45:308–311
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
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
Kastrati A, Elezi S, Dirschinger J, Hadamitzky M, Neumann FJ, Schömig A (1999) Influence of lesion length on restenosis after coronary stent placement. Am J Cardiol 83:1617–1622
Kastrati A, Mehilli J, Von Beckerath N, Dibra A, Hausleiter J, Pache J, Schühlen H, Schmitt C, Dirschinger J, Schömig A (2005) Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 293:165–171
Kastrati A, Schömig A, Elezi S, Schühlen H, Dirschinger J, Hadamitzky M, Wehinger A, Hausleiter J, Walter H, Neumann FJ (1997) Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol 30:1428–1436
Laarman GJ, Suttorp MJ, Dirksen MT, van HL, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M (2006) Paclitaxel- eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 355:1105–1113
Lemos PA, Arampatzis CA, Saia F, Hoye A, Degertekin M, Tanabe K, Lee CH, Cummins P, Smits PC, McFadden E, Sianos G, de Feyter P, van der Giessen WJ, van Domburg RT, Serruys PW (2004) Treatment of very small vessels with 2.25-mm diameter sirolimus-eluting stents (from the RESEARCH registry). Am J Cardiol 93:633–636
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
Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schömig A (2006) Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 27:260–266
Mercado N, Boersma E, Wijns W, Gersh BJ, Morillo CA, de Valk V, van Es GA, Grobbee DE, Serruys PW (2001) Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-to-stent era. J Am Coll Cardiol 38:645–652
Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP (2006) Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA 295:895–904
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 sirolimuseluting 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, Kim YH, Lee BK, Lee SW, Lee CW, Hong MK, Kim JJ, Mintz GS, Park SW (2005) Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation. J Am Coll Cardiol 45:351–356
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
Pfisterer M E (2006) BASKET late. American College of Cardiology Meeting
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 (2004) Drug-coated stents. Where do we stand in 2004? Z Kardiol 93:646–648
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, Kay IP, Disco C, Deshpande NV, de Feyter PJ (1999) Periprocedural quantitative coronary angiography after Palmaz-Schatz stent implantation predicts the restenosis rate at six months: results of a metaanalysis of the BElgian NEtherlands Stent study (BENESTENT) I, BENESTENT II Pilot, BENESTENT II and MUSIC trials. Multicenter Ultrasound Stent In Coronaries. J Am Coll Cardiol 34:1067–1074
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
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
Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C (2006) Sirolimuseluting versus uncoated stents in acute myocardial infarction. N Engl J Med 355:1093–1104
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
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
van Buuren F, Horstkotte D (2006) 21. Bericht über die Leistungszahlen der Herzkatheterlabore in der Bundesrepublik Deutschland. Clin Res Cardiol 95:383–387
Werner GS, Krack A, Schwarz G, Prochnau D, Betge S, Figulla HR (2004) Prevention of lesion recurrence in chronic total coronary occlusions by paclitaxel-eluting stents. J Am Coll Cardiol 44:2301–2306
Windecker S, Remondino A, Eberli FR et al (2005) Nine months results from the SIRTAX trial: A randomized comparison of a sirolimus with a paclitaxel eluting stent for coronary revascularization. J Am Coll Cardiol 45:(9)25–27
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 GermanyResults 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 trade mark Registry. Herz 29:181–186
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Zahn, R., Hamm, C.W., Schneider, S. et al. The Sirolimus-eluting coronary stent in daily routine practice in Germany:. Clin Res Cardiol 96, 548–556 (2007). https://doi.org/10.1007/s00392-007-0531-y
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DOI: https://doi.org/10.1007/s00392-007-0531-y