Skip to main content

Advertisement

Log in

Clinical outcomes of different first- and second-generation drug-eluting stents in routine clinical practice: results from the prospective multicenter German DES.DE registry

  • Original Paper
  • Published:
Clinical Research in Cardiology Aims and scope Submit manuscript

Abstract

Background

Second-generation drug-eluting stents (DES) have provided better results over both bare-metal stents and first-generation DES. However, comparative data of different first- and second-generation DES in a clinical setting of all-comers have not been well studied.

Methods and results

Baseline clinical and angiographic characteristics and in-hospital and follow-up events were recorded for enrolled patients. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events (MACCE), as well as target vessel revascularization (TVR) was used as the primary end point. Between May 2007 and May 2009, 10,852 patients subjected to drug-eluting stent implantation were enrolled at 74 sites. 3,032 patients (27.9 %) were treated with Taxus™, 4,382 (40.4 %) with Cypher™, 1,012 (9.3 %) with Endeavor™, 1,693 (15.6 %) with Xience V™ and 733 (6.8 %) with Promus™ during this period. At 1-year follow-up, the comparison between groups revealed no significant differences with respect to overall death, MACCE, definite stent thrombosis, TVR, stroke and major bleeding. After adjustment for risk factors in final regression models, a modestly significant association of DES type to MACCE was observed (p = 0.046); however, this association could not be attributed to one particular DES. An impact of DES type on TVR was not seen after risk adjustment.

Conclusion

Data generated from the prospective German drug-eluting stent (DES.DE) registry confirm that safety and efficacy of different first- and second-generation DES are clinically equivalent in the first year of follow-up, even in a more complex setting.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB (2007) Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stent. N Engl J Med 356:998–1008

    Article  PubMed  CAS  Google Scholar 

  2. Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig 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, Jüni P (2007) Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 370:937–948

    Article  PubMed  CAS  Google Scholar 

  3. Nienaber CA, Akin I, Schneider S, Senges J, Fetsch T, Tebbe U, Willich SN, Stumpf J, Sabin GV, Silber S, Richardt G, Kuck KH, DES.DE Study Group (2009) Clinical outcomes after sirolimus-eluting, paclitaxel-eluting, and bare-metal stents (from the first phase of the prospective multicenter German DES.DE Registry). Am J Cardiol 104:1362–1369

    Google Scholar 

  4. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersch B, Pocock SJ, Dangas G, Wong SC, Fahy M, Parise H, Mehran R, on behalf of the HORIZONS-AMI Trial Investigators (2009) Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZON-AMI): final 3-year results from a multicentre, randomized controlled trial. Lancet 374:1149–1159

    Google Scholar 

  5. Leon MB, Allocco DJ, Dawkins KD, Baim DS (2009) Late clinical events after drug-eluting stents. The interplay between stent-related and natural history-driven events. J Am Coll Cardiol Intv 2:504–512

    Google Scholar 

  6. Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L; SCAAR Study Group (2007) Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356:1009-1019

    Google Scholar 

  7. Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jemsem LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW (2009) Safety and efficacy of drug-eluting and bare-metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation 119:3198–3206

    Article  PubMed  CAS  Google Scholar 

  8. Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorja K, Weber DK, Gold HK, Virmani R (2005) Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation 112:270–278

    Article  PubMed  CAS  Google Scholar 

  9. Sabate M (2011) A clinical evaluation of Xience-V stent in acute myocardial infarction: the EXAMINATION trial. Presentation at Congress of European Society of Cardiology. Paris, France

  10. Kaiser C, Galatius S, Erne P, Eberli F, Alber H, Rickli H, Pedrazzini G, Hornig B, Bertel O, Bonetti P, De Servi S, Brunner-La Rocca HP, Ricard I, Pfisterer M, BASKET-PROVE Study Group (2010) Drug-eluting versus bare-metal stents in large coronary arteries. N Engl J Med 363:2310–2319

    Google Scholar 

  11. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ, SPIRIT IV Investigators (2010) Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med 362:1663–1674

  12. Kedhi E, Joesoef KS, McFadden E, Wassiing J, van Mieghem C, Goedhart D, Smith PC (2010) Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet 375:201–209

    Article  PubMed  CAS  Google Scholar 

  13. Sarno G, Lagerqvist B, Fröbert O, Nilsson J, Olivecrona G, Omerovic E, Saleh N, Venetzanos D, James S (2012) Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 33:606–613

    Article  PubMed  Google Scholar 

  14. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-thoracic Surgery (EACTS), European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario M, Falk V, Folliquet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifert N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggert D. Guidelines on myocardial revascularization (2010) The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 31:2501–2555

  15. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Holenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH, American College of Cardiology Foundation, American Heart Association Task Force on Practice Guidelines, Society of Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for percutaneous coronary intervention (2011) A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Intervention. J Am Coll Cardiol 58:e44–e122

    Google Scholar 

  16. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, Academic Research Consortium (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115:2344–2351

    Google Scholar 

  17. The GUSTO Investigators (1993) An interventional randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 329:673–682

    Article  Google Scholar 

  18. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A (2005) Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293:2126–2130

    Article  PubMed  CAS  Google Scholar 

  19. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, serruys PW (2007) Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 369:667–678

    Article  PubMed  CAS  Google Scholar 

  20. Wenaweser P, Daemen J, Zwahlen M, van Domburg R, Jüni P, Vaina S, Hellige G, Tsuchida K, Morger C, Boersma E, Kukreja N, Meier B, Serruys PW, Windecker S (2008) Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice: 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol 52:1134–1140

    Article  PubMed  CAS  Google Scholar 

  21. Garg P, Cohen DJ, Gaziano T, Mauri L (2008) Balancing the risks of restenosis and stent thrombosis in bare-metal versus drug-eluting stents: results of a decision analytic model. J Am Coll Cardiol 51:1844–1853

    Article  PubMed  CAS  Google Scholar 

  22. Stone GW, Ellis SG, Colombo A, Dawkins KD, Grube E, Cutlip DE, Friedman M, Baim DS, Koglin J (2007) Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation 115:2842–2847

    Article  PubMed  Google Scholar 

  23. Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A (2002) Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation 106:2649–2651

    Article  PubMed  CAS  Google Scholar 

  24. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R (2006) Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48:193–202

    Article  PubMed  Google Scholar 

  25. Ong AT, Serruys PW, Aoki J, Hoye A, van Mieghem CA, Rodriguez-Granillo GA, Valgimigli M, Sonnenschein K, Regar E, van der Ent M, de Jaegere PP, McFadden EP, Sianos G, van der Giessen WJ, de Feyter PJ, van Domburg RT (2005) The unrestricted use of paclitaxel- versus sirolimus-eluting stents for coronary artery disease in an unselected population: one-year results of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry. J Am Coll Cardiol 45:1135–1141

    Article  PubMed  CAS  Google Scholar 

  26. Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamäki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Krisrensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF, SORT OUT II Investigators (2008) Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 299:409–416

  27. Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schühlen H, Neumann FJ, Fleckenstein M, Pfafferott C, Seyfarth M, Schömig A (2001) Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation 103:2816–2821

    Article  PubMed  CAS  Google Scholar 

  28. Popma JJ, Mauri L, O`Shaughnessy C, Overlie P, NcLaurin B, Almonacid A, Kirtane A, Leon MB (2009) Frequency and clinical consequences associated with sidebranch occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary stents. Circ Cardiovasc Interv 2:133–139

    Google Scholar 

  29. Awata M, Nanto S, Uematsu M, Morozumi T, Watanabe T, Onishi T, Iida O, Sera F, Kotani J, Hori M, Nagata S (2008) Angioscopic comparison of neointimal coverage between zotarolimus- and sirolimus-eluting stents. J Am Coll Cardiol 52:789–790

    Article  PubMed  CAS  Google Scholar 

  30. Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R (2008) Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 52:333–342

    Article  PubMed  CAS  Google Scholar 

  31. Leon MB, Mauri L, Popma JJ, Cutlip DE, Nikolsky E, O`Shaughnessy C, Overlie PA, McLaurin BT, Solomon SL, Douglas JS Jr, Ball MW, Caputo RP, Jain A, Tolleson TR, Reen BM III, Kirtane AJ, Fitzgerald PJ, Thompson K, Kandzari DE, ENDEAVOR IV Investigators (2010) A randomized comparison of the ENDEAVOR zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial. J Am Coll Cardiol 55:543–554

  32. Martin-Reyes R, Moreno R, Sanchez-Recalde A, Navarro F, Franco J, Pinero A, Sendon JL (2012) Comparison of the safety between first- and second-generation drug-eluting stents: meta-analysis from 19 randomized trials and 16,924 patients. Int J Cardiol 160:181–186

    Google Scholar 

  33. Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, Maddux JT, Cutlip DE, Simonton CA, Sood P, Kereiakes DJ, for the SPIRIT IV Investigators (2011) Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (clinical evaluation of the XIENCE V everolimus eluting coronary stent system) IV trial. J Am Coll Cardiol 58:19–25

  34. Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristenses SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HAT, Thuesen L, Lassen JF, for the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) Investigators (2012) Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) Circulation 125:1246–1255

    Google Scholar 

  35. de Waha A, Cessese S, Park DW, Burzotta F, Byrne RA, Tada T, King LA, Park SJ, Schömig A, Kastrai A (2012) Everolimus-eluting versus sirolimus-eluting stents: an updated meta-analysis of randomized trials. Clin Res Cardiol 101:461–467

    Article  PubMed  CAS  Google Scholar 

  36. Akin I, Wiemer M, Schneider S, Senges J, Hochadel M, Richardt G, Abdel-Wahab M, Kuck KH, Nienaber CA, DES.DE Study Group (2012) Real-world experience of drug-eluting stents in saphenous vein grafts compared to native coronary arteries: results from the prospective multicenter German DES.DE registry. Clin Res Cardiol 101:201–208

    Google Scholar 

  37. Wöhrle J, Rottbauer W, Imhof A (2012) Everolimus-eluting stents for treatment of chronic total coronary occlusions. Clin Res Cardiol 101:23–28

    Article  PubMed  Google Scholar 

  38. Akin I, Bufe A, Schneider S, Reinecke H, Eckhardt L, Richardt G, Burska D, Senges J, Kuck KH, Nienaber CA (2010) Clinical outcomes in diabetic and non-diabetic patients with drug-eluting stents: results from the first phase of the prospective multicenter German DES.DE registry. Clin Res Cardiol 99:393–400

    Article  PubMed  CAS  Google Scholar 

  39. Diehl P, Halscheid C, Olivier C, Helbing T, Bode C, Moser M (2011) Discontinuation of long term clopidogrel therapy induces platelet rebound hyperaggregability between 2 and 6 weeks post cessation. Clin Res Cardiol 1000:765–771

    Article  Google Scholar 

  40. de la Torre Hernández JM, Alfonso F, Gimeno F, Diarte JA, Lopez-Palop R, Perez de Prado A, Rivero F, Sanchis J, Larman M, Diaz JF, Elizaga J, Moreiras JM, Gomez Jaume A, Hernandez JM, Mauri J, Recalde AS, Bullones JA, Rumoroso JR, Del Blanco BG, Baz JA, Bosa F, Botas J, Hernandez F, ESTROFA-2 Study Group (2010) Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Espanol Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2). J Am Coll Cardiol Intv 3:911–919

  41. Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S (2010) Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 363:136–146

    Article  PubMed  CAS  Google Scholar 

  42. Palmerini T, Biondi-Zoccai G, Riva DD, Stettler C, Sangiorgi D, D`Ascenzo F, Kimura T, Brigouri C, Sabate M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW (2012) Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet 379:1393–1402

    Google Scholar 

  43. Baber U, Mehran R, Sharma SK, Brar S, Yu J, Suh JW, Kim HS, Park SJ, Kastrati A, de Waha A, Krisnan P, Moreno P, Sweeny J, Kim MC, Suleman J, Pyo R, Wiley J, Kovacic J, Kini AS, Dangas GD (2011) Impact of everolimus-eluting stent on stent thrombosis. A meta-analysis of 13 randomized trials. J Am Coll Cardiol 58:1569–1577

    Article  PubMed  CAS  Google Scholar 

Download references

Conflict of interest

No conflict of interest expressed by all authors.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Christoph A. Nienaber.

Additional information

For the DES.DE Study Group.

Appendix: Organization of the DES.DE registry

Appendix: Organization of the DES.DE registry

Members of the Steering Committee:

 Christoph A. Nienaber (Chairman), Karl-Heinz Kuck (Chairman), Christoph Bode, Fokko de Haan, Gert Richardt, Georg Sabin, Jochen Senges, Sigmund Silber, Jürgen Stumpf, Ulrich Tebbe, Stephan Willich, Thomas Fetsch, Gabriele Sailer, Steffen Schneider.

Members of the Clinical Event Committee:

Bernhard Meier and Martin G Gottwick.

Internet data acquisition (Institute of Clinical Research of the German Cardiac Society): Thomas Fetsch, Petra Kremer.

Statistical analysis (Heart Center Ludwigshafen):

Steffen Schneider, Matthias Hochadel.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Akin, I., Hochadel, M., Abdel-Wahab, M. et al. Clinical outcomes of different first- and second-generation drug-eluting stents in routine clinical practice: results from the prospective multicenter German DES.DE registry. Clin Res Cardiol 102, 371–381 (2013). https://doi.org/10.1007/s00392-013-0546-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-013-0546-5

Keywords

Navigation