Skip to main content
SpringerLink
Log in

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

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

Abstract

Background

Bypass-graft intervention was associated with worse outcomes in the bare-metal stent era. Without sufficiently powered data from subgroup analyses, and in absence of randomized controlled trials targeting clinical endpoints, controversy is ongoing over safety and efficacy of drug-eluting stents (DES) in saphenous vein graft (SVG) lesions.

Methods and results

Between October 2005 and October 2006, 5,183 patients receiving DES in SVG (n = 251) or native coronary arteries (NCA) (n = 4,932) were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target-vessel revascularization (TVR) were defined as primary endpoints. Baseline clinical and descriptive morphology of coronary artery disease revealed more severe lesions and comorbidities in the SVG group. At 1-year follow-up, the SVG group suffered from higher rates of overall death (6.6 vs. 2.5%; p < 0.0001), myocardial infarction (5.9 vs. 2.2%; p < 0.0001), MACCE (13.6 vs. 5.4%; p < 0.0001), TVR (17.7 vs. 10.4%; p < 0.001) and overall stent thrombosis (10.0 vs. 3.7%; p < 0.0001).

Conclusion

Data collected in DES.DE revealed that first generation DES used in SVG lesions did not offset the worse clinical outcomes of bypass-graft intervention. Such sobering results in SVG may suggest to opt for native vessel PCI preferentially or occasionally for surgical reintervention as decided by the Heart Team.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. Yusuf S, Zucker D, Peduzzi P, Fisher LD, Takaro T, Kennedy JW, Davis K, Killip T, Passamani E, Norris R (1994) Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomized trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 344:563–570

    Article  PubMed  CAS  Google Scholar 

  2. Izzat MB, West RR, Bryan AJ, Angelini GD (1994) Coronary artery bypass surgery: current practice in the United Kingdom. Br Heart J 71:382–385

    Article  PubMed  CAS  Google Scholar 

  3. Kaneko Y, Schlechta B, Steinberger W, Agstner I, Wolner E, Mohl W (2002) The impact of graft selection on outcome of coronary bypass surgery and influence of surgical experience. Heart Views 3:3

    Google Scholar 

  4. Raja SG, Haider Z, Ahmad M, Zaman H (2004) Saphenous vein grafts: to use or not to use? Heart Lung Circ 13:150–156

    Article  PubMed  Google Scholar 

  5. Eagle KA, Guyton RA, Davidoff R, Edwards FH, Ewy GA, Gardner TJ, Hart JC, Hermann HC, Hillis LD, Hutter AM Jr, Ltle BW, Marlow RA, Nugent WC, Orszulak TA, American College of Cardiology; American Heart Association (2004) ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery). Circulation 110:e340–e437

    Article  PubMed  Google Scholar 

  6. Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR (1996) Coronary bypass graft fate and patient outcome: angiographic follow-up of 5, 065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol 28:616–626

    Article  PubMed  CAS  Google Scholar 

  7. Weintraub WS, Jones EL, Craver JM, Guyton RA (1994) Frequency of repeat coronary bypass or coronary angioplasty after coronary artery bypass surgery using saphenous venous grafts. Am J Cardiol 73:103–112

    Article  PubMed  CAS  Google Scholar 

  8. European Association for Percutaneous Cardiovascular Interventions; Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D; ESC Committee for Practice Guidelines, Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Fillippatos G, Funck-Brentano C, Hobbs R, Kearney P, McDonagh T, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Verdas PE, Widimsky P; EACTS Clinical Guidelines Committee, Kolh P, Alfieri O, Dunning J, Elia S, Kappetein P, Lockowandt U, Sarris G, Vouhe P, Kearney P, von Segesser L, Agawall S, Aladashvilli A, Alexopoulos D, Antunes MJ, Atalar E, Brutel de la Riviere A, Doganov A, Aha J, Fajadet J, Ferreira R, Garot J, Halcox J, Hasin Y, Janssens S, Kervinen K, Laufer G, Legrand V, Nashef SA, Neumann FJ, Niemela K, Nihoyannopoulos P, Noc M, Piek JJ, Rozenman Y, Sabate M, Starc R, Thielmann M, Wheatley DJ, WIndecker S, Zembala M (2010) Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Hart J 31:2501–2555

    Google Scholar 

  9. Cameron A, Kemp HG, Green GE (1988) Reoperation for coronary artery disease: 10 years of clinical follow-up. Circulation 78:1158–1162

    Google Scholar 

  10. de Jaegere PP, van Domburg RT, Feyter PJ, Ruygrok PN, van der Giessen WJ, van den Brand MJ, Serruys PW (1996) Long-term clinical outcome after stent implantation in saphenous vein grafts. J Am Coll Cardiol 28:89–96

    Article  PubMed  Google Scholar 

  11. Savage MP, Douglas JS Jr, Fischman DL, Pepine CJ, King SB 3rd, Werner JA, Bailey SR, Overlie PA, Fenton SH, Brinker JA, Leon MB, Goldberg S (1997) Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. Saphenus Vein De Novo Trial Investigators. N Engl J Med 337:740–747

    Article  PubMed  CAS  Google Scholar 

  12. 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, SIRIUS Investigators (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323

    Article  PubMed  CAS  Google Scholar 

  13. 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, TAXUS-IV Investigators (2004) One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV Trial. Circulation 109:1942–1947

    Article  PubMed  CAS  Google Scholar 

  14. Akin I, Bufe A, Schneider S, Reinecke H, Eckardt 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 

  15. Dibra A, Tiroch K, Schulz S, Kelbaek H, Spaulding C, Laarman GJ, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Campo G, Thuesen L, Vink MA, Schalij MJ, Schömig A, Kastrati A (2010) Drug-eluting stent in acute myocardial infarction: updated meta-analysis of randomized trials. Clin Res Cardiol 99:345–357

    Article  PubMed  CAS  Google Scholar 

  16. Hoffmann R, Klinker H, Adamu Ul Kelm M, Blindt R (2009) The risk of definite stent thrombosis is increased after “off-label” stent implantation irrespective of drug-eluting stent or bare-metal stent use. Clin Res Cardiol 98(9):549–554

    Article  PubMed  CAS  Google Scholar 

  17. Bauer T, Nienaber CA, Akin I, Kuck KH, Hochadel M, Senges J, Fetsch T, Tebbe U, Willich SN, Stumpf J, Sabin GV, Silber S, Richardt G, Zanh R, for the DES.DE Study Group (2011) Comparison between on-label versus off-label use of drug-eluting coronary stents in clinical practice: results from the German DES.DE registry. Clin Res Cardiol 100:701–709

    Article  PubMed  CAS  Google Scholar 

  18. Zahn R, Hamm CW, Schneider S, Zeymer U, Richardt G, Kelm M, Levenson B, Bonzel T, Tebbe U, Sabin G, Nienaber CA, Pfannebecker J, Senges J, German Cypher Stent Registry (2007) The sirolimus-eluting coronary stent in daily practice in Germany: trends in indications over the years: results from the prospective multicenter German Cypher Stent Registry. Clin Res Cardiol 96(8):548–556

    Article  PubMed  CAS  Google Scholar 

  19. 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 outcome after sirolimus-eluting, paclitaxel-eluting, and bare-metal stents (from the first phase of prospective multicenter German DES.DE registry. Am J Cardiol 104:1362–1369

    Article  PubMed  CAS  Google Scholar 

  20. Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W, Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology (2005) Guidelines for Percutaneous Coronary Intervention: the task force for percutaneous coronary interventions of the European society of cardiology. Eur Heart J 26:804–847

    Article  PubMed  Google Scholar 

  21. 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

    Article  PubMed  Google Scholar 

  22. Keeley EC, Grines CL (1998) Scraping of aortic debris by coronary guiding catheters: a prospective evaluation of 1,000 cases. J Am Coll Cardiol 32:1861–1865

    Article  PubMed  CAS  Google Scholar 

  23. Mauri L, Cox D, Hermiller J, Massaro J, Wahr J, Tay SW, Jonas M, Popma JJ, Wahr D, Rogers C (2007) The PROXIMAL trial: proximal protection during saphenous vein graft intervention using the Praxis Embolic Protection System: A randomized prospective, multicenter clinical trial. J Am Coll Cardiol 50:1442–1449

    Article  PubMed  Google Scholar 

  24. Brilakis ES, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Haagen D, Saeed B, Gadiparthi C, Bissett JK, Sachdeva R, Vourris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Baerjee S (2009) A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous graft lesions. The SOS (Stenting Of Saphenous Vein Grafts) Trial. J Am Coll Cardiol 53:919–928

    Article  PubMed  CAS  Google Scholar 

  25. Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Bruining N, Van den Branden F, Van Langenhove G (2006) Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol 48:2423–2431

    Article  PubMed  CAS  Google Scholar 

  26. Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G, DELAYED RRISC (Death and Events at Long-term follow-up AnalYsis: Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent) Investigators (2007) Increased late mortality after sirolimus-eluting sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC trial. J Am Coll Cardiol 50:261–267

    Article  PubMed  CAS  Google Scholar 

  27. Hoffmann R, Hamm C, Nienaber CA, Levenson B, Bonzel T, Sabin G, Senges J, Zahn R, Tebbe U, Pfannebecker T, Richardt HG, Schneider S, Kelm M, for the German Cypher Registry (2007) Implantation of sirolimus-eluting stents in saphenous vein grafts is associated with higher clinical follow-up event rates compared with treatment of native vessels. Coron Artery Dis 18:559–564

    Article  PubMed  Google Scholar 

  28. Vignali L, Saia F, Manari A, Santarelli A, Rubboli A, Varani E, Piovaccari G, Menozzi A, Percoco G, Benassi A, Rusticali G, Marzaroli P, Guastaroba P, Grilli R, Maresta A, Marzocchi A (2008) Long-term outcomes with drug-eluting stents versus bare metal stents in the treatment of saphenous vein graft disease (results from the REgistro Regionale AngiopLastiche Emillial-Romagna Registry). Am J Cardiol 101:947–952

    Article  PubMed  CAS  Google Scholar 

  29. Brodie BR, VerSteeg DS, Brodie MM, Hansen C, Richter SJ, Stuckey TD, Gupta N, Pulsipher M, Downey W (2005) Poor long-term patient and graft survival after primary percutaneous coronary intervention for acute myocardial infarction due to saphenous vein graft occlusion. Catheter Cardiovasc Interv 65:504–509

    Article  PubMed  Google Scholar 

  30. Lins M, Heuer M, Braun P, Franz N, Simon R, FIRST Trial Investigators (2007) Distal embolic protection during percutaneous intervention of aorto-coronary venous bypass grafts: the FIRST Trial. Clin Res Cardiol 96(10):738–742

    Article  PubMed  CAS  Google Scholar 

  31. Kalan JM, Roberts WC (1990) Morphologic findings in saphenous veins used as coronary arterial bypass conduits for longer than 1 year: necropsy analysis of 53 patients, 123 saphenous veins, and 1865 five-millimeter segments. Am Heart J 119:1164–1184

    Article  PubMed  CAS  Google Scholar 

  32. Mathew V, Berger PB, Lennon RJ, Gersh BJ, Holmes DR Jr (2000) Comparison of percutaneous interventions for unstable angina pectoris in patients with and without previous coronary artery bypass grafting. Am J Cardiol 86:931–937

    Article  PubMed  CAS  Google Scholar 

Download references

Conflict of interest

No conflict of interest.

Author information

Authors and Affiliations

  1. Divisions of Cardiology, Pulmology and Intensive Care Medicine, Department of Internal Medicine I, Heart Center Rostock, University Hospital Rostock, Rostock School of Medicine, Ernst-Heydemann-Str. 6, 18057, Rostock, Germany

    Ibrahim Akin & Christoph A. Nienaber

  2. Department of Cardiology, Heart Center Bad Oeynhausen, Bad Oeynhausen, Germany

    Marcus Wiemer

  3. Department of Cardiology, Heart Center Ludwigshafen/IKKF Ludwigshafen, Ludwigshafen, Germany

    Steffen Schneider, Jochen Senges & Matthias Hochadel

  4. Department of Cardiology, Heart Center Bad Segeberg, Bad Segeberg, Germany

    Gert Richardt & Mohamed Abdel-Wahab

  5. Department of Cardiology, Asklepios Hospital Hamburg, Hamburg, Germany

    Karl-Heinz Kuck

Authors
  1. Ibrahim Akin
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marcus Wiemer
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Steffen Schneider
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jochen Senges
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Matthias Hochadel
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Gert Richardt
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Mohamed Abdel-Wahab
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Karl-Heinz Kuck
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Christoph A. Nienaber
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Christoph A. Nienaber.

Additional information

For the DES.DE Study Group.

Members of the Organization of the German DES.DE Registry are given in the Appendix.

Appendix

Appendix

Organization of the German 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, Ahmed Khattab, Martin G. Gottwik.

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

Statistical analysis (Heart Center Ludwigshafen): Steffen Schneider, Mathias Hochadel.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Akin, I., Wiemer, M., Schneider, S. et al. 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 (2012). https://doi.org/10.1007/s00392-011-0381-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-011-0381-5

Keywords

Search

Navigation