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Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with Diabetes mellitus: a patient-level meta-analysis of randomized trials

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An Erratum to this article was published on 12 August 2011

Abstract

Background

Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking.

Methods

We performed a meta-analysis of individual patient data from four randomized trials including 583 patients comparing sirolimus eluting with bare metal stents (median follow-up of 4.2 years). These were the only specific trials reporting on drug-eluting stents in diabetic patients. The primary endpoint was the incidence of major cardiac events. The secondary endpoints were all-cause mortality and myocardial infarction as a safety endpoint and target lesion re-intervention as an efficacy endpoint. Stent thrombosis was also evaluated.

Results

There was a significant reduction in the overall hazard of major cardiac events (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.36–0.63, P < 0.001) with sirolimus-eluting stents. This was mostly due to a significant reduction in the overall hazard of repeat revascularization (HR 0.27, 95% CI 0.18–0.41, P < 0.001) in favor of sirolimus-eluting stents. However, the overall hazard of death (HR 0.91, 95% CI 0.59–1.41, P = 0.68) as well as death or myocardial infarction (HR 0.77, 95% CI 0.54–1.09, P = 0.14) were not significantly different between the groups. No significant differences were observed regarding stent thrombosis (HR 0.50, 95% CI 0.15–1.69, P = 0.26).

Conclusions

Sirolimus-eluting stents are highly effective in reducing the risk for major cardiac events and safe in diabetic patients with coronary artery disease.

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References

  1. Hammoud T, Tanguay JF, Bourassa MG (2000) Management of coronary artery disease: therapeutic options in patients with diabetes. J Am Coll Cardiol 36(2):355–365

    Article  PubMed  CAS  Google Scholar 

  2. Berry C, Tardif JC, Bourassa MG (2007) Coronary heart disease in patients with diabetes: part II: recent advances in coronary revascularization. J Am Coll Cardiol 49(6):643–656

    Article  PubMed  CAS  Google Scholar 

  3. Abizaid A, Kornowski R, Mintz GS et al (1998) The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. J Am Coll Cardiol 32(3):584–589

    Article  PubMed  CAS  Google Scholar 

  4. Elezi S, Kastrati A, Pache J et al (1998) Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol 32(7):1866–1873

    Article  PubMed  CAS  Google Scholar 

  5. Weber FD, Schneider H, Wiemer M et al (2008) Sirolimus eluting stent (Cypher™) in patients with diabetes mellitus: results from the German Cypher Stent Registry. Clin Res Cardiol 97(2):105–109

    Article  PubMed  Google Scholar 

  6. Morice MC, Serruys PW, Sousa JE et al (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346(23):1773–1780

    Article  PubMed  CAS  Google Scholar 

  7. Moussa I, Leon MB, Baim DS et al (2004) Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy. Circulation 109(19):2273–2278

    Article  PubMed  CAS  Google Scholar 

  8. Abizaid A, Costa MA, Blanchard D et al (2004) Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J 25(2):107–112

    Article  PubMed  CAS  Google Scholar 

  9. Hermiller JB, Raizner A, Cannon L et al (2005) Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial. J Am Coll Cardiol 45(8):1172–1179

    Article  PubMed  CAS  Google Scholar 

  10. Briguori C, Colombo A, Airoldi F et al (2005) Sirolimus-eluting stent implantation in diabetic patients with multivessel coronary artery disease. Am Heart J 150(4):807–813

    Article  PubMed  CAS  Google Scholar 

  11. Chan C, Zambahari R, Kaul U, Cohen S, Buchbinder M (2007) Outcomes in diabetic patients with multivessel disease and long lesions: results from the DECODE STUDY. http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1382193. Accessed 9 Feb 2007

  12. Maresta A, Varani E, Balducelli M et al (2008) Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study). Am J Cardiol 101(11):1560–1566

    Article  PubMed  CAS  Google Scholar 

  13. Sabate M, Jimenez-Quevedo P, Angiolillo DJ et al (2005) Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation 112(14):2175–2183

    Article  PubMed  CAS  Google Scholar 

  14. Jimenez-Quevedo P, Sabate M, Angiolillo DJ et al (2007) Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial. Eur Heart J 28(16):1946–1952

    Article  PubMed  Google Scholar 

  15. Baumgart D, Klauss V, Baer F et al (2007) One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. J Am Coll Cardiol 50(17):1627–1634

    Article  PubMed  Google Scholar 

  16. Egger M, Ebrahim S, Smith GD (2002) Where now for meta-analysis? Int J Epidemiol 31(1):1–5

    Article  PubMed  Google Scholar 

  17. Altman DG, Schulz KF (2001) Statistics notes: concealing treatment allocation in randomised trials. BMJ 323(7310):446–447

    Article  PubMed  CAS  Google Scholar 

  18. Juni P, Altman DG, Egger M (2001) Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 323(7303):42–46

    Article  PubMed  CAS  Google Scholar 

  19. Sterne JAC, Bradburn MJ, Egger M (2001) Meta-analysis in StataTM. In: Egger M, Smith GD, Altman D (eds) Systematic reviews in health care. Blackwell BMJ Books, London, p 357

    Google Scholar 

  20. Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327(7414):557–560

    Article  PubMed  Google Scholar 

  21. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7(3):177–188

    Article  PubMed  CAS  Google Scholar 

  22. Grundy SM, D’Agostino RB Sr, Mosca L et al (2001) Cardiovascular risk assessment based on US cohort studies: findings from a National Heart, Lung, and Blood institute workshop. Circulation 104(4):491–496

    PubMed  CAS  Google Scholar 

  23. Goraya TY, Leibson CL, Palumbo PJ et al (2002) Coronary atherosclerosis in diabetes mellitus: a population-based autopsy study. J Am Coll Cardiol 40(5):946–953

    Article  PubMed  Google Scholar 

  24. Luscher TF, Creager MA, Beckman JA, Cosentino F (2003) Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: part II. Circulation 108(13):1655–1661

    Article  PubMed  Google Scholar 

  25. Hurst RT, Lee RW (2003) Increased incidence of coronary atherosclerosis in type 2 diabetes mellitus: mechanisms and management. Ann Intern Med 139(10):824–834

    PubMed  Google Scholar 

  26. Carrozza JP Jr, Kuntz RE, Fishman RF, Baim DS (1993) Restenosis after arterial injury caused by coronary stenting in patients with diabetes mellitus. Ann Intern Med 118(5):344–349

    PubMed  Google Scholar 

  27. Kuntz RE (1999) Importance of considering atherosclerosis progression when choosing a coronary revascularization strategy: the diabetes-percutaneous transluminal coronary angioplasty dilemma. Circulation 99(7):847–851

    PubMed  CAS  Google Scholar 

  28. Frye RL, Brooks MM, Nesto RW (2003) Gap between clinical trials and clinical practice: lessons from the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 107(14):1837–1839

    Article  PubMed  Google Scholar 

  29. Stone GW, Ellis SG, Cox DA et al (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350(3):221–231

    Article  PubMed  CAS  Google Scholar 

  30. Akin I, Bufe A, Schneider S et al (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(6):393–400

    Article  PubMed  CAS  Google Scholar 

  31. Tu JV, Bowen J, Chiu M et al (2007) Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 357(14):1393–1402

    Article  PubMed  CAS  Google Scholar 

  32. Marroquin OC, Selzer F, Mulukutla SR et al (2008) A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med 358(4):342–352

    Article  PubMed  CAS  Google Scholar 

  33. Iijima R, Byrne RA, Dibra A et al (2009) Drug-eluting stents versus bare-metal stents in diabetic patients with ST-segment elevation acute myocardial infarction: a pooled analysis of individual patient data from seven randomized trials. Rev Esp Cardiol 62(4):354–364

    Article  PubMed  Google Scholar 

  34. Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW (2007) A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356(10):989–997

    Article  PubMed  CAS  Google Scholar 

  35. Kastrati A, Mehilli J, Pache J et al (2007) Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356(10):1030–1039

    Article  PubMed  CAS  Google Scholar 

  36. Kirtane AJ, Ellis SG, Dawkins KD et al (2008) Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials. J Am Coll Cardiol 51(7):708–715

    Article  PubMed  CAS  Google Scholar 

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Acknowledgment

Financial support for this meta-analysis was provided by Deutsches Herzzentrum, Munich.

Conflict of interest

Dr. Kastrati received lecture fees from Astra-Zeneca, Biotronik, Bristol-Myers, Cordis and Lilly. No other potential conflict of interest relevant to this article was reported.

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Authors and Affiliations

  1. Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636, Munich, Germany

    Antoinette de Waha, Alban Dibra, Sebastian Kufner, Albert Schömig & Adnan Kastrati

  2. Preventicum-Klinik für Diagnostik, Essen, Germany

    Dietrich Baumgart

  3. Cardiovascular Institute, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

    Manel Sabate

  4. Division of Cardiology, Interventional Center, S. Maria delle Croci Hospital, Ravenna, Italy

    Aleardo Maresta

Authors
  1. Antoinette de Waha
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  2. Alban Dibra
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  3. Sebastian Kufner
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  4. Dietrich Baumgart
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  5. Manel Sabate
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  6. Aleardo Maresta
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  7. Albert Schömig
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  8. Adnan Kastrati
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Corresponding author

Correspondence to Adnan Kastrati.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1007/s00392-011-0354-8

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de Waha, A., Dibra, A., Kufner, S. et al. Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with Diabetes mellitus: a patient-level meta-analysis of randomized trials. Clin Res Cardiol 100, 561–570 (2011). https://doi.org/10.1007/s00392-010-0278-8

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