Abstract
Background
Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary.
Methods and results
1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS).
Conclusion
The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.
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References
Briguori C, Colombo A, Airoldi A, Iakovou I, Chieffo A, Michev I, Montorfano E, Ricciarelli B, Condorelli G (2005) Sirolimus-eluting stent implantation in diabetic patients with multivessel coronary artery disease. Am Heart J 150:807–813
Carlsson J, von Wangenheim B, Linder R, Anwari TM, Qvist J, Petersson I, Magounakis T, Lagerquist B (2007) Is late stent thrombosis in drug-eluting stents a real clinical issue? Clin Res Cardiol 96:86–93
Carson JL, Scholz PM, Chen AY, Peterson ED, Gold J, Schneider SH (2002) Diabetes mellitus increases short-term mortality and morbidity in patients undergoing coronary artery bypass graft surgery. J Am Coll Cardiol 40:418–423
Elsässer A, Möllmann H, Nef HM, Hamm CW (2006) How to revascularize patients with diabetes mellitus—bypass or stents and drugs? Clin Res Cardiol 95:195–203
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S, for the Stent Restenosis Study Investigators (1994) A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 331:496–501
Khattab AA, Hamm CW, Senges J, Toelg R, Geist V, Bonzel T, Kelm M, Levenson B, Nienaber CA, Sabin G, Tebbe U, Schneider S, Richardt G (2007) Incidence and predictors of target vessel revascularization after sirolimus-eluting stent treatment for proximal left anterior descending artery stenoses among 2274 patients from the prospective multicenter German Cypher Stent Registry. Clin Res Cardiol 96:279–284
Kip KE, Faxon DP, Detre KM, Yeh W, Kelsey SF, Currier JW (1996) Coronary angioplasty in diabetic patients. The National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 94:1818–1825
Laarman G, Suttoro MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JGP, Rensing BJ, Patterson M (2006) Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 355:1105–1113
Moussa I, Leon MB, Baim DS, O’Neill WW, Popma J, Buchbinder M, Midwall J, Simonton CA, Keim E, Wang P, Kuntz RE, Moses JW (2004) Impact of sirolimus-eluting stents on outcome in diabetic patients. A SIRIUS substudy. Circulation 109:2273–2278
Myler RK, Topol EJ, Shaw RE, Stertzer SH, Clark DA, Fishman J, Murphy MC (1987) Multiple vessel coronary angioplasty: classification, results, and pattern of restenosis in 494 consecutive patients. Cathet Cardiovasc Diagn 13:1–15
Scheen AJ, Warzee F, Legrand VM (2004) Drug-eluting stents: meta-analysis in diabetic patients. Eur Herat J 23:2168–2169
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materene P, Belardi J, Sigwart U, Colombo J, Morel M-A, for the Benestent Study Group (1994) A comparison of balloon-expendable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 331:490–495
Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrié D, Slama MA, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll H-P, Snead DB, Bode C, for the TYPHOON Investigators (2006) Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 355:1093–1104
Stein B, Weintraub WS, Gebhart SP, Cohen-Bernstein CL, Grosswald R, Liberman HA, Douglas JS Jr, Morris DC, King SB III (1995) Influence of diabetes mellitus on early and late outcome after percutaneous transluminal coronary angioplasty. Circulation 91:979–989
Stettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P (2005) Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of randomized controlled trials. Heart Online 1–23
The Bypass Angioplasty Revascularization Investigation (BARI) Investigators (1996) Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. N Engl J Med 335:217–225
Van Belle E, Bauters C, Hubert E, Bodart J-C, Abolmaali K, Meurice T, McFadden EP, Lablanche J-M, Bertrand ME (1997) Restenosis rates in diabetic patients: a comparison of coronary stenting and balloon angioplasty in native coronary vessels. Circulation 96:1454–1460
Weintraub WS, Kosinski AS, Brown CL III, SB King SB III (1993) Can restenosis after coronary angioplasty be predicted from clinical variables? Am J Cardiol 21:6–14
Whang W, Bigger JT Jr (2000) Diabetes and outcomes of coronary artery bypass graft surgery in patients with severe left ventricular dysfunction: results from the CABG Patch Trial database. The CABG Patch Trial Investigators and Coordinators. J Am Coll Cardiol 36:1166–1172
Zahn R, Hamm CW, Schneider S, Zeymer U, Richardt K, Kelm M, Levenson B, Bonzel T, Tebbe U, Sabin G, Nienaber CA, Pfannebecker T, Senges J, for the German Cypher Stent Registry (2007) The Sirolimus-eluting coronary stent in daily routine practice in Germany: trends in indications over years. Results from the prospective multi-centre German Cypher Stent Registry. Clin Res Cardiol 96:548–556
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All the authors belong to German Cypher™ Registry.
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Weber, F.D., Schneider, H., Wiemer, M. et al. Sirolimus eluting stent (Cypher™) in patients with diabetes mellitus: results from the German Cypher Stent Registry. Clin Res Cardiol 97, 105–109 (2008). https://doi.org/10.1007/s00392-007-0595-8
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DOI: https://doi.org/10.1007/s00392-007-0595-8