European Heart Journal Advance Access published online on November 10, 2009
European Heart Journal, doi:10.1093/eurheartj/ehp424
Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term of follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
1 Department of Cardiology, University Hospital, 581 85 Linköping, Sweden
2 Uppsala Clinical Research Center, Uppsala, Sweden
3 Department of Cardiology, Uppsala, Sweden
4 Department of Cardiology, Örebro, Sweden
5 Department of Cardiology, Kalmar, Sweden
6 Department of Cardiology, Lund, Sweden
7 Department of Cardiology, Karlstad, Sweden
Received 7 January 2009; revised 27 May 2009; accepted 6 July 2009 * Corresponding author. Tel: +46 70 5944404, Fax: +46 18 506638, Email: stefan.james{at}akademiska.se
Aims: Patients with diabetes mellitus have more extensive coronary artery disease, more disease progression, and restenosis. The use of drug-eluting stents (DES) in these patients is widespread, despite uncertain long-term safety and efficacy.
Methods and results: All consecutive patients with diabetes mellitus in Sweden who underwent percutaneous coronary intervention were entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2003–06 with complete follow-up for 1–4 years (median 2.5). Patients who received at least one DES (n = 4754) were compared with those who received only bare metal stents (BMS) (n = 4956) at the index procedure. Combined outcome of death or myocardial infarction (MI) showed no difference for DES vs. BMS, relative risk (RR), 0.91 [95% confidence interval (CI), 0.77–1.06]. Myocardial infarction was significantly less common with DES in patients who received only one stent RR, 0.80 (95% CI, 0.66–0.96). The restenosis rate was 50% lower in DES-treated patients RR, 0.50 (95% CI, 0.35–0.70) and was associated with a higher adjusted RR of MI, RR, 5.03 (95% CI, 4.25–5.97). DES was associated with reduced restenosis rates in all subgroups of diabetic patients with the greatest benefit in stent diameters <3 mm or stent length >20 mm. The number of lesions treated with DES to prevent one restenosis ranged from 11 to 47 in various subgroups.
Conclusion: This real-life registry study shows that restenosis was halved by DES in diabetic patients with stable or unstable coronary disease, with similar risk of death or MI up to 4 years compared with BMS.
Key Words: Outcome • Myocardial infarction • Diabetes mellitus • Mortality • Drug-eluting stent • Percutaneous coronary intervention • Revascularization
Members of the SCAAR/SWEDEHEART study group are listed in Appendix.