Background: Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus (DM) are associated with an increased risk of adverse clinical outcomes after a percutaneous coronary intervention (PCI). Available information on the efficacy and safety of DES and bare metal stent (BMS) in diabetic patients remains scarce.
Methods: From April 2004 to October 2006, 1565 patients with diabetes, who successfully underwent elective stenting at Fu Wai Hospital in Beijing, China, were enrolled in this study. All enrolled patients were assigned to a drug eluting stent group and a bare metal stent group. We obtained follow-up data: death, myocardial infarction (MI), thrombus, target lesion revascularization (TLR), and target vessel revascularization (TVR) at 30 days and 12 and 24 months, as defined by the Academic Research Consortium (ARC). We calculated and compared all the unadjusted cumulative frequencies of the various adverse events in the two groups. Cox's proportional-hazards models adjusted with the propensity score were used to assess the relative risks of all the outcome measures at 24 months.
Results: At 24 months, all ARC defined stent thrombosis in the two groups were similar; at 30 days, a more definite thrombosis was found in the BES group (0.08% vs 0.81%, P = 0.016). Patients treated with DES showed a significant lower risk of TLR (3.88% vs 10.89%; hazard ratio (HR) 0.159 (95% CI: 0.151-0.444), P < 0.001), TVR (5.48% vs 11.69%; HR 0.383 (95% CI: 0.232-0.633), P < 0.001), and any revascularization (12.47% vs 18.55%; HR 0.555 (95% CI: 0.370-0.831), P = 0.0004) at 24 months. No significant difference was apparent in terms of all-cause mortality, MI, and all-cause mortality/MI.
Conclusions: In contemporary society's large, diabetic population, the use of DES is associated with long-term significant reductions in the risks of TLR, TVR, and any revascularization. There is no significant difference in all-cause mortality, MI, and thrombosis between DES and BMS in the patients with diabetes at 24-month follow-up.