Native vessel PCI in the diabetic: DES whenever feasible

For some patient subsets, the incremental efficacy, safety, and cost-effectiveness of drug-eluting stents (DES) relative to bare metal stents (BMS) remain uncertain. In particular, the data for patients with saphenous vein graft disease, acute STEMI, and larger vessels present mixed results. Hence, DES utilization in the United States has decreased from 82% in 2004 to approximately 50% [1]. The DECODE randomized trial and KOMATE registry presented in this issue of Catheterization and Cardiovascular Interventions, however, further advance the evidence that diabetic patients reap considerable early and sustained benefit from DES [2,3]. Diabetic patients were well represented in the landmark SIRIUS and TAXUS IV studies (Table 1) [4,5]. The DECODE and previously reported DIABETES trials exclusively enrolled diabetic patients to expand the randomized controlled trial (RCT) data directly comparing SES with BMS [6]. Extending these observations to longer-term clinical results in ‘‘real world’’ patients, the KOMATE registry reported here demonstrates Target lesion revascularization (TLR) rates remaining <7% in patients with diabetics at greater than 3 years follow-up. In sum, the angiographic and clinical restenosis benefit of DES versus BMS in diabetic patients is profound and clinically significant, particularly in vessels <3.0 mm in caliber. In 2005, however, the EVASTENT registry of 356 diabetic patients undergoing Cypher stenting reported 1-year stent thrombosis rates of 2.3% in diabetic patients with single vessel disease and 4.3% with multivessel disease compared to 0.8% and 3.0%, respectively, for nondiabetic patients [7]. The platelet response of diabetic patients to clopidogrel is attenuated [8]. The OPTIMUS study showed improved but still frequently suboptimal platelet inhibition in diabetic patients with a 150-mg maintenance dose instead of 75 mg [9]. In the DECODE trial (SES 54 patients, BMS 29 patients) with approximately 50% remaining on dual antiplatelet therapy at and beyond 6 months, no stent thrombosis was observed. In the DIABETES randomized trial (SES 80 patients, BMS 80 patients) with 1 year of dual antiplatelet therapy, no stent thrombosis was observed. In a pooled analysis of 13 RCTs with 2,422 diabetic patients receiving either SES or PES, the stent thrombosis rate was 1.48% with PES and 0.55% with SES at an average follow-up of 1 year (P 5 ns) [10]. Using the ARC definitions, the combined probable and definite stent thrombosis rate was 3.1% at 38 months of average follow-up in the KOMATE registry. Mean duration of dual antiplatelet therapy was slightly more than 1 year. Cumulative very late stent thrombosis was 0.8% in years 2 and 3 postimplant. Metaanalysis of the diabetic patients in head-to-head SES versus PES trials as well as registries demonstrates no significant difference in TLR or MACE [10]. Most of these studies and registries had a 1 year time horizon. With more ‘‘real world’’ patients and a longer follow-up, the KOMATE registry supplements and extends the RCT observations. Using propensity score matching to adjust for baseline differences, the KOMATE registry demonstrates comparable results at 3 years follow-up for patients treated with SES or PES. In KOMATE, over half the patients presented with an acute coronary syndrome and 20% had multivessel stenting. Ten percent had bifurcation lesions and mean lesion length was 21–22 mm. The totality of the randomized trials and registries provide a very clear picture of the expected outcomes in diabetic patients treated with stents. Bare metal stents are associated with a 30–60% angiographic restenosis rate and TLR of 20–30%. First-generation DES, whether SES or PES, have reduced angiographic restenosis to 10% with single digit rates of TLR. These results are durable out to 3 or more years. A higher risk of stent thrombosis, almost twice that of nondiabetic patients, remains a limitation of current therapy. The imminent availability of more potent and consistent platelet inhibitors such as prasugrel, AZD6140,