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).
Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.
Maresta
Aleardo
A
Department of Cardiology, S. Maria delle Croci Hospital, Ravenna, Italy. ra.cardiologia@ausl.ra.it
Varani
Elisabetta
E
Balducelli
Marco
M
Varbella
Ferdinando
F
Lettieri
Corrado
C
Uguccioni
Lucia
L
Sangiorgio
Pietro
P
Zoccai
Giuseppe Biondi
GB
D000368:Aged; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000150:complications / Q000453:epidemiology / Q000601:surgery*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000453:epidemiology; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008670:Metals; D009203:Myocardial Infarction / Q000175:diagnosis / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000295:instrumentation*; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000494:pharmacology*; D015607:Stents; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D008670:Metals; D020123:Sirolimus