Abstract 2148: Sirolimus-eluting Stent Versus Bare-metal Stent In Diabetic Patients: Results Of The Italian Multicenter, Randomized “Dessert” Study.
Background: The real benefit of DES in diabetic patients is still debated since few studies have performed a direct randomized comparison between DES and BMS in such a population.
Methods: The “Dessert” study is a multicenter, randomized trial conducted in Italy to demonstrate the efficacy of sirolimus-eluting stents (SES) compared to BMS in de novo lesions in native coronary arteries of diabetic patients, treated with insulin and/or oral antidiabetics for at least 3 months. Intraprocedural abciximab or pre-procedural tirofiban were administered to all patients. The primary end point was in-stent late loss as assessed by centralized quantitative coronary angiography at 8-month follow up. Centrally adjudicated composite MACE (death, Q wave and non-Q wave myocardial infarction, emergent bypass surgery or repeat target lesion revascularization) and target vessel failure (TVF: death, treated vessel related AMI, TLR) at 30 days, 9 and 12 months, and binary restenosis 8 months post-procedure were the secondary endpoints.
Results:One hundred fifty patients were randomized to SES (75 patients, 109 lesions) or BMS (75 patients, 109 lesions). The two groups were well balanced for clinical, anatomic and procedural characteristics. On average, 45% of patients had multivessel or multilesion PCI, reference diameter was 2.66±0.43 mm and lesion length was 14.9±7.1 mm. In-stent late lumen loss was reduced from 0.96±0.61 mm for BMS to 0.14±0.33 mm for SES (p<0.001); in-segment binary restenosis resulted 38.8% vs 3.6% respectively (p<0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACE 22.1% vs 38.6%, p=0.035; TLR 5.9% vs 30%, p<0.001; TVF 14.7% vs 34.3%, p=0.008. One case of subacute stent thrombosis occurred in sirolimus group, and one late stent thrombosis in bare-metal group. At multivariable analysis, stent type confirmed as independent predictor of in-segment late loss (p<0.001), binary restenosis (p<0.001), 12 month TVF (p=0.010) and 12-month MACE (p=0.037).
Conclusions: The randomized “Dessert” study demonstrated that SES are safe and efficacious in reducing both angiographic and clinical parameters of restenosis compared with BMS in diabetic patients with de novo 1 or 2 vessel coronary stenoses.