Diabetes and Sirolimus-Eluting Stent Trial - DIABETES

Description:

The goal of the trial was to evaluate the use of sirolimus-eluting stents compared with bare metal stents among diabetic patients undergoing percutaneous coronary intervention (PCI).

Study Design

Study Design:

Patients Enrolled: 160
Mean Follow Up: 2 years
Mean Patient Age: Mean age 66.5 years
Female: 38
Mean Ejection Fraction: Mean 65%

Patient Populations:

Diabetic patients presenting with de novo coronary stenoses in at least 1 native vessels with symptoms or objective evidence of ischemia; stenoses amenable for stent implantation, with vessel size <4.0 mm.

Exclusions:

Impaired glucose tolerance without pharmacological treatment, gestational diabetes, or transient hyperglycemia; stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main, or that involved important side branches (>2 mm) that needed treated during the procedure; left ventricle ejection fraction <25%; prior treatment with intracoronary brachytherapy or other drug-eluting stent at target site; restenotic lesions; known allergies to aspirin, ticlopidine, and clopidogrel; acute coronary syndromes with persistent ST elevation <72 hours and/or CK 2x the upper limit of normal; severe hepatic or renal disease; and life expectancy <1 year.

Primary Endpoints:

In-segment late lumen loss at 9 month follow-up

Secondary Endpoints:

Binary restenosis and minimal luminal diameter at 270-day follow-up; major adverse cardiac events, including cardiac death, MI, target lesion revascularization at 1, 9, 12, and 24-month follow-up; stent thrombosis.

Drug/Procedures Used:

Patients with diabetes were randomized to sirolimus-eluting stents (n=80 patients with 111 lesions) or standard stent implantation (n=80 patients with 110 lesions).

Principal Findings:

Baseline characteristics were well-balanced between treatment groups, with 33% insulin-dependent and 67% non-insulin dependent diabetics. Present syndrome was unstable angina for the majority of patients (58%). Multivessel disease was present in 65% of patients, with 23% of patients receiving multivessel stenting.

The primary endpoint of in-segment late lumen loss at 9 months was significantly lower in the sirolimus-eluting stent group (0.06 mm vs 0.47 mm, p<0.001), as was binary in-segment restenosis (7.8% vs 33.7%, p<0.001). Results were similar in insulin-dependent and non-insulin-dependent diabetics. Target lesion revascularization was lower in the sirolimus-eluting stent group (31.3% vs 6.3%, p<0.001), as was MACE (36.3% vs 10.0%, p<0.001). Stent thrombosis occurred in 2 patients in the bare metal stent group and no patients in the sirolimus-eluting stent group.

Interpretation:

Among diabetic patients undergoing PCI, use of a sirolimus-eluting stent was associated with a reduction in the primary endpoint of in-segment late lumen loss at 9 month follow-up compared with bare metal stent.

Diabetic patients with coronary artery disease often have more diffuse disease, with higher rates of restenosis compared with non-diabetics. Several studies have demonstrated the efficacy of drug-eluting stents compared with bare metal stents and have reported on the diabetic subgroup. The present study is the first-large scale randomized trial in diabetic patients exclusively to evaluate bare metal stents with drug-eluting stents, although the ISAR-DIABETES trial demonstrated a greater reduction in late lumen loss with sirolimus-eluting stent versus paclitaxel-eluting stent in diabetic patients.

References:

Sabaté M, et al. Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients. Circulation. 2005;112:2175-2183.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Insulin, Follow-Up Studies, Drug-Eluting Stents, Sirolimus, Constriction, Pathologic, Percutaneous Coronary Intervention, Stents, Paclitaxel, Metals, Coronary Stenosis, Thrombosis, Diabetes Mellitus


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