Coronary Artery Disease
Conditions
Brief summary
The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de novo coronary artery stenosis.
Interventions
DEVICEDrug eluting stent
Drug eluting stent implantation
DEVICEBare metal stent
Sponsors
Hospital Clínico Universitario de Valladolid
Hospital Universitari de Bellvitge
Hospital de Meixoeiro
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diabetic either non-insulin or insulin-dependent (according to World Health Organization Report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. Stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography)
Exclusion criteria
* Impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia * Stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (\> 2 mm) that should be 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 CPK twice the upper normal limit * Non-ST elevation acute coronary syndromes with CPK twice the upper normal limit * Severe hepatic or renal disease (creatinin clearance \< 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography | 270-day follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Other angiographic parameters of restenosis such as binary restenosis, and minimal luminal diameter; major adverse cardiac events including cardiac death, myocardial infarction, target lesion (in-segment zone) revascularization stent thrombosis | 1, 9, 12 and 24-month follow-up |
Countries
Spain
Outcome results
None listed