Sirolimus-Eluting Stent Versus Standard Stent in Diabetic (DIABETES)

San Carlos Clinical Hospital

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Bare metal stent

Device: Drug eluting stent

Study type

Interventional

Funder types

Other

Identifiers

NCT00755443

DIABETES I TRIAL

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Volunteers

No Healthy Volunteers

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