Clinical trial NCT00755443: Sirolimus-Eluting Stent Versus Standard Stent in Diabetic
Official title: A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario de Valladolid
name: Hospital Universitari de Bellvitge
name: Hospital de Meixoeiro
First posted: 2008-09-19
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography
timeFrame: 270-day follow-up
Secondary outcomes:
measure: 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
timeFrame: 1, 9, 12 and 24-month follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San carlos
Study officials:
affiliation: Hospital Clinico San Carlos
name: Manel Sabate, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sabate M, Jimenez-Quevedo P, Angiolillo DJ, Gomez-Hospital JA, Alfonso F, Hernandez-Antolin R, Goicolea J, Banuelos C, Escaned J, Moreno R, Fernandez C, Fernandez-Aviles F, Macaya C; DIABETES Investigators. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation. 2005 Oct 4;112(14):2175-83. doi: 10.1161/CIRCULATIONAHA.105.562421.