Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). Demographic, angiographic and procedural characteristics were similar for all three groups. The incidence of 6-month major adverse coronary events were analysed.

Detailed Description
-----------------
Background: Percutaneous coronary intervention with stent implantation is a standard therapy for patients with acute coronary syndrome. The in-stent restenosis is still a problem. Recently, drug eluting stents reduce the incidence of this unfavorable event. The primary role of the polytetrafluoroethylene stent graft (PTFE) is management of coronary perforations, closure of coronary aneurysms, and in degenerated saphenous vein grafts. We compared these stents in native coronary vessels in patients with acute coronary syndrome with sirolimus and bare metal stents, for possible reduction of in-stent restenosis. Methods and results: During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). Demographic, angiographic and procedural characteristics were similar for all three groups. The incidence of 6-month major adverse coronary events was similar in all three groups. The target lesion revascularisation was higher in the bare metal stent group (P=0.044). The primary end-point, restenosis rate at six-month follow-up was higher in the bare metal stent group, compared with the stent graft and sirolimus eluting stent groups. The percent diameter stenosis in follow-up was significantly higher in bare metal stent group (P=0.005). The late loss was significantly lower in the sirolimus eluting stent group (0.23 mm), compared with the bare metal stent group (P= 0.034). There was a trend of lower late loss in the stent graft group, compared with bare metal stent group. Conclusion: Three groups of stents implanted in patients with acute coronary syndrome (stent-graft, sirolimus and bare metal), did not differ regarding the incidence of major adverse cardiac events. Sirolimus-eluting stents had a lower incidence of in-stent restenosis in comparison with bare metal stent group. Stent graft implanted in native coronary arteries appears to be safe and efficient in patients with acute coronary syndrome, but a significant reduction of in-stent restenosis was not achieved.

Official Title
-----------------
Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome: Clinical and Angiographic Follow-up

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Procedure: Percutaneous Coronary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stent implantation in acute coronary syndrome Exclusion Criteria: previous percutaneous coronary intervention or coronary artery bypass graft surgery multivessel, diffuse disease, tortuous vessel arteries less than 3 mm in diameter distal stenosis location left main and bifurcation lesions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous Coronary Intervention|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three groups of stents implanted in patients with acute coronary syndrome (stent-graft, sirolimus and bare metal), did not differ regarding the incidence of major adverse cardiac events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bare metal stents, sirolimus-eluting stents, coronary polytetrafluoroethylene stent graft, acute coronary syndrome, quantitative coronary angiography analysis, major adverse cardiac events, in-stent restenosis, target lesion revascularisation