Long-Term Safety of Drug Eluting Stents in the Real World (FReIburger STent Registry)

Study Overview
=================
Brief Summary
-----------------
The FReIburger STent Registry (FRIST) is designed to determine the long term safety and efficacy of Drug Eluting Stents (DES) in a real-world patient population requiring stent implantation. FRIST included patients treated with DES and bare-metal stents (BMS) in the University Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which virtually all consecutive patient subsets were considered eligible.

Official Title
-----------------
Long-Term Safety and Efficacy of Drug Eluting Stents in Real World - Results From the FReIburger STent Registry

Conditions
-----------------
Stent Thrombosis

Intervention / Treatment
-----------------
* Procedure: transluminal percutaneous coronary intervention
* Device: Drug-Eluting and Bare-Metal stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients undergoing percutaneous coronary intervention Exclusion Criteria: Patient refusal or inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DES<br>Patients underwent percutaneous coronary intervention and received at least one drug-eluting stent during their index hospitalisation. | Procedure: transluminal percutaneous coronary intervention<br>* All interventions were done according to current practice guidelines. The operator was responsible for the decision to choose a specific treatment strategy. Angiographic success was defined as residual stenosis <30% by visual analysis in the presence of TIMI 3 flow grade. The patients were prescribed aspirin plus clopidogrel 75 mg per day, after a loading dose of 300 mg or 600 mg, before or during the index coronary intervention. After procedure, all patients were advised to maintain lifelong use of aspirin. The use of clopidogrel (75 mg per day) was always adapted according to guideline recommendations. Heparin was infused throughout the procedure to maintain an activated clotting time of at least 250 sec. The administration of platelet glycoprotein IIb/IIIa receptor blocker was encouraged, unless in existing contraindications.<br>Device: Drug-Eluting and Bare-Metal stents<br>* Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents<br>|
| BMS<br>Patients underwent percutaneous coronary intervention and received at least one uncoated stent during their index hospitalisation. | Procedure: transluminal percutaneous coronary intervention<br>* All interventions were done according to current practice guidelines. The operator was responsible for the decision to choose a specific treatment strategy. Angiographic success was defined as residual stenosis <30% by visual analysis in the presence of TIMI 3 flow grade. The patients were prescribed aspirin plus clopidogrel 75 mg per day, after a loading dose of 300 mg or 600 mg, before or during the index coronary intervention. After procedure, all patients were advised to maintain lifelong use of aspirin. The use of clopidogrel (75 mg per day) was always adapted according to guideline recommendations. Heparin was infused throughout the procedure to maintain an activated clotting time of at least 250 sec. The administration of platelet glycoprotein IIb/IIIa receptor blocker was encouraged, unless in existing contraindications.<br>Device: Drug-Eluting and Bare-Metal stents<br>* Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality (cardiac- and non-cardiac death). |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of death and MI and stent thrombosis. |  | 5 years | 
| The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug-eluting stent, bare-metal stent, long-term safety, mortality, stent thrombosis, Angioplasty, Transluminal, Percutaneous Coronary