Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk

Not Applicable

Completed

Conditions: Coronary artery disease
Circulatory System

Registration Number: ISRCTN72444640

Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2400

Inclusion Criteria

1. All comers, 24 hours a day, seven days a week, irrespective of indication for Percutaneous Coronary Intervention (PCI)
2. With the need for large (more than or equal to 3.0 mm stents only) native vessel stenting

Exclusion Criteria

1. In-stent-restenosis
2. Bypass graft disease
3. Main stem disease to be stented
4. Cardiogenic shock
5. Planned surgery within the next six months
6. Oral anticoagulation needed (artificial heart valves, atrial fibrillation)
7. No compliance expected
8. Enrolled in another study
9. No consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom of combination of: <br>1. Cardiac death (all death not clearly of extra cardiac origin)<br>2. Documented non-fatal MI (according to the current European Society of Cardiology [ESC]-guidelines after 24 months

Secondary Outcome Measures

Name	Time	Method
1. Non-MI related Target Vessel Revascularisation (TVR)<br>2. Major Adverse Cardiac Events (MACE) = primary outcomes and non-MI related TVR<br>3. Primary outcomes up to 18 and 36 months (for comparison with BASKET and BASKET-LATE)<br>4. Components of the primary outcomes <br>5. Non-cardiac death (total death)<br>6. Major non-Coronary Artery Bypass Graft (CABG) bleeding (need for surgery, blood transfusions, cerebral haemorrhages) during dual antiplatelet therapy (up to twelve months) - ?net clinical benefit? = primary outcomes and bleeding<br>7. Subgroups with: <br>a. diabetes<br>b. acute coronary syndrome<br>c. ST-elevation MI<br>d. need for GlycoProtein (GP) IIb/IIIa inhibitors<br>e. lesions more than 25 mm