Coronary disease
Conditions
Interventions
The treatment is a procedure percutaneous coronary intervention. Patients are randomised to receive either a Drug eluting stent or a Bare metal stent. Both arms are followed up for 1 year.
Sponsors
Brighton and Sussex University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 80 years 2. Stable angina or acute coronary syndrome 3. Coronary narrowing suitable for stenting that is either =15mm long and/or =3mm diameter. 4. Any lesion with high risk of restenosis eg chronic total occlusion (CTO), bifurcation, severe calcification 5. Any left main stem lesion
Exclusion criteria
Exclusion criteria: 1. Acute ST-Segment Elevation Myocardial Infarction (STEMI) 2. Cardiogenic shock 3. Platelet count =50 x 109/mm^3 4. Patient life expectancy < 1 year 5. Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant 6. Recent major gastrointestinal (GI) haemorrhage (within 3 months) 7. Any previous cerebral bleeding episode 8. Participation in another investigational drug or device study 9. Patient unable to give consent 10. Clinical decision precluding the use of DES
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined primary outcome at 1 year 1.1. Death 1.2. Myocardial infarction 1.3. Target Vessel Failure 1.4. Major haemorrhage 2. Procedural cost | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Angina status 2. Antianginal tablet prescription (Rx) 3. Procedural 3.1. Procedure success 3.2. Procedure Major Adverse Cardiac Events (MACE) 3.3. In-hospital complications All secondary outcomes will be measured at 3, 6, 12 months. | — |
Countries
Spain, United Kingdom
Outcome results
None listed