Xience or Vision Stent Management of Angina in the Elderly

Study Overview
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Brief Summary
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The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.

Official Title
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Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention using drug eluting stents
* Procedure: Percutaneous Coronary Intervention using bare metal stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AGE>80 Stable angina or acute coronary syndrome Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter. Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification Any left main stem lesion Exclusion Criteria: Acute ST segment elevation myocardial infarction Cardiogenic shock Platelet count =50 x 109/mm3 Patient life expectancy < 1 year Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant Recent major GI haemorrhage (within 3 months) Any previous cerebral bleeding episode Participation in another investigational drug or device study Patient unable to give consent Clinical decision precluding the use of drug eluting stent

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Drug eluting stent<br>Percutaneous coronary intervention | Procedure: Percutaneous Coronary Intervention using drug eluting stents<br>* Percutaneous Coronary Intervention using drug eluting stents<br>* Other names: Xience Drug eluting stent;|
| Other: Bare Metal Stent<br>Percutaneous Coronary Intervention | Procedure: Percutaneous Coronary Intervention using bare metal stents<br>* Percutaneous Coronary Intervention using bare metal stents<br>* Other names: Vision BM stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage | This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angina status | This will be assessed in two ways: i) by interview according to the Canadian Cardiovascular Society classification ii) by patient self-assessment using the Seattle questionnaire | 1 year | 
| Antianginal medication | This will be assessed using a single point scoring system, where a point is scored for each of the following: Nitrate (sublingual or spray) used 1 or mnore times during week prior to question Nitrate (oral) beta-blocker Calcium antagonist Use of Nicorandil | 1 year | 
| Procedural success | Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch | 1 Year | 
| MACE (major adverse cardiovascular events) | Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting. | 1 year | 
| In-hospital complications | Major procedural complications include Death Myocardial infarction Emergency coronary artery bypass surgery Stroke Bleeding ('Thrombolysis In Myocardial Infarction) Minor procedural complications include Ventricular rhythm disorder (tachy or brady) requiring intervention (e.g defibrillation, DC cardioversion or temporary pacing) Bleeding Pseudoaneurysm requiring compression or surgery Vascular access complication extending hospital stay by 1 or more night Transient ischaemic attack Wire loss or fracture Stent loss Undeployed stent detachment from balloon | 1 Year | 
| Procedural cost | The difference in procedural cost will be assessed using a composite of the number of, guidewires, balloons and stents opened or used and procedural time. Prolonged hospital stay is a further potential cost pressure in this age group. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Elderly, Angina