Xience or Vision Stent Management of Angina in the Elderly

N/ACompletedNCT02198716

Brighton and Sussex University Hospitals NHS Trust800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

800

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention using drug eluting stentsPROCEDURE

Percutaneous Coronary Intervention using drug eluting stents

Percutaneous Coronary Intervention using bare metal stentsPROCEDURE

Percutaneous Coronary Intervention using bare metal stents

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiac Research Unit

Brighton, Sussex, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 1 year

Procedural success

Defined as TIMI 3 flow and \<30% stenosis in the main vessel and TIMI 3 flow in the side branch

Time frame: 1 Year

MACE (major adverse cardiovascular events)

Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.

Time frame: 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

Data from ClinicalTrials.gov

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