Xience or Vision Stent Management of Angina in the Elderly (XIMA)

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention using drug eluting stents; Procedure: Percutaneous Coronary Intervention using bare metal stents

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sussex
    • Brighton, Sussex, United Kingdom, BN2 1ES
      • Cardiac Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Drug eluting stent; Percutaneous coronary intervention	Procedure: Percutaneous Coronary Intervention using drug eluting stents; Percutaneous Coronary Intervention using drug eluting stents; Other Names: Xience Drug eluting stent
Other: Bare Metal Stent; Percutaneous Coronary Intervention	Procedure: Percutaneous Coronary Intervention using bare metal stents; Percutaneous Coronary Intervention using bare metal stents; Other Names: Vision BM stent

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brighton and Sussex University Hospitals NHS Trust
• Collaborators: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Elderly; Angina; Percutaneous coronary intervention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Version 2.0 20.06.2008