SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal MI
The population is getting older and heart artery disease is the biggest killer in the UK. Over recent years, there have been improvements in medications and technologies to treat it, but these have been primarily tested in younger patients. Previous research studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients in particular those that are frail and those with co-morbidities are less likely to receive advanced medications and medical procedures. The current study will enrol patients 75 years and over, presenting with a heart attack. If patients agree to participate, they will be randomly allocated to one of two treatment groups. In the first group, patients will receive the latest medications recommended in heart attack. In the second group, in addition to these medications, patients will have coronary angiography. This will show whether they have any blockages in heart arteries. If appropriate, coronary revascularisation by percutaneous coronary intervention (PCI) commonly known as coronary angioplasty or coronary artery bypass grafting, sometimes called CABG (a surgical procedure in which a blood vessel from the leg, arm or chest is used to bypass a narrowed section of a coronary artery) will be carried out. During the trial, frailty scores, cognition measures, co-morbidity indices, questionnaires on quality of life, NHS and personal social services utilization will be collected from the participant and in addition proxy quality of life information will be collected from the participant's carers. Investigators will evaluate which one of the two treatment groups will do better and live longer. Investigators will also collect information on their quality of life and frailty measures for a 5 year period. The trial hopes to recruit 2300 patients from approximately 30 centres across the UK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,518
Coronary angiography to determine location of blocked or narrowed arteries.
PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.
Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.
Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization
To determine the impact of a routine invasive strategy on cardiovascular death and non-fatal myocardial infarction (MI) compared with a conservative treatment strategy in older patients (≥75 years) with NSTEMI.
Time frame: Up to 5 years
All cause, cardiovascular and non-cardiovascular death rates
Time frame: Up to 5 years
Recurrent myocardial infarction
Time frame: Up to 5 years
Hospitalisation for heart failure
Time frame: Up to 5 years
Urgent coronary revascularisation
Time frame: Up to 5 years
Recurrent hospitalisation for myocardial infarction
Time frame: Up to 5 years
Stroke
Time frame: Up to 5 years
Length of time spent at home
Time frame: Up to 5 years
Fried and Rockwood frailty scores
Time frame: Up to 5 years
Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)
Quality of life will be measured using the EQ-5D-5L instrument\[REF: The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16(3):199-208html \] (paper and telephone versions), with the results for each participant converted into quality-adjusted life-years (QALYs) using the area under the curve approach, a standard methodology for this process,\[REF: Drummond MOB, B; Stoddart, G; Torrance, G. . Methods for the economic evaluation of Health Care Programmes: Oxford University Press 2005.\] with the responses to the EQ-5D-5L scored using the appropriate value set for the United Kingdom, which is expected to be available by the time of the analysis. REF: Office for Health Economics. New OHE Publications: An EQ-5D-5L Value Set for England. Available at: https://www.ohe.org/news/new-ohe-publications-eq-5d-5l-value-set-england. Accessed February 03 2017\]
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Pinderfields General Hospital
Wakefield, West Yorkshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Basildon & Thurrock University Hospitals NHS Foundation Trust
Basildon, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
Broomfield Hospital, Mid Essex Hospitals NHS Trust
Broomfield, United Kingdom
Cumberland Infirmary, North Cumbria University Hospitals NHS Trust
Carlisle, United Kingdom
St Helier Hospital, Epsom & St Helier University Hospitals NHS Trust
Carshalton, United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield, United Kingdom
County Durham & Darlington NHS Foundation Trust
Darlington, United Kingdom
...and 30 more locations
Time frame: Up to 5 years
Costs to the NHS and personal social services
Time frame: Up to 5 years
Incremental cost per QALY gained at 1 year
Time frame: Up to 5 years
Procedural complications
Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection
Time frame: Within 7 days of invasive care
Bleeding
Bleeding according to BARC Criteria
Time frame: Up to 1 year
Renal replacement therapy
Need for renal replacement therapy
Time frame: Within 7 days of invasive care
25% increase in serum creatinine concentration
25% increase in serum creatinine concentration from baseline (hospitalisation)
Time frame: Within 7 days of invasive care