The British Heart Foundation SENIOR-RITA Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial

Conditions
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NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
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* Procedure: Coronary Angiography
* Procedure: Coronary revascularisation
* Other: Optimal Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 75 years Type 1 NSTEMI during index hospitalisation Exclusion Criteria: Patients presenting with STEMI or unstable angina Patients with cardiogenic shock Patients with known life expectancy <1 year Patients in whom neither the patient nor the consultee are able and willing to provide written informed consent Previous inclusion in the BHF SENIOR-RITA trial Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation

Ages Eligible for Study
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Minimum Age: 75 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: Invasive Treatment<br>Coronary angiography with a view to coronary revascularisation | Procedure: Coronary Angiography<br>* Coronary angiography to determine location of blocked or narrowed arteries.<br>Procedure: Coronary revascularisation<br>* PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.<br>Other: Optimal Medical Therapy<br>* Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.<br>|
| Other: Optimal Medical Therapy<br>Patients to be treated with guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE inhibitors, betabloackers | Other: Optimal Medical Therapy<br>* Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cardiovascular death or non-fatal MI (defined by the third 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. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause, cardiovascular and non-cardiovascular death rates |  | Up to 5 years | 
| Recurrent myocardial infarction |  | Up to 5 years | 
| Hospitalisation for heart failure |  | Up to 5 years | 
| Urgent coronary revascularisation |  | Up to 5 years | 
| Recurrent hospitalisation for myocardial infarction |  | Up to 5 years | 
| Stroke |  | Up to 5 years | 
| Length of time spent at home |  | Up to 5 years | 
| Fried and Rockwood frailty scores |  | 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] | Up to 5 years | 
| Costs to the NHS and personal social services |  | Up to 5 years | 
| Incremental cost per QALY gained at 1 year |  | Up to 5 years | 
| Procedural complications | Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection | Within 7 days of invasive care | 
| Bleeding | Bleeding according to BARC Criteria | Up to 1 year | 
| Renal replacement therapy | Need for renal replacement therapy | Within 7 days of invasive care | 
| 25% increase in serum creatinine concentration | 25% increase in serum creatinine concentration from baseline (hospitalisation) | Within 7 days of invasive care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome