1. The British Heart Foundation older patients with non-ST SEgmeNt elevatIOn myocaRdial infarction Randomized Interventional TreAtment Trial The BHF SENIOR-RITA Trial
working together as Newcastle Academic Health Partners

2. Trial Summary
Multi-centre study involving 30 NHS sites (England, Scotland, Wales and [Northern Ireland to include])
Patients over 75 years admitted with Type 1 NSTEMI
5 Year follow up, 10 years collecting HES & ONS data
Total Recruitment target: 2300 patients over 3 years

3. Timelines Open to recruitment: September 2016
36 month recruitment period
Interventional arm: Coronary angiography and coronary revascularisation within 7 days of randomisation
Recruitment end date: 30th September 2019
End of trial: 30th September 2029

4. Regulatory approvals REC favourable ethical opinion (UK):
3rd August 2016
HRA Approval (England):
8th August 2016

5. Background: Our Population is Ageing.....
ONS 2012

6. Burden of Coronary Disease in Older Patients
Patients >70 years represent over half of all myocardial infarctions
Average age of first non ST elevation MI (NSTEMI) is 70 years
Yet fewer older patients receive contemporary care
MiNAP Database
Eur Heart J 2014; 35(23):1551-8

7. Frail versus Non-Frail
p=0.28
Frail older patients with NSTEMI have a significantly higher mortality at one year *
p=<0.0001
p=0.48
p=0.74
Eur J Prev Cardiol (10):

8. Representation of Older Patients In Clinical Trials/Registries
Patients >75 years account for 9% of trial participants!
32% trials actively excluded participants >75 years!
JAMA. 2001;286(6):

9. Current Problem NHS/Economy
Older patients are under represented in clinical trials – patients aged ≥75 years are excluded from clinical trials (9% of all patients enrolled in trials)
Existing guidelines (ESC, NICE) on invasive care are based on younger age group (mean age 62 years)
Advanced care including revascularisation and pharmacotherapy are under utilised in older patients
Frail, comorbid, cognitively impaired patients presenting with NSTEMI have not been previously studied in clinical trials
Heart Mar;102(6):416-24

10. The BHF SENIOR-RITA
Whether the beneficial effects of revascularisation will be demonstrated in frail older patients with co-morbidities presenting with NSTEMI is unknown and will be investigated
SENIOR-RITA specifically aims to investigate all-comer older patients with NSTEMI high-risk co-morbid frail older patients and those with cognitive impairment who normally would be denied invasive care due to underlying co-morbidity and in whom there is lack of evidence currently in the management of NSTEMI.

11. The BHF SENIOR-RITA Study Setting and Flow Chart n=2300
Multicentre prospective randomised controlled trial of invasive versus conservative management
30 NHS centres with on and offsite cardiac catheter lab facilities throughout the UK

12. The BHF SENIOR-RITA: Primary Objective
To determine if a routine invasive strategy reduces overall one-year cardiovascular death and non-fatal myocardial infarction compared with a conservative treatment strategy in older patients (≥75 years) with NSTEMI.

13. The BHF SENIOR-RITA: Secondary Objective(s)
To determine the impact of a routine invasive strategy compared with a conservative strategy on:
All-cause, cardiovascular and non-cardiovascular death rates
Recurrent myocardial infarction
Hospitalisation for heart failure
Urgent coronary revascularisation
Recurrent hospitalisation for myocardial infarction
Stroke
Bleeding (BARC 2)
Procedural complications (including death, MI, major bleeding (BARC definition), 25% increase in serum creatinine concentration from baseline, need for renal replacement therapy, stroke)
Length of time spent at home
Fried and Rockwood frailty scores
Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)
Costs to the NHS and personal social services
Incremental cost per QALY gained at 1 year

14. The BHF SENIOR-RITA Eligibility Criteria
Inclusion Criteria
Aged ≥75 years
Type 1 NSTEMI during index hospitalisation
Exclusion Criteria
STEMI or unstable angina, cardiogenic shock
Neither the patient nor the consultee able to provide written informed consent
Previous inclusion in the SENIOR-RITA trial
Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation.

15. The BHF SENIOR-RITA: Consent
Patients with ability to provide informed consent:
Patients will be provided with the PIS to read
Informed consent will be obtained from patients
Patients unable to provide informed consent:
Some patients with cognitive impairment will be able to provide informed consent.
In patients who lack the capacity to provide informed consent, identify and approach a consultee as defined by the Mental Capacity Act (2005).
The consultee will be provided with the PIS and an information sheet for consultees and where appropriate, asked to sign the consultee declaration form

16. The BHF SENIOR-RITA: Schedule of EventsV1
Postal V2 V3 V4 V5 V6 V7
Event
In-patient with NSTEMI
30 days
±14 days
3-months ±14 days
6-month ±14 days
1 year
2 year ± 28 days
3 year ±28 days
4 year ± 28 days
5 year
± 28 days
Eligibility X
Informed Consent
Fried and Rockwood Frailty Score
Required pre- randomisation
Montreal Cognitive Assessment
Randomize (Web)
Patient Demographics, Baseline Admission Data
Medical History, Risk Factors, Co-morbidities
Baseline ECG
Baseline Bloods (FBC, urea, creatinine, glucose, lipids, peak troponin)
Angiography/Procedural Data
Concomitant Medications
Evaluate End-points
Either Clinic or Post or Telephone or ONS, HES
EQ-5D-5L Patient and Proxy
NHS & PSS Utilisation† X† X‡
Time and Travel Questions

17. Recruitment Target Update
The BHF SENIOR-RITA:
Recruitment Target Update

18. Please think of SENIOR RITA for all >75 NSTEMI cases
Please do get in touch with Newcastle CTU SENIOR RITA Trial Team with any questions relating to the trial
With all your help we can achieve our target!!!

19. Key Contacts: Newcastle CTU
Trial Manager Jaki Begum Tel Trial Administrator Carol Shields Trial Secretary Laura Robertson Tel Database Manager Jonathan Pritchard