A study to evaluate the benefit of medical therapy versus angiography and stenting in patients with heart attacks - The BHF SENIOR RITA Trial

INTERVENTION: Following consent, patients will be randomized to one of two groups. Group 1: PArticipants undergo a coronary angiography (heart artery X‐ray test) and, if appropriate, coronary revascularisation (treatment with balloon or stents or bypass surgery) plus optimal medical therapy. Group 2: Participants receive conservative management (optimal medical therapy alone) The study interventions are standard of care in patients with coronary artery disease and will be performed by interventional cardiologists at local sites with considerable experience in these clinical procedures. Following randomization, all baseline data required for the study including baseline demographics, medical history/co‐morbidities (Charlson Index), risk factors, current NSTEMI/admission details, medications history will be collected during hospitalisation. Results of investigations performed as part of routine care of patients including full blood count, serum urea, creatinine concentrations, lipids, glucose and peak troponin concentration will be recorded. Data from baseline ECG will be collected for information on ST‐T changes. Additional study related data including MoCA scores (baseline and 1‐year), frailty scores, quality of life (EQ‐5D‐5L), use of health services and patient costs will also be collected. Echocardiographic data will be collected where available. Angiographic and procedural data will be collected from those that undergo invasive care. Detailed angiographic analysis will be carried out in Newcastle. Rockwood and Fried frailty score will be calculated for all patients at baseline, 6 months, 1 year and yearly thereafter for 5 years. Quality of life (QOL) assessments using the EQ‐5D‐5L will be requested at baseline (pre‐randomisation), 30 days, 3 months, 6 months, and at 1 year. Data will be collected during research clinic follow‐up visits where feasible (i.e. at baseline, 6 and 12 months). Where this is not feasible, patients will be given the questionnaires to take home a CONDITION: Specialty: Cardiovascular disease, Primary sub‐specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Diseases of arteries, arterioles and capillaries ; Circulatory System ; Cardiovascular disease PRIMARY OUTCOME: Time to cardiovascular death or non‐fatal MI within one year is determined by analysing the number of deaths one year after randomisation. INCLUSION CRITERIA: 1. Aged =75 years 2. Type 1 NSTEMI during index hospitalisation SECONDARY OUTCOME: 1. All‐cause, cardiovascular and non‐cardiovascular death rates are measured using hospital records and ONS continuously until study end; 2. Recurrent myocardial infarction rates are measured using patient records and HES data during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years; 3. Hospitalisation for heart failure rate is measured using patient records during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years; 4. Urgent coronary revascularisation rate is measured using patient records during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years; 5. Recurrent hospitalisation for myocardial infarction is measured using patient records during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years; 6. Stroke rate is measured using patient records and HES data during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years; 7. Bleeding (BARC =2) rate is measured using patient records and HES data during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years; 8. Procedural complication (including death, MI, major bleeding (BARC definition), = 25% increase in serum creatinine concentration from baseline, need for renal replacement therapy, stroke) rate is measured using hospital records during index hospitalisation (baseline); 9. Length of time spent at home is measured using the Time & Travel Questionnaire‐ telephone or clinic visit at 6 months; 10. Frailty is measured using Fried and Rockwood frailty scores at baseline 6 months and 1 year and annually up to 5 years; 11. Quality of Life is measured using EQ‐5D‐5L and quality adjusted life years (QALY) at baseline, 6 months and 1 year and annually up to 5 years; 12. Costs to the NHS and personal social services are measured using a questionnaire at clinic or telephone at baseline, 6 months and 1 year and annually up to 5 years; 13. Incremental cost per QALY gained at 1 year is measured using a questionnaire at clinic or telephone at 1 year