Declarations Funder Chief Scientist Office, Scotland, UK (CZH/4/588)

Declarations Funder Chief Scientist Office, Scotland, UK (CZH/4/588)

Declarations Funder Chief Scientist Office, Scotland, UK (CZH/4/588) Supplementary awards from Edinburgh and Lothian Health Foundation and the Heart Diseases Research Fund Sponsors University of Edinburgh and NHS Lothian Conflicts of Interest DEN, EvB, GMcK and GR have undertaken consultancy for one or more of the following companies: Toshiba, Bracco, Bayer-Schering, GE Healthcare and Guerbet Clinic Assessment of Patients with Suspected Angina due to CHD Fatal and Non-fatal Myocardial Infarction Angina due to Coronary Heart Disease Non-cardiac Chest Pain Sekhri et al. Heart 2007;93:458463 Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial First trial to determine the effect of CTCA on the clinical assessment of patients presenting with suspected angina due to coronary heart disease Diagnosis (Primary Endpoint) Investigations Treatments Outcomes Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Diagnosis: Primary Endpoint Diagnosis of Coronary Heart Disease Diagnosis of Angina due to Coronary Heart Disease Yes Probable

Unlikely No Certainty: Yes/No versus Probable/Unlikely Frequency: Yes/Probable versus Unlikely/No Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Entry Criteria Inclusion Criteria Age 18-75 years Suspected angina due to coronary heart disease Exclusion Criteria Inability to undergo CT scanning Renal failure (estimated GFR <30 mL/min) Allergy to contrast media Pregnancy Acute coronary syndrome within 3 months Previous recruitment to the trial No restriction according to: Arrhythmia Obesity (65 kg/m2) Calcium score (9015 AU) The SCOT-HEART Trial Study Protocol Primary Care Physician Referral Clinic Consultation History, Examination, 12-lead ECG Computed Tomography Coronary Angiogram Cardiovascular

Risk Assessment: ASSIGN Score Exercise ECG if appropriate Result to Attending Clinician Diagnosis, Investigations and Treatment Plan Documented 6-Week Attending Clinician Review Diagnosis, Investigations and Treatment Plan Approached for Study Inclusion Angina Questionnaire Randomised 1:1 to CTCA + Standard Care or Standard Care alone 6-Week Patient Review Angina Questionnaire Clinical Outcome NHS Health Records Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Trial Centers Complete Health Record Data Capture One National Healthcare Provider 12 Centers Across Scotland Perth Royal Infirmary, Perth Ninewells, Dundee Victoria Hospital, Kirkcaldy Royal Alexandra Hospital, Paisley

Western Infirmary, Glasgow Glasgow Royal Infirmary, Glasgow University Hospital, Ayr Forth Valley Hospital, Larbert Western General Hospital, Edinburgh Royal Infirmary, Edinburgh St Johns Hospital, Livingston Borders General Hospital, Melrose Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Trial Population Patients Referred for Evaluation of Suspected Angina due to Coronary Heart Disease n=9,849 Only 11% of All Patients Excluded From the Trial Ineligible Patients n=1,082 Eligible Patients for SCOT-HEART trial n=8,767 Eligible Recruited Patients for SCOT-HEART trial n=4,146 Randomization 1:1 n=4,146 Eligible Non-recruited Patients n=4,621 Missing Patient preference Clinician choice Not Approached Other 137 2613 547

992 332 47% of Eligible Patients Recruited Into the Trial Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Trial Population Randomization 1:1 n=4,146 Standard of Care n=2,073 Computed Tomography Coronary Angiogram n=3 Standard of Care + CT Coronary Angiogram n=2,073 100% Data for the Primary End-point Intention-to-Treat Analysis Data for Primary Endpoint n=2,073 CT Coronary Angiogram n=1,778 Non-completion Ill-health/death Patient default Technical Other Data for Primary Endpoint n=2,073

295 6 245 10 34 All Participants Standard Care + CTCA Standard Care Number 4146 (100%) 2073 (50%) 2073 (50%) Male 2325 (56%) 1162 (56%) 1163 (56%) Age (years) 5710 5710 5710 Body-mass Index (kg/m2) 306 306

306 Atrial Fibrillation 84 (2%) 42 (2%) 42 (2%) Prior Coronary Heart Disease 372 (9%) 186 (9%) 186 (9%) Prior Cerebrovascular Disease 139 (3%) 91 (4%) 48 (2%) Prior Peripheral Vascular Disease 53 (1%) 36 (2%) 17 (1%) Current or Ex-smoker 2185 (53%) 1095 (53%) 1090 (53%)

Hypertension 1395 (34%) 712 (34%) 683 (33%) Diabetes Mellitus 444 (11%) 223 (11%) 221 (11%) Hypercholesterolemia 2176 (53%) 1099 (53%) 1077 (52%) Family History 1716 (41%) 887 (43%) 829 (40%) Serum Total Cholesterol (mg/dL) 20646 20647 20644 Serum High-density Lipoprotein Cholesterol (mg/dL) 5116

5116 5116 All Participants Standard Care + CTCA Standard Care Typical 1462 (35%) 737 (36%) 725 (35%) Atypical 988 (24%) 502 (24%) 486 (23%) Non-anginal 1692 (41%) 833 (40%) 859 (41%) Normal 3492 (84%) 1757 (85%) 1735 (84%)

Abnormal 608 (15%) 292 (14%) 316 (15%) Performed 3517 (85%) 1764 (85%) 1753 (85%) Normal 2188 (62%) 1103 (63%) 1085 (62%) Inconclusive 566 (16%) 284 (16%) 282 (16%) Abnormal 529 (15%) 264 (15%) 265 (15%) 1315 (32%)

633 (31%) 682 (33%) Radionuclide 389 (9%) 176 (9%) 213 (10%) Other 30 (1%) 16 (1%) 14 (1%) Invasive Coronary Angiography 515 (12%) 255 (12%) 260 (13%) Baseline Diagnosis Coronary Heart Disease 1938 (47%) 982 (47%) 956 (46%) Angina due to CHD 1485 (36%) 742 (36%)

743 (36%) 1712% 1811% 1712% Anginal Symptoms Electrocardiogram Stress Electrocardiogram Further Investigation Stress Imaging Predicted 10-year Coronary Heart Disease Risk CT Coronary Angiography Prevalence of Coronary Heart Disease Clinicians Reporting CTCA Frequency Diagnosis of Angina due to CHD Certainty RR 3.76 [95% CI, 3.61-3.89] Frequency RR 0.78 [95% CI, 0.70-0.86] Normal Obstructive Non-Obstructive Coronary Artery Disease CT Coronary Angiography Safety Adverse Reactions & Radiation Dose

Contrast Reactions Frequency 13 (0.7%) Contrast Extravasation 7 (0.4%) Vasovagal Reaction 4 (0.2%) Headache 4 (0.2%) Other 3 (0.2%) TOTAL 31 (1.7%) Median Radiation Dose: 4.1 mSv (Interquartile Range 3.0-5.6) Dose-length Product: 291 mGy.cm (Interquartile Range 216-397) 37% Radiation Dose Attributable to Coronary Artery Calcium Score CT Coronary Angiography: Diagnosis Baseline Compared to 6 Weeks Overall Changes in Diagnosis: 25% versus 1%, P<0.001 Attending Clinician: Diagnosis of Coronary Heart Disease Certainty 2.56 [2.33-2.79] Frequency 1.09 [1.02-1.17] Attending Clinician: Diagnosis of Angina due to CHD (Primary End-point)

1.79 [1.62-1.96] 0.93 [0.85-1.02] Certainty Frequency 0.0 1.0 2.0 3.0 4.0 Relative Risk [95% Confidence Intervals] CTCA and Investigations Baseline Compared to 6 Weeks Overall Changes in Investigations: 15% versus 1%, P<0.001 Frequency Cancellations Stress Testing Invasive All Tests Coronary Angiography CTCA + Standard Care CTCA Report in those with cancelled Invasive Coronary Angiogram: Normal 52% Non-obstructive 31% Obstructive

17% Standard Care CTCA and Investigations Baseline Compared to 6 Weeks Overall Changes in Investigations: 15% versus 1%, P<0.001 Frequency New Investigations Stress Testing Invasive All Tests Coronary Angiography CTCA + Standard Care CTCA Report in those with new Invasive Coronary Angiogram: Normal 0% Non-obstructive 12% Obstructive 88% Standard Care CTCA and Medical Therapy Baseline Compared to 6 Weeks Overall Changes in Treatments: 23% versus 5%, P<0.001 New Treatments Frequency

Frequency Cancellations Preventative AntiAll Therapy Anginal Therapies Therapy CTCA + Standard Care Preventative AntiAll Therapy Anginal Therapies Therapy Standard Care CTCA and Symptoms Baseline Compared to 6 Weeks Seattle Angina Questionnaire No Overall Change in Symptoms at 6 Weeks Overall Treatment Satisfaction High (92/100) in Both Groups Baseline 6 Weeks Angina Stability CTCA + Standard Care Baseline 6 Weeks Angina Frequency Standard Care CTCA and Clinical Outcome 1.7 Years of Follow-up CHD Death and Non-Fatal MI 5

3 2 4% Standard Care 3% strata 5% HR 0.64 [0.41-1.01], P=0.056 4 3 Cumulative incidence, % 4 Proportion of patients with an event (%) 5% HR 0.62 [0.38-1.01], P=0.053 Cumulative incidence, % Proportion of patients with an event (%) 5 CHD Death, Non-Fatal MI and Non-fatal Stroke 4% Standard Care 3% AllocatedTreatment=2

AllocatedTreatment=1 2% 1 1% 0 0% CTCA 2073 0 CTCA Standard Care 2073 0 1571 1550 1 500 853 837 Time, days 2 Follow Up (years) 323 316 1000

3 1500 2 2% CTCA 1 1% 0 0% 0 2073 CTCA 2073 Standard Care 0 1569 500 1547 1 851 835 Time, days 2 Follow Up (years) 1000 321

315 3 CTCA and Clinical Outcome Coronary Angiography & Revascularisation Coronary Angiography 15 Standard Care 15 10 5 CTCA Standard Care 2073 2073 1249 1263 0 1 634 660 227 226 2 3 Follow Up (years)

15% CTCA 10 10% Cumulative incidence, % CTCA 20 0 HR 1.20 [0.99-1.45], P=0.061 HR 1.06 [0.92-1.21], P=0.451 Proportion of patients with an event (%) Proportion of patients with an event (%) 25 Coronary Revascularisation Standard Care 5 5% 0 0% CTCA Standard Care 0 2073

2073 0 1386500 1413 1 733 755 Time, days 2 Follow Up (years) 1000 270 276 3 1500 Conclusions In patients presenting with suspected angina due to coronary heart disease, the addition of computed tomography coronary angiography Clarifies the diagnosis: 1 in 4 Increases the diagnosis of CHD but appears to reduce the diagnosis of angina due to CHD Alters subsequent investigations: 1 in 6 Changes treatments: 1 in 4 Does not affect short-term anginal symptoms May increase coronary revascularisation and reduce fatal and non-fatal myocardial infarction Royal Infirmary of Edinburgh, Edinburgh: Ms Barbara Allen, Prof Edwin van Beek, Dr Miles Behan, Miss Danielle Bertram, Mr David Brian, Ms Amy Cowan, Dr Nicholas Cruden, Dr Martin Denvir, Dr Marc Dweck, Ms Laura Flint, Dr Andrew Flapan, Miss Samantha Fyfe, Dr Neil Grubb, Mrs

Collette Keanie, Dr Chris Lang, Dr Tom MacGillivray, Dr David MacLachlan, Miss Margaret MacLeod, Dr Saeed Mirsadraee, Mrs Avril Morrison, Dr Nicholas Mills, Dr David Northridge, Mrs Alyson Phillips, Miss Laura Queripel, Dr John Reid, Dr Neal Uren, Dr Nicholas Weir St Johns Hospital, Livingston; Dr Ashok Jacob, Mrs Fiona Bett, Mrs Frances Divers, Ms Katie Fairley, Ms Edith Keegan, Ms Tricia White, Ms Julia Fowler University Hospital, Ayr: Dr John Gemmill, Dr James McGowan, Mrs Margo Henry Victoria Hospital, Kirkcaldy: Dr Mark Francis, Mr Dennis Sandeman Ms Lorraine Dinnel Western General Hospital, Edinburgh: Prof David Newby Dr Peter Bloomfield, Dr Martin Denvir, Dr Peter Henriksen, Dr Donald MacLeod, Mrs Avril Morrison Western Infirmary, Glasgow & Institute of Cardiovascular & Medical Sciences, University of Glasgow: Prof Colin Berry, Dr Kenneth Mangion, Dr Ify Mordi, Dr Giles Roditi, Dr Nikolaos Tzemos, Dr Eugene Connolly, Mrs Heather Boylan, Mrs Ammani Brown, Ms Lesley Farrell, Mrs Alison Frood, Ms Caroline Glover, Mrs Janet Johnstone, Mrs Tracey Steedman, Mrs Kirsten Lanaghan, Mrs Deborah McGlynn, Ms Lorraine McGregor, Ms Evonne McLennan, Ms Laura Murdoch, Miss Victoria Paterson, Ms Fiona Teyhan, Ms Marion Teenan, Ms Rosie Woodward Borders General Hospital, Melrose: Dr Paul Neary Mrs Gillian Donaldson, Mr Terry Fairbairn, Mrs Marlene Fotheringham, Mrs Fiona Hall. Forth Valley Royal Hospital, Larbert: Dr Allister Hargreaves, Dr James Spratt, Dr Stephen Glen, Ms Sarah Perkins, Ms Fiona Taylor Mrs Louisa Cram, Ms Catherine Beveridge, Ms Avril Cairns, Ms Frances Dougherty Glasgow Royal Infirmary: Dr Hany Eteiba, Dr Alan Rae, Ms Kate Robb, Ms Wenda Crawford, Ms Patricia Clarkin, Ms Elizabeth Lennon Ninewells Hospital, Dundee: Prof. Graeme Houston, Prof Stuart Pringle, Dr Prasad Guntur Ramkumar, Dr Thiru Sudarshan, Dr Yvonne Fogarty, Ms Dawn Barrie, Ms Kim Bissett, Dr Adelle Dawson, Mr Scott Dundas, Mrs Deborah Letham, Ms Linda ONeill, Mrs Valerie Ritchie. Perth Royal Infirmary, Perth: Dr Hamish Dougall Royal Alexandra Hospital, Paisley: Dr Faheem Ahmed, Dr Alistair Cormack, Dr Iain Findlay, Dr Stuart Hood, Dr Clare Murphy, Dr Eileen Peat, Ms Lynne McCabe, Ms Margaret McCubbin.

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