16/10/2020 F NCT03187639 on behalf of the FORECAST Investigators. on behalf of the FORECAST Investigators. C Roobottom, M Mamas, R Rajani, I Ford, P Douglas, M Hlatky C Roobottom, M Mamas, R Rajani, I Ford, P Douglas, M Hlatky J Nuttall, K Fox, D Connolly, P O’Kane, A Hobson, A Chauhan, N Uren, G McCann, C Berry, J Carter, J Nuttall, K Fox, D Connolly, P O’Kane, A Hobson, A Chauhan, N Uren, G McCann, C Berry, J Carter, , Z Nicholas, B Stuart, S Wilding, K Hill, J Shambrook, Z Eminton, D Ball, C Barrett, L Johnson, N Curzen able Chest Pain Management of St Management of ngiography in the Assessment & A ngiography in the Assessment & Tomography Coronary A Tomography Coronary omputed C omputed serve Derived from C w Re F ractional Fl NCT03187639 ractional Fl o o w Re serve Derived from St able Chest Pain N Curzen , Z Nicholas, B Stuart, S Wilding, K Hill, J Shambrook, Z Eminton, D Ball, C Barrett, L Johnson,
16/10/2020 Conflicts of Interest FORECAST is an investigator-initiated trial NC applied for & was awarded an unrestricted research grant from HeartFlow … The company had no formal role in the design, prosecution, data collection, analysis of the trial The sponsor for FORECAST is R&D Department, University Hospital Southampton NHS FT NC has received speaker fees and travel sponsorship from HeartFlow in the last 3 years
16/10/2020 BACKGROUND assessment of stable new onset chest pain § There is value in determining the presence of both atheroma (anatomy) & ischaemia (physiology)… § Most commonly used tests focus on only 1 of these parameters physiological information non-invasively 1-3 1 J Am Coll Cardiol . 2011;58(19):1989-1997 2 JAMA . 2012;308(12):1237-1245 3 J Am Coll Cardiol . 2014;63(12):1145-1155 § There is wide variation in practice in the § FFR CT is a well validated test that provides both anatomical & § FFR CT utilises the output from CTCA & derives FFR in major epicardial vessels using FD & 3D modelling
16/10/2020 § In the UK, NICE Technology Appraisal CT with routine assessment No randomized trial has compared FFR 8 NICE Medical Technologies Guidance MTG32, Feb 2017 5 J Am Coll Cardiol . 2015 Dec 1;66(21):2315-23 . 2016;9(10):1188-1194 6 JACC Cardiovasc Imaging 7 Eur Heart J . 2018;39(41):3701-3711 4 Eur Heart J . 2015;36(47):3359-3367 8 CT >0.8 (p<0.001) BACKGROUND 2 43.8% in those with FFR CT <0.8 vs. CT led to a change in management in 36% of 200 cases cf CTCA alone routine care in the cohort assigned to ICA, but not in the cohort assigned to non-invasive assessment significantly lower cost than § In a prespecified economic analysis of PLATFORM as the initial testing strategy § In the PLATFORM study 4 , CTCA with FFR CT resulted in a 61% reduction in the need for ICA compared with routine care 5 , CTCA+FFR CT was associated with § In FFR CT RIPCORD 6 , the availability of FFR § In the ADVANCE Registry 7 , the rate of unobstructed coronaries at ICA was 14.4% in patients with FFR
16/10/2020 stable chest pain? § NHS Innovation & Technology Payment Scheme invests in FFR CT as a frontline test that is clinically effective and will save money § NICE recommends CTCA+FFR CT patient cohorts (ie it is SAFE) -is not associated with an increase in ischaemic events in the FFR -is associated with lower costs… ? But only in those allocated to an invasive strategy? -reduces rate of ICA & reduces ICA showing no significant CAD CT : § Evidence so far from non-randomized clinical studies suggests that FFR stable chest pain? will it be cost effective as an initial strategy in patients with TRIAL RATIONALE: BUT: will it be cost effective as an initial strategy in patients with BUT: of death, MI or revascularisation… of death, MI or revascularisation… will reduce ICA without increased rates CT will reduce ICA without increased rates CT Previous data suggest that FFR Previous data suggest that FFR the primary endpoint? Why is resource utilisation CT for front line clinical practice
16/10/2020 STUDY SECONDARY OBJECTIVES randomizing 700 patients in each group Based upon PLATFORM cost analysis… Sample Size Calculation between the 2 groups at 9 months general wellbeing To compare the effect on 2. between the 2 groups at 9 months To compare clinical outcomes 1. when compared with routine clinical pathway algorithms recommended by NICE CG95 STUDY HYPOTHESIS & PRIMARY OBJECTIVE when compared with routine clinical pathway algorithms recommended by NICE CG95 , , resource utilisation resource utilisation as a default test is superior, in terms of CT as a default test is superior, in terms of UK, routine CTCA+FFR To determine whether, in a population of patients presenting to Rapid Access Chest Pain Clinics (RACPC) in the To determine whether, in a population of patients presenting to Rapid Access Chest Pain Clinics (RACPC) in the would provide 90% power to detect 20% difference in costs UK, routine CTCA+FFR CT
16/10/2020 Inclusion Criteria : QOL/Health -QOL -Patient satisfaction -angina status -time to definitive management plan -time to completion of initial management plan -age >18 yrs -procedural complications -chest pain deemed to require investigation Exclusion Criteria -unstable angina or ACS -prior PCI/CABG -new onset AF -contraindications to CTCA -prosthetic valve Secondary Endpoints -Requirement for ICA METHOD -invasive angiography • Randomised controlled trial • 1400 patients attending RACPC in 11 UK centres Primary Endpoint: Resource Utilisation at 9 months -non-invasive cardiac tests -revascularization -Requirement for non-invasive cardiac tests -hospitalization for cardiac event -cardiac meds -outpatient attendances Secondary Endpoints : Clinical -MACCE (All cause mortality, non fatal MI, CVA) -Death + MI + CVA + unplanned revasc + cardiac hospitalization -life expectancy<12 months
16/10/2020 METHOD 2 “Those patients with a coronary stenosis of >40% in at least one major epicardial vessel of stentable/graftable diameter will be referred for FFR CT . ( NB Lesions in distal vessels beyond the reach of stents or grafts or vessels of a diameter not suitable for stenting/grafting will not qualify for FFR CT if there are no other more significant lesions ).“
16/10/2020 RESULTS: CONSORT & DEMOGRAPHICS
16/10/2020 RESULTS 14 (6.4%) CT ? Non-invasive test after FFR 100 (45.5%) CT ? ICA after FFR 98.2% 57.3% 39 (8.2%) Not analysable 415 (86.6%) No lesion >40% 25 (5.2%) No CTCA done Reason not performed? 479 (68.5%) No 220 (31.5%) Yes Test Arm N=699 Initial Tests Undertaken FFR CT performed? Any FFR CT <0.8 FFR CT result used in Mx plan?
16/10/2020 RESULTS: 9 month tests & revascularisation § 14% lower total ICA in test vs. reference group (p=0.02) § 22% fewer patients had ICA in test vs reference group (p=0.01) Data are numbers of tests (number of patients) 66% 96%
16/10/2020 RESULTS: PRIMARY ENDPOINT TOTAL CARDIAC COSTS TOTAL CARDIAC COSTS
RESULTS: SECONDARY CLINICAL ENDPOINT MACCE/CLINICAL EVENTS • Metastatic lung Ca • Community acquired pneumonia Reference Group Test Group
RESULTS: SECONDARY CLINICAL ENDPOINT QoL/Angina status
16/10/2020 LIMITATIONS § The cut off for sending patients for FFR CT of > 40% stenosis was pragmatic § The proportion of patients in the Reference arm undergoing CTCA increased through the recruitment period, as anticipated from CG95 NICE guidelines, but at a rate of rise that was impossible to model at the start of the trial
16/10/2020 CONCLUSION MACCE or revascularisation associated with significantly different rates of is not associated with significantly different rates of ü is associated with a significantly lower rate of invasive angiography (22%) ü significantly reduce costs in the NHS system id not significantly reduce costs in the NHS system MACCE or revascularisation ü when compared with a strategy of routine care: when compared with a strategy of routine care: , CT , CT In patients presenting with new onset stable CP, a strategy of CTCA with FFR In patients presenting with new onset stable CP, a strategy of CTCA with FFR ü d d id not ü is associated with a significantly lower rate of invasive angiography (22%) ü is not
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