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1 No Conflict of Interests Disclosure PI of Study Divaka Perera Senior Lecturer and Consultant Cardiologist St Thomas Hospital Campus, King s College London

2 Heart Failure Management: Evidence Based Medicine > 50,000 pafents enrolled in RCTs over 25 years Gheorghiade et al; Circulation 2006

3 Viability and RevascularisaFon Annual Mortality (%) RR 80% (p<0.0001) 16.0 % 3.2 % RR 58% (p<0.0001) 6.6 % 7.7 % n=3088 EF 32 ± 8% 0.0 Viable Non-viable Medical Revasc. Allman et al; JACC 2002

4 RevascularisaFon for Heart Failure ESC guidelines LVEF < 35% + Angina LVEF < 35%, No Angina ( CCS class 2)

5 All-Cause Mortality As Randomized HR 0.86 (0.72, 1.04) P =

6 Time-varying Hazard Ratios As Randomized

7 Why (else) did STICH fail to show benefit? Adequately powered? YES 41% mortality with OMT (predicted 39% vs. 29%) The right pafents? NO Viability not mandated No minimum CAD threshold LMS disease excluded Medical Therapy (too) good? NO 41% mortality 54% mortality or heart failure hosp n 64% mortality or CV hosp n

8 RevascularisaFon for Heart Failure PosiFon LVEF < 35%, No Angina ( CCS class 2) Revise IndicaFon (IIb or III?) No randomised data (yet)

9 REVascularisation for Ischaemic VEntricular Dysfunction () A UK mulecentre randomised control trial of PCI (with opemal medical therapy, OMT) versus OMT alone for severe ischaemic cardiomyopathy

10 REVascularisation for Ischaemic VEntricular Dysfunction () A UK mulecentre randomised control trial of PCI (with opemal medical therapy, OMT) versus OMT alone for severe ischaemic cardiomyopathy Funding: NIHR (HTA) CET Grant (subject to contract) Grant Co-applicants: Divaka Perera, Tim Clayton, Simon Redwood, Gerry Carr-White, Theresa McDonagh, Tony Gershlick, Mark De Belder, Michael Marber, Mark Sculpher

11 REVascularisation for Ischaemic VEntricular Dysfunction () Independent Trial Steering Commi\ee (Chair: Prof Andrew Clark) Independent Data & Safety Monitoring Commi\ee (Chair: Dr Peter Ludman) Independent Clinical Events Commi\ee (Chair tbc) Medical and Device Therapy Commi\ee (Chair: Prof Michael Marber) PCI and Heart Failure Leads at each centre + Study Coordinator

12 20-25 UK Centres

13 PCI vs. OMT for Ischaemic Cardiomyopathy Inclusion Criteria 1. LVEF 30% 2. Coronary Artery Disease (BCIS-1 Jeopardy Score 6) 3. Viable Myocardium (>30% of dysfuncfonal segments)

14 PCI vs. OMT for Ischaemic Cardiomyopathy Exclusion Criteria 1. CCS class 3 angina 2. AMI <6 weeks prior to randomisafon 3. Decompensated heart failure <72 hours previously 4. Sustained VT/VF or ICD discharges <72 hours previously 5. More than mild AS or AR on echocardiography 6. Contra-indicaFons to PCI

15 Meets other eligibility criteria LVEF 30% C.A.D (JS 8) Dob Stress Echo >30% of dysfunctional segments viable? yes MDT Review Suitable for PCI? yes RANDOMISE OMT PCI Clinical f/u (30d, 6m, 1yr, 2yr, then yearly) Echo at 6 m, 1yr ICD f/u at 1, 2 yrs

16 : PCI vs. OMT for Ischaemic Cardiomyopathy Primary Endpoint All-cause Death or HospitalizaFon due to Heart Failure SAMPLE SIZE = 700 >85% power, 5% 2-tailed significance Accrual: 42 months, Minimum f/u: 24 months Predicted Composite Event Rate with OMT = 36% at 2 years. Expected RRR with PCI = 25% (2 yr MACE 27%)

17 PCI vs. OMT for Ischaemic Cardiomyopathy Major Secondary Endpoints 1. NYHA FuncFonal Class 2. Quality of life scores 3. Angina at follow-up (CCS class and Sea\le QuesFonnaire) 4. LVEF on echocardiography at 6m and 1 year 5. HospitalizaFon for heart failure 6. Unplanned further revascularizafon 7. Appropriate ICD therapy

18 Study Timelines Enrol Centres R&D, contracts PaFent Recruitment June 2013 Dec p.a. (10 per centre p.a.) Follow-up (min 2 yrs) Range of follow-up: yrs from randomisa@on results

19 Meets other eligibility criteria LVEF 30% C.A.D (JS 6) Dob Stress Echo yes MDT Review >30% of dysfunctional segments viable? Suitable for PCI? yes RANDOMISE OMT PCI Clinical f/u (30d, 6m, 1yr, 2yr, then yearly) Echo at 6 m, 1yr ICD f/u at 1, 2 yrs

20 LVEF 30% C.A.D (JS 6) Pending independent funding Meets other eligibility criteria Dob Stress Echo >30% of dysfunctional segments viable? yes no MDT Review Suitable for PCI? yes RANDOMISE Non-Viable Registry OMT PCI OMT Clinical f/u (30d, 6m, 1yr, 2yr, then yearly) Echo at 6 m, 1yr ICD f/u at 1, 2 yrs Clinical f/u at 1, 2 yrs Echo at 1 yr ICD f/u at 1, 2 yrs

21 LVEF 30% C.A.D (JS 6) Pending independent funding Meets other eligibility criteria Dob Stress Echo >30% of dysfunctional segments viable? yes RANDOMISE no Non-Viable Registry MRI substudy (n=300) OMT n=100 PCI n=100 OMT n=100 Clinical f/u (30d, 6m, 1yr, 2yr, then yearly) Echo at 6 m, 1yr ICD f/u at 1, 2 yrs Clinical f/u at 1, 2 yrs Echo at 1 yr ICD f/u at 1, 2 yrs

22 For more informafon or if you would like to be involved in the trial, please contact Divaka Perera, St Thomas Hospital, London Tim Clayton, CTU, London School of Hygiene & Tropical Medicine Karen Wilson or Lucy Clack, St Thomas Hospital, London