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B alloon-pump assisted C oronary I ntervention S tudy ( BCIS-1 ): Long term Mortality Data

B alloon-pump assisted C oronary I ntervention S tudy ( BCIS-1 ): Long term Mortality Data. Divaka Perera MA, MRCP, MD St Thomas’ Hospital, London & Kings College London United Kingdom On behalf of the BCIS-1 Investigators

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B alloon-pump assisted C oronary I ntervention S tudy ( BCIS-1 ): Long term Mortality Data

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  1. Balloon-pump assisted Coronary Intervention Study (BCIS-1): Long term Mortality Data Divaka Perera MA, MRCP, MD St Thomas’ Hospital, London & Kings College London United Kingdom On behalf of the BCIS-1 Investigators Steering Committee: Divaka Perera, Rod Stables, Martyn Thomas, Jean Booth, Simon Redwood

  2. Disclosure • Speaker’s name: Divaka Perera • √ I do NOT have any potential conflict of interest • I have previously received speaker fees from Maquet Cardiovascular • BCIS-1 was supported by unrestricted educational grants from Datascope (now Maquet) and Cordis. Abciximab was provided by Lilly • BCIS-1 extended follow-up was supported by an unrestricted educational grant from Maquet Cardiovascular 1

  3. Balloon-pump assisted Coronary Intervention Study (BCIS-1) The first randomized controlled trial of elective Intra-Aortic Balloon Pump (IABP) insertion prior to high-risk PCI vs. PCI with no planned IABP use 17 UK centres n=301 (150 in each arm) predicted control MACCE 15% 80% power to show 10% difference in MACCE

  4. Inclusion Criteria Impaired LV function (EF < 30%) and Extensive Myocardium at Risk BCIS-1 Jeopardy Score > 8 or...Target vessel supplying occluded vessel which supplies >40% of myocardium Am Heart J 2009;158:910-916

  5. Balloon-pump assisted Coronary Intervention Study (BCIS-1) Primary Endpoint: MACCE at hospital discharge Hierarchical Composite of Death, MI, CVA or Revascularization Secondary Endpoints: Procedural Complications (prolonged hypotension, VT/VF or cardiorespiratory arrest) 6-month all-cause mortality Bleeding Complications Vascular Complications Am Heart J 2009;158:910-916

  6. BCIS-1 Endpoint DefinitionsMyocardial Infarction Am Heart J 2009;158:910-916

  7. LVEF ≤ 30% BCIS-1 Jeopardy Score ≥ 8 Randomize Elective IABP Insertion No Planned IABP PCI Remove IABP 4-24 hrs after PCI Hospital Follow-up To discharge or 28 days 6 month follow-up ONS / GROS Am Heart J 2009;158:910-916

  8. Baseline Characteristics JAMA 2010; 304(8):867-874

  9. BCIS-1: Major Outcomes HR 1.86 (0.93 - 3.79) HR 0.94 (0.51 - 1.76) HR 0.11 (0.01 - 0.49) Adverse Events (%) HR 0.61 (0.24 - 1.62) JAMA 2010; 304(8):867-874

  10. Secondary Outcome: 6 month Mortality 20% ___Elective IABP ___No Planned IABP 15% Hazard Ratio 0.61 (95% CI 0.24 to 1.62) 10% Cumulative percentage 5% 0% 0 1 2 3 4 5 6 Time since randomisation (months) Elective IABP No Planned IABP 151 150 146 147 146 144 146 141 145 140 144 140 144 139 JAMA 2010; 304(8):867-874

  11. Ethics/IRB: Approval granted for extended follow-up Primary Endpoint: All-cause Mortality via Office of National Statistics (England) and General Register Office (Scotland) Follow-up status: Mortality data collection completed for 301 patients (100%) in October 2011 (randomisation period Dec 2005 – Jan 2009) BCIS-1 Follow-up Study

  12. Duration of follow-up (from randomisation): Median 51 months (IQR 41-58 months) 100 DEATHS (33%) BCIS-1 Follow-up: Results

  13. All-cause Mortality by treatment assignment

  14. Time-varying Hazard Ratios p=0.91 for interaction (<1yr vs. >1yr)  IABP Better No planned IABP Better 

  15. Reduction in peri-procedural ischaemia and infarction with counterpulsation? • No difference in pre-defined MACCE at hospital discharge in BCIS-1 • No reduction in infarct size on MRI with counterpulsation in CRISP-AMI • More complete revascularisation in the group assigned to elective IABP? Possible mechanisms of observed difference in mortality

  16. Revascularisation Details

  17. Reduction in peri-procedural ischaemia and infarction with counterpulsation? • No observed difference in pre-defined MACCE at hospital discharge in BCIS-1 • No reduction in infarct size on MRI with counterpulsation in CRISP-AMI • 2. More complete revascularisation in the group assigned to elective IABP? • No apparent difference in revascularisationcharacterisitics • 3. Statistical considerations • BCIS-1 was powered to detect a specified difference in MACCE rather than all-cause mortality alone • But note high event rate in enrolled cohort Possible mechanisms of observed difference in mortality

  18. In patients with severe ischaemic cardiomyopathy treated with PCI, all cause-mortality was 33% at 51 months (median) Conclusions Elective IABP use during PCI was associated with an observed 34% reduction in long-term all-cause mortality The mode of death and the putative mechanism of benefit of counterpulsation are unclear at present

  19. BCIS-1 Centres Investigators Study Coordinators Birmingham Heartlands Hospital, Birmingham Michael Pitt, Jerome Ment, Nadia Elgaylani Joanne Pitt, Juliet Hulse, Melissa Reeve Brighton and Sussex University Hospital, Brighton Adam de Belder, David Hildick-Smith, Stephen Holmberg, Nick Pegge, Rob Hatrick Elaine Joyce, Ailie Mackenzie, Nina Cooter Dorset County Hospital, Dorchester Fraser Witherow Pauline Chambers, Sally Breakspear Glenfield Hospital, Leicester Tony Gershlick, Gayle Richardson, Mohsin Farooq Kathryn Fairbrother, Pat Desouza Guy’s and St Thomas’ Hospital, London Simon Redwood, Divaka Perera, Martyn Thomas, James Coutts, Brian Clapp, Sundip Patel, Aldo Rinaldi, Balwinder Wasan Lucy Woodhead, Karen Wilson, Matthew Allen King’s College Hospital, London Martyn Thomas, Phillip Maccarthy, Jonathan Hill Michelle Andrews, Jayne Damm, Joanne Gregory Leeds Teaching Hospitals, Leeds Daniel Blackman, Jonathan Blaxill, Philip Batin, John Greenwood, Maurice Pye, Stephen Wheatcroft Claire Priestly, Kathryn Somers Liverpool Heart and Chest Hospital, Liverpool Rodney Stables, Joe Mills, Nicholas Palmer Heather Rogers, Claire Prince Manchester Royal Infirmary, Manchester Douglas Fraser, Faz Ordoubadi Karen Palmer Nottingham University Hospitals, Nottingham Robert Henderson, Kamran Baig, Leong Lee, William Smith Jane Burton Royal Bournemouth Hospital, Bournemouth Rosie Swallow, Peter O’Kane, Suneel Talwar, Terry Levy Nicki Lakeman, Priscilla Ryder Royal Victoria Hospital, Blackpool David Roberts, Simon Eccleshall Lesley Hutt, Lesley Helliwell Royal Wolverhampton Hospitals, Wolverhampton James Cotton, Michael Norell, Michael Cusack, Saib Khogali Andrew Smallwood St George’s Hospital, London Stephen Brecker, Charles Pumphrey Sue Brown, Jo Ann Multaney Southampton University Hospitals, Southampton Nick Curzen, Alison Calver, Keith Dawkins Zoe Nicholas, Sue Kitt University Hospital of North Staffordshire, Stoke-on-Trent Jim Nolan, Mark Gunning Julie Machin Western Infirmary, Glasgow Keith Oldroyd, Colin Petrie, Colin Berry, Stephen Robb, John Boyle Joanne Kelly, Fiona Stevenson Statistical support Tim Clayton (London School of Hygiene and Tropical Medicine) St Thomas’ Hospital/ Kings College London Kalpa De Silva Matthew Lumley Lucy Woodhead Karen Wilson DašaZugwitz Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London Jean Booth Fiona Nugara Winston Banya Marcus Flather Data Monitoring and Safety Committee Peter Ludman Gerard Stansby ChrisPalmer Michael Roughton Acknowledgements

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