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Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

Balloon Pump Assisted Coronary Intervention Study (BCIS-1). B alloon-pump assisted C oronary I ntervention S tudy ( BCIS-1 ): Long term Mortality Data. On behalf of the BCIS-1 Investigators Steering Committee: Divaka Perera, Rod Stables, Martyn Thomas, Jean Booth, Simon Redwood. BCIS-1.

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Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

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  1. Balloon Pump Assisted Coronary Intervention Study (BCIS-1)

  2. Balloon-pump assisted Coronary Intervention Study (BCIS-1): Long term Mortality Data On behalf of the BCIS-1 Investigators Steering Committee: Divaka Perera, Rod Stables, Martyn Thomas, Jean Booth, Simon Redwood

  3. BCIS-1 The first randomized controlled trialof 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. InclusionCriteria Am Heart J 2009;158:910-916 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

  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. BCIS-1 Follow-up Study 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)

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

  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 ischemia 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 revascularization in the group assigned to elective IABP? Possible mechanisms of observed difference in mortality

  16. Revascularisation Details

  17. Reduction in peri-procedural ischemia 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 revascularization in the group assigned to elective IABP? • No apparent difference in revascularization characteristics • 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 ischemic 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

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