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

2. 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=300 (150 in each arm)
80% power, predicted control MACCE 15%
(incl. 10% contingency for incomplete data)

3. 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:

4. 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:

5. Elective IABP Insertion
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:

6. Baseline Characteristics
Elective IABP
N=151
No Planned
N=150
Mean E.F. (SD)
23.6 (5.2)
BCIS-1 Jeopardy Score
Mean (SD)
10.38 (1.71)
10.32 (1.72) 8
40 (26.5%)
42 (28%) 10
39 (25.8%)
39 (26%) 12
71 (47%)
68 (45.3%)
JAMA 2010; 304(8):

7. BCIS-1: Major Outcomes Adverse Events (%) JAMA 2010; 304(8):867-874
p=0.35
p=0.001
p=0.32
p=0.06
JAMA 2010; 304(8): 6

8. Secondary Outcome: 6 month Mortality
JAMA 2010; 304(8):

9. BCIS-1 Follow-up Study Ethics/IRB: Primary Endpoint:
Approval granted for follow-up up to 5 years post randomisation
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)

10. Duration of follow-up (from randomisation):
BCIS-1 Follow-up Study
Duration of follow-up (from randomisation):
Median 51 months (IQR months)
100 DEATHS (33%)

11. All-cause Mortality by treatment assignment

12. Time-varying Hazard Ratios
 IABP Better
No planned IABP Better 

13. All-cause Mortality by IABP usage (elective and rescue)
HR 0.64, 95% CI to 0.94
p=0.024
18 patients (12%) assigned to No Planned IABP required rescue counterpulsation during index PCI

14. Possible mechanisms of observed difference in mortality
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?

15. Revascularisation Details
Elective IABP
No Planned IABP
Procedural Success
94%
93%
No. of Vessels treated
1 vessel
2 vessels
3 vessels
73 (48%)
64 (42%)
13 (9%)
69 (46%)
64 (43%)
16 (11%)
Coronary Segment treated
Left Main Stem
Proximal LAD
35 (23%)
41 (27%)
71 (47%)
Lesions treated (per patient)
2.15 ± 1.04
2.05 ± 1.02
Rotational Atherectomy
20 (13%)
17 (11%)
Drug-eluting stent use
67%
GP2b3a inhibitor use
39%
43%

16. Possible mechanisms of observed difference in mortality
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
2. More complete revascularisation in the group assigned to elective IABP?
No difference in revascularisation characterisitics
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

17. Conclusions
In patients with severe ischaemic cardiomyopathy treated with PCI, all cause-mortality was 33% at 4 years
Elective IABP use during PCI was associated with a 34% reduction in all-cause mortality on long-term follow-up
The mode of death and the putative mechanism of benefit of counterpulsation are unclear at present