Balloon Pump Assisted Coronary
Intervention Study (BCIS-1)

B
C
I
S
BCIS-1
On behalf of the BCIS-1 Investigators
Steering Committee: Divaka Perera, Rod Stables, Martyn
Thomas, Jean Booth, Simon Redwood

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

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

B alloon-pump assisted C oronary
I ntervention S tudy ( 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

BCIS-1 Endpoint Definitions
Myocardial Infarction
<72 hrs after PCI, baseline CKMB normal
<72 hrs after PCI, baseline CKMB elevated
>72 hrs after PCI
CKMB > 3 x ULN
CKMB > 1.5 x baseline value
<72 hrs after CABG
Sudden Death
Elevation of Troponin T or I, with typical symptoms or ECG changes
CKMB > 5 x ULN and new Q waves or new LBBB on ECG
Cardiac arrest accompanied by new
ST elevation/LBBB on ECG and/or evidence of fresh coronary thrombus at autopsy/angiography
Am Heart J 2009;158:910-916

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

Baseline Characteristics
Elective IABP
N=151
23.6 (5.2) Mean E.F. (SD)
BCIS-1 Jeopardy Score
Mean (SD) 10.4 (1.7)
8
10
12
40 (26%)
39 (26%)
71 (47%)
No Planned
N=150
23.6 (5.5)
10.3 (1.7)
42 (28%)
39 (26%)
68 (45%)
JAMA 2010; 304(8):867-874

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

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

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)

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

All-cause Mortality by treatment assignment
50%
40%
30%
IABP
No IABP
20%
10%
Hazard ratio 0.66 (95% CI 0.44 to 0.98)
0%
0 6 m 1 year
IABP
No IABP
151
150
144
139
137
130
2 years 3 years
Time since randomisation
4 years
127
117
111
93
66
52
5 years
21
19

Time-varying Hazard Ratios
6 months
< 1 year
> 1 year overall
0,1
 IABP Better
3,5
3
2,5
2
4,5
4
1,5
1
0,5
0.63
(0.24 to 1.62)
0.68
(0.34 to 1.35)
0.65
(0.40 to 1.06) p=0.91 for interaction
(<1yr vs. >1yr)
0.66
(0.40 to 0.98)
0
1 10
No planned IABP Better 

Possible mechanisms of observed difference in mortality
1.
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
2.
More complete revascularization in the group assigned to elective IABP?

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

Possible mechanisms of observed difference in mortality
•
•
1.
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 CRISPAMI
•
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 allcause mortality alone
But note high event rate in enrolled cohort

Conclusions
In patients with severe ischemic cardiomyopathy treated with PCI, all cause-mortality was 33% at 51 months
(median)
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