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Balloon Pump Assisted Coronary
Intervention Study (BCIS-1)
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
BCIS-1
The first randomized controlled trial of elective IntraAortic 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
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
BCIS-1 Endpoint Definitions
Myocardial Infarction
<72 hrs after PCI, baseline CKMB
normal
CKMB > 3 x ULN
<72 hrs after PCI, baseline CKMB
elevated
CKMB > 1.5 x baseline value
>72 hrs after PCI
Elevation of Troponin T or I, with
typical symptoms or ECG changes
<72 hrs after CABG
CKMB > 5 x ULN and new Q waves or
new LBBB on ECG
Sudden Death
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
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
Baseline Characteristics
Elective IABP
No Planned
N=151
N=150
23.6 (5.2)
23.6 (5.5)
10.4 (1.7)
10.3 (1.7)
8
10
40 (26%)
39 (26%)
42 (28%)
39 (26%)
12
71 (47%)
68 (45%)
Mean E.F. (SD)
BCIS-1 Jeopardy Score
Mean (SD)
JAMA 2010; 304(8):867-874
BCIS-1: Major Outcomes
Adverse Events (%)
HR 1.86
(0.93 - 3.79)
HR 0.94
(0.51 - 1.76)
HR 0.11
(0.01 - 0.49)
HR 0.61
(0.24 - 1.62)
JAMA 2010; 304(8):867-874
Secondary Outcome: 6 month Mortality
___
20%
Elective IABP
___ No Planned IABP
Cumulative percentage
15%
Hazard Ratio 0.61 (95% CI 0.24 to 1.62)
10%
5%
0%
0
1
2
3
151
150
151
146
146
146
146
143
146
146
140
146
150
147
144
141
4
5
6
145
139
145
144
139
144
144
138
144
140
140
139
Time since randomisation (months)
Elective IABP
No Planned IABP
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%
IABP
No IABP
40%
30%
20%
Hazard ratio 0.66 (95% CI 0.44 to 0.98)
10%
0%
0
6 m 1 year
2 years
3 years
4 years
5 years
66
52
21
19
Time since randomisation
IABP
No IABP
151
150
144
139
137
130
127
117
111
93
Time-varying Hazard Ratios
4.5
6 months
0.63
(0.24 to 1.62)
4
3.5
< 1 year
0.68
(0.34 to 1.35)
3
p=0.91 for interaction
2.5
(<1yr vs. >1yr)
> 1 year
0.65
(0.40 to 1.06)
2
1.5
overall
0.66
(0.40 to 0.98)
1
0.5
0
0.1
1
10
 IABP Better
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
Elective IABP
No Planned IABP
94%
93%
73 (48%)
64 (42%)
13 (9%)
69 (46%)
64 (43%)
16 (11%)
35 (23%)
73 (48%)
41 (27%)
71 (47%)
2.15 ± 1.04
2.05 ± 1.02
Rotational Atherectomy
20 (13%)
17 (11%)
Drug-eluting stent use
67%
67%
GP2b3a inhibitor use
39%
43%
Procedural Success
No. of Vessels treated
1 vessel
2 vessels
3 vessels
Coronary Segment treated
Left Main Stem
Proximal LAD
Lesions treated (mean ± SD)
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 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 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