Balloon Pump Assisted CoronaryIntervention 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

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

BCIS-1

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

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

Balloon-pump assisted Coronary Intervention Study (BCIS-1)

Am Heart J 2009;158:910-916

BCIS-1 Endpoint DefinitionsMyocardial 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

6 month follow-up

ONS / GROS

Elective IABP Insertion

No Planned IABP

PCI

Remove IABP 4-24 hrs.

after PCIHospital Follow-up

To discharge or 28 days

Am Heart J 2009;158:910-916

Baseline Characteristics

Elective IABP

N=151

No Planned

N=150

Mean E.F. (SD) 23.6 (5.2) 23.6 (5.5)

BCIS-1 Jeopardy Score

Mean (SD) 10.4 (1.7) 10.3 (1.7)

8 40 (26%) 42 (28%)

10 39 (26%) 39 (26%)

12 71 (47%) 68 (45%)JAMA 2010; 304(8):867-874

BCIS-1: Major OutcomesA

dve

rse

Eve

nts

(%

)

JAMA 2010; 304(8):867-874

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)

Secondary Outcome: 6 month Mortality

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%)

Hazard ratio 0.66 (95% CI 0.44 to 0.98)

0%

10%

20%

30%

40%

50%

Cum

ula

tive

perc

enta

ge

150 139 130 117 93 52 19No IABP151 144 137 127 111 66 21IABP

0 6 m 1 year 2 years 3 years 4 years 5 years

Time since randomisation

IABP

No IABP

All-cause Mortality by treatment assignment

IABP Better No planned IABP Better

Time-varying Hazard Ratios

p=0.91 for interaction

(<1yr vs. >1yr)

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

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%)

73 (48%)

41 (27%)

71 (47%)

Lesions treated (mean ± SD) 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%

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 all-

cause 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