Balloon-pump assisted

Coronary Intervention
Study

BCIS-1
Simon Redwood
King’s College London/ St Thomas’ Hospital

Steering Committee:
Divaka Perera, Rod Stables, Jean Booth, Martyn Thomas
Potential conflicts of interest

Speaker’s name: Simon Redwood

√ I do not have any potential conflict of interest

This trial was supported by

unrestricted grants from:
Datascope/ Maquet
Eli Lilly
Cordis

2
 Trial Organization
• Steering Committee
• Divaka Perera, Rod Stables, Martyn Thomas, Jean
Booth, Simon Redwood

• Clinical Events Committee

• James Cotton, Nick Curzen, Adam de Belder, David
Roberts

• Data Monitoring and Safety Committee

• Peter Ludman (Chair) , Gerald Stansby, Chris
Palmer

• Clinical Trials and Evaluation Unit

• Jean Booth, Fiona Nugara, Marcus Flather,
Charlotte Gillam, Michael Roughton, Winston Banya
 Elective vs provisional IABP
in high-risk PCI
• 133 pts EF <30, elective P = 0.01
PCI
%
• Elective IABP, 61 pts.
Jeopardy Score 8.0 + 2.8
P = 0.29
• Provisional IABP, 72 pts.
Jeopardy Score 6.7 + 2.4
(p=0.008)

Correlates of MACE
Odds Ratio
Elective IABP 0.11
Jeopardy Score 5.37

Briguori et al, AHJ 2003;145:700-7

 Balloon-pump assisted
Coronary Intervention Study
Objectives:
To compare the efficacy and safety of elective Intra-Aortic
Balloon Pump (IABP) insertion prior to high-risk PCI vs.
conventional treatment (with no planned IABP use)
Structure:
• Prospective, open, randomized trial
• 17 UK centres
• n=300 (150 in each arm)

Sample Size = 274 pts (predicted MACE 5% vs. 15%, β=80%, α= 5%)
 LVEF < 30%
Jeopardy Score ≥ 8

Randomize

Elective IABP No Planned

Insertion IABP

PCI
Remove IABP 4-24 hrs
after PCI

Hospital Follow-up
To discharge or 28 days

6 month follow-up
 BCIS-1
Primary Outcome Measure

Major Adverse Cardiovascular or Cerebral Events

(MACCE) at hospital discharge or 28 days
(whichever is sooner), including
• All-Cause Death
• Acute MI (CKMB > 3xULN)
• Further revascularization by PCI or CABG
• CVA
Perera et al AHJ 2009; in press
 Secondary Outcome Measures

• Six month mortality

• Procedural complications
• Prolonged hypotension OR
• VT/VF requiring cardioversion OR
• Cardiac arrest requiring CPR/ventilation

• Bleeding complications
• Vascular complications
• Procedural success
• Duration of hospital stay
 Study Definitions
Myocardial Infarction
1. < 72 hrs post PCI, baseline CKMB normal
• CKMB > 3x ULN
2. < 72 hrs post PCI, baseline CKMB high
• CKMB > 1.5 x baseline
3. > 72 hrs post PCI
• Elevated Tn with symptoms or ECG changes
4. < 72 hrs post CABG
• CKMB > 5 x ULN and new Q waves or LBBB
5. Sudden Death
• Cardiac Arrest with ST elevation/LBBB and/or
evidence of thrombus at autopsy/angiography
 Study Definitions

• Prolonged Hypotension
 1. Elective IABP
• MAP <75 mmHg for >10 mins despite fluids OR new
inotropes to maintain MAP >75mmHg
 2. No Planned IABP
• Above OR insertion of IABP to maintain MAP
>75mmHg

• Major bleed
 >4g/dl drop in Hb
• Minor bleed
 2-4g/dl drop in Hb
 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
 Exclusion Criteria

• Cardiogenic Shock
 Systolic BP <85 mmHg despite correction of hypovolemia

• Acute MI < 48 hours before randomization

• Planned staged PCI within 28 days
• Complications of acute MI
 VSD, severe MR or intractable VT/VF

• Contraindication to IABP
 Jeopardy Score
6 Major Coronary
Segments
2 2
2 points for each 2
lesion + 2 for each
territory distal to 2
lesion
2

Califf et al JACC 1985;5:1055-63

 BCIS-1 Jeopardy Score
Allows LM and Graft Classification
6 Major Coronary
Segments
2 2
2 points for each 2
lesion + 2 for each
territory distal to 2
lesion
2
Negative points for
functioning grafts

Perera et al AHJ 2009; in press

 BCIS-1 Recruitment
Completed 21st Jan 09

Total 301 patients

 Baseline Characteristics

IABP No Planned
N=151 N=150 p value
Male (%) 122 (81.0) 117 (78.0) 0.55
Mean Age (SD) 71 (9.3) 71 (9.7) 0.74
Diabetes (%) 56 (37.1) 50 (33.1) 0.50
Prior MI (%) 113 (74.8) 108/148 (72.9) 0.71
Prior PCI (%) 17 (11.3) 14 (9.3) 0.58
Prior CABG (%) 25 (16.6) 20 (13.3) 0.48
NYHA 3/4 (%) 99 (66) 108 (72) 0.26
CCS 3/4 (%) 72 (48) 68 (45.5) 0.68
GFR median (IQR) 58.2 (45.0, 78.6) 60.0 (41.9, 80.0) 0.94
 Inclusion Characteristics
IABP No Planned
N=151 N=150 p value

Mean E.F. (SD) 23.6 (5.2) 23.6 (5.2) 0.99

BCIS-1 Jeopardy Score

Mean (SD) 10.38 (1.71) 10.32 (1.72) 0.75

8 40 (26.5%) 42 (28%) 0.95

10 39 (25.8%) 39 (26%)
12 71 (47%) 68 (45.3%)
 Procedural Details

IABP No Planned P value

Lesions attempted 323 305

Lesions successfully revasc 94.7% 94.1% 0.73
Mean lesions per patient 2.15 2.05 0.40
Vessels attempted 247 244
Mean stents per patient 2.56 2.31

GP2b3a use 39.3% 43.3%

 Primary Endpoint: MACCE
to Hospital Discharge/ 28 days

IABP No Planned

n=151 (%) n=150 (%) p value*

Death 3 (2.0) 1 (0.7) 0.40
CVA 2 (1.3) 0 (0.0)

MI 19 (11.3) 20 (13.3) 0.43

Revasc 1 (0.0) 4 (1.4) 0.13
Total 23 14.6 24 15.3 0.35

* Cox regression
1 patient had MI and died; 2 patients had MI and PCI
Kaplan-Meier Survival Estimates for MACCE

15.3%

14.6%

P = 0.35
 Major Secondary Outcomes
IABP No Planned p value
6/12 Mortality 7 (4.6%) 11 (7.3%) 0.32†
Procedural complication 2 (1.3) 16 (10.7) 0.001
Access site complication 5 (3.3) 0 (0) 0.06*
All bleeds 29 (19.3) 17 (11.3) 0.058

Major bleeds 5 (3.3) 6 (4.0) 0.77

Minor bleeds 24 (15.9) 11 (7.3) 0.021
Procedural success 230 (93.5) 237 (93.3) 0.93
LOS - mean days (SD) 2 (1,5) 2 (1,4) 0.12

†
χ2 test * Fisher’s exact test
 IABP Use
IABP No Planned
IABP Inserted 147 (98%) 18 (12%)

Reason for Insertion

Randomized Allocation
Hypotension
Ventricular Arrhythmia
Pulmonary Oedema
Vessel Closure
Other
147 0
0 13
0 0
0 1
0 1
0 3

Median duration of use (hrs) 8.63 22.94

(IQR) (6, 23.1) (17.3, 26.4)
K-M 6 month mortality

7.3%

4.6%

P = 0.32
 Conclusions
• BCIS have performed the first randomized trial
of elective vs. ‘bailout’ IABP in patients with
poor LV function and severe coronary disease

• We did not find evidence that Elective IABP to

support high risk PCI is associated with a
reduction in MACCE at hospital discharge

• 12% in the no-planned group required

emergency IABP, supporting the important role
of provisional IABP use

• Patients with poor LV function and severe

coronary disease treated by PCI appear to have
acceptable in-hospital and 6 month mortality
(1.3% and 6%)