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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
2
Trial Organization
• Steering Committee
• Divaka Perera, Rod Stables, Martyn Thomas, Jean
Booth, Simon Redwood
Correlates of MACE
Odds Ratio
Elective IABP 0.11
Jeopardy Score 5.37
Sample Size = 274 pts (predicted MACE 5% vs. 15%, β=80%, α= 5%)
LVEF < 30%
Jeopardy Score ≥ 8
Randomize
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
• 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
• Cardiogenic Shock
Systolic BP <85 mmHg despite correction of hypovolemia
• 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
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
IABP No Planned
* 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
†
χ2 test * Fisher’s exact test
IABP Use
IABP No Planned
IABP Inserted 147 (98%) 18 (12%)
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