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Balloon-pump assisted Coronary Intervention Study BCIS-1 Simon Redwood St Thomas’ Hospital / King’s College London On behalf of the BCIS-1 Investigators

Steering Committee: Divaka Perera, Rod Stables, Jean Booth, Martyn Thomas


LVEF < 30% Jeopardy Score â&#x2030;Ľ 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


BCIS-1 Jeopardy Score Allows LM and Graft Classification 6 Major Coronary Segments

2

2

2

2 points for each lesion + 2 for each territory distal to lesion

2 2

Negative points for functioning grafts

2 Perera et al AHJ 2009; in press


Components of the Primary Outcome: 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

23

14.6

24

15.3

0.35

Total

* Cox regression † Hierarchical 1 patient had MI and died; 2 patients had MI and PCI


Major Secondary Outcomes IABP

No Planned

p value

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*

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

2 (1,5)

2 (1,4)

0.12

6/12 Mortality

All bleeds

LOS - median days (IQR) †

χ2 test

* Fisher’s exact test


Kaplan Meier 6 month mortality

7.3% vs 4.6%, p = 0.32

Elective IABP

No Planned


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%)


Ballon Assisted Intervention Study