Balloon-pump assisted Coronary Intervention

Study

BCIS-1Simon Redwood

King’s College London/ St Thomas’ Hospital

Steering Committee: Steering Committee:

Divaka Perera, Rod Stables, Jean Booth, Martyn ThomasDivaka Perera, Rod Stables, Jean Booth, Martyn Thomas

22

Potential conflicts of interestPotential conflicts of interest

Speaker’s name: Speaker’s name: Simon RedwoodSimon Redwood

√√ I do not have any potential conflict of interestI do not have any potential conflict of interest

This trial was supported by This trial was supported by unrestricted grants from:unrestricted grants from:

Datascope/ MaquetDatascope/ MaquetEli LillyEli LillyCordisCordis

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 PCI

• Elective IABP, 61 pts. Jeopardy Score 8.0 + 2.8

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

P = 0.01

P = 0.29

Objectives:Objectives:To compare the efficacy and safety of elective Intra-Aortic To compare the efficacy and safety of elective Intra-Aortic

Balloon Pump (IABP) insertion prior to high-risk PCI vs. Balloon Pump (IABP) insertion prior to high-risk PCI vs.

conventional treatment (with no planned IABP use)conventional treatment (with no planned IABP use)

Structure:Structure:• Prospective, open, randomized trialProspective, open, randomized trial• 17 UK centres17 UK centres• n=300 (150 in each arm)n=300 (150 in each arm)

Sample Size = 274 pts (predicted MACE 5% vs. 15%, β=80%, α= 5%)Sample Size = 274 pts (predicted MACE 5% vs. 15%, β=80%, α= 5%)

BBalloon-pump assisted alloon-pump assisted

CCoronary oronary IIntervention ntervention SStudy tudy

LVEF < 30%LVEF < 30%Jeopardy Score Jeopardy Score ≥ 8≥ 8

Randomize

6 month follow-up

Elective IABP Elective IABP InsertionInsertion

No Planned No Planned IABP IABP

PCIRemove IABP 4-24 hrs

after PCI

Hospital Follow-up

To discharge or 28 days

Primary Outcome MeasurePrimary Outcome Measure

Major Adverse Cardiovascular or Cerebral Major Adverse Cardiovascular or Cerebral

Events (MACCE) Events (MACCE) at hospital discharge or 28 at hospital discharge or 28

days days (whichever is sooner), including(whichever is sooner), including• All-Cause DeathAll-Cause Death• Acute MI (CKMB > 3xULN)Acute MI (CKMB > 3xULN)• Further revascularization by PCI or CABGFurther revascularization by PCI or CABG• CVACVA

BCIS-1BCIS-1

Perera et al AHJ 2009; in press

Secondary Outcome MeasuresSecondary Outcome Measures

• Six month mortalitySix month mortality

• Procedural complications Procedural complications • Prolonged hypotension ORProlonged hypotension OR

• VT/VF requiring cardioversion ORVT/VF requiring cardioversion OR

• Cardiac arrest requiring CPR/ventilationCardiac arrest requiring CPR/ventilation

• Bleeding complicationsBleeding complications

• Vascular complicationsVascular complications

• Procedural successProcedural success

• Duration of hospital stayDuration of hospital stay

Study DefinitionsMyocardial 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 functionImpaired LV function (EF (EF << 30%) 30%)

andand

• Extensive Myocardium at RiskExtensive Myocardium at Risk

BCIS-1 Jeopardy Score BCIS-1 Jeopardy Score >> 8 8

or...or...Target vessel supplying occluded Target vessel supplying occluded

vessel which supplies >40% of vessel which supplies >40% of

myocardiummyocardium

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

2

2

22

22

Califf et al JACC 1985;5:1055-63

6 Major Coronary 6 Major Coronary SegmentsSegments

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

lesionlesion

2

2

22

22

Jeopardy ScoreBCIS-1Allows LM and Graft Classification

Perera et al AHJ 2009; in press

6 Major Coronary 6 Major Coronary SegmentsSegments

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

lesionlesion

Negative points Negative points for functioning for functioning

graftsgrafts

BCIS-1 Recruitment Completed 21st Jan 09

Total 301 patients

Baseline Characteristics

IABP

N=151

No Planned

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) 0.58Prior CABG (%) 25 (16.6) 20 (13.3) 0.48NYHA 3/4 (%) 99 (66) 108 (72) 0.26CCS 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

N=151

No Planned

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: MACCEto 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 regression1 patient had MI and died; 2 patients had MI and PCI

Kaplan-Meier Survival Estimates for MACCE

P = 0.35

15.3%

14.6%

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

† 2 test * Fisher’s exact test

IABP Use

IABP No PlannedIABP Inserted 147 (98%) 18 (12%)

Reason for Insertion

Randomized Allocation 147 0

Hypotension 0 13

Ventricular Arrhythmia 0 0

Pulmonary Oedema 0 1

Vessel Closure 0 1

Other 0 3

Median duration of use (hrs) 8.63 22.94

(IQR) (6, 23.1) (17.3, 26.4)

K-M 6 month mortality

P = 0.32

7.3%

4.6%

ConclusionsConclusions• 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%)