redwood bcis 1

8/14/2019 Redwood BCIS 1

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Balloon-pumpassisted

Coronary InterventionStudy

BCIS-1Simon Redwood

Kings College London/ St Thomas Hospital

Steering Committee:Steering Committee:

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


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22

Potential conflicts of interestPotential conflicts of interest

Speakers name:Speakers 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 byThis trial was supported by

unrestricted grants from:unrestricted grants from:

Datascope/ MaquetDatascope/ MaquetEli LillyEli Lilly

CordisCordis


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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


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Elective vs provisional IABP

in high-risk PCI

133 pts EF


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Objectives:Objectives:

To compare the efficacy and safety of elective Intra-AorticTo 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%, =80%, = 5%)Sample Size = 274 pts (predicted MACE 5% vs. 15%, =80%, = 5%)

BBalloon-pump assistedalloon-pump assisted

CCoronaryoronary IInterventionntervention SStudytudy


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LVEF < 30%LVEF < 30%

Jeopardy ScoreJeopardy Score 8 8

Randomize

6 month follow-up

Elective IABPElective IABP

InsertionInsertionNo PlannedNo Planned

IABPIABP

PCI

Remove IABP 4-24 hrs

after PCI

Hospital Follow-upTo discharge or 28 days


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Primary Outcome MeasurePrimary Outcome Measure

Major Adverse Cardiovascular or Cerebral EventsMajor Adverse Cardiovascular or Cerebral Events

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


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Secondary Outcome MeasuresSecondary Outcome Measures

Six month mortalitySix month mortality

Procedural complicationsProcedural 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


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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 andnew Q waves or LBBB

5. Sudden Death Cardiac Arrest with ST elevation/LBBB and/or

evidence of thrombus at autopsy/angiography


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Study Definitions

Prolonged Hypotension 1. Elective IABP

MAP 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


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Inclusion Criteria

Impaired LV functionImpaired LV function (EF(EF > 88

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

vessel which supplies >40% ofvessel which supplies >40% ofmyocardiummyocardium


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Exclusion Criteria

Cardiogenic Shock Systolic BP


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Jeopardy Score

2

2

2

2

2

2

Califf et al JACC 1985;5:1055-63

6 Major Coronary6 Major Coronary

SegmentsSegments

2 points for each2 points for each

lesion + 2 for eachlesion + 2 for eachterritory distal toterritory distal to

lesionlesion


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2

2

2

2

2

2

Jeopardy ScoreBCIS-1Allows LM and Graft Classification

Perera et al AHJ 2009; in press

6 Major Coronary6 Major Coronary

SegmentsSegments

2 points for each2 points for each

lesion + 2 for eachlesion + 2 for eachterritory distal toterritory distal to

lesionlesion

Negative points forNegative points forfunctioning graftsfunctioning grafts


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BCIS-1 RecruitmentCompleted 21stJan 09

Total 301 patients


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Baseline Characteristics

IABPN=151

No PlannedN=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


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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%)


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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%


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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 regression

1 patient had MI and died; 2 patients had MI and PCI


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Kaplan-Meier Survival Estimates for MACCE

P = 0.35

15.3%

14.6%


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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 * Fishers exact test


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IABP Use

IABP No Planned

IABP 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)


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K-M 6 month mortality

P = 0.32

7.3%

4.6%


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ConclusionsConclusions

BCIS have performed the first randomized trial

of elective vs. bailout IABP in patients withpoor LV function and severe coronary disease

We did not find evidence that Elective IABP tosupport high risk PCI is associated with a

reduction in MACCE at hospital discharge

12% in the no-planned group requiredemergency IABP, supporting the important roleof provisional IABP use

Patients with poor LV function and severecoronary disease treated by PCI appear to haveacceptable in-hospital and 6 month mortality(1.3% and 6%)

redwood bcis 1

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