Redwood Bcis 1
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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 P = 0.01
• 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;145:700-7
P = 0.29
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 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 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
2 points for each lesion + 2 for each territory distal to lesion
2 2
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
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
BCIS-1 Recruitment Completed 21st Jan 09 Total 301 patients
Baseline Characteristics IABP
No Planned
N=151
N=150
p value
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)
Prior CABG (%)
25 (16.6)
20 (13.3)
NYHA 3/4 (%)
99 (66)
108 (72)
CCS 3/4 (%)
72 (48)
68 (45.5)
0.58 0.48 0.26 0.68
58.2 (45.0, 78.6)
60.0 (41.9, 80.0)
0.94
Male (%)
GFR median (IQR)
Inclusion Characteristics IABP
No Planned
N=151
N=150
p value
23.6 (5.2)
23.6 (5.2)
0.99
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%)
Mean E.F. (SD)
BCIS-1 Jeopardy Score Mean (SD)
Procedural Details
Lesions attempted
IABP
No Planned
323
305
Lesions successfully revasc 94.7%
94.1%
0.73 0.40
Mean lesions per patient
2.15
2.05
Vessels attempted
247
244
Mean stents per patient
2.56
2.31
39.3%
43.3%
GP2b3a use
P value
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
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
230 (93.5)
237 (93.3)
0.93
2 (1,5)
2 (1,4)
0.12
6/12 Mortality
All bleeds
Procedural success LOS - mean days (SD) †
χ2 test
* Fisher’s exact test
IABP Use IABP Inserted Reason for Insertion Randomized Allocation Hypotension Ventricular Arrhythmia Pulmonary Oedema Vessel Closure Other Median duration of use (hrs) (IQR)
IABP
No Planned
147 (98%)
18 (12%)
147 0 0 0 0 0
0 13 0 1 1 3
8.63 (6, 23.1)
22.94 (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%)
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 P = 0.01
• 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;145:700-7
P = 0.29
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 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 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
2 points for each lesion + 2 for each territory distal to lesion
2 2
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
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
BCIS-1 Recruitment Completed 21st Jan 09 Total 301 patients
Baseline Characteristics IABP
No Planned
N=151
N=150
p value
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)
Prior CABG (%)
25 (16.6)
20 (13.3)
NYHA 3/4 (%)
99 (66)
108 (72)
CCS 3/4 (%)
72 (48)
68 (45.5)
0.58 0.48 0.26 0.68
58.2 (45.0, 78.6)
60.0 (41.9, 80.0)
0.94
Male (%)
GFR median (IQR)
Inclusion Characteristics IABP
No Planned
N=151
N=150
p value
23.6 (5.2)
23.6 (5.2)
0.99
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%)
Mean E.F. (SD)
BCIS-1 Jeopardy Score Mean (SD)
Procedural Details
Lesions attempted
IABP
No Planned
323
305
Lesions successfully revasc 94.7%
94.1%
0.73 0.40
Mean lesions per patient
2.15
2.05
Vessels attempted
247
244
Mean stents per patient
2.56
2.31
39.3%
43.3%
GP2b3a use
P value
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
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
230 (93.5)
237 (93.3)
0.93
2 (1,5)
2 (1,4)
0.12
6/12 Mortality
All bleeds
Procedural success LOS - mean days (SD) †
χ2 test
* Fisher’s exact test
IABP Use IABP Inserted Reason for Insertion Randomized Allocation Hypotension Ventricular Arrhythmia Pulmonary Oedema Vessel Closure Other Median duration of use (hrs) (IQR)
IABP
No Planned
147 (98%)
18 (12%)
147 0 0 0 0 0
0 13 0 1 1 3
8.63 (6, 23.1)
22.94 (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%)
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