1. Debate: Prophylactic Support Increases Risk With Little Benefit
SCAI 2012
Fall Fellows Course
The Cosmopolitan of Las Vegas
Las Vegas, NV Dec 5th-8th
Debate: Prophylactic Support Increases Risk With Little Benefit
James B. Hermiller, MD, FACC, FSCAI
St Vincent Medical Group
The Heart Center of Indiana
St. Vincent Hospital
Indianapolis, IN

2. Disclosures Consultant: Abbott, St Jude, BSC
Speaker: Lilly, Gore, Medtronic
Research Support: Medtronic, Gore, Abbott, BSC

3. Pantheon of Hemodynamic Support Science
Introduction
Pantheon of Hemodynamic Support Science

4. Introduction

5. Introduction

6. Lions against the Minimalists!!!
Introduction
Lions against the Minimalists!!!

7. Introduction

8. The Argument
Introduction
Elective IABP Use
PROTECT II
Summary

9. BCIS-1 Trial
“Elective IABP insertion did not reduce the incidence of MACCE following PCI. These results do not support a strategy of routine IABP placement before PCI in all patients with severe left ventricular dysfunction and extensive coronary disease.”
JAMA 2010; 304(8):

10. 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

11. 1 patient had MI and died; 2 patients had MI and PCI
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) MI 19
(11.3) 20
(13.3)
0.43
Revasc 4
(1.4)
0.13
Total † 23
14.6 24
15.3
0.35
† Hierarchical
1 patient had MI and died; 2 patients had MI and PCI
* Cox regression

12. 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
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 - median days (IQR)
2 (1,5)
2 (1,4)
0.12
* Prolonged hypotension (MAP<75 for 10 mins or inotropes), VT/VF, arrest
† 2 test/* Fisher’s exact test

13. Major vascular complications occurred in 7 patients (4. 3%; 95% CI, 1
Major vascular complications occurred in 7 patients (4.3%; 95% CI, 1.8%-8.8%) in the IABC plus PCI group and in 2 patients (1.1%; 95% CI, 0.1%-4.0%) in the PCI alone group (P=.09)
“Among patients with acute anterior STEMI without shock, IABC plus primary PCI compared with PCI alone did not result in reduced infarct size.”
Patel, JAMA 2011

14. IABP-SHOCK II Trial
NEJM 2012

15. Primary Study Endpoint (30-Day Mortality)50
Control
41.3% 40
IABP
39.7% 30
Mortality (%) 20
P=0.92 by log-rank test
Relative risk 0.96; 95% CI ; P=0.69 by Chi2-Test 10 5 10 15 20 25 30
Time after Randomization (Days)

16. How About Impella?
Circulation. 2012;126: )

17. How About Impella?
“The primary end point was the 30-day incidence of major adverse events. The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP,P = ”
Circulation. 2012;126: )

18. Major Adverse Events
Not Significant

20. Dredge

21. Dredging the Data

22. Strategies for a Negative Study
Change from intention to treat to as treated or per protocol
Change the endpoint to a time that is positive
Find some good subgroups where therapy works!!
Throw out those where it doesn’t!!!

23. Per Protocol 30 day 90 day IABP Imp IABP Imp Death% 6.2 6.9 9.0 11.6
MI%
Repeat Revasc%

24. Dredging the Data

25. Primary Endpoints not Met
Summary
Prophylactic IABP support has not been shown to be more effective than provisional support
More vascular complications too!!!!
BCIS 1
CRISP AMI
SHOCK II
Primary Endpoints not Met

26. Summary
Prophylactic Impella has not been shown to be more effective than IABP (Vascular complications and bleeding at least as great as IABP)
Primary endpoint not met in PROTECT II
Subsequent subgroup analysis including 90 day event rate, per protocol analysis, temporal improvements in differential efficacy, impact of rotational atherectomy all post hoc and hypothesis generating

27. Conclusions Prophylactic IABP not effective
Prophylactic Impella no more effective than IABP (much more costly $$$$)
Therefore:
Prophylactic Hemodynamic Support Increases Risk With Little Benefit

28. Final Thoughts
Difficult to demonstrate significant benefit of prophylactic support as a strategy – intention to treat
Use support when LV function, complexity of disease, and/or territory at risk suggests support will facilitate the procedure
If I have to think about support more than 5 seconds, I do it

29. Thanks for Your Attention
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