1. Jeff Macemon Waikato Cardiothoracic Unit
Coronary-Artery Bypass Surgery in Patients with Ischaemic Cardiomyopathy (STICHES) Surgical Treatment for Ischaemic Heart Failure Extended Study
Jeff Macemon
Waikato Cardiothoracic Unit

2. Background
“Coronary artery disease is the most common substrate for heart failure in industrialised nations.”
CABG has been evaluated for its roll in Angina and MI
Many of these studies excluded patients with significant LV impairment
STITCH was designed to evaluate the role of CABG in patients with coronary artery disease and LV systolic dysfunction.
Hypothesis: CABG plus intensive medical treatment (compared to medical treatment alone) would reduce mortality. 

4. STICH 5 year outcome

5. STICH, death from any cause

6. Stich, composite outcome

7. stich Hazard ratio for primary outcome with CABG 0.70 (P<0.001)
In the “as treated” analysis

9. STICHES Following the data set from STICH 10 year outcomes
CABG + Medical therapy vs Medical therapy alone
Ongoing hypothesis “CABG plus Medical therapy would reduce mortality compared to medical therapy alone”

10. Methodology

11. Methods Multicenter Non-blinded Randomised
127 Clinical sites in 26 Countries or
99 Clinical sites in 22 Countries

12. Methods – Inclusion Criteria
Coronary artery disease amendable to CABG
LV Ejection Fraction < 35%
(determined at each enrolling site)
> 18 years of age

13. Methods – Exclusion Criteria (from supplementary appendix – STICH)
LMS > 50%
ACS
Recent MI or cardiogenic shock in prev 72 hours
Prev CABG
Aortic valvular disease requiring surgery
High risk for operative mortality
Prev heart, Kidney, Liver, or Lung transplantation
Life expenctancy < 3 years
Poor medical adherence
Childbearing potential

14. Additional exclusion criteria (from supplementary appendix – STICHES)
Failure to provide informed consent
Plan for percutaneousintervention of CAD
Recent acute MI judged to be an important cause of LV dysfunction
History of more than 1 prior coronary bypass operation

15. Study Protocol – surgical conduct
Patients randomised via an interactive telephone voice response system
Those assigned to undergo CABG, within 14 days from randomisation
Pre-approved CABG Surgeons
Provided evidence of >5% mortality with similar patient risk profile
Follow up evaluations at discharge, 30 days, 4 monthly for 1 year, 6 monthly thereafter

16. Study protocol – Medical therapy
Lead Cardiologist at each centre responsible for recommending the most appropriate medications and devices based on current guidelines
A Medical therapy committee monitored adherence to guidelines

17. Methods – Endpoints Primary: Secondary:
Death from any cause
Secondary:
death from cardiovascular cause
death from any cause or hospitilisation for cardiovascular cause
death from any cause or Hospitilisation for heart failure
Death from any cause or revascularisation
…. Or non fatal MI
….. Or non fatal stroke

18. Statistical analysis
Initially estimated sample of 2,000 followed for 3 years
90% power to detect a 25% reduction in mortality
Slow enrolment  modified design
Sample size reduced, follow up increased
1,200 patients followed for 5 years
Given lack of definite difference, further funding for 10 years followup
Allowed for up to 20% crossover without reducing power
INTENTION TO TREAT ANALYSIS

19. Results

20. Results 1212 Patients 99 Clinical centres 22 Countries
July 2002 – May 2007
Median followup 9.8 years
97.9% followup complete

27. Results (Tables and Diagrams)

28. Author’s Conclusion
The results of the STICH Extended Study support a significant benefit of CABG plus medical therapy over medical therapy alone
With respect to death from any cause
Among patients with ischaemic cardiomyopathy

29. Discussion

30. Strengths of the study Initial study design appears solid
Able to show a difference in outcome in both intention to treat and as treated

31. Limitations of the study
Dubious statistics with additional 5 years of followup
May have been some data trolling to find further significant outcomes