1. Stent or Surgery: What is Best for a Woman ? Dr R H Stables Cardiothoracic Centre Liverpool UK

2. Conflict of Interest I am (or at one time was) a man

3. Understanding the Problem

4. Cardiovascular Disease - The Facts 3 million UK residents have coronary disease Effective treatment and prevention strategies exist Kills 3 times as many women as cancer Causes one quarter of all early death

5. Medical Advice: Not Consistently Helpful

6. Background: Coronary Artery Disease in Women Initial presentation at an older age Natural history of disease process Systematic failure of early recognition More frequent acute event presentations More advanced patterns of disease Risk factor profiles - Increased co-morbidity Smaller body surface area Coronary vessels of smaller calibre

7. Background: Coronary Artery Disease in Women Female patients under-represented in clinical trials Major cardiovascular drug classes Revascularisation Compounds problems with generalisation of trials Undermines the evidence base May lead to use of inappropriate treatments Increases reliance on observational studies Compromised by bias (recognised or covert)

8. Coronary Artery Bypass Surgery Surgical results - improved over the last 20 years Majority of additional risk explained by Age and more advanced disease patterns Conventional risk factors and co-morbidity Excess, unexplained gender risk persists EUROSCORE surgical risk calculations

9. EUROSCORE Surgical Risk Calculator 60 Years Stable angina Good LV No Risks Logistic Mortality: Male 0.94% Female 1.3% 60 Years Unstable angina Poor LV No Risks Logistic Mortality: Male 4.77% Female 6.51%

10. CABG in Female Patients Smaller coronary arteries - technical difficulties Also affects choice of graft conduit Less IMA pedicle grafting Smaller radial arteries Younger patients may be particularly affected

11. CABG in the Younger Female Patient Circulation 2002;105:1176-1181

12. Greater Mortality Difference in Younger Patients

13. CABG in Female Patients Smaller coronary arteries - technical difficulties Also affects choice of graft conduit Less IMA pedicle grafting Smaller radial arteries Younger patients may be particularly affected Higher rates of ‘surgical morbidity’

14. Surgical Morbidity in Female Patients

15. PCI in the Female Patient No additional mortality - beyond conventional risk May be associated with an increased MACCE rate NWQIP risk model for in-hospital MACCE Odds ratio 1.58 (1.08 - 2.33, p = 0.019)

16. PCI in the Female Patient Observational studies suggest ↓ BMS restenosis Seems odd - smaller vessels, more diabetes ? Protective effect of oestrogen Selection bias At time of revascularisation Quality of follow-up Willingness to re-intervene DES efficacy confirmed in female patients

17. PCI in the Female Patient Increased vascular complications Most marked with big sheathes / adjunctive kit Smaller peripheral vessels More frequent peripheral vascular disease Reduced availability of the radial (small size?) CTC Liverpool 2005 4 operators All PCI Radial access access for procedure Male 94% Female 90.4%

18. PCI v CABG: Randomised Studies SYNTAX awaited Previous generation trials - limited female numbers ARTS Females 23% SoS Females 21% Higher risk profile eg SoS Age > 65 Male 37% Female 53% Unstable pres n Male 19% Female 26% NYHA III / IV Male 26% Female 66%

19. Substudy From The ‘Stent or Surgery’ Trial (SoS) Am J Cardiol 2004;93:404-409

20. PCI v CABG: SoS Substudy No male - female differences in LIMA grafts Total number of grafts created Number of PCI lesions attempted Number of PCI lesions revascularised Stent rates No statistical power for mortality or MACE Analysis of angina symptoms and QoL

21. QoL Outcomes Magnitude of improvement in QoL compared to baseline PCI CABG Both improve with revasc BUT Men get more improvement than women CABG gives more gain than PCI - except at 1 year in women

22. Conclusions Revascularisation procedures in women are Being performed in increasing numbers Have better outcomes than historic controls CABG and PCI outcomes less good than in males Not fully explained by natural history and risk Scope for advances in therapy to close gap Urgent need to improve evidence base - research PCI attractive option - anatomy dependent Only when high quality revasc is possible

23. Questions and Discussion