PCI in Women versus Men: Is it really different?

1. PCI in Women versus Men: Is it really different? David J. Clark Director of Interventional Research Austin Health Melbourne, Australia On behalf of the MIG Investigators

2. DISCLOSURE STATEMENT: The presenter has advised that the following presentation will NOT include discussion on any commercial products or services The Melbourne Interventional Group gratefully acknowledges funding from Abbott, Aspen Pharmacare, Astra-Zeneca, Biotronik, Boston Scientific, Bristol-Myers Squibb, Cordis Johnson & Johnson, CSL, Medtronic, MSD, Pfizer, Sanofi-Aventis, Servier, and Schering-Plough. These companies do not have access to data and do not have the right to review manuscripts or abstracts before publication. Acknowledgements / Disclosures

3. Overview : Aim To compare outcomes of women compared to men undergoing PCI utilizing a large, multi-centre Australian registry (MIG Registry) • ACS • Non – ACS (stable CAD)

4. Background : ACS in Women • Randomized studies comparing medical therapy with revascularization in non-ST-elevation ACS have differed in their results with respect to outcomes in women (TACTICS TIMI 18, RITA 3, FRISC II) • In randomized studies of primary PCI for ST elevation MI (STEMI), women benefit over thrombolysis but may have higher MACE than men (CADILLAC) • A recent authoritative review of the effects of gender on outcome following PCI recommended selective use of PCI in women, particularly for ACS. Glaser R, et al. JAMA 2002;288:3124–9 Lagerqvist B et alJ Am CollCardiol2001;38(1):41–8. Lansky AJ et al. Circulation 2005;111(13):1611–8. Jacobs AK. Circulation 2009;2(1):69–78.

6. 2,953 Consecutive patients undergoing PCI for ACS from the MIG registry

7. Bleeding Definition : The bleeding should require a transfusion and/or prolong the hospital stay and/or cause a drop in haemoglobin > 3.0 gm/dl.

9. ACS : Multivariate Analysis: OR (95% CI) Women • 30 day mortality : 1.70 (0.98 -2.99) • 30 day MACE : 1.45 (1.04 – 2.02) • 12 month mortality : 0.91 (0.59 – 1.39) • 12 month MACE : 1.04 (0.81 – 1.34) • In-hospital bleeding : 4.37 (2.0–9.56)

10. Conclusion : ACS in Women In this study: • After adjustment for their greater co-morbidities, women with ACS undergoing PCI had higher adjusted rates of bleeding and 30 day MACE • One year after their revascularization for ACS, women have similarly low event rates as men.

11. Background 2013 ESC Guidelines for stable CAD Section 9 : Special groups or considerations 9.1 Women “…..it may be prudent to adopt a more conservative approach in undertaking PCI and CABG in women.” European Heart Journal, August 30, 2013, page 46

12. Methods • 5704 consecutive non ACS patients treated with PCI were identified between April 2004 and July 2013 from the Melbourne Interventional Group (MIG) registry. • There were 4,332 (76%) men and 1373 (24%) women • The baseline clinical and procedural characteristics, in hospital complications, and 30 day / 12 month death, MI, TVR, MACE were compared between women and men. • Multivariate logistic regression analysis was used to determine independent predictors of bleeding, 12 month mortality, MACE.

13. Stable CAD: Background Characteristics

14. Stable PCI: Procedural Characteristics

15. Stable CAD : In-hospital complications

16. 30 dayOutcomes P=0.80 % P=0.41 P=0.60 P = 0.02

17. 1 year Outcomes P=0.36 % P=0.58 P = 0.006 P=0.22

18. Stable CAD : Multivariate Analysis: OR (95% CI) Women • 12 month mortality : 1.76 (1.11 – 2.77) • 12 month MACE : 1.14 (0.94 – 1.39) • In-hospital bleeding : 2.41 (1.50 – 3.86) (Other independent predictors in-hospital bleeding: age, PVD, 2B3A Inhibitors, No reflow)

19. Stable CAD : Study Limitations • Although large, multi-centre registry, number of deaths small (non ACS) • Observational data, may not be able to adjust all important variables (frailty, occult disease – eg malignancy) • Long term follow up to 5 years would help (NDI)

20. Conclusion : Stable CAD • In this recent study of non – ACS (stable CAD) population, incidence of in-hospital, 30 day, and 12 month adverse outcomes is low in both men and women, and mortality is very low • However, women remain at a significantly increased risk of bleeding and mortality (in-hospital and 12 month)

21. Conclusion: Clinical Implications • In the setting of ACS, gender should not affect the decision to offer PCI, but effort to minimize procedural bleeding is required. • In stable coronary disease, cardiologists should take into account the small but significantly increased risk of bleeding and mortality when discussing the benefits and hazards of PCI with their female patients.

22. Melbourne Interventional Group Investigators: Alfred Hospital: SJ Duffy, JA Shaw, A Walton, R Johnston, A Dart, A Broughton, J Federman, C Keighley, C Hengel, KH Peter, W Chan, D Stub, W Childs, R Sharma, B Ryan Austin Hospital: DJ Clark, O Farouque, M Horrigan, J Johns, L Oliver, J Brennan, R Chan, G Proimos, T Dortimer, B Chan, V Nadurata, R Huq, D Fernando, A Tonkin, K Charter, L Brown, A Sahar, M Freeman, M Mok, A Al-Fiadh, M Wong, T Lancefield Box Hill Hospital: G New, L Roberts, M Rowe, G Proimos, Y Cheong, C Goods, D Fernando, R K Munnan, S Sidharta, C Shields, J Beale Frankston Hospital: R Lew, G Szto, R Teperman, R HuqGeelong Hospital: A Black, M Sebastian, T Yip, C Hiew, J Dyson, T Du Plessis, B McDonald, L Duff Monash University: H Krum, C Reid, N Andrianopoulos, A Brennan, P Loane, L Curran, A Finlay, D Dinh, M HuqNorthern Hospital: W VanGaal, P BarlisRoyal Melbourne Hospital: AE Ajani, R Warren, D Eccleston, J Lefkovits, BP Yan, R Iyer, W Wilson, R Gurvitch, M Watts, A Sharifi Western Hospital: Y-L Lim, D Eccleston, A Walton.