1. Female Gender Is An Independent Predictor Of In-Hospital Mortality After STEMI In The Era of Primary PCI. Insights From The Greater Paris Area PCI Registry Hakim Benamer, Muriel Tafflet, Sophie Bataille, Sylvie Escolano, Xavier Mouranche, Jean-Pierre Tresca, Bernard Livarek, Vincent Fourchard, Christophe Caussin, Emmanuel Teiger, Philippe Garot, Yves Lambert, Xavier Jouven, and Christian Spaulding CARDIO-ARHIF Scientific Committee and INSERM U 970, Paris Descartes University, Paris, France

2. Presenter Disclosure Information Christian Spaulding Female gender is an independent predictor of in- hospital mortality after STEMI in the era of primary PCI: Insights from the Greater Paris Area Registry FINANCIAL DISCLOSURE: The Greater Paris Area registry is funded by a French government hospital agency (ARH) UNLABELED/UNAPPROVED USES DISCLOSURE: none

3. Introduction In patients presenting with STEMI, PCI has been shown to significantly improve survival and rescue and adjunctive PCI are effective therapies after thrombolytic therapy Studies of sex differences in mortality after STEMI have consistently indicated that women have higher death rates, especially for short-term follow-ups Although different baseline and procedural characteristics may account for increased mortality, they are not sufficient to explain the discrepancy in outcome. Furthermore, most of these studies were performed before the widespread use of PCI for STEMI

4. Introduction Greater Paris Area Registry: mandatory registry which gathers the clinical and angiographic data on all coronary angiograms and PCIs performed in this region Aim of the study: to determine if female gender is still an independent predictor of mortality in patients with STEMI treated by PCI

5. Methods Population : The Greater Paris area comprises 11 million inhabitants and accounts for 18% of the French population. 42 centers perform PCI. In 2001, the government hospital agency of the Greater Paris area set up a mandatory registry of all PTCAs performed in this region Variables entered: Patients demographics, procedural information, per and post-procedural complications and clinical status at hospital discharge Quality check: Internal and external audits are performed twice a year. Deaths are crossed-checked in another hospital-based data-base (PMSI)

6. French guidelines for AMI The majority of STEMI patients are transported to hospital by a pre-hospital emergency system ambulance with a physician on board French guidelines recommend primary PCI as reperfusion therapy if the transportation time to a catheterization laboratory is less than 45 minutes If the expected transportation time is more than 45 minutes, pre-hospital thrombolytic therapy is administered if no contra-indications are noted In all cases, patients are transported to a PCI capable hospital

7. Outcomes of interest Aim of this study: to examine the relationship between gender and in-hospital outcome in STEMI treated by PCI within 24 hours of onset of chest pain Data entered between 2003 and 2007 in 16 726 procedures was screened for: –STEMI of less than 12 h of duration or STEMI of more than 12 but less than 24 h of duration if the operator considered emergency PCI necessary because of continuous ischemia or complications – cardiogenic shock and/or successfully resuscitated OHCA due to acute coronary artery occlusion In-hospital all-cause mortality rate was chosen as the primary endpoint and independent predictors were assessed

8. Baseline characteristics N Men N=13096 Women N=3664 p Clinical factors Age, years (SD)1672659.3 (13.0)69.7 (14.3)<0.0001 Diabetes Mellitus, n (%)165382016 (15.6)687 (19.0)<0.0001 Cardiogenic shock, n (%)16760522 (4.0)246 (6.7)<0.0001 Reperfusion strategy Primary PCI, n (%) Successful thrombolysis, n (%) Failed thrombolysis, n (%) 1628010496 (82.6) 1254 (9.8) 956 (7.5) 3177 (88.9) 228 (6.4) 169 (4.7) <0.0001

9. Angiographic characteristics N Men N=13096 Women N=3664 p Coronary artery disease extension Coronary lesions <50% One vessel disease (%) Two vessel disease (%) Three vessel disease (%) Left main stenosis (%) 16749 331 (2.5) 5627 (43.0) 4081 (31.2) 3049 (23.3) 421 (3.2) 96 (2.6) 1599 (43.7) 1111 (30.3) 855 (23.3) 136 (3.7) 0.8 0.1

10. Percutaneous coronary intervention data N Men N=13096 Women N=3664 p No Treated lesions mean +/- SD163281.28 (0.60)1.30 (0.61)0.4 Primary success %1632695.994.70.002 No of BMS/patient mean +/- SD163751.15 (0.84)1.14 (0.85)0.9 No of DES/patient mean +/- SD159480.15 (0.47)0.14 (0.46)0.06 PCI of SVG, n (%)16584132 (1.0)28 (0.8)0.2

11. In-hospital all cause mortality and complications N Men N=13096 Women N=3664 p In hospital mortality163584.3 (551)9.8 (350)<0.0001 Vascular complications 165365.4 (708)7.9 (289)<0.001 Transfusion165140.4 (45)1.2 (42)<0.0001 Vascular surgery165140.2 (16)0.2 (7)0.3

12. Independent predictors of mortality by multivariate analysis OR[IC]p Female genderFemale vs Male1.29[1.06 – 1.56]0.01 AgePer year1.06[1.05 – 1.07]<0.0001 Diabetes Mellitus Yes vs no1.54[1.25 – 1.90]<0.0001 Cardiogenic ShockYes vs no19.10[15.48 – 23.58]<0.0001 PCI failureper %0.26[0.18 – 0.35]<0.0001 BMS no BMS vs at least one BMS0.76[0.58 – 1.00]0.05 DES No DES vs at least one DES 0.40[0.26 – 0.61]<0.0001 Left mainYes vs no2.04[1.50 – 2.79]<0.0001 Lesion extension 2 and 3 vessel vs one or none 0.58[0.33 – 1.03]0.06 ThrombolysisFailed thrombolysis vs successful1.80[1.05 – 3.08]0.03

13. In-hospital mortality according to age and gender

14. Limitations To obtain a high rate of patients with complete data, the number of clinical and angiographic variables entered in the database was limited Out of hospital mortality is unknown Analysis of subgroups in registries is limited by the observational nature of the analysis. However, the large number of patients included in our registry limits this potential bias The analysis was limited to patients who were catheterized within 24 hours of an acute myocardial infarction and no data is available on patients who were not reperfused

15. Conclusion Previous studies have demonstrated that female gender was an independent predictor of in-hospital mortality after STEMI However, PCI was not widely used in these registries In our large registry based analysis, in patients treated with PCI for STEMI, female gender was still an independent predictor of in-hospital mortality after STEMI There is a clear need for further studies to explain this difference so that gender inequities in clinical care can be eliminated