Women in Interventional Cardiology Strong Position Interventional Cardiology

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Women in Interventional Cardiology: Strong Position Interventional Cardiology (NON-CME) - Sponsored by Abbott (2:

Women in Interventional Cardiology: Strong Position Interventional Cardiology (NON-CME) - Sponsored by Abbott (2: 30 PM – 4: 00 PM) Do We Need Designated Studies for Women in Interventional Cardiology? Alaide Chieffo MD Interventional Cardiology Unit San Raffaele Hospital Milan, Italy

Disclosures Alaide Chieffo MD Lectures fee Abbott, Abiomed, Alvimedica, Biosensor, Terumo

Disclosures Alaide Chieffo MD Lectures fee Abbott, Abiomed, Alvimedica, Biosensor, Terumo

Different Pathophysiology in ACS SCAD (Spontaneous Coronary Artery Dissections) more frequent in young women

Different Pathophysiology in ACS SCAD (Spontaneous Coronary Artery Dissections) more frequent in young women and peri partum

Different Symptoms and Presentation

Different Symptoms and Presentation

Non Obstructive CAD Pts with non obstructive CAD at Coronary Angiography

Non Obstructive CAD Pts with non obstructive CAD at Coronary Angiography

Phase I Female Trials Participants

Phase I Female Trials Participants

Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Device

Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Device Dhruva et al. Circ Cardiovasc Qual Outcomes. 2011; 4: 165 -171

Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Device

Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Device Dhruva et al. Circ Cardiovasc Qual Outcomes. 2011; 4: 165 -171

Women Undertreated and Underrepresented in Clinical Trials Yearly DES Procedure Representation Clinical Trial Representation

Women Undertreated and Underrepresented in Clinical Trials Yearly DES Procedure Representation Clinical Trial Representation 26% 33% Circulation 2013; 127: e 6–e 245. Lancet 2013; 382: 1879– 88

Disparities in Clinical Practice are Mirrored in Clinical Research Women comprise 30% of PCI

Disparities in Clinical Practice are Mirrored in Clinical Research Women comprise 30% of PCI procedures and PCI clinical trial enrollment Gender Representation in PCI Clinical Trials Patients: N=596, 000 National Hospital Discharge Survey/National Center for Health Statistics, 2009 Estimates are based on a sample of inpatient records from short-stay hospitals in the United States. Heart Disease and Stroke Statistics-2012 Update. Circulation. http: //circ. ahajournals. org/content/125/1/e 2 Einstein et al. 2009. “ 4 -Year Follow-Up From the ENDEAVOR II Trial. ” JACC: Cardiovascular Interventions, 2(12): 1178 -87. ; Holmes et al. 2004. “Analysis of 1 -Year Clinical Outcomes in the SIRIUS Trial. ” Circulation, 109: 634 -640; Stone et. al. 2009. “Everolimus-and Paclitaxel-Eluting Stents. ” Circulation, 119: 680 -686. ; Lansky et al. 2005. “Gender Differences After Paclitaxel-Eluting Stents. ” JACC, 45(8): 1180 -5. Morice, MC. 2008. “XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Women’s Health, 4(5): 439 -443.

Need to Action

Need to Action