PCI Complications: Bleeding, Stent Thrombosis, and Restenosis Roxana Mehran, MD Professor of Medicine (Cardiology) Director, Interventional Cardiovascular Research and Clinical Trials Mount Sinai School of Medicine Chief Scientific Officer Cardiovascular Research Foundation Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below Affiliation/Financial Relationship Company • Grant/Research Support • Sanofi/BMS, TMC- • Consulting/ Advisory • Astra Zeneca, Regado Significant Biosciences, Ortho McNeal, Abbott Vascular The Dilemmas During PCI ischemic events bleeding Issues in Pharmacotherapy and PCI: Stent Thrombosis bleeding Bleeding Bleeding: The New Risk Factor Bleeding and Mortality Major Bleeding Hypotension Cessation of ASA/Clop Transfusion Ischemia Stent Thrombosis Inflammation Mortality Bhatt DL In Braunwald EB, Harrison’s Online 2005 Impact of In-hospital Bleeding in ACS 34,146 Pts with ACS in the OASIS-1/2 and CURE Major bleeding occurred in 2.3% of pts Mortality (%) 12 12.8% P5 g/dL fall in hgb Intracranial bleeding Intraocular bleeding Access site bleed requiring intervention ≥ cm hematoma at puncture site Reoperation for bleeding Blood product transfusion ACUITY and HORIZONS Major Bleeding Hgb ⇓ ≥3g/dL with an overt source TIMI Minor Hgb ⇓ ≥4g/dL w/o overt source Retroperitoneal bleeding Gross hematuria or hematemesis Rao AK et al JACC 1988;11:1-11; Stone GW et al NEJM 2006;355:2203-16 Influence of Bleeding Severity within 30 Days After PCI on the Risk of Death Over Year Baseline covariate-adjusted time-updated Cox multivariable model HR (95% CI) Pvalue Attributable deaths within yr TIMI major bleed 4.85 (3.56-6.60)