How to Minimize Bleeding in STEMI Patients Outline: -Know about bleeding -Think about consequences of bleeding -Identify bleeding risk factors -Maximize risk : benefit Steven V. Manoukian, M.D., F.A.C.C., F.S.C.A.I. Vice President and Medical Director of Cardiovascular Services Hospital Corporation of America (HCA) Nashville, Tennessee Disclosures: COI-none, Off Label-yes

I/we have no real or apparent conflicts of interest to report. Steven V. Manoukian, MD I/we have no real or apparent conflicts of interest to report.

Rates of PCI Bleeding: NCDR 2010-11 PCI Patients Without STEMI (n=787,980) PCI Patients With STEMI (n=153,268) CathPCI Bleeding: (1) occurring at percutaneous entry site, during or after cath lab visit until dc, may be external or hematoma >10 cm femoral, >5 cm brachial, or >2 cm radial; (2) retroperitoneal; (3) GI; (4) GU; and (5) other/unknown during or after cath lab visit until dc. All bleeding events required transfusion, prolonged stay, and/or drop in Hgb >3.0 g/dL. Dehmer GJ et al. JACC 2012.

Types of CCL Bleeding: NCDR 2010-11 Dehmer GJ et al. JACC 2012.

Impact of Bleeding on Mortality (ACS) Manoukian SV, Feit F, Mehran R, et al. J Am Coll Cardiol 2007;49:1362-8.

Severity of Bleeding and Impact on Mortality (R2, ACUITY, HORIZONS) Mehran R et al. JACC INTV 2011.

Patient Risk Factors for Bleeding (ACS) Manoukian SV, Feit F, Mehran R, et al. J Am Coll Cardiol 2007;49:1362-8.

Bleeding Risk Score (R2, ACUITY, HORIZONS) Mehran R et al. JACC INTV 2011.

Bleeding Risk Score (R2, ACUITY, HORIZONS) Mehran R et al. JACC INTV 2011.

Bleeding Risk Score (NCDR) Ahmed B and Dauerman HL. Circulation 2013.

PCI Anticoagulation Use 2010-11 (NCDR) Dehmer GJ et al. JACC 2012.

HCA Anticoagulation Use: Abciximab, Eptifibatide, Tirofiban and Bivalirudin Percentage of Overall Dollars (Estimates) Abciximab 7% Bivalirudin 59% Eptifibatide 34% Tirofiban <1%

PCI Bleeding and Pharmacology in STEMI HORIZONS 30-Day Endpoints Stone GW et al. NEJM 2008.

PCI Bleeding and Pharmacology Across Presentations 30-Day: REPLACE-2, ACUITY-PCI, HORIZONS ITT STEMI ACS PCI Adapted from REPLACE-2, ACUITY-PCI, HORIZONS ITT.

Avoidance of Excess Pharmacology Dosing Alexander KP, et al. JAMA 2005;294:3108-3116.

Avoidance of Excess Pharmacology Duration in PCI Shortened Course of Glycoprotein IIb/IIIa Inhibition BRIEF-PCI Trial Fung AY et al. JACC 2009.

Avoidance of Excess Pharmacology Duration in PCI Shortened Aggrastat vs. Integrilin in PCI SAVI-PCI Trial 600 patients undergoing elective or ACS PCI in approximately 20 U.S. centers Tirofiban 1-2 hour infusion 25 mcg/kg + 0.15 mcg/kg/min Eptifibatide 12-18 hour infusion Standard Dosing Endpoints: Death, MI, UR or bleeding at discharge or 48 hours, whichever comes first. Hypothesis: Efficacy will be maintained with a 50-75% reduction in bleeding and transfusion. Manoukian SV et al. http://clinicaltrials.gov/ct2/show/NCT01522417?term=savi-pci&rank=1.

FABOLUS PRO: Prasugrel vs. Tirofiban in STEMI Valgimigli M et al. JACC INTV 2012.

Non-Pharmacologic Approaches to Bleeding: Access Site Utilization 2010-11 (NCDR) Dehmer GJ et al. JACC 2012.

Non-Pharmacologic Approaches to Bleeding: r-PCI Success and Complication Rates Rao SV et al. JACC Intv 2008;1:379-86.

Non-Pharmacologic Approaches to Bleeding: Vascular Closure Devices Major ASB = Hgb drop >3, RP bleed, ASB operation, hematoma >5cm. Sanborn TA, Ebrahimi R, Manoukian SV et al. Circ Cardiovasc Interv 2010;3:57-62.

Comprehensive Approaches to Bleeding: Individualized ePRISM Informed Consents Courtesy, Spertus JA.

Conclusions Know about bleeding Think about consequences of bleeding Rates increase with STEMI Half are access site-related Think about consequences of bleeding Associated with mortality, adverse outcomes Linked to cost, LOS, readmission Identify bleeding risk factors Especially age, sex, renal, anemia, presentation Perform individualized baseline assessment Do maximize risk : benefit Pharmacologic: drug, dose, duration Non-pharmacologic: site, size, VCD, IABP