ACC EDUCATIONAL COURSES Feb. 17 – 18 Advancing Cardiovascular Care of the Oncology Patient Park Hyatt Washington Washington, DC Course Directors: Ana Barac, MD, PhD, FACC Bonnie Ky, MD, FACC ACC.org/Cardio-OncologyCourse Feb. 20 – 24 Big Sky Cardiovascular Update: Practical Applications in Clinical Cardiology The Huntley Lodge Big Sky, MT Course Directors: Kim A. Eagle, MD, MACC Patrick T. O’Gara, MD, MACC ACC.org/BigSky2017 March 13 – 15 NCDR Annual Conference Gaylord Resort and Convention Center Washington, DC ACC.org/NCDR17AnnualConference March 17 – 19* ACC’s 66th Annual Scientific Session & Expo Walter E. Washington Convention Ctr. Washington, DC Course Directors: Jeffrey T. Kuvin, MD, FACC Andrew M. Kates, MD, FACC accscientificsession.org CE 11.25 CME 11.25 CE CME CE CME * Note new days for 2017 only TRITON-TIMI 38: GREATER REDUCTIONS IN THROMBOTIC CV EVENTS AND STENT THROMBOSIS WITH EFFIENT + ASA VS CLOPIDOGREL + ASA* Thrombotic CV events (primary composite of CV death, nonfatal MI, nonfatal stroke) relative risk reduction (RRR) in STEMI-PCI patients was 21% through 450 days (9.8% Effient + ASA vs 12.2% clopidogrel + ASA, P =0.02) 1 — RRR was 30% through 7 days (5.5% Effient + ASA vs 7.8% clopidogrel + ASA, P =0.008) and 32% through 30 days (6.5% Effient + ASA vs 9.4% clopidogrel + ASA, P =0.002) 2,3 Difference in treatments was primarily driven by a significant reduction in nonfatal MIs, with no significant difference in CV death or nonfatal stroke 1 — In the overall study population, approximately 40% of MIs occurred periprocedurally and were detected solely by changes in CK-MB Stent thrombosis (secondary endpoint) RRR in ACS-PCI patients was 52% through 450 days (1.1% Effient + ASA vs 2.2% clopidogrel + ASA, P < 0.0001) 4 Stent thrombosis RRR in STEMI-PCI patients was 42% through 450 days ( 1.6% Effient + ASA vs 2.8% clopidogrel + ASA, P =0.02) 5 SELECTED SAFETY: EFFIENT INCREASED THE RISK OF TIMI MAJOR OR MINOR BLEEDING VS CLOPIDOGREL Effient can cause significant, sometimes fatal, bleeding. Overall rates of non-CABG TIMI major or minor bleeding were significantly higher with Effient + ASA (4.5%) compared with clopidogrel + ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient + ASA and 0.1% with clopidogrel + ASA. In patients who underwent CABG (N=437), the rates of CABG-related TIMI major or minor bleeding were 14.1% with Effient + ASA and 4.5% with clopidogrel + ASA *In TRITON-TIMI 38, the LD of clopidogrel was delayed relative to the placebo-controlled trials that supported its approval for ACS. 1 Effient is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:  patients with unstable angina (UA) or non–ST-elevation myocardial infarction (NSTEMI);  patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. The loading dose (LD) of Effient is 60 mg and the maintenance dose (MD) is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets. IMPORTANT SAFETY INFORMATION WARNING: BLEEDING RISK Effient ® (prasugrel) can cause significant, sometimes fatal, bleeding. Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke. In patients ≥ 75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered. Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery. Additional risk factors for bleeding include: body weight < 60 kg propensity to bleed concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs]) Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient. If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events. Please see Brief Summary of Prescribing Information, including Boxed Warning regarding bleeding risk, on subsequent pages. CONTRAINDICATIONS Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product WARNINGS AND PRECAUTIONS Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure ( < 2 weeks), and requires urgent treatment, including plasmapheresis Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction TRITON-TIMI 38 TRIAL DESIGN TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg LD followed by a 10-mg once-daily MD) plus aspirin (ASA) with clopidogrel (300-mg LD followed by a 75-mg once-daily MD) plus ASA in 13,608 patients with ACS managed with PCI (median duration 14.5 months). 1,6 References: 1. Effient ® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company. 2. Data on file: #EFF20130920a: DSI/Lilly. 3. Data on file: #EFF20080929c: DSI/Lilly. 4. Data on file: #EFF20091204b: DSI/Lilly. 5. Data on file: #EFF20100129c: DSI/Lilly. 6. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. N Engl J Med . 2007;357:2001-2015.