State of the Art in the ACS Atrial Fibrillation Overlap Syndrome

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1 State of the Art in the ACS Atrial Fibrillation Overlap Syndrome C. Michael Gibson, M.S., M.D. Professor of Medicine, Harvard Medical School Chief, Clinical Research, Beth Israel Deaconess CV Division Chairman, PERFUSE Study Group Founder, Editor-In-Chief The World s Open Source Textbook of Medicine Hundreds of Million Viewers Annually Harvard Medical School

2 Disclosure Dr. Gibson has received research grant support and consulting fees in the past from all major manufacturers of antiplatelets and antithrombins This is an educational lecture and is not intended to be an inducement to use any drug or drug in a fashion that is inconsistent with the drug or device label. Rivaroxaban is not approved for use in acute coronary syndromes in the US, but is so in over 50 other countries The slides were prepared by C. Michael Gibson, M.S., M.D. and / or were under the editorial control of C. Michael Gibson, M.S., M.D. Slide by C. Michael Gibson, M.S., M.D.

3 Conflict of Interest Statement Present Research/Grant Funding Angel Medical Corporation Atrium Medical Systems Bayer Corp. Bristol Meyers Squibb Company Ikaria, Inc. Janssen Pharmaceuticals Johnson & Johnson Corporation Lantheus Medical Imaging Medtronic Vascular, Inc. Portola Pharmaceuticals Stealth Peptides, Inc. St. Jude Medical Volcano Corp Walk Vascular Peer to Peer Communications Daiichi Sankyo Company, Inc Eli Lilly and Company The Medicines Company Consultant (all with moderate support) Atrium Medical Systems Baxter Healthcare Boehringer Ingelheim Bristol Myers Squibb Company Cardiovascular Research Foundation CSL Behring Cytori Therapeutics Daiichi Sankyo Company, Inc. Eli Lilly and Company Exeter Group Google, Inc. Navigant St. Jude Medical The Medicines Company Web MD Consultant (with $0.00 monies received by Dr. Gibson) Bayer Corporation Janssen Pharmaceuticals Johnson & Johnson Corporation Ortho McNeil Spouse: Employee of Boston Clinical Research Institute, she has equity position Slide prepared by C. Michael Gibson, M.S., M.D.

4 Incidence of Atrial Fibrillation in ACS Patients 2 % to 21% of ACS Patients 1 Acute Coronary Syndrome ACS + Afib Atrial Fibrillation 1. Schmitt J et al Atrial fibrillation in acute myocardial infarction: a systematic review of the incidence, clinical features and prognostic implications. Eur Heart J 2009;30:

5 WOEST Study Primary Endpoint Incidence of TIMI Bleeding Events Cumulative Incidence of Bleeding (%) Triple therapy group Double therapy group 44.9% HR= % CI p< % Treatment duration (days) N at risk: DeWilde W, et al. ESC Munich, August 28, 2012

6 Cumulative Incidence of Events (%) WOEST Study Secondary Endpoint Incidence of Death, MI, Stroke, Stent Thrombosis & Target Vessel Revascularization Triple therapy group Double therapy group 17.7% HR= % CI p= % 5 0 N at risk: Treatment duration (days) DeWilde W, et al. ESC Munich, August 28, 2012

7 Estimated Cumulative incidence (%) EFFICACY ENDPOINTS: Very Low Dose 2.5 mg BID Patients Treated with ASA + Thienopyridine 12% CV Death / MI / Stroke HR 0.85 mitt p=0.039 ITT p=0.011 Cardiovascular Death Placebo HR 0.62 Placebo HR % 9.0% 5% 5% mitt p<0.001 ITT p< % 2.5% All Cause Death mitt p<0.001 ITT p<0.001 Placebo 4.5% 2.7% Rivaroxaban 2.5 mg BID Rivaroxaban 2.5 mg BID NNT = 71 NNT = Months Months Months 0 24 Rivaroxaban 2.5 mg BID NNT = Rivaroxaban is not approved for use in ACS in Japan Rivaroxaban is approved for ACS by EMEA Gibson CM, AHA 2011

8 Estimated Cumulative Incidence (%) STENT THROMBOSIS ARC Definite / Probable / Possible Placebo 2 Yr KM Estimate 2.9% 2.3% Rivaroxaban (both doses) ARC Definite/probable: HR=0.65, mitt p=0.017, ITT p=0.012 HR 0.69 ( ) mitt p = ITT p = Months After Randomization Rivaroxaban is not approved for use in ACS in Japan Rivaroxaban is approved for ACS by EMEA Gibson CM, AHA 2011

9 Novel Thienopyridines Do Not Block Activation by Thrombin Ex vivo effects of single administration of CS-747 on washed platelet aggregation induced by ADP (A), collagen (B), and thrombin (C) in rats. CS-747 was orally administered once to rats at doses of 0.3 and 3 mg kg 1. The aggregation was measured 4 h after the dosing. Results are presented as the mean±s.e.mean (n=6). ** P<0.01 vs control (vehicle-treated group). Treatment with CS-747 (Prasugrel) inhibited ex vivo washed platelet aggregation in response to ADP but not to thrombin. This is consistent with the hypothesis that the antiaggregative action of CS-747 (Prasugrel) is due to its specific inhibition of the G i -linked P2T receptor rather than its interference with the fibrinogen receptors. Sugidachi A et al; Br J Pharmacol. Apr 2000; 129(7):

10 Rivaroxaban and Ticagrelor Work Synergistically to Inhibit Thrombin Mediated Platelet Aggregation Perzborn et al, J Cardiovasc Pharmacol Ther Apr 6.

11 In-vivo Rat Shunt Thombosis Model: Riva + Clopi as Efficacious as Triple Therapy Figure 3. Effects on thrombus formation after the administration of rivaroxaban 0.1 mg/kg [C], i.v.; ASA (3 The combination of 0.1 mg/kg rivaroxaban plus clopidogrel or the triple mg/kg), clopidogrel (1 mg/kg), or their combination in anaesthetized rats. combination was more effective than ASA plus clopidogrel in reducing thrombin *p<0.05, **p<0.01, ***p<0.001 vs control; #p<0.05 vs rivaroxaban; p<0.01 vs ASA; p<0.05 vs ASA + clopidogrel. formation (52% vs 37% and 51% vs 37%, respectively) Slide by C. Michael Gibson, M.S., M.D. Perzborn et al, J Cardiovasc Pharmacol Ther Apr 6.

12 In-vivo Rat Bleeding Time Model: Riva + Clopi May be Safer Than Triple Therapy Figure 4. Prolongation of bleeding time after administration of rivaroxaban 0.1mg/kg, ASA 3 mg/kg, clopidogrel 1mg/kg or their combination in anesthetized rats Results are presented as mean values ± standard error of the mean. *p<0.05, **p<0.01 versus control; #p<0.05, ##p<0.01 versus rivaroxaban; p<0.05 versus ASA; #p<0.01 versus clopidogrel; - in one animal bleeding time >1800 seconds. Slide by C. Michael Gibson, M.S., M.D. Perzborn et al, J Cardiovasc Pharmacol Ther Apr 6.

13 Bewildering Number of Strategies in the ACS Patient with Atrial Fibrillation ASA Dose: None Low High 2 ASA Duration (mos): Thineopyridine: None Clop Ticlid Pras Ticag 4 Thienopyridine duration (mos): AC: None Warf Dabi Riva Apix Edox 5 AC INR/Dose: Low High = 9 ASA 1+16 = 17 Thieno 1+10 = 11 ACs Permutations of Single, Dual or Triple Therapy as Early Initial Therapy (0,1,3,6 mos) following ACS: 9 X 17 X 11 = 1,683 Permutations of Single or Dual Therapy Late After Early Therapy (0,1,3,6 mos) following ACS: 1,683 Total Permutations throughout one year: 2.8 Million Slide by C. Michael Gibson, M.S., M.D.

14 XARELTO (rivaroxaban) Use in Patients With AF Undergoing PCI: PIONEER AF-PCI 2100 patients with NVAF No prior stroke/tia PCI with stent placement 72 hours After Sheath removal R A N D O M I Z E 1,6, or 12 months XARELTO 2.5 mg bid Clopidogrel 75 mg qd Aspirin mg qd 1,6, or 12 months VKA (target INR ) Clopidogrel 75 mg qd Aspirin mg qd XARELTO 15 mg qd* Clopidogrel 75 mg qd XARELTO 15mg QD Aspirin mg qd VKA (target INR ) Aspirin mg qd End of treatment at 12 months Primary endpoint: TIMI major, minor, and bleeding requiring medical attention Secondary endpoint: CV death, MI, stroke, and stent thrombosis *XARELTO dosed at 10 mg once daily in patients with CrCl of 30 to <50 ml/min. Alternative P2Y 12 inhibitors: 10 mg once-daily prasugrel or 90 mg twice-daily ticagrelor. Low-dose aspirin ( mg/d). Data on File. Janssen Pharmaceuticals, Inc.

15 RE-DUAL PCI: design Assessment of high-risk vs non-high-risk characteristics (bridging therapy at physician s discretion) Screening R n=2840 patients / arm Randomization can occur 72 hours post- PCI Study drug should be administered 6 hours after sheath removal, 72 hours post-pci Dabigatran 150 mg BID + P2Y12 inhibitor Dabigatran 110 mg BID + P2Y12 inhibitor Warfarin (INR ) + P2Y12 inhibitor + ASA Follow-up visits at month 1, 3, 6, 9, 12, and 15; and 18, 24, and 30 postrandomization or end of trial Minimum treatment duration: 6 months 1 EP Slide by C. Michael Gibson, M.S., M.D. BMS = bare metal stent; DES = drug-eluting stent; DAT = dual antithrombotic therapy; ISTH = International Society on Thrombosis and Haemostasis Cannon C. AHA 2013.

16 RE-DUAL PCI: design Dabigatran 150 mg BID + P2Y12 inhibitor Screening R n=2840 patients / arm Dabigatran 110 mg BID + P2Y12 inhibitor Warfarin (INR ) + P2Y12 inhibitor + ASA 1 EP ASA discontinuation: Dabigatran arms: immediately after successful procedure (immediate initiation of DAT) Warfarin arm: 1 month after BMS or 3 months after DES P2Y12 inhibitor can be discontinued after month 12 at physician s discretion Follow-up visits at month 1, 3, 6, 9, 12, and 15; and 18, 24, and 30 postrandomization or end of trial Minimum treatment duration: 6 months Slide by C. Michael Gibson, M.S., M.D. BMS = bare metal stent; DES = drug-eluting stent; DAT = dual antithrombotic therapy; ISTH = International Society on Thrombosis and Haemostasis Cannon C. AHA 2013.

17 RE-DUAL PCI: design Dabigatran 150 mg BID + P2Y12 inhibitor Screening R n=2840 patients / arm Dabigatran 110 mg BID + P2Y12 inhibitor Warfarin (INR ) + P2Y12 inhibitor + ASA 1 EP Dual primary endpoints of efficacy and safety Time to death or first thrombotic event (death, MI, stroke/se) Time to first ISTH major bleeding event Slide by C. Michael Gibson, M.S., M.D. BMS = bare metal stent; DES = drug-eluting stent; DAT = dual antithrombotic therapy; ISTH = International Society on Thrombosis and Haemostasis Cannon C. AHA 2013.

18 Apixaban Versus Warfarin in Patients with AF and ACS or PCI: The AUGUSTUS Trial Inclusion AF (prior, persistent, or >6 hrs duration) Physician decision that oral anticoag is indicated ACS and/or PCI with planned P2Y12 inhibitor for 6 months Apixaban Randomize n =4,600 Patients R Open Label 650 sites, 30 countries Exclusion Contraindication to DAPT Other reason for warfarin (prosthetic valve, mod/sev MS) Warfarin R P2Y12 inhibitor for all patients x 6 months Aspirin for all on the day of ACS or PCI Aspirin versus placebo after randomization ASA Placebo Blinded ASA Placebo R Primary outcome: major/clinically relevant bleeding (through 6 months) Secondary objective: Death, MI, stroke, stent thrombosis

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