Cangrelor: Is it the new CHAMPION for PCI? Robert Barcelona, PharmD, BCPS Clinical Pharmacy Specialist, Cardiac Intensive Care Unit November 13, 2015

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1 Cangrelor: Is it the new CHAMPION for PCI? Robert Barcelona, PharmD, BCPS Clinical Pharmacy Specialist, Cardiac Intensive Care Unit November 13, 2015

2 Objectives Review the pharmacology and pharmacokinetic parameters of cangrelor Evaluate clinical trials where cangrelor has been investigated Describe situations where cangrelor may be utilized 2

3 Epidemiology In United States > 400,000 die of coronary artery disease > 1,000,000 suffer acute coronary syndromes (ACS) ~ 600,000 procedures performed/year in United States Cost are projected to triple to over $800 billion by 2030 Recent approved therapies aimed at reducing events rates Arbab-Zadeh A. Circulation 2012;125: Brilakis ES. JAMA 2013;310:

4 Pathophysiology of Acute Coronary Syndromes Unstable Plaque Plaque Rupture Thrombus Formation Incomplete / Transient Occlusion Complete Occlusion USA / Non STEMI STEMI Davies MJ. Heart 2000;83:

5 Plaque Composition: Treatment Targets Cholesterol Platelets Other treatment targets Vasodilators Decrease O 2 demand Increase O 2 supply Thrombin 5

6 Platelet Activation Vorapaxar PAR-1 Thrombin Dipyridamole Adenosine Thromboxane A 2 Platelet Serotonin Collagen ADP 2Y12 Epinephrine Aspirin Cangrelor Clopidogrel Prasugrel Ticagrelor Ticlopidine GP IIb/IIIa Abciximab Eptifibatide Tirofiban Fibrinogen Platelet Hall R. Anesth Analg 2011;112: Ther Adv Cardiovasc Dis 2012; 6:

7 PCI Pharmacotherapy Over Time Heparin Heparin + GP IIb/IIIa Bivalirudin + P2Y 12 inhibitors Bivalirudin + more potent P2Y 12 inhibitors 7

8 Current Oral P2Y 12 Antiplatelets Drug Clopidogrel (Plavix ) Prasugrel (Effient ) Ticagrelor (Brilinta ) Ticlopidine (Ticlid ) PCI Use Decrease rate of a combined end point of cardiovascular death, MI, or stroke, as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia in patients with non-st-segment elevation ACS Reduction of thrombotic events cardiovascular events (including stent thrombosis) in patients with ACS who are to be managed with percutaneous coronary intervention (PCI) Reduces rate of stent thrombosis in patients who have been stented for treatment of ACS. To reduce incidence of subacute stent thrombosis in patients undergoing coronary stent implantation 8

9 Current Oral P2Y 12 Antiplatelets: Pharmacokinetics Drug Onset Offset Clopidogrel 2 12 hours depending on dose given Duration of platelet since irreversibly binds (~ 5 7 days) Prasugrel 1 4 hours Duration of platelet since irreversibly binds (~ 5 7 days) Ticagrelor 2 hours Reversibly binds to platelet (~ 3 5 days) Ticlopidine 6 hours Duration of platelet since irreversibly binds (~ 5 7 days) Hall R. Anesth Analg 2011;112:

10 Antiplatelet Clinical Trials: Clinical Complications Events (%) ISIS-2 (1988; ASA vs. Placebo) CURE (2001; ASA + Clopidogrel vs. ASA) TRITON (2007; Prasugrel vs. Clopidogrel) PLATO (2009; Ticagrelor vs. Clopidogrel) Death: Active therapy Death: Std. therapy MI: Active therapy MI: Std. therapy ISIS-2. Lancet 1988;8607: Yusuf S. N Engl J Med 2001;345: Wiviott SD. N Engl J Med 2007;357: Wallentin L. N Engl J Med 2009;361:

11 Antiplatelet Clinical Trials: Bleeding Complications 6 Events (%) CURE (2001; ASA 100mg vs. ASA + Clopidogrel) CURE (2001; ASA vs. Clopidogrel vs. ASA mg) CURE (2001; ASA vs. Clopidogrel + ASA 200mg) TRITON (2007; Clopidogrel vs. Prasugrel) PLATO (2009; Clopidogrel vs. Ticagrelor) Major bleeding: Active therapy Major bleeding: Std. therapy Peters RJ. Circulation 2003;108: Wiviott SD. N Engl J Med 2007;357: Wallentin L. N Engl J Med 2009;361:

12 Limitations of Current P2Y 12 Inhibitors Genetic differences may lead to less response with clopidogrel Variability in onset and duration of agents Increased bleeding Image displays two 300 mg clopidogrel tablets in stomach Ghobrial J. J Invasive Cardiol 2015;27:E

13 Cangrelor (Kengreal ) Indication: Adjunct to PCI for reducing the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor Pharmacology: P2Y 12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation Binds selectively and reversibly to the P2Y 12 receptor Platelet inhibition within 2 minutes after administration of a 30 mcg/kg IV bolus followed by a 4 mcg/kg/min IV infusion Platelet function normalizes within 1 hour after discontinuation of infusion 13

14 Cangrelor Pharmacokinetics Linear pharmacokinetics, rapidly distributed and metabolized C max within 2 minutes after IV bolus followed by infusion Volume of distribution: 3.9 L Plasma protein binding: is 97-98% Deactivated rapidly in circulation by dephosphorylation Approximately 60% recovered in urine and 35% in feces Average elimination half-life: 3-6 minutes. 14

15 Cangrelor Dosing 30 mcg/kg IV bolus (using actual weight) followed by a 4 mcg/kg/min continuous infusion Continuous infusion lasts duration of procedure or for 2 hours, whichever is longer Patients weighing >100 kg will require 2 vials 15

16 Adverse Effects and Drug Interactions Adverse effects: Bleeding Dyspnea Drug Interactions: Clopidogrel: 600 mg immediately after cangrelor discontinuation Prasugrel: 60 mg immediately after cangrelor discontinuation Ticagrelor: 180 mg at any time during or immediately after discontinuation 16

17 CHAMPION Trials Clinical Trial CHAMPION PCI (N=8,716) CHAMPION PLATFORM (N=5,362) CHAMPION PHONEIX (N=11,145) Study Design Prospective, randomized controlled trial, double-blind, double-dummy, active control, parallel group Cangrelor vs. oral loading dose of 600 mg clopidogrel within 30 minutes BEFORE PCI Prospective, randomized controlled trial, double-blind, double-dummy, active control, parallel group Cangrelor vs. oral loading dose of 600 mg clopidogrel oral (clopidogrel given at END of PCI) Prospective, randomized controlled trial, double-blind, double-dummy, active control, parallel group Cangrelor vs. oral loading dose of mg clopidogrel (clopidogrel given at BEFORE or DURING/WITHIN 1 HOUR of PCI completion per physician) 17

18 CHAMPION PCI (N=8,716) Patients: stable angina, unstable angina, STEMI, or NSTE ACS were scheduled to undergo PCI Excluded: received fibrinolytic agent, GPIIb/IIIa inhibitor within 12 hours, or clopidogrel greater than 75 mg/day in previous 5 days Primary endpoint: composite of death from any cause, MI, or ischemia-driven revascularization (IDR) at 48 hours Cangrelor (%) Clopidogrel (%) Age Male NSTEMI STEMI Unfractionated heparin Bivalirudin GP IIb/IIIa inhibitors Harrington RA. N Engl J Med 2009;361:

19 CHAMPION PCI Results Cangrelor (%) Clopidogrel P value Death/MI/IDR MI IDR Stent thrombosis Access site bleeding ACUITY criteria Minor GUSTO criteria Mild RBC transfusion

20 CHAMPION PLATFORM (5,362) Patients: at least 1 atherosclerotic lesion eligible for PCI with or without stent implantation, and evidence of either MI without ST-segment elevation or unstable angina Primary endpoint: Composite of death, MI, or ischemia-driven revascularization 48 hours after PCI in modified ITT population (randomized and received at least 1 dose) Cangrelor (%) Clopidogrel (%) Age Male NSTEMI Unstable angina Unfractionated heparin Bivalirudin GP IIb/IIIa inhibitors Bhatt D. N Engl J Med 2009;361:

21 CHAMPION PLATFORM Results Cangrelor (%) Clopidogrel P value Death/MI/IDR MI IDR Stent thrombosis Access site bleeding ACUITY criteria Minor Major <0.001 GUSTO criteria Mild <0.001 RBC transfusion

22 CHAMPION PHOENIX (N=11,145) Patients: coronary atherosclerosis who required PCI for stable angina, NSTE ACS, or STEMI Excluded: prior treatment with P2Y 12 inhibitors or abciximab at least 7 days before randomization; or eptifibatide, tirofiban, or fibrinolytic therapy at least 12 hours before randomization Primary endpoint: composite of death from any cause, MI, ischemia-driven revascularization, or stent thrombosis in the 48 hours after randomization Cangrelor (%) Clopidogrel (%) Age Male Stable angina NSTE-ACS STEMI Unfractionated heparin Bivalirudin GP IIb/IIIa inhibitors Bhatt DL. N Engl J Med 2013;368:

23 CHAMPION PHOENIX Results Cangrelor (%) Clopidogrel P value Death/MI/IDR/ST MI IDR Stent thrombosis Access site bleeding ACUITY criteria Major Minor <0.001 <0.001 GUSTO criteria Severe/moderate Blood transfusion

24 Differences in CHAMPION Trials PCI/PLATFORM Patient population 70% Troponin elevated at baseline Clopidogrel maintenance (PCI only) PCI required w/ following: o STEMI: safety only (PCI) o NSTEMI: Tn elevated o UA: ECG changes & pain & age/diabetes o Stable angina: capped (15%) PHOENIX Assume 35% Troponin elevated at baseline P2Y 12 inhibitor naïve Comparator 600 mg clopidogrel 300 (25.6%) or 600 mg (74.4%) Endpoint Primary: death/mi/idr at 48 hour Primary: death/mi/idr at 48 hour MI definition Reliance on cardiac markers alone to define PCI MI Universal definition of MI: reliance on cardiac markers and other evidence of ischemia to define PCI MI 24

25 Summary of PCI Clinical Trials Modest benefit compared to clopidogrel Clopidogrel administration varied between trials More use of GP IIb/IIIa inhibitors in initial trials Variety of anticoagulation strategies used More potent oral P2Y 12 inhibitors not studied against cangrelor 25

26 BRIDGE (N=207) Patients: patients who planned to undergo nonemergency coronary artery bypass grafting (CABG) surgery who had received at least 500 mg of ticlopidine, 75 mg of clopidogrel, or 10 mg of prasugrel within 72 hours prior to randomization Primary endpoint: Stage 1: dose finding study to show maintenance of platelet inhibition above 60% in at least 80% of patient samples: 0.75 mcg/kg/min Stage 2: proportion of patients with platelet reactivity of < 240 P2Y 12 reaction units for all samples assessed during infusion of study drug Angiolillo DJ. JAMA 2012;307:

27 BRIDGE Results Median time from thienopyridine discontinuation to study drug infusion: 29.1 hours Median duration of infusion: 2.8 days Drug discontinued 1-6 hours before CABG Median time to surgical infusion: 3.2 hours Cangrelor (%) Placebo P value PRU < <0.001 Excessive bleeding PRBC transfusions >4 units BARC bleeding

28 Current Guidelines 2015 European Society of Cardiology Acute Coronary Syndromes in patients without persistent ST-segment elevation Cangrelor may be considered in P2Y12 inhibitor-naïve patients undergoing PCI (IIb) 2015 ACC/AHA/SCAI Focused update on Primary PCI in patients with ST-elevation myocardial infarction Not addressed Roffi M. Eur Heart J 2015 [Epub ahead of print] 28

29 Conclusion Cangrelor may be beneficial in patients not previously exposed to oral P2Y 12 inhibitor Pharmacokinetic profile make it useful in following patients: May need surgical revascularization Require interruption of oral P2Y 12 inhibitor 29

30 Questions? 30

31 Cangrelor: Is it the new CHAMPION for PCI? Robert Barcelona, PharmD, BCPS Clinical Pharmacy Specialist, Cardiac Intensive Care Unit November 13, 2015

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