1 5into ml Sample collection directly vacuum collection tubes 1 1. Use 2 mL Greiner Bio-One partial-fill vacuette tubes with 3.2% sodium citrate (blue top). Greiner #454322. 1 2 2. Collect 2 tubes of whole blood using a 21 gauge or larger needle. First, collect a discard tube (at least 2 mL) making sure the discard tube does not contain any platelet 1 3 inhibiting substance (e.g. EDTA). Butterfly (21 gauge) is OK to use. 2 CBC 2 3 4 2 X5 5 6. Label the tube with the patient ID, date and time it was drawn. Do not refrigerate. Indwelling Catheter 5 ml 1. Discard the first 5 mL from an indwelling catheter to clear the line. Ensure the catheter is free of clots. 2. Immediately transfer blood to a 2 mL Greiner Bio-One partial-fill vacuette tube with 3.2% sodium citrate (blue top). Greiner #454322. Fill to the black line (1/2 tube). Do not under fill. 3 1 CBC 2 Prasugrel (Effient®) 4. If drawing blood for a CBC at the same time, fill the CBC 5 tube last 5. Gently invert the tube at least 5 times to ensure complete mixing of the contents. Samples with evidence of clotting should not be used. 6 1 Ticlopidine (Ticlid®) P2Y12 3. Fill the second tube (sample tube) to the black line (1/2 X5 4 tube). Do not under fill. Discard the first tube. Keep the second tube for testing. CBC 2 Clopidogrel (Plavix®) Aspirin Aspirin 75 mg 7 days on maintenance1 300 mg 8 hours post bolus2 600 mg 6 hours post bolus3 250 mg 2 hours post does4 250 mg (bid) 21 days (steady state)4 5 mg 5 days on maintenance5 10 mg 5 days on maintenance5 60 mg 45 minutes post bolus 81 - 325 mg 2 hours post dose 5 X5 Run Time (Minutes) System 10 ~3 30 ~5 Common error codes related to Attention 24 or 28 • • • • Platelet count less than 119,000 HCT < 33% Recent IIb/IIIa drug use Improper sample collection For more details, see the VerifyNow Test package insert. 1 Plavix (clopidogrel bisulfate) tablets Prescribing Information. Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. 3/2010 Update. 2 Price, MJ et al. Am J Cardiol 2006;98:681-684. 3 Hochholzer W. et al. Circulation. 2005;111:2560-2564. 4 Ticlid (ticlopidine hydrochloride) tablets Prescribing Information. Roche Laboratories Inc. Revised 12/2005. 5 Effient (prasugrel) tablets Prescribing Information. Daiichi Sankyo, Inc. and Eli Lilly and Company. July 10, 2009. 6 VerifyNow IIb/ IIIa Test Package Insert. 14320.K. 2009-06-10. 3. If drawing blood for a CBC at the same time, fill the CBC tube last 4 Sample Incubation (Minutes) Suggested Test Timing Dose Given Direct Venipuncture Medication(s) Tested Sample Collection Procedure VerifyNow Test VerifyNow Aspirin or P2Y12 3985 Sorrento Valley Boulevard San Diego, California USA 92121 Toll Free: 800.643.1640 [email protected] 4. Gently invert the tube at least 5 times to ensure complete mixing of the contents. Samples with evidence of clotting should not be used. www.accumetrics.com 5. Label the tube with the patient ID, date and time it was drawn. Do not refrigerate. The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc., ©2012 Accumetrics, Inc. PN:148039.D 3/30/12 6 Month Outcomes After Drug Eluting Stent Implantation 12 13 Responders (n=699) 10.5 P2Y12 Inhibitors Plavix® (clopidogrel) Effient® (prasugrel) Ticagrelor® (Brilinta) 8.6 ADP (P2Y12) Epinephrine 2.7 Factor Platelet Activating 2.3 1.4 Cardiac Death p< 0.001 Stent Thrombosis p< 0.001 AA Cardiac Death & ST p< 0.001 Aspirin Non-responders defined as >70% aggregation by LTA 12 hours TXA Thromboxane A after 600-mg clopidogrel plavix load 2 Thrombin Receptors GP IIb/IIIa Inhibitors ReoPro® (abciximab) Integrilin® (eptifibatide) Post -PCI 30 d 6 mo N=1109 N=1012 N=944 Post -PCI VerifyNow Aspirin Test: Platelet response to2.8P2Y12 inhibitors (e.g clopidogrel (Plavix), 2.8 prasugrel (Effient) and ticlopidine (Ticlid). Platelet response to aspirin 1.6 0.0 • ADP induced aggregation - extent CV Death non-fatal MI of platelet ST aggregation in the presence of P2Y12 inhibitors p=0.04 p=0.6 p=0.004 6 mo ARU (Aspirin Reaction Units) pharmacodynamic responses to study drug. 1.0 • Arachidonic aggregation Patients with low acid levelsinduced of OTR after PCI appeared to have few (if any) CV e • Reference range: 620-672 ARU (pre-drug administration) Price MJ, AHA 2010 CV Death/MI/ST • Measurement range: 350–700 ARU p=0.008 • Residual Platelet Reactivity (RPR) ADP P2Y12 receptor Non-responders defined as >235 of PRU (upper tertile) on VerifyNow 2 30 d In patients with high on-treatment reactivity (OTR) after PCI, there was subs 1.9 PRU (P2Y12 Reaction Units) 1.3 Result Interpretation: • Recommended cut-off: 550 ARU GP IIb-IIIa Example PRU’s As measured by aggregometry 350 Fibrinogen GP IIb-IIIa 30 Blood Sample Showing Inhibition of Platelet Function 20 Blood Sample Showing Normal Platelet Function Agonist High Residual Platelet Reactivity 250 200 150 100 Red Blood Cells 50 Fibrinogen-Coated Beads Platelet-Bead Aggregates Platelets 1st (0-8%) 300 ASA Resistant ASA Sensitive PRU Range Incidence of early failure To Order this Test: N=1105 N=1013 N=940 VerifyNow P2Y12 Test: Importance of Aspirin Response to Graft Patency 10 6.5 0 0.9 reference range 1.0 • Post-drug of 18-435 0.0 Collagen Shear Forces To Order this Test: 2nd Low Light (9-20%) Transmittance 3rd (21-57%) 4th Increased Light (58-100%) Transmittance Poston et al. J Thorac Cardiovasc Surg 2006;131:122-30 Low Residual Platelet Reactivity Aspirin Reaction Units (ARU) % of Patients 3.5 3.1 VerifyNow Aspirin Results Non-Responders (n=108) 4.6 Plasmin 2.4 Responders (n=209) 8.6 ADP (P2Y1) Serotonin Overall (n=317) Non-Responders (n =105) % of Patients Overall (n=804) 100 VerifyNow P2Y12 Results VerifyNow Activates Specific Drug Receptor Light Transmittance AggregometrySites 40 reactivity @ 30 days: 62% vs 40%, p<0.001 Findings comparable regardless of test method. How It Works: 700 650 Non-Therapeutic Range 600 550 500 450 Therapeutic Range 400 350 Post Aspirin Ingestion
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