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ARMYDA-5 ( A ntiplatelet therapy for R eduction of MY ocardial D amage during A ngioplasty) study

Germano Di Sciascio, MD, FACC, FESC Professor & Chairman of Cardiology Director, Department of Cardiovascular Sciences Institute Campus Biomedico University of Rome Rome, Italy  . ARMYDA-5 ( A ntiplatelet therapy for R eduction of MY ocardial D amage during A ngioplasty) study.

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ARMYDA-5 ( A ntiplatelet therapy for R eduction of MY ocardial D amage during A ngioplasty) study

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  1. Germano Di Sciascio, MD, FACC, FESCProfessor & Chairman of CardiologyDirector, Department of Cardiovascular Sciences InstituteCampus Biomedico University of RomeRome, Italy   ARMYDA-5 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study

  2. Name of the speaker: Germano DiSciascio I have the following potential conflicts of interest to report:  Consulting  Employment in industry  Stockholder of a healthcare company  Owner of a healthcare company  Other(s)  I do not have any potential conflict of interest TCT 2007 – Disclosure Slide

  3. ARMYDA-5 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) Study Prospective, multicenter, randomized trial investigating influence on outcome of in-lab 600 mg clopidogrel loading vs 6-hour pre-PCI treatment – “ARMYDA-Preload” Chairman: Germano Di Sciascio Principal Investigators:Giuseppe Patti, Vincenzo Pasceri, Giuseppe Colonna Investigators:Antonio Montinaro, Leonardo Lassandro Pepe, Francesco Ciccirillo, Laura Gatto, Fabio Mangiacapra, Antonio Tondo, Andrea D’Ambrosio, Annunziata Nusca, Giordano Dicuonzo, Gennaro Sardella, Bibi NGuyen

  4. P=0.041 12% 4% ARMYDA-2 RESULTS Primary end-point 30-day Death, MI, TVR (%) Circulation 2005;111:2099-2106

  5. ARMYDA-5: BACKGROUND • The ARMYDA-2 trial demonstrated a 61% RR of MACE in patients undergoing PCI pretreated (mean 6 hrs) with 600 mg clopidogrel loading , compared with a 300 mg dose • Concerns about surgical bleeding (with preloading), and/or adequacy of antiplatelet effect (with in-lab loading) GOAL OF THE STUDY • To evaluate safety and effectiveness of a strategy of 600 mg clopidogrel load given in the cath-lab, at the time of PCI, after diagnostic coronaryangiography

  6. ARMYDA-5: Study design 30 days Medical Rx N= 53 Clopidogrel 600 mg given 4-8 hrs before angio N= 218 N= 350 438Patients with PCI 600 mg Preload N= 174 Primary end point: Death, MI*, TVR - Stable angina or Angiography Randomization - NSTE ACS PCI 600 mg in-lab N= 176 Clopidogrel 600 mg at the time of PCI N= 220 undergoing coronary angiography CABG N= 35 1st blood sample before PCI 2nd and 3rd blood sample at 8 and 24 hours - CK-MB, troponin-I, myoglobin, CRP * MI defined as >3 times UNL post-procedural elevation of CK-MB

  7. ARMYDA-5: STUDY END POINTS • Primary end point • 30-day incidence of death, MI, target vessel revascularization • (MI definition: post-procedural increase of CK-MB >3 times above UNL • in patients with normal baseline levels of creatine kinase-MB) • Secondary end points • Post-procedural increase of markers of myocardial injury above UNL (CK-MB, troponin I, myoglobin) • Peak values of CK-MB, troponin I and myoglobin after intervention • Occurrence of any vascular/bleeding complications • “Point of care” measurement of platelet reactivity at different time points in the two arms

  8. ARMYDA-5 Inclusion criteria - Clopidogrel-naïve pts with stable angina or non-STE ACS undergoing PCIExclusion criteria-Primary PCI- Platelet count <70x103/mL- Pts at high risk of bleeding- Coronary by-pass grafting in the previous 3 months- Therapy with clopidogrel within 10 days

  9. ARMYDA-5 Clinical characteristics N = 350 pts Pre-load N=176 In-lab treatment N=174 P • Age (years) • Male sex • Systemic hypertension • Diabetes mellitus • Hypercolesterolemia • Current smokers • Clinical pattern: • non-STE ACS • non STEMI • Previuos MI • Previous PCI • Previous CABG • Multivessel coronary disease • LV ejection fraction 66±9 83% 69% 30% 67% 15% 45% 5% 34% 18% 7% 39% 53±9% 65±10 80% 74% 29% 73% 20% 43% 9% 37% 28% 5% 35% 53±14% 0.34 0.55 0.43 0.44 0.25 0.29 0.89 0.33 0.71 0.03 0.60 0.50 1

  10. ARMYDA-5 Procedural features Pre-load N=176 In-lab treatment N=174 P • Vessel treated: • Left main • LAD • LCx • Right coronary • PCI for restenosis • Lesions B2/C • Multivessel Intervention • No. of stent/patient • Stent diameter (mm) • Stent Length (mm) • Use of DES • Direct Stenting • Stent deployment pressure (atm) • Duration of stent deployment (sec) • Post-dilatation • Glycoprotein IIb/IIIa inhibitors - 46% 22% 32% 4% 57% 18% 1.3±0.6 3.04±0.7 16.1±5.4 33% 33% 13.2± 3.4 17±6.1 35% 18% 1% 47% 24% 28% 5% 53% 19% 1.3±0.5 3±0.7 16.2±6.5 35% 34% 13.2± 3.5 16±6.5 29% 19% 0.49 0.96 0.72 0.50 0.84 0.16 0.94 0.69 0.07 0.66 0.86 0.87 0.97 0.25 0.30 0.64

  11. ARMYDA-5 trial Composite primary end-point (30-day death, MI, TVR) 11 P=0.56 % 8

  12. ARMYDA-5 trial Individual components of primary endpoint 11 % 8 Pre-load In-lab

  13. ARMYDA-5 trial Secondary end points Post-procedural CK-MB and Troponin-I elevation above UNL P=0.30 47 P=0.90 39 31 33 % of patients with elevation CK-MB Tn-I

  14. ARMYDA-5 Trial Secondaryend points Post-procedural peak levelsof markers of myocardial injury Troponin-I CK-MB P= 0.50 P= 0.46 8.1±95 6.4±8 1.02±1.2 0.76±0.9 Peak value of CK-MB (ng/ml) Peak value of Tn-I (ng/ml) Preload In-lab

  15. ARMYDA-5 Trial Secondary end points Bleeding rates 5 4 Preload Patients with bleeding (%) In-lab 0 0

  16. ARMYDA-5: Platelet aggregometry* Clopidogrel 600 mg 300 272±82 280 245±84 260 245±89 P=0.04 240 215±91 241±58 220 Pre-load 223±71 P= 0.005 187±56 200 Platelet Reaction Units (PRU) In-lab 195±72 180 188±74 160 Clopidogrel 600 mg 167±60 140 120 100 Study PCI 2 hrs 6 hrs 24 hrs entry * By VerifyNow TM

  17. CONCLUSIONS • ARMYDA-5 indicates that 600 mg “in lab” clopidogrel load pre-PCI does not have unfavorable influence on outcome (vs 6 hrs preload). • Differences in platelet reactivity by aggregometry (at PCI and at 2 hrs) do not translate into different event rates in the “upstream” vs the in-lab strategy. • No bleeding differences and no major bleedings were observed in the 2 arms. • The in-lab strategy may obviate the need of preloading before knowing patients’ anatomy: thus, when indicated, in-lab 600 mg clopidogrel administration can be a safe and effective alternative to pretreatment given several hours pre-PCI.

  18. ARMYDA-2 RESULTS Primary end-point 20 P=0.041 15 12% 10 Composite primary end point (%) 4% 5 0 600 mg 300 mg Circulation 2005;111:2099-2106

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