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Principal Investigator: Giuseppe Patti

ARMYDA-5 ( A ntiplatelet therapy for R eduction of MY ocardial D amage during A ngioplasty) Study Prospective, multicenter, randomized trial investigating influence on outcome of in-lab 600 mg clopidogrel loading vs 6-hour pre-PCI treatment – “ARMYDA-PRELOAD”.

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Principal Investigator: Giuseppe Patti

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  1. 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 Investigator:Giuseppe Patti Investigators:Vincenzo Pasceri, Giuseppe Colonna,Antonio Montinaro, Leonardo Lassandro Pepe, Francesco Ciccirillo, Laura Gatto, Fabio Mangiacapra, Antonio Tondo, Andrea D’Ambrosio, Annunziata Nusca, Giordano Dicuonzo, Gennaro Sardella, Bibi NGuyen

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

  3. ARMYDA-5 PRELOAD: 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

  4. ARMYDA-5 PRELOAD: Study design 30 days Medical Rx N= 72 Clopidogrel 600 mg given 4-8 hrs before angio N= 267 N= 409 536Patients with PCI 600 mg Preload N= 204 - Stable angina Primary end point: cardiac death, MI, TVR Randomization or Angiography - NSTE ACS PCI 600 mg in-lab N= 205 Clopidogrel 600 mg at the time of PCI N= 269 undergoing coronary angiography CABG N= 55 1st blood sample 2nd, 3rd, 4th and 5th blood samples Baseline At the time of PCI 2 hrs after PCI 8 and 24 hrs after PCI • CK-MB • Troponin-I • PRU • PRU • PRU • CK-MB • Troponin-I • PRU

  5. ARMYDA-5: STUDY END POINTS • Primary end point • 30-day incidence of cardiac death, MI, target vessel revascularization • (MI definition: post-procedural increase of CK-MB >3 times above UNL in patients with normal • baseline levels of CK-MB; subsequent elevation 50% the baseline value of CK-MB in patients with ACS • and raised baseline CK-MB levels) • Secondary end points • Post-procedural increase of markers of myocardial injury above UNL (CK-MB, troponin I, myoglobin) • Occurrence of any vascular/bleeding complications (Safety secondary end point) • “Point of care” measurement of platelet reactivity at different time points in the two arms

  6. ARMYDA-5 PRELOAD 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

  7. ARMYDA-5 PRELOAD Clinical characteristics N = 409 pts Pre-load N=204 In-lab treatment N=205 P • Age (years) • Male sex • Systemic hypertension • Diabetes mellitus • Hypercolesterolemia • Current smokers • Clinical pattern: • Non-STE ACS • Troponin positive • Previuos MI • Previous PCI • Previous CABG • Multivessel coronary disease • LV ejection fraction 66±9 82% 74% 33% 69% 21% 43% 45% 34% 24% 9% 43% 55±9% 65±10 81% 75% 36% 75% 22% 36% 47% 33% 32% 6% 36% 56±8% 0.29 0.82 0.89 0.56 0.21 0.92 0.18 0.59 0.81 0.10 0.45 0.18 0.22

  8. ARMYDA-5 PRELOAD Procedural features Pre-load N=204 In-lab treatment N=205 P • Vessel treated: • Left main • LAD • LCx • Right coronary • SVG • 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 1% 44% 25% 29% 1% 10% 53% 15% 1.14±0.7 3.15±0.6 20±9 35% 35% 14.8± 2 22±12 34% 19% 2% 43% 26% 28% 1% 11% 54% 16% 1.12±0.6 3.14±0.5 19±10 39% 35% 14.9± 2.1 20±11 34% 20% 0.69 0.96 0.97 0.81 0.69 0.99 0.96 0.91 0.75 0.84 0.28 0.50 0.95 0.62 0.08 0.97 0.82

  9. ARMYDA-5 PRELOAD: Primary end point Adverse events at 30 days (Clopidogrel in-lab load vs preload) In-lab load Preload 20 16 P=0.72 12 Cumulative incidence of MACE (%) 8 4 0 10 15 20 25 30 5 Days after PCI

  10. ARMYDA-5 PRELOAD Individual components of the primary end point at 30 days 20 16 12 In-lab load % of patients 9.3 8.8 Preload 8 4 0.5 0.5 0 0 0 Death MI TVR

  11. ARMYDA-5 PRELOAD: Secondary end point 1-3 times 1-3 times >3 times >3 times 40 75 P=0.83 P=0.85 60 30 45 20 Creatine kinase-MB (%) Troponin-I (%) 30 10 15 0 0 In-lab load Preload In-lab load Preload

  12. ARMYDA-5 PRELOAD: Safety secondary end point 20 16 P=0.42 12 In-labload % of patients 7.8 Preload 8 5.4 4 0 0 0 Major bleeding Minor bleeding

  13. ARMYDA-5 PRELOAD: Platelet reactivity curves Clopidogrel 600 mg 315 290 276±63 265 245±72 P=0.043 224±74 240 227±71 250±75 P=0.01 P2Y12 reaction Units (PRU) 215 212±72 206±73 209±70 182±72 190 165 174±74 Clopidogrel600 mg 140 0 Study entry PCI 2 hrs 8 hrs 24 hrs In-lab load Preload

  14. CONCLUSIONS • ARMYDA-5 PRELOAD 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.

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