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Presenter Disclosure

Presenter Disclosure. Anthony Fung The BRIEF-PCI Trial. No conflict of interest. Br ief I nfusion of E ptifibatide F ollowing PCI. The BRIEF-PCI Trial. AY Fung, J Saw, A Starovoytov, C Densem, P Jokhi, SJ Walsh, RS Fox, KH Humphries, E Aymong, DR Ricci, JG Webb, JN Hamburger,

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Presenter Disclosure

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  1. Presenter Disclosure Anthony Fung The BRIEF-PCI Trial No conflict of interest

  2. Brief Infusion of Eptifibatide Following PCI The BRIEF-PCI Trial AY Fung, J Saw, A Starovoytov, C Densem, P Jokhi, SJ Walsh, RS Fox, KH Humphries, E Aymong, DR Ricci, JG Webb, JN Hamburger, RG Carere, CE Buller. Vancouver General Hospital & St. Paul’s Hospital,University of British Columbia, Vancouver, Canada

  3. Background • 2b3a inhibitors are widely used in PCI to prevent ischemic complications • EPIC* (1994) showed that abciximab bolus plus 12 hr infusion reduced ischemic complications of PTCA, while bolus alone did not • ESPRIT** (2000) established the standard eptifibatide regimen: • double boluses 180 mcg/Kg, 10 min apart • 18 - 24 hr infusion @ 2 mcg/Kg/min *EPIC. N Engl J Med 1994; 330: 956. **ESPRIT. Lancet 2000; 356: 2037.

  4. Disadvantages of an 18-hourInfusion of Eptifibatide • Full dose cost ~$ 450 US • Prohibits same day discharge • Prolongs hospital stay • Increases nursing time • May promote bleeding complications

  5. Contemporary PCI • Dual anti-platelet oral therapy with aspirin and clopidogrel • High dose clopidogrel loading is well tolerated and has rapid onset of action • Routine use of coronary stents reduces abrupt vessel closure • Prolonged 18-hour eptifibatide infusion may not be necessary

  6. Hypothesis • Following non-emergent uncomplicated PCI with coronary stenting, the infusion of eptifibatide can be abbreviated to less than 2 hours without adverse ischemic outcome Trial Design • A prospective, randomized, double-blinded, placebo-controlled study

  7. Primary End-point • The incidence of post procedural myonecrosis within 24 hours: • Troponin-I elevation > 0.26 mcg/L (99th percentile of upper reference limit, and coefficient of variation <10%)*; or • CK-MB > 3 X upper reference limit if baseline troponin-I is elevated • Biomarkers measured at baseline, 6 hr & 18 hr in core lab *Joint ESC/ ACC Committee on MI Definition. JACC 2000; 36: 959.

  8. Adjudicated Secondary End-points • Composite triple end-points: • Incidence of death, MI, or target vessel revascularization (TVR) at 30 days • Composite quadruple end-points: • Triple end-points plus in-hospital major bleeding (*REPLACE – 2 criteria) • * REPLACE-2. JAMA 2003;289:853.

  9. Key Entry Criteria • ACS, STEMI > 48 hrs or stable angina, • No visible thrombus pre-procedure • Uncomplicated PCI with stenting, performed under the coverage of eptifibatide • TIMI-3 flow, no dissection, no major side branch loss, no thrombus post procedure • Randomize after successful PCI

  10. Sample Size • Non-inferiority design • Estimated reference rate* – 50% • Upper margin – 10% • Power 80% • One sided α 0.05 • N = 620 (310 per group) *Bonz AW, et al. J Am Coll Cardiol 2002; 40: 662.

  11. *Reasons for exclusion • 51 unsatisfactory angiographic results • 42 eptifibatide not given • 15 logistics & other issues • 14 femoral puncture site complications • 4 filling defect • 4 withdrew consent • 3 PTCA only (no stenting)

  12. 75 mg ≥ 4 days; • 300 mg ≥ 6 hrs; • 600 mg ≥ 2 hrs Placebo Eptifibatide

  13. Baseline Characteristics

  14. Procedural Characteristics

  15. Post-PCI Myonecrosis @ 24 hrs 1° end-point ∆ 1.8%; 95% CI 7.8%; p< 0.012 for non inferiority

  16. Incidence of Myonecrosis in Subgroups

  17. Composite Triple End-points @ 30 Days % P=NS 2° end-point

  18. Bleeding & Quadruple End-points % P = NS 2° end-point P=NS P=0.02 REPLACE-2 criteria

  19. Conclusion • Eptifibatide infusion can safely be abbreviated to < 2 hours following successful non-emergent coronary stenting without an increase in post procedural myonecrosis • We observed less major bleeding when the eptifibatide infusion is abbreviated • Funded by: • VGH & UBC Hospital Foundation • VGH Cardiology Research

  20. Acknowledgement • Cardiac science nursing staffs and research coordinators • Data & Safety Monitoring Board • Dr. W. Douglas Weaver (Detroit, MI), Chair • Dr. Simon Dixon (Royal Oak, MI) • Dr. Krishnan Ramanathan (Vancouver, BC) • Events Committee • Dr. Graham Wong (Vancouver, BC), Chair • Chemistry Core Lab • Dr. Morris Pudek (Vancouver, BC)

  21. 90 STEMI 319 Acute presentation • ACS • 178 TnI Pos 624 Randomized 305 Stable angina 140 Stable, inadequate clopidogrel 165 Stable, adequate clopidogrel (ISAR-REACT like)

  22. ISAR-REACT Ineligible Subgroups

  23. Definition of MI & Incidence of Myonecrosis • 99th percentile = 0.11; 10% CV = 0.26; • ESC / ACC (2007) definition: 0.11 X 3 = 0.33

  24. REPLACE – 2 Major Bleeding • Results in death • Retroperitoneal, intracranial or intraocular • Results in hemodynamic compromise • Requiring surgical intervention • Any transfusion > 2 units • Decrease in hemoglobin ≥ 4 g/dL • Clinically overt bleeding resulting in a decrease in hemoglobin ≥ 3 g/dL

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