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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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slide1
Presenter Disclosure

Anthony Fung

The BRIEF-PCI Trial

No conflict of interest

br ief i nfusion of e ptifibatide f ollowing pci

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

background
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.

disadvantages of an 18 hour infusion of eptifibatide
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
contemporary pci
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
slide6
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
primary end point
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.

adjudicated secondary end points
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.
key entry criteria
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
sample size
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.

slide11
*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)
slide12
75 mg ≥ 4 days;
  • 300 mg ≥ 6 hrs;
  • 600 mg ≥ 2 hrs

Placebo

Eptifibatide

post pci myonecrosis @ 24 hrs
Post-PCI Myonecrosis @ 24 hrs

1° end-point

∆ 1.8%; 95% CI 7.8%;

p< 0.012 for non inferiority

bleeding quadruple end points
Bleeding & Quadruple End-points

%

P = NS

2° end-point

P=NS

P=0.02

REPLACE-2 criteria

conclusion
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
acknowledgement
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)
slide22
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)

definition of mi incidence of myonecrosis
Definition of MI & Incidence of Myonecrosis
  • 99th percentile = 0.11; 10% CV = 0.26;
  • ESC / ACC (2007) definition: 0.11 X 3 = 0.33
replace 2 major bleeding
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
ad