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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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Presenter disclosure

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


Presenter disclosure

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.


Presenter disclosure

  • *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)


Presenter disclosure

  • 75 mg ≥ 4 days;

  • 300 mg ≥ 6 hrs;

  • 600 mg ≥ 2 hrs

Placebo

Eptifibatide


Baseline characteristics

Baseline Characteristics


Procedural characteristics

Procedural Characteristics


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


Incidence of myonecrosis in subgroups

Incidence of Myonecrosis in Subgroups


Composite triple end points @ 30 days

Composite Triple End-points @ 30 Days

%

P=NS

2° end-point


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)


Presenter disclosure

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)


Isar react ineligible subgroups

ISAR-REACT Ineligible Subgroups


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


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