Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention - BRIEF-PCI

Sep 17, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Vancouver General Hospital and University of British Columbia Hospital, Foundation Cardiology Research Fund
Date Presented:
01/01/2007
Date Published:
01/01/2009
Date Updated:
09/17/2010
Original Posted Date:
09/17/2010
References

Description:

The goal of this trial was to evaluate a brief infusion of eptifibatide compared with an 18-hour infusion after elective percutaneous coronary intervention (PCI).

Hypothesis:

An abbreviated duration of eptifibatide would result in a similar frequency of periprocedural myonecrosis.

Study Design

Study Design:

  • Randomized
  • Parallel

Patients Screened: 925
Patients Enrolled: 624
Mean Follow Up: 30 days
Mean Patient Age: 62 years
Female: 20%

Patient Populations:

  • Patients were eligible for enrollment immediately after undergoing elective coronary stenting

Exclusions:

  • Age >18 years 
  • Recent STEMI
  • Visible thrombus
  • Use of bivalirudin
  • Unprotected left main intervention
  • Use of adjunctive devices such as ablative or thrombectomy
  • Allergy to aspirin, thienopyridine, or eptifibatide
  • Unsatisfactory PCI results

Primary Endpoints:

  • Elevation of troponin I >0.26 µg/L

Secondary Endpoints:

  • Death, MI, urgent target vessel revascularization at 30 days
  • In-hospital major bleeding

Drug/Procedures Used:

Following successful nonemergent PCI, patients were randomized to the standard 18-hour infusion of eptifibatide (n = 312) or to a shortened infusion of eptifibatide of less than 2 hours (brief group, n = 312). Biomarkers were measured at baseline, 8 hours, and 24 hours and were analyzed at a central core laboratory.

Concomitant Medications:

At enrollment, the use of aspirin was 100%, adequate clopidogrel pretreatment was 71%, angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker was 67%, beta-blocker was 84%, and statin was 80%.

In the catheterization laboratory, clopidogrel was loaded (300-600 mg) unless patients had chronically been treated with this medication. Heparin was administered to achieve an activated clotting time of 200-300 seconds. Enoxaparin could also be used according to operator discretion. Eptifibatide was given intravenously as a double bolus (180 µg/kg) 10 minutes apart, followed by infusion of 2 µg/kg/min.

Principal Findings:

Overall, 624 patients were randomized. There was no difference in baseline characteristics between the groups. The mean age was 62 years, 20% were women, 12% had diabetes, and the mean body mass index was 28 kg/m2. Index diagnosis was stable angina in 49% of patients, acute coronary syndrome in 37%, and ST-elevation myocardial infarction (STEMI) >48 hours in 15% of patients. Approximately two-thirds of patients received a clopidogrel loading dose. One-half of the patients in the trial had multivessel disease (52%), and lesion type was predominantly B2 or C classification (63%). Two or more stents were used in 41% of cases.

The primary endpoint of periprocedural ischemic myocardial injury was present in 30.1% of the brief group and 28.3% of the standard 18-hour infusion group (p = 0.012 for noninferiority). MI at 30 days did not differ between groups (4.8% in the brief group vs. 4.5% in the standard group; p = NS), nor did urgent target vessel revascularization (0.6% in each group). There were no deaths in either group. The overall major adverse cardiac event (MACE) rate was 4.8% in the brief group and 4.5% in the standard group (p = NS). Major bleeding occurred less frequently in the brief group (1.0% vs. 4.2%, p = 0.02). There was no difference in minor bleeding (17.6% vs. 21.2%).

Interpretation:

Among patients who underwent successful nonemergent PCI with use of intravenous eptifibatide during the procedure, use of an abbreviated, 2-hour infusion of eptifibatide was noninferior with regard to periprocedural ischemic myocardial injury when compared with the standard, 18-hour infusion of eptifibatide.

Glycoprotein IIb/IIIa inhibitors have been associated with improved efficacy with regard to ischemic events in ACS patients undergoing PCI, but this benefit has come at the expense of additional bleeding. While there was no difference in periprocedural biomarker elevations, major bleeding events were lower in the brief infusion group. The overall sample size of the trial was relatively small; a larger confirmatory trial would be needed to validate these findings.

References:

Presented by Dr. Anthony Fung at the American Heart Association Annual Scientific Session, Orlando, FL, November 2007.

Fung AY, Saw J, Starovoytov A, et al. Abbreviated infusion of eptifibatide after successful coronary intervention: the BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial. J Am Coll Cardiol 2009;53:837-45.

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Angina, Stable, Peptides, Ticlopidine, Diabetes Mellitus, Stents, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex


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