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

Anthony A. Bavry, M.D., M.P.H.; Deepak L. Bhatt, M.D., F.A.C.C.

Disclosures

Cardiosource 

Description

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

Hypothesis

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

Drugs/Procedures Used

Patients with stable and unstable coronary artery disease undergoing stenting were eligible for study participation immediately after successful PCI. Patients were randomized to abbreviated eptifibatide infusion (<2 hours) (n = 312) versus standard 18-hour infusion (n = 312).

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. The clinical presentation was stable angina in 47%, acute coronary syndrome in 39% (80% with elevated biomarkers), and ST-elevation >48 hours in 15%.

The duration of eptifibatide was 1.4 hours in the brief infusion group versus 16.8 hours in the standard infusion group. The mean number of vessels treated were (1.2 vs. 1.2), total stent length was (29.4 mm vs. 28.6 mm), and the proportion of drug-eluting stent use was (31.9% vs. 35.4%), respectively.

The incidence of the primary outcome, troponin I elevation >0.26 µg/L, was 30.1% in the brief infusion group versus 28.3% in the standard infusion group (p < 0.012 for noninferiority). There was no significant interaction among any of the tested subgroups (diabetes, acute coronary syndrome presentation, and adequate clopidogrel pretreatment). Death, myocardial infarction, or target vessel revascularization was similar between the groups (4.8% vs. 4.5%, p = NS). Major bleeding was reduced in the brief infusion group (1.0% vs. 4.2%, p = 0.02).

Interpretation

Among patients undergoing successful coronary stenting and adequately pretreated with clopidogrel, a brief infusion of eptifibatide (<2 hours) was not inferior to standard infusion (18 hours) in regard to cardiac enzyme elevation. Composite cardiac outcomes were similar between the groups, although major bleeding was reduced with a brief infusion of eptifibatide. The studied patient population mainly consisted of stable angina, although a significant proportion was acute coronary syndrome and recent ST-elevation myocardial infarction. These results do not apply to unsuccessful or complicated PCI where a standard infusion of eptifibatide might still be beneficial.

This trial should be placed in the context of the ISAR-REACT trial, which showed that a glycoprotein IIb/IIIa inhibitor (abciximab) is not beneficial in elective coronary intervention among patients loaded with clopidogrel. This trial enrolled a significant proportion of acute coronary syndrome and recent ST-elevation myocardial infarction patients. Although the use of a glycoprotein IIb/IIIa inhibitor might be beneficial in the former group of patients, revascularization in general for the latter group is controversial. Abbreviated infusion of a glycoprotein IIb/IIIa inhibitor in acute coronary syndrome patients will need to be specifically addressed in an adequately powered trial.

Conditions

  • Coronary heart disease / Angina pectoris / Stable

  • Coronary heart disease / Angina pectoris / Unstable

  • Coronary heart disease / Acute MI / Non-Q-Wave

Therapies

  • Antiplatelet agent / GPIIbIIIa / Eptifibatide

Study Design

Randomized. Parallel.

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

Primary Endpoints

  • Elevation of troponin I >0.26 µg/L

Secondary Endpoints

  • Death, myocardial infarction, urgent target vessel revascularization at 30 days

  • In-hospital major bleeding

Patient Population

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

Exclusions:

  • Age <18 years

  • Recent ST-elevation myocardial infarction (<48 hours)

  • 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

Comments

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