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Facilitated Intervention With Enhanced Reperfusion Speed to Stop Events - FINESSE
Description:
The goal of the trial was to evaluate percutaneous coronary intervention (PCI) facilitated by abciximab with half-dose thrombolytic (reteplase), abciximab alone, or placebo among patients with ST-elevation myocardial infarction (STEMI).
Hypothesis:
Facilitation of PCI among STEMI patients will be more effective with a regimen of abciximab and half-dose reteplase.
Study Design
- Placebo Controlled
- Randomized
- Blinded
Patients Enrolled: 2,452
Mean Follow Up: 90 days
Mean Patient Age: 62 years
Female: 26
Patient Populations:
STEMI patients age ≥21 years, and presentation within 6 hours of onset of symptoms of prolonged and continuous ischemia (≥20 minutes) with specific electrocardiographic (ECG) criteria that is not relieved by nitrate administration
Exclusions:
• Low-risk clinical presentation
• Patients who will undergo PCI within 60 minutes of the qualifying ECG or >4 hours after the qualifying ECG
• Planned use of a direct thrombin inhibitor during PCI
• MI precipitated by a condition other than atherosclerotic coronary artery disease
• Use of fibrinolytic within 14 days
• Use of low molecular weight heparin within 24 hours
• PCI within 7 days
• Known or suspected bleeding
• Confirmed uncontrolled hypertension
• Other contraindications to fibrinolytic treatment
• Unfractionated heparin dose >40 U/kg (3000 U maximum)
• Activated partial thromboplastin time >70 seconds
Primary Endpoints:
Composite of all-cause mortality or complications of MI by 90 days. Complications of MI are defined as rehospitalization or emergency department visit for congestive heart failure, cardiogenic shock, or resuscitated ventricular fibrillation occurring >48 hours after randomization.
Secondary Endpoints:
• Components of the primary endpoint through 90 days
• ST-segment resolution >70% from baseline at 60-90 minutes following randomization
• TIMI major and minor bleeding through discharge/day 7
• Intracranial hemorrhage through discharge/day 7
Drug/Procedures Used:
Patients with STEMI were randomized in a double-blind, double-dummy manner to abciximab with half-dose of the thrombolytic reteplase (n = 828), abciximab alone (n = 818), or placebo (n = 806). Patients then underwent PCI. An intravenous (IV) infusion of abciximab 0.125 µg/kg/min was to be administered to all patients in the catheterization laboratory and continued for 12 hours.
The trial was designed so that approximately 50% of patients were to be entered into the trial at "spoke" (non-PCI) hospitals, initiate randomized therapy, and be transferred urgently to the "hub" (PCI) hospital.
Concomitant Medications:
Aspirin (81-325 mg orally or 250-500 mg IV) and unfractionated heparin (40 U/kg bolus to a maximum of 3000 U). Some centers could use low molecular weight heparin (enoxaparin) at a dose of 0.5 mg/kg IV, followed by 0.3 mg/kg subcutaneously. Clopidogrel or ticlopidine administration was at the discretion of the investigator.
Principal Findings:
Time from arrival at the hospital to PCI (i.e., door-to-balloon time) was 120 minutes in 60% of the patients who were randomized at a hospital with PCI facilities, and 155 minutes among the 40% of patients who were transferred from a non-PCI hospital, an average time delay of 35 minutes. Anterior MI was present in 48% of the population.
Upon arrival at the catheterization lab, more patients in the combination facilitated PCI arm (reteplase + abciximab + PCI) had an open artery prior to PCI (TIMI flow grade of 3) (33%) compared with either the abciximab facilitated PCI arm (14%; p < 0.001) or the primary PCI alone group (12%; p < 0.001). ST-segment resolution of >70% by 60-90 minutes was also more common in the combination facilitated PCI arm (44%) compared with either the abciximab facilitated PCI arm (33%; p = 0.013) or the primary PCI alone group (31%; p = 0.003).
There was no difference in the primary endpoint of death, cardiogenic shock, heart failure, or resuscitated ventricular fibrillation by 90 days between the three groups (9.8% of the combination facilitated PCI arm, 10.5% of the abciximab facilitated PCI arm, and 10.7% of the primary PCI alone arm; p = 0.55). There was also no difference in the components of the primary endpoint, including mortality (5.2%, 5.5%, 4.5%, respectively; p = 0.49), heart failure (1.9%, 2.9%, 2.2%, respectively), cardiogenic shock (5.3%, 4.8%, 6.8%, respectively), or ventricular fibrillation (0.6%, 0.2%, 0.4%, respectively).
TIMI major or minor bleeding through discharge or day 7 was higher in the combination facilitated PCI arm (14.5%) compared with either the abciximab facilitated PCI arm (10.1%; p = 0.008) or the primary PCI alone group (6.9%; p < 0.001). Intracranial hemorrhage occurred in 0.6% of the combination facilitated PCI arm, but none of the abciximab facilitated PCI arm, and in 0.1% of the primary PCI alone group.
Interpretation:
Among patients undergoing PCI for STEMI, there was no difference in the frequency of death or complications of MI by 90 days when comparing a facilitated PCI strategy of abciximab and half-dose reteplase, a facilitated PCI strategy of abciximab alone, or primary PCI. However, both facilitated PCI strategies were associated with an increased risk of bleeding.
An approach of facilitated PCI increases the speed of myocardial reperfusion by opening the infarct-related artery rapidly, as was observed in the present trial with the combination facilitated PCI arm. It was hypothesized that this more rapid reperfusion with pharmacologic agents followed by PCI to ensure sustained and more complete reperfusion would result in less myocardial damage and consequently a decrease in clinical events. Although there was more rapid reperfusion, as shown on angiography and in ST resolution in the combination facilitated PCI strategy in the present study, the translation to a reduction in clinical observations was not found.
From a safety perspective, there was a significant increase in bleeding with a facilitated PCI strategy compared with primary PCI, as well as a small, but nonsignificant increase in intracranial hemorrhage in the combination group.
Another trial of facilitated PCI, the ASSENT-4 PCI study, showed no benefit, but did show a hazard associated with a facilitated PCI strategy using full-dose thrombolysis with tenecteplase prior to PCI. Unlike the ASSENT-4 trial, where few patients were treated with a glycoprotein IIb/IIIa inhibitor during the PCI, all patients in the present study received abciximab in the catheterization laboratory.
References:
Ellis SG, Tendera M, de Belder MA, et al., on behalf of the FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med 2008;358:2205-2217.
Presented by Dr. Stephen Ellis at the European Society of Cardiology Congress, September 2007, Vienna, Austria.
Keywords: Platelet Aggregation Inhibitors, Ventricular Fibrillation, Coronary Disease, Electrocardiography, Immunoglobulin Fab Fragments, Fibrinolytic Agents, Percutaneous Coronary Intervention, Shock, Cardiogenic, Intracranial Hemorrhages, Catheterization, Heart Failure, Recombinant Proteins, Tissue Plasminogen Activator, Myocardial Reperfusion, Platelet Glycoprotein GPIIb-IIIa Complex
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