The Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial was designed to test the hypothesis that PCI that is facilitated with the use of a combination of abciximab and reduced-dose reteplase would be more effective than primary PCI, in which abciximab is administered in the catheterisation laboratory immediately before PCI. A group for whom PCI was facilitated by abciximab alone was included to help clarify the contribution of this component of the combination therapy to the clinical outcome.
FINESSE: Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events
Patients were randomised in a 1:1:1 fashion to 3 treatment arms:
- Facilitated PCI with reduced-dose reteplase and abciximab bolus doses administered in the emergency department;
- Facilitated PCI with abciximab bolus administered in the emergency department;
- Primary PCI with abciximab initiated in the cardiac catheterisation laboratory.
FINESSE: Study design
The primary endpoint was a composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomisation, cardiogenic shock, and congestive heart failure requiring rehospitalisation or an emergency room visit through 90 days.
Secondary endpoints were complications of MI through 90 days, death from all causes through 90 days, and ST-segment resolution of more than 70% from baseline as assessed at 60 to 90 minutes after randomisation.
The 90-day primary composite endpoint occurred in 9.8% of the patients in the combination-facilitated PCI group, 10.5% of the patients in the abciximab-facilitated PCI group, and 10.7% of the patients in the primary PCI group (hazard ratio in the combination-facilitated PCI group as compared with the primary PCI group, 0.91; 95% confidence interval [CI], 0.67 to 1.23).
Complications of myocardial infarction occurred in 7.4%, 7.5%, and 9.0% of patients in the three groups, respectively, with no significant differences.
The individual components of the primary endpoint did not differ significantly among the combination facilitated PCI, abciximab-facilitated PCI, and primary-PCI groups.
FINESSE: Kaplan-Meier curves for the primary endpoint at 90 days
All-cause mortality at 1 year was, 6.3%, 7.4%, and 7.0% in the combination- facilitated PCl, abciximab-facilitated PCI, and primary PCI with in-Iab abciximab groups, respectively (p=non-significant), which represented a 1.1%, 1.9%, and 2.5% increment from the initial 90-day endpoint (p=0.053 for combination vs. primary PCI).
FINESSE: All-cause mortality at 1 year
- The primary endpoint did not differ significantly between the treatment groups.
- Neither of the facilitated PCI strategies provided a clinical benefit compared with primary PCI with in-lab abciximab.
- Reteplase/abciximab facilitation, and to a lesser extent abciximab facilitation, increased bleeding compared with the in-lab administration of abciximab.
- Primary PCI with in-lab abciximab provides a better benefit-to-risk ratio than the two facilitated strategies in patients with STEMI who can undergo PCI within 4 hours of the first medical contact.
- 1-year follow-up survival data confirms the overall lack of significant clinical benefit with either of the treatment regimens tested for non-high-risk patients.
- ln a subgroup of patients identified as high risk on the basis of a modified TIMI risk score ≥3, presentation to a spoke site without PCI capability, and with a symptom-to-randomisation time ≤4 h, facilitation of PCI with early administration of a combination of abciximab and half-dose reteplase or abciximab alone may reduce 90-day clinical outcomes compared with abciximab given just before PCI.
- Furthermore, combination-facilitated PCI significantly reduced 1-year mortality as compared with primary PCI.
- Ellis SG, et al. Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial. Am Heart J 2004;147:684.
- Ellis SG, et al. Facilitated PCI in Patients with ST-Elevation Myocardial Infarction. N Eng J Med 2008;358:2205-2217.
- Ellis SG, et al. 1-Year Survival in a Randomized Trial of Facilitated Reperfusion. JACC 2009;2(10):909-916.
- Herrmann HC, et al. Benefit of Facilitated Percutaneous Coronary Intervention in High-Risk ST-Segment Elevation Myocardial lnfarction Patients Presenting to Nonpercutaneous Coronary Intervention Hospitals. JACC 2009;2(10):917-924.