Primary percutaneous coronary intervention (PCI) performed within 90 minutes of first medical contact is often difficult to achieve, especially when inter-hospital transfer is necessary. In light of this, investigators have evaluated the benefit of facilitated PCI, or PCI performed early after the administration of a fibrinolytic agent or GPIIb/IIIa inhibitor or a combination of these agents. The FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) study was designed to compare the outcomes of standard primary PCI with two different facilitated PCI strategies.

In the FINESSE trial, 2,452 patients with acute ST-elevation myocardial infarction (STEMI) were randomly assigned to 1 of 3 primary PCI strategies: facilitated PCI with reduced-dose reteplase and abciximab (reteplase/abciximab-facilitated PCI); facilitated PCI with upstream abciximab alone (abciximab-facilitated PCI); and abciximab administered in the catheterization laboratory just prior to PCI (in-lab axciximab). The primary endpoint was a composite of death (all-cause mortality), rehospitalization for heart failure, resuscitated ventricular fibrillation (within 48 hours after randomization), and cardiogenic shock at 90 days. The study was stopped prematurely (at 82% of its planned size) because of difficulty with enrollment and was therefore underpowered.

Stephen Ellis, MD, Cleveland Clinic, Ohio, reported that there were no significant differences among the three arms with respect to the primary endpoint; reteplase/abciximab-facilitated PCI 9.8%, abciximab-facilitated PCI 10.5%, and in-lab abciximab 10.7% (p=0.55). There were also no significant differences in the individual components of this endpoint among the three groups. Reteplase/abciximab-facilitated PCI significantly increased the patency of the infarct-related artery before PCI; the rate of TIMI 2/3 blood flow was 80% for this group vs 45% in abciximab-facilitated PCI group, and 37% in the in-lab abciximab group (p<0.0001). TIMI 3 blood flow did not differ among the three groups after PCI. The prevalence of TIMI major and minor bleeding was lower in the in-lab abciximab group (6.9%) than in the abciximab-facilitated PCI group (10.1%; p=0.008) or the reteplase/abciximab-facilitated PCI group (14.5%; p<0.001).

Dr. Ellis concluded, “Primary PCI with in-lab abciximab provides a better benefit-risk profile than the facilitated strategies in patients with STEMI who can undergo PCI within 4 hours of first medical contact.”

In discussing the study, Frans van de Werf, MD, University of Leuven, Belgium, addressed the reasons for the negative results of the two facilitated PCI strategies tested in the FINESSE trial. “An important explanation could be suboptimal antithrombotic co-therapy,” he said, noting that upfront clopidogrel was not given and upfront enoxaparin was given to only a subset of patients.

Prof. van de Werf concluded, “FINESSE does not support a strategy of facilitated PCI. Facilitation with either full-dose lytic [based on the ASSENT-4 study] or combination therapy cannot therefore be recommended” [ASSENT-4 PCI Investigators. Lancet 2006]. He added that a strategy of early lytic-based pharmacologic treatment preceding PCI may be beneficial in selected populations, such as those patients who present early (2–3 hours after symptom onset), with a large amount of viable myocardium, and who also receive adequate antithrombotic co-therapy. Another subgroup of patients with STEMI in whom an early lytic-based facilitated strategy should be studied include those in whom a long delay before PCI is anticipated, with the proviso that PCI be postponed if there is evidence of successful (TIMI 3) reperfusion after pharmacologic treatment.