FINESSE Studies Facilitated Reperfusion PCI

October 19, 2009—In the Journal of American College of Cardiology: Cardiovascular Interventions, Stephen G. Ellis, MD, et al published an evaluation of 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention With Enhanced Reperfusion Speed to Stop Events) trial (2009;2:909-916).

According to the investigators, treatment delays remain common for patients with primary PCI, leading to studies evaluating the possible benefit of “facilitated” PCI. In the FINESSE trial, there was no reduction in the 90-day primary ischemic endpoint, and an increase in bleeding was observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups.

In the study, a total of 2,452 patients with ST-segment elevation myocardial infarction (STEMI) and anticipated 1- to 4 -hour delays until catheterization were randomized to reduced-dose reteplase plus abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the catheterization lab. One-year mortality was a prespecified secondary endpoint.

The investigators reported that 1-year mortalities in the three groups noted above were 6.3%, 7.4%, and 7%, respectively (P = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (P = .053 for combination treatment vs primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (P = .09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure < 100 mm Hg, previous MI, age, Killip class > 1, anterior MI, body mass index ≤25 kg/m², heart rate > 100 beats/min, and no statin use.

These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups, such as patients with anterior MI, may deserve further study, the investigators concluded.

Also in the Journal of American College of Cardiology: Cardiovascular Interventions, Howard C. Herrmann, MD, et al published a study of the benefit of facilitated PCI in high-risk STEMI patients presenting to non-PCI hospitals (2009;2:917-924). The investigators hypothesized that the patients who were most likely to benefit would be those at high risk with a shorter duration of acute ischemia and who required transfer for PCI.

The investigators noted that the FINESSE study failed to demonstrate an improvement in the 90-day composite clinical endpoint of early treatment with abciximab plus half-dose reteplase or abciximab alone.

In this study, the investigators performed a retrospective analysis of 2,452 patients in the double-blind, placebo- controlled study. They stratified patients by thrombolysis in myocardial infarction (TIMI) risk score for STEMI, presentation to a spoke (no PCI available) or hub site, and symptom-to-randomization time. Outcomes included the primary composite endpoint of death, ventricular fibrillation after 48 hours, cardiogenic shock, and congestive heart failure through 90 days, as well as 1-year mortality.

The investigators reported that mortality for all patients at 1 year was directly related to TIMI risk score (23 of 1,223 = 1.9% in patients with a score < 3, and 145 of 1,229 = 11.8% in patients with TIMI risk score ≥3; P < .001). Patients with TIMI risk score 3 and presentation to a spoke site with a symptom-to-randomization time ≤4 hours had significantly better 1-year survival if treated with combination-facilitated PCI (hazard ratio [HR], 0.351; P = .01), as well as 90-day composite outcome (HR, 0.45; P = .009). A trend for improved survival was also observed in patients with TIMI score ≥3 and spoke site alone (HR, 0.549; P = .06).

The investigators concluded that facilitation of PCI with a combination of abciximab and half-dose reteplase improved survival at 1 year in high-risk patients presenting to a spoke hospital with symptom-to-randomization time ≤4 hours. Further prospective study of facilitated PCI in this subgroup of patients is warranted, they advised.