FINESSE: Study results could bring an end to facilitated PCI following ST-elevation myocardial infarction

Thrombolytic therapy with reteplase/abciximab before percutaneous coronary intervention (PCI) (facilitated PCI) has no effect on post-myocardial infarction (MI) complications, including death, but the treatment significantly increases the risk of bleeding compared with primary PCI performed with in-lab abciximab in patients with ST-elevation MI, according to the results of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study.

Key Points

The results of the trial were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.

An earlier study, the Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT)-4 PCI trial, demonstrated that immediate fibrinolysis with full-dose tenecteplase was associated with a significant increase in the combined incidence of death, cardiogenic shock, or congestive heart failure at 90 days compared with primary PCI with unfractionated heparin (18.8% vs 13.7%; P=.006).

According to Stephen Ellis, MD, section head, invasive cardiology, Cleveland Clinic, Ohio, based on the results of the FINESSE study and the ASSENT-4 PCI study, "the broad approach of offering thrombolytic therapy prior to PCI is now dead."

In the FINESSE study, 2,452 patients with acute ST-elevation MI (or new left bundle branch block) who presented within 6 hours of symptom onset were randomized to receive abciximab just before (in-lab) PCI (n=806), PCI facilitated by abciximab (n=818), or PCI facilitated by reteplase/abciximab (n=828).

The percentage of patients with patent infarct-related arteries, defined as TIMI-2 or TIMI-3 blood flow, was significantly greater among those who received reteplase/abciximab-facilitated PCI compared with the other 2 study arms (P<.0001 for each comparison), but post-PCI TIMI-2 and TIMI-3 flow was similar with all 3 treatment strategies.

ST-segment resolution before balloon inflation was also significantly superior in the reteplase/abciximab arm compared with the other arms but was no better after balloon inflation or at 180 to 240 minutes after presentation.

The primary end point was a composite of all-cause mortality, resuscitated ventricular fibrillation occurring after 48 hours, cardiogenic shock, or hospital readmission or emergency department visit for heart failure at 90 days. The end point occurred with similar frequency in all study groups (in-lab abciximab before primary PCI, 10.7%; abciximab-facilitated PCI, 10.5%; reteplase/abciximab-facilitated PCI, 9.8%).

The rate of major and minor nonintracranial bleeding was significantly higher among patients who received reteplase/abciximab-facilitated PCI compared with those who received primary PCI (major, 4.8% vs 2.6%; P=.026; minor, 9.7% vs 4.3%; P<.001). Overall, nonintracranial bleeding was significantly more common in patients who received reteplase/abciximab-facilitated PCI than in those who received the other treatments.

Treatment with reteplase/abciximab-facilitated PCI was associated with a greater risk of intracerebral hemorrhage compared with primary PCI, but the difference (0.6% vs 0.1%) was not statistically significant (P=.218).

Dr Ellis said the preferred approach to PCI is to administer abciximab in the lab. "Primary PCI has the better risk:benefit profile in patients who can undergo PCI within 4 hours of first medical contact," he said.

According to Dr Ellis, patients who present within the first hour of experiencing an MI may represent an exception, because for those patients thrombolytic therapy may be equivalent to primary PCI. He said facilitated PCI might also serve a role for patients who receive treatment >4 hours after MI. "Not all patients fall into the 1- to 4-hour range," he said.

Frans van de Werf, MD, PhD, head of faculty for cardiovascular disorders, University of Leuven, Belgium, outlined several possible reasons for the failure of facilitated PCI in the FINESSE and ASSENT-4 PCI studies, including suboptimal adjunctive antithrombotic therapy, a lack of up-front clopidogrel administration, and the use of single-bolus heparin (ASSENT-4 PCI). According to Dr van de Werf, the approaches tested "should no longer be called 'facilitated PCI,' but a 'pharmacoinvasive' strategy."

"There's little to gain in patients presenting after 3 to 4 hours by increasing patency rates with pharmacologic treatment," Dr van de Werf said, adding that the pharmacoinvasive strategy may still be valid in patients presenting 2 to 3 hours after MI, when the amount of viable myocardium is still large.