Although primary PCI is widely recognised as the most effective treatment after MI, time delays are frequent with only a minority of patients reaching cath labs within the 90 minute window recommended by current guidelines. It has been suggested that additional early pharmacological interventions to achieve good blood flow might improve outcomes. This theory, however, was dashed when the ASSENT-4 PCI study, published in 2006, showed patients randomised to tenecteplase followed by primary PCI had excessive inhospital mortality compared to the control group receiving PCI alone.
Study design
The FINESSE study reviewed the same approach with a different treat
ment regimen. FINESSE randomised 2453 patients presenting with acute ST elevation MI from 20 countries who had been referred for primary PCI into three groups. The first two groups received two different facilitated PCI treatments regimens - early administration of reduced-dose reteplase and abciximab combination therapy (n=828) or abciximab alone (n=818). Both treatments were followed by PCI after an interval. The third group received primary PCI with abciximab alone administered just prior to PCI in the cath lab (n=806).
Results at 90 days show that there were no statistically significant differences in the primary end points of death, rehospitalisation for heart failure, cardiogenic shock and resuscitated ventricular fibrillation between the three arms. There were, however, found to be significantly better blood flow in the combination therapy arm. Bleeding was greatest in the facilitated abciximab/reteplase group, followed by the facilitated abciximab group followed by the primary PCI with lab abciximab group.
Ellis concluded that despite the negative finding, the FINESSE study does not totally rule out the prospect of new drug combinations that might offer future benefits in facilitated PCI.
Discussant Frans Van de Werf (Leuven, BE), said: “The explanation of the negative effects of Finesse and Assent-4 could be that the trials had no upfront clopidogrel. There are also difficulties that patients could be randomised up to six hours and there is little to gain from pharmacological therapy after three to four hours.