Facilitated PCI refers to a strategy of planned immediate PCI after the administration of an initial pharmacological regimen aimed at improving the patency of coronary arteries before the procedure. Such regimens have included GP IIb/IIIa inhibitors, full-dose or reduced-dose fibrinolytic therapy, and the combination of a GP IIb/IIIa inhibitor and a reduced-dose fibrinolytic agent. Facilitated PCI is an attempt to capitalize on the timeliness of pharmacological reperfusion and the superior outcome of PCI. Despite the potential advantages of this strategy, clinical trials of facilitated PCI have not shown any benefit in improving outcomes.
The ASSENT-4 PCI trial randomly assigned 1667 patients with STEMI of less than 6 hours' duration to standard PCI or PCI preceded by the administration of full-dose tenecteplase.57
The trial was terminated prematurely because the in-hospital mortality rate was significantly higher in the facilitated PCI group (6%) than in the standard PCI group (3%; P
=.01). The primary end point, a composite of death, shock, and CHF within 90 days, was significantly higher with facilitated PCI (18.6%) than with primary PCI (13.4%; P
=.0045). Patients assigned to facilitated PCI also experienced more strokes and ischemic complications than those assigned to primary PCI.
A quantitative review of 17 trials showed that, compared with primary PCI, facilitated PCI was associated with substantially higher rates of short-term mortality, nonfatal reinfarction, urgent target-vessel revascularization, total and hemorrhagic stroke, and major bleeding.58
The increased rates of adverse events with the facilitated approach were seen mainly in regimens based on fibrinolytic therapy, whereas no significant differences were observed in efficacy or safety between primary PCI and PCI facilitated with a GP IIb/IIIa inhibitor.
The FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial randomly assigned patients (in a 1:1:1 fashion) to early administration of combination therapy with reduced-dose reteplase and abciximab (n=828), early administration of abciximab alone followed by PCI (n=818), or abciximab alone administered just before PCI (n=806). The primary end point was the composite of all-cause mortality or complications after MI within 90 days.59
On arrival at the catheterization laboratory, the percentage of patients with an open artery before PCI was higher in the reteplase plus abciximab group (61%) than in the abciximab group (26%) or the primary PCI group (25%; P
<.001). The percentage of patients experiencing the primary end point was 9.8% in the combination-facilitated PCI group, 10.5% in the abciximab-facilitated PCI group, and 10.7% in the primary PCI group (P
=.55). TIMI major or minor bleeding occurred more often in the combination-facilitated PCI group than in either the abciximab-facilitated PCI group or the primary PCI group (P
The 2007 update of the STEMI guidelines gives a class IIb recommendation (level of evidence, C) to the selective use of a facilitated strategy with regimens other than full-dose fibrinolytic therapy for subgroups of high-risk patients when PCI is not available within 90 minutes, provided the risk of bleeding is low.5