Seventeen RCTs were included to compare facilitated (n=2,237) and primary (n=2,267) PCI.
The authors reported that most trials fulfilled their validity criteria. All trials used a concealed allocation method. Four of the 17 trials were double-blinded and placebo-controlled. Three trials were stopped early.
Clinical outcomes.
Mortality was significantly increased (5% versus 3%) as a result of the facilitated intervention compared with the primary PCI (OR 1.38, 95% CI: 1.01, 1.87, P=0.04). The effect was largely in trials using thrombolytic therapy alone (6% versus 4%) (OR 1.43, 95% CI: 1.01, 2.02, P=0.04). There was no evidence of heterogeneity amongst the studies.
Nonfatal reinfarction was significantly increased in those receiving a facilitated intervention (3% versus 2%) (OR 1.71, 95% CI: 1.16, 2.51, P=0.006). Again, this was largely in those regimens employing thrombolytic therapy alone (4% versus 2%) (OR 1.81, 95% CI: 1.19, 2.77, P=0.006). There was no evidence of heterogeneity amongst the studies.
Urgent target vessel revascularisation rates were higher in patients receiving the facilitated intervention (4% versus 1%) (OR 2.39, 95% CI: 1.23, 4.66, P=0.010). Thrombolytic therapy alone represented a large contributor to this finding (5% versus 1%) (OR 4.81, 95% CI: 2.47, 9.37, P<0.0001). There was no evidence of heterogeneity amongst the studies.
Major bleeding rates were higher in those receiving the facilitated intervention (7% versus 5%) (OR 1.51, 95% CI: 1.10, 2.08, P=0.010). Rates of haemorrhage (0.7% versus 0.1%, P=0.0014) and total stroke (1.1% versus 0.3%, P=0.0008) were higher in those receiving thrombolytic therapy as part of the intervention.
Angiographic outcomes.
The facilitated PCI was associated with a two-fold increase (37% versus 15%) in those with initial TIMI grade 3 flow compared with those receiving the primary intervention (OR 3.18, 95% CI: 2.22, 4.55, P=0.0001); there was substantial heterogeneity amongst these studies (I-squared 74%). There was no significant difference between the final flow rates (OR 1.19, 95% CI: 0.86, 1.64, P=0.30); no heterogeneity was found between these studies.
In 8 trials using single or combination therapy, initial rates of myocardial perfusion grade 3 flow were significantly higher in studies of facilitated intervention with platelet glycoprotein IIb/IIIa inhibitors than in those with the primary intervention (31% versus 19%) (OR 2.60, 95% CI: 1.36, 4.95, P=0.04). However, there was no difference in the final rates (OR 1.79, 95% CI: 0.93, 3.44, P=0.08). In one small trial that compared the facilitated approach using thrombolytic therapy, a significant improvement in initial and final rates of mycocardial perfusion grade 3 flow was reported (P=0.0001).
A significant difference (P<0.03) was noted in favour of the facilitated intervention in 4 of the 9 trials reporting ST-segment resolution data.