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Early Treatment of ST Elevation Myocardial Infarction Incorporating Results of the Finesse Trial
(2.75 versus 2.9%) and major bleeding (4 versus 2.9%). Indeed, there Table 1: Clinical Outcome at 30 Days After
was a difference in thrombotic bail-out (19.9 versus 28.5%; p=0.002)
Percutaneous Coronary Intervention
(see Table 1).
Placebo (%) Tirofiban (%) p-value
Recent data
103
combining the on-TIME 2 patients with 414 open-label
(n=477) (n=473)
STEMI patients randomised to tirofiban or placebo showed one-year
Death, recurrent MI, urgent 32.9 26 0.020
survival benefit for those who ultimately went on to have primary PCI
TVR, thrombotic bail-out
(n=1,555, 97.6 versus 94.5%; p=0.007). As the rate of bail-out tirofiban
Death 4 2.3 NS
was 20% in the tirofiban group and only 29% in the placebo group, one
Recurrent MI 2.9 2.7 NS
Thrombotic bail-out 28.5 19.9 0.002
can argue that the on-TIME 2 trial does not prove the concept of early
Major bleeding 2.9 4 NS
GPIs, but merely the class effect of this type of therapy in STEMI
MI = myocardial infarction; TVR = target vessel revascularisation; PCI = percutaneous
patients. This is confirmed by the Comparison of the Pre-hospital or
coronary intervention; NS = not significant.
Cath-lab Administration of High Dose Tirofiban in Patients Undergoing
Primary Angioplasty (AGIR 2) data.
104
This study randomised 320 STEMI
Table 2: In-hospital Events According to Time of
Tirofiban Administration
patients who were being transferred for primary PCI to the GPI
tirofiban (loading dose of 25µg/kg followed by an infusion of
Pre-hospital (%) Catheterisation p-value
0.15µg/kg/min) during ambulance transfer (n=164) or in the
Laboratory (%)
catheterisation laboratory (n=156). On average, patients in the pre-
Death 5.5 3.2 0.15
hospital group received tirofiban 48 minutes earlier than the
Severe bleeding 3.7 1.3 0.15
catheterisation laboratory group. All patients were also given
Acute stent thrombosis 0.6 1.9 0.29
clopidogrel (600mg loading dose), aspirin and heparin. Baseline and Stroke 1.2 0.6 0.26
procedural characteristics were similar between the two groups, with
the exception of previous PCI, which was more common in the receive reteplase plus abciximab (combination-facilitated PCI),
catheterisation laboratory group (14.7 versus 7.9%; p=0.05). abciximab alone (abciximab-facilitated PCI) or placebo (primary PCI).
Immediately after randomisation, patients in the combination-
The proportion of patients with TIMI grade 2–3 flow at initial angiography facilitated PCI group received intravenous doses of abciximab
(primary end-point) was similar in both groups (44.2% in the pre-hospital (0.25mg/kg) and reteplase (two 5U boluses separated by 30 minutes
group versus 39.7% in the catheterisation laboratory group; p=0.42). In for those <75 years of age, or one 5U dose for those ≥75 years of
fact, no differences were observed between the groups in TIMI flow age); patients in the abciximab-facilitated PCI group received an
grade either before or after PCI. Patients given pre-hospital tirofiban intravenous bolus of abciximab at a dose of 0.25mg/kg.
were more likely to have ST-segment resolution >70% on admission to
the catheterisation laboratory, although the difference was not The primary end-point was a composite of death from all causes,
significant (15.2 versus 8.7%; p=0.10). Indeed, the difference had ventricular fibrillation occurring more than 48 hours after
disappeared one-hour post-PCI (52.6% in the pre-hospital group versus randomisation, cardiogenic shock and congestive heart failure
55.4% in the catheterisation laboratory group; p=0.64). Troponin and requiring re-hospitalisation or an emergency room visit over a 90-day
creatine kinase (CK) levels were similar in the two groups. In-hospital follow-up. Major secondary end-points were complications of MI over
clinical events were also similar, with death and severe bleeding casting 90 days (as in the primary end-point), death from all causes over 90
further negative light on pre-hospital tirofiban (see Table 2). days and ST-segment resolution of more than 70% from baseline as
assessed at 60–90 minutes after randomisation. Major safety end-
The length of time between symptom onset and treatment or the points were non-intracranial major or minor bleeding as assessed by
duration of tirofiban infusion did not significantly influence TIMI the TIMI classification and intracranial haemorrhage up to discharge or
flow grade or ST-segment resolution. Although the trial was not day seven, whenever was sooner.
powered for clinical events, the data do not support pre-hospital
administration of tirofiban provided that patients are pre-treated The baseline characteristics of the patients and the initial treatments
with a high loading dose of clopidogrel, aspirin and heparin in the received were similar across all groups. At randomisation, 66.7% of the
pre-hospital setting and that they receive tirofiban on admission to patients were considered to be at high risk. The median door-to-
the catheterisation laboratory. balloon time for all patients was 2.2 hours (interquartile range 1.8–2.8),
and 92% of the patients underwent PCI (see Figure 1). Significantly
The largest study on the concept of facilitated PCI is the Facilitated more patients in the combination-facilitated PCI group than in the
Intervention with Enhanced Reperfusion Speed to Stop Events abciximab-facilitated PCI group or the primary PCI group had ST-
(FINESSE) trial,
105
designed to compare the efficacy and safety of the segment resolution that was greater than 70% in 60–90 minutes (43.9
early administration of reduced-dose reteplase and abciximab in versus 33.1 and 31%, respectively; p=0.003 for combination-facilitated
combination or abciximab alone followed by PCI with abciximab only PCI versus primary PCI; p=0.01 for combination-facilitated PCI versus
administered just before PCI. A total of 2,452 patients were enrolled, abciximab-facilitated PCI). Significantly more patients in the group that
all presenting within six hours after the onset of signs and symptoms received reteplase plus abciximab than in the group that received
of cardiac ischaemia. All patients had ST-segment elevation abciximab alone or underwent primary PCI had a TIMI flow grade of 3,
suggestive of an acute MI, were eligible for fibrinolytic therapy or as determined by the site investigator, before PCI was performed (32.8
primary PCI and the estimated time to diagnostic catheterisation was versus 14.1 and 12%, respectively; p<0.001 for both comparisons). No
one to four hours after randomisation. These patients were randomly substantial difference among treatment groups was seen for TIMI flow
assigned through a central randomisation centre in a 1:1:1 ratio to grade after PCI or for ST-segment resolution at 180–240 minutes.
EUROPEAN CARDIOLOGY 87
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