ASSENT- 4 PCI研究
The Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT-4 PCI) Trial
ASSENT- 4 PCI Trial
Presented at
The European Society of Cardiology
Hot Line Session 2005
Presented by Dr. Frans Van de Werf
Full-dose TNK + Primary PCI
60 IU/kg, maximum 4000 IU
n=829
GP IIb/IIIa inhibitors allowed only for bail out use
ASSENT- 4 PCI Trial
1667 patients age > 18 years with ST elevation myocardial infarction (summed ST deviation > 6 mm); time from symptom onset within 6 hrs; intent to perform primary PCI
Randomized
Mean follow-up: 6 mos (30 days reported to date)
63% of patients received clopidogrel/ticlopidine during PCI
Additional UFH was given to 67.4% in the TNK + PCI group and 70.1% in the PCI alone group
Presented at ESC 2005
Primary PCI
70 IU/kg, no maximum dose
n=838
GP IIb/IIIa inhibitors allowed at physician discretion
Primary Endpoint: Composite of death, shock, or congestive heart failure at 90 days.
Secondary Endpoint: Composite of death, shock, or congestive heart failure at 30 days; shock or CHF at 90 days; single components of the composite endpoint.
ASSENT- 4 PCI Trial: PCI
Patients undergoing PCI
among two treatment groups (%)
p=0.01
Patients undergoing PCI with stent (%)
Presented at ESC 2005
p=0.02
p=0.97
PCI was performed at a median of 104 minutes following TNK bolus administration
Median time from symptom onset to randomization was 140 minutes in the combined therapy group and 135 minutes in the PCI alone group
19% of patients were randomized in the ambulance
GP IIb/IIIa inhibitor administration prior to and during PCI (%)
p<0.001
p<0.001
GP IIb/IIIa inhibitors were given more often prior to PCI in the PCI alone treatment group
GP IIb/IIIa inhibitors were given more often during PCI in the PCI alone treatment group
ASSENT- 4 PCI Trial: GP IIb/IIIa Inhibitors
Presented at ESC 2005
ASSENT- 4 PCI Trial: TIMI Flow Grade
TIMI grade 3 flow prior to PCI and TIMI grade 2/3 flow post-PCI (%)
p<0.001
TIMI grade 3 flow prior to PCI was present more frequently in the TNK + PCI arm (43.6% vs 15.0%)
TIMI grade 2/3 post-PCI was slightly higher in the PCI alone group (95.3% vs 97.6%)
p=0.03
Presented at ESC 2005
ASSENT- 4 PCI Trial: Abrupt Closure, Re-infarction, and Repeat TVR
Analysis of in-hospital abrupt closure, re-infarction, and repeat TVR (%)
p<0.001
In-hospital abrupt closure occurred more often in the TNK + PCI treatment group (1.9% vs 0.1%)
Re-infarction occurred more often in the TNK + PCI treatment group (4.1% vs 1.9%)
Repeat TVR occurred more often in the TNK + PCR treatment group (4.4% vs 1.0%)
p<0.001
p=0.01
Presented at ESC 2005
Presented at ESC 2005
ASSENT- 4 PCI Trial: Pericarditis, Tamponade, and Cardiac Rupture
Analysis of in-hospital pericarditis, tamponade, and cardiac rupture (%)
p=0.07
Pericarditis occurred more often in the TNK + PCI treatment group (0.7% vs 0.1%)
Presence of tamponade did not differ significantly between the two treatment groups
Cardiac rupture occurred more often in the TNK + PCR treatment group (0.9% vs 0.2%)
p=0.11
p=0.50
Presented at ESC 2005
Presented at ESC 2005
ASSENT- 4 PCI Trial: EM Dissociation, Pulmonary Edema, and VF
Analysis of in-hospital EM dissociation, pulmonary edema, and VF (%)
p=0.20
Presence of EM dissociation did not differ significantly between the two treatment groups
Presence of pulmonary edema did not differ significantly between the two treatment groups
VF occurred more often in the TNK + PCR treatment group (5.6% vs 3.7%)
p=0.08
p=0.78
ASSENT- 4 PCI Trial: Mortality at 30 days
The primary endpoint of mortality was higher in the
TNK + PCI treatment group compared with the PCI alone group (6.0% vs 3.8%, p=0.04) at 30 days
Analysis of mortality at 30 days (%)
p = 0.04
Presented at ESC 2005
n=50
n=32
ASSENT- 4 PCI Trial: Mortality Subgroup Analysis
The greatest mortality difference by treatment group was seen in hospitals with on-site PCI (7.3% vs 3.8%), with less difference in community hospitals (6.0% vs 4.0%), and a shift in direction for patients enrolled in the ambulance (3.1% vs 3.7%)
Subgroup analysis of mortality based on site of randomization (%)
Presented at ESC 2005
n=754
n=588
n=325
ASSENT- 4 PCI Trial: Total Stroke and ICH at 30 days
Total stroke occurred more often in the TNK + PCI group (1.81% vs 0%), as did ICH (0.97% vs 0%) at 30 days
Analysis of total stroke and ICH at 30 days (%)
Presented at ESC 2005
p<0.001
p=0.004
ASSENT- 4 PCI Trial: Ischemic Stroke, Haemorrhagic Conversion, and Unclassified Stroke Rates at 30 days
Ischemic stroke occurred more often in the TNK + PCI group (0.60% vs 0%), as did haemorrhagic conversion (0.12% vs 0%) at 30 days
Analysis of ischemic stroke, haemorrhagic conversion, and unclassified stroke rates at 30 days (%)
Presented at ESC 2005
p=0.03
p=0.50
p=0.25
ASSENT- 4 PCI Trial: Bleeding Events at 30 days
No difference in the frequency of major bleed existed between the two treatment groups (5.7% vs 4.4%) at 30 days
The presence of any bleeding event (major + minor bleeding) was more common in the TNK+ PCI treatment group (31.3% vs 23.4%) at 30 days (p<0.001)
Analysis of bleeding events at 30 days (%)
Presented at ESC 2005
p=0.26
p<0.001
ASSENT- 4 PCI Trial: Transfusions at 30 days
The percentage of transfusions administered was greater in the TNK + PCI treatment group
93.8% received no transfusion in the TNK + PCI treatment group; 95.8% received no transfusion in the PCI alone treatment group (p=0.21)
Analysis of transfusions at 30 days (%)
Presented at ESC 2005
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)
Outcomes in the TNK + PCI treatment group did not differ from previous ASSENT trials
Outcomes in the PCI alone treatment group showed a significant decrease in percentage of deaths at 30 days
Analysis of 30-day death among other ASSENT trials (%)
Presented at ESC 2005
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)
Outcomes in the TNK + PCI treatment group did not differ from previous ASSENT trials
Outcomes in the PCI alone treatment group showed a significant decrease in percentage of ICH cases
Analysis of ICH across all ASSENT trials (%)
Presented at ESC 2005
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)
Outcomes in the TNK + PCI treatment group did not differ significantly from previous ASSENT trials
Outcomes in the PCI alone treatment group showed a significant decrease in percentage of total stroke
Analysis of total stroke across all ASSENT trials (%)
Presented at ESC 2005
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)<