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ASSENT- 4 PCI Trial. The Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT-4 PCI) Trial. Presented at The European Society of Cardiology Hot Line Session 2005 Presented by Dr. Frans Van de Werf. ASSENT- 4 PCI Trial.

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ASSENT- 4 PCI Trial

The Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT-4 PCI) Trial

Presented at

The European Society of Cardiology

Hot Line Session 2005

Presented by Dr. Frans Van de Werf

assent 4 pci trial
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

Full-dose TNK + Primary PCI

60 IU/kg, maximum 4000 IU

n=829

GP IIb/IIIa inhibitors allowed only for bail out use

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.

Presented at ESC 2005

slide3

ASSENT- 4 PCI Trial: PCI

Patients undergoing PCI

among two treatment groups (%)

p=0.01

Patients undergoing PCI with stent (%)

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

Presented at ESC 2005

slide4

ASSENT- 4 PCI Trial: GP IIb/IIIa Inhibitors

GP IIb/IIIa inhibitor administration prior to and during PCI (%)

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

p<0.001

slide5

ASSENT- 4 PCI Trial: TIMI Flow Grade

TIMI grade 3 flow prior to PCI and TIMI grade 2/3 flow post-PCI (%)

p=0.03

  • 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<0.001

Presented at ESC 2005

slide6

ASSENT- 4 PCI Trial: Abrupt Closure, Re-infarction, and Repeat TVR

Analysis of in-hospital abrupt closure, re-infarction, and repeat TVR (%)

  • 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

p<0.001

Presented at ESC 2005

slide7

ASSENT- 4 PCI Trial: Pericarditis, Tamponade, and Cardiac Rupture

Analysis of in-hospital pericarditis, tamponade, and cardiac rupture (%)

  • 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=0.07

p=0.50

Presented at ESC 2005

Presented at ESC 2005

slide8

ASSENT- 4 PCI Trial: EM Dissociation, Pulmonary Edema, and VF

Analysis of in-hospital EM dissociation, pulmonary edema, and VF (%)

  • 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

p=0.20

Presented at ESC 2005

Presented at ESC 2005

assent 4 pci trial mortality at 30 days
ASSENT- 4 PCI Trial: Mortality at 30 days

Analysis of mortality at 30 days (%)

p = 0.04

  • 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

n=50

n=32

Presented at ESC 2005

assent 4 pci trial mortality subgroup analysis
ASSENT- 4 PCI Trial: Mortality Subgroup Analysis

Subgroup analysis of mortality based on site of randomization (%)

  • 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%)

n=754

n=588

n=325

Presented at ESC 2005

assent 4 pci trial total stroke and ich at 30 days
ASSENT- 4 PCI Trial: Total Stroke and ICH at 30 days

Analysis of total stroke and ICH at 30 days (%)

p<0.001

  • Total stroke occurred more often in the TNK + PCI group (1.81% vs 0%), as did ICH (0.97% vs 0%) at 30 days

p=0.004

Presented at ESC 2005

assent 4 pci trial ischemic stroke haemorrhagic conversion and unclassified stroke rates at 30 days
ASSENT- 4 PCI Trial: Ischemic Stroke, Haemorrhagic Conversion, and Unclassified Stroke Rates at 30 days

Analysis of ischemic stroke, haemorrhagic conversion, and unclassified stroke rates at 30 days (%)

p=0.03

  • 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

p=0.25

p=0.50

Presented at ESC 2005

assent 4 pci trial bleeding events at 30 days
ASSENT- 4 PCI Trial: Bleeding Events at 30 days

Analysis of bleeding events at 30 days (%)

p<0.001

  • 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)

p=0.26

Presented at ESC 2005

assent 4 pci trial transfusions at 30 days
ASSENT- 4 PCI Trial: Transfusions at 30 days

Analysis of 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)

Presented at ESC 2005

assent 4 pci trial comparison with previous assent trials tnk in mi patients
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)

Analysis of 30-day death among other ASSENT trials (%)

  • 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

Presented at ESC 2005

assent 4 pci trial comparison with previous assent trials tnk in mi patients16
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)

Analysis of ICH across all ASSENT trials (%)

  • 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

Presented at ESC 2005

assent 4 pci trial comparison with previous assent trials tnk in mi patients17
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)

Analysis of total stroke across all ASSENT trials (%)

  • 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

Presented at ESC 2005

assent 4 pci trial comparison with previous assent trials tnk in mi patients18
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)

Analysis of re-infarction among other ASSENT trials (%)

  • 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 re-infarction cases

Presented at ESC 2005

assent 4 pci trial comparison with previous assent trials tnk in mi patients19
ASSENT- 4 PCI Trial: Comparison with Previous ASSENT Trials (TNK in MI patients)

Analysis of major bleed among other ASSENT trials (%)

  • Outcomes in the TNK + PCI treatment group differed significantly from the ASSENT-3 and ASSENT 3+ Trials results
  • Outcomes in the PCI alone treatment group did not differ from the ASSENT-2 Trial, but were more significant in comparison to the ASSENT-3 and ASSENT 3+ Trials

Presented at ESC 2005

assent 4 pci trial comparison with those in primary pci overview
ASSENT- 4 PCI Trial: Comparison with Those in Primary-PCI Overview

Analysis of 30-day death among ASSENT-4 and those in the primary-PCI overview (%)

  • Outcomes in the TNK + PCI treatment group did not differ significantly compared with the primary-PCI overview
  • Outcomes in the PCI alone treatment group were significantly lower than those in the primary-PCI overview

Presented at ESC 2005

assent 4 pci trial comparison with those in primary pci overview21
ASSENT- 4 PCI Trial: Comparison with Those in Primary-PCI Overview

Analysis of ICH among ASSENT-4 and those in the primary-PCI overview (%)

  • Outcomes in the TNK + PCI treatment group were significantly higher compared with the primary-PCI overview
  • Outcomes in the PCI alone treatment group did not differ from the primary-PCI overview

Presented at ESC 2005

assent 4 pci trial comparison with those in primary pci overview22
ASSENT- 4 PCI Trial: Comparison with Those in Primary-PCI Overview

Analysis of total stroke among ASSENT-4 and those in the primary-PCI overview (%)

  • Outcomes in the TNK + PCI treatment group were higher compared with the primary-PCI overview
  • Outcomes in the PCI alone treatment group were significantly lower compared with the primary-PCI overview

Presented at ESC 2005

assent 4 pci trial comparison with those in primary pci overview23
ASSENT- 4 PCI Trial: Comparison with Those in Primary-PCI Overview

Analysis of re-infarction among ASSENT-4 and those in the primary-PCI overview (%)

  • Outcomes in the TNK + PCI treatment group were higher compared with the primary-PCI overview
  • Outcomes in the PCI alone treatment group did not differ with the primary-PCI overview

Presented at ESC 2005

assent 4 pci trial comparison with those in primary pci overview24
ASSENT- 4 PCI Trial: Comparison with Those in Primary-PCI Overview

Analysis of major bleed among ASSENT-4 and those in the primary-PCI overview (%)

  • Outcomes in the TNK + PCI treatment group were lower compared with the primary-PCI overview
  • Outcomes in the PCI alone treatment group were significantly lower compared with the primary-PCI overview

Presented at ESC 2005

assent 4 pci trial summary
ASSENT- 4 PCI Trial: Summary
  • The trial intended to enroll 4,000 patients, but was discontinued early after enrollment of 1,667 patients.
  • Among patients with ST elevation MI intended for primary PCI, administration of full-dose fibrinolytic (TNK) immediately prior to PCI was associated with increased mortality and stroke at 30 days compared with primary PCI alone.
  • Primary endpoint data are not yet available.
  • Further evaluation of the clinical benefit of fibrinolytics among patients undergoing early PCI for STEMI appears warranted (FINESSE).

Presented at ESC 2005