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

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

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

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