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ASSENT- 4 PCI Trial

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  1. ASSENT- 4 PCI Trial 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 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 n=829 GP IIb/IIIa inhibitors allowed only for bail out use Primary PCI n=838 GP IIb/IIIa inhibitors allowed at discretion of physician • 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 Patients undergoing PCI among two treatment groups (%) p=0.01 GP IIb/IIIa inhibitor administration prior to and during PCI (%) p<0.001 • 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: TIMI Flow Grade TIMI grade 3 flow prior to PCI and TIMI grade 2/3 flow post-PCI (%) • 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

  5. ASSENT- 4 PCI Trial: Abrupt Closure and Re-infarction Analysis of in-hospital abrupt closure and re-infarction among two treatment groups (%) p=0.01 • 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%) p<0.001 Presented at ESC 2005

  6. 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

  7. ASSENT- 4 PCI Trial: 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 (1.8% vs 0%), as did ICH (0.97% vs 0%) at 30 days p=0.004 Presented at ESC 2005

  8. 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 was more common in the TNK+ PCI treatment group (31.3% vs 23.4%) at 30 days p=0.26 Presented at ESC 2005

  9. 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