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Presented at The European Society of Cardiology Scientific Congress 2006

FRISC II Trial. Fragmin and Fast Revascularization during Instability in Coronary Artery Disease (FRISC II): Five-Year Follow-up of the FRISC-II Invasive Study. Presented at The European Society of Cardiology Scientific Congress 2006 Presented by Dr. Bo Lagerqvist.

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Presented at The European Society of Cardiology Scientific Congress 2006

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  1. FRISC II Trial Fragmin and Fast Revascularization during Instability in Coronary Artery Disease (FRISC II): Five-Year Follow-up of the FRISC-II Invasive Study Presented at The European Society of Cardiology Scientific Congress 2006 Presented by Dr. Bo Lagerqvist

  2. FRISC II (5 Year Follow Up): Background • The goal of this study was to evaluate treatment with an early invasive strategy compared with a conservative management strategy on late clinical events. • The FRISC II trial was a prospective, randomized trial comparing an early invasive strategy with a conservative management strategy in patients with unstable coronary artery disease (UA). • At two year follow-up, lower rates of death (3.7% vs 5.4%, p=0.038), MI (9.2% vs 12.7%, p=0.005), and the composite endpoint of death or MI (12.1% vs 16.3%, p=0.003) were observed in the invasive strategy group compared with the conservative management strategy group. • During the second year, 18 patients died in the invasive group and 19 in the conservative group (p=NS). Presented at ESC 2006

  3. FRISC II (5 Year Follow Up): Study Design 2457 patients with ischemic symptoms in previous 48 hours accompanied by ECG changes (ST depression or T wave inversion ≥ 0.1 mv) or elevated markers (e.g. CK-MB >6 mg/L, troponin T >0.0.10 mg/L) Prospective. Randomized. 30% female, median age 66 years, mean follow-up 5 years All patients received aspirin; beta blockers given unless contraindicated Early invasive strategy Angiography in all patients and revascularization if needed n=1222 Conservative Management Strategy: Initial medical management with exercise testing; angiography if indicated n=1235 • Primary Endpoint: Composite endpoint of death or MI at 6 months Presented at ESC 2006

  4. FRISC II (5 Year Follow Up): Primary Endpoint Composite of Death or MI at five years (%) • The composite of death or MI was lower in the invasive strategy (19.9% vs 24.5%, p=0.009). • This difference was largely driven by the reduction in MI (12.9% vs 17.7%, p=0.002). p=0.009 Mortality at 5 years Presented at ESC 2006

  5. FRISC II (5 Year Follow Up): Primary Component Endpoints Mortality and MI at 5 years (%) • At five years, mortality did not differ between treatment groups (9.7% vs 10.1%, p=0.69). • There was, however, a significant difference in MI between the two groups (12.9% vs 17.7%, p=0.002). p=0.002 p=0.69 % of patients Presented at ESC 2006

  6. FRISC II (5 Year Follow Up): Primary Endpoint Cardiac Death at five years (%) • There was no difference in cardiac death between the two groups (5.6% vs 5.9%, p=0.77). p=0.77 Cardiac Death at 5 years Presented at ESC 2006

  7. FRISC II (5 Year Follow Up): Considerations • When analyzed according to patient risk, based on the FRISC scoring system, investigators found that the benefit of the invasive strategy at five years was only significant in high-risk patients. • The decline in the relative mortality benefit between two and five years may be related to differences in the rates of revascularization. The difference in absolute in-hospital revascularization declined from 63% to 30% by two years between the two treatment arms, with more of the noninvasive patients undergoing late revascularization. • For comparison, the mortality benefit was maintained at five years in the RITA-3 trial; however, this may reflect differences in the risk of the populations studied. Presented at ESC 2006

  8. FRISC II (5 Year Follow Up): Summary • Among patients with unstable angina, an early invasive strategy was associated with a reduction in mortality compared with a conservative management strategy at two years. However, through 5 years there was no difference in death between treatment strategies. • Myocardial infarction was lower for the invasive strategy at both two and five years. • Reductions in the composite of death or MI were limited to the high-risk patients. Presented at ESC 2006

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