1. The European Society of Cardiology Presented by Dr. Bo Lagerqvist
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 > 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 (%)
p=0.77
There was no difference in cardiac death between the two groups (5.6% vs 5.9%, 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