FRISC-II
Trial question
Is early invasive treatment strategy superior to non-invasive treatment strategy in patients with unstable coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 2457
2457 patients (749 female, 1708 male).
Inclusion criteria: patients with unstable coronary artery disease.
Key exclusion criteria: on waiting list for coronary revascularization, other acute or severe cardiac disease, renal or hepatic insufficiency, osteoporosis, hypersensitivity to randomized drugs, previous open-heart surgery, or advanced age (eg, > 75 years).
Interventions
N=1222 early invasive treatment (target to perform all invasive procedures, aiming for revascularization, within 7 days of starting open-label dalteparin).
N=1235 non-invasive treatment (coronary angiography in patients with refractory or recurrent symptoms, despite maximum medical treatment, or severe ischemia on a symptom-limited exercise test before discharge).
Primary outcome
Death or MI
12.1%
9.4%
12.1 %
9.1 %
6.0 %
3.0 %
0.0 %
Early invasive
treatment
Non-invasive
treatment
Significant
decrease ▼
NNT = 37
Significant decrease in death or MI (12.1% vs. 9.4%; RR 0.78, 95% CI 0.62 to 0.98).
Secondary outcomes
Significant decrease in MI (10.1% vs. 7.8%; RR 0.77, 95% CI 0.6 to 0.99).
No significant difference in death (1.9% vs. 2.9%; RR 0.65, 95% CI 0.39 to 1.09).
Safety outcomes
No significant difference in stroke (0.2% vs. 0.2%) and thrombocytopenia (0.1% vs. 0.1%).
Significant difference in serious adverse events (3.8% vs. 1.6%) and major bleeding (1.6% vs. 0.7%).
Conclusion
In patients with unstable coronary artery disease, early invasive treatment was superior to non-invasive treatment with respect to death or MI.
Reference
FRISC II Investigators. Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. FRagmin and Fast Revascularisation during InStability in Coronary artery disease Investigators. Lancet. 1999 Aug 28;354(9180):708-15.
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