6/28/23, 10:41 PM FRISC-II Pathway Feedback Search Clinical Topics Home Studies FRISC II FRISC II Disease Disease Disease Coronary artery disease Non-ST-elevation myocardial inf ST-elev 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 N = 2457 70.0% male 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 https://web.pathway.md/studies/recE4aT6TtWKDjWwD 1/2 6/28/23, 10:41 PM FRISC-II Pathway Death or MI 12.1 % 12.1 9.4 9.1 % 6.0 % Significant decrease 3.0 % NNT = 37 0.0 % Early invasive treatment Non-invasive treatment 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 myocardial infarction (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. Open reference URL https://web.pathway.md/studies/recE4aT6TtWKDjWwD 2/2