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Long-term low-molecular-weight heparin (Fragmin) and/or early revascularization during instability in coronary artery
L Wallentin1, S Husted, F Kontny
1Department of Cardiology, University of Uppsala, Sweden.
Insights
The FRISC II trial investigated dalteparin (Fragmin) versus placebo and early invasive versus selective strategies for unstable coronary artery disease. It assessed treatments for reducing death or myocardial infarction in these patients.
Area of Science:
- Cardiology
- Thrombosis Research
- Clinical Trials
Background:
- Unstable coronary artery disease (CAD) requires effective antithrombotic and revascularization strategies.
- Optimizing treatment pathways for unstable CAD is crucial for improving patient outcomes.
Purpose of the Study:
- To compare the efficacy of extended low-molecular-weight heparin (dalteparin) treatment versus placebo.
- To evaluate a direct invasive strategy against a stepwise selective approach for coronary angiography and revascularization in unstable CAD.
- To analyze treatment effects on mortality, myocardial infarction, and other clinical outcomes.
Main Methods:
- Prospective, multicenter, factorial randomized study (FRISC II trial).
- Involved 3,100 patients across Scandinavian centers.
- Primary endpoints: death or myocardial infarction at 3 and 6 months.
Main Results:
- The study aimed to elucidate optimal antithrombotic and invasive strategies.
- Subgroup analyses were planned based on various clinical and biochemical markers.
- Results were anticipated to guide tailored treatment for unstable coronary syndromes.
Conclusions:
- The FRISC II trial provides insights into managing unstable coronary syndromes.
- Findings contribute to understanding the benefits of specific antithrombotic and revascularization approaches.
- The study supports the development of individually tailored treatment plans for CAD patients.
Abstract:
The Fragmin and/or Early Revascularisation during Instability in Coronary Artery Disease (FRISC II) trial will, in a prospective multicenter factorially randomized study, compare the efficacy of 3 months continuation of subcutaneous treatment with the low-molecular-weight heparin dalteparin (Fragmin) with that of placebo and will also compare a direct invasive strategy with a stepwise selective approach with regard to the utilization of coronary angiography and revascularization in patients with unstable coronary artery disease. The primary endpoints are death or myocardial infarction after 3 and 6 months respectively. Secondary endpoints are the same events after 12-24 months and also cardiac symptoms, exercise capacity, and/or signs of myocardial ischemia, readmission, and costs. Analyses will also be made of subgroups based on inclusion diagnosis, initial elevation of biochemical markers of myocardial damage, elevation of fibrinogen or C-reactive protein, signs of ischemia in electrocardiography at rest or at continuous 24-hour ischemia monitoring, and left ventricular function at echocardiography. Altogether, 3,100 patients will be recruited in 65-70 Scandinavian centers. Completion of follow-up is anticipated in the second half of 1998. The FRISC II study will further elucidate new alternatives for antithrombotic, invasive, and individually tailored treatment of unstable coronary syndromes.