Why the study?
Does dalteparin sodium reduce the incidence of death and/or MI in patients with unstable coronary artery disease?
Does dalteparin sodium reduce the incidence of death and/or MI in patients with unstable coronary artery disease?
Dalteparin sodium can be used as an effective bridge to revascularization in patients with unstable coronary artery disease by protecting against early cardiac events.
May support dalteparin bridging in unstable CAD; leaves open comparative efficacy versus modern regimens in RCTs.
The mainstay of treatment for unstable coronary artery disease (UCAD) currently consists of antithrombotic therapy with aspirin plus unfractionated heparin (UFH), together with anti-ischemic treatment with beta blockers and nitrates. Recently, there has been a trend toward replacement of UFH with low-molecular-weight heparins (LMWHs), since these products offer significant advantages over the parent compound. Several lines of evidence suggest that prolongation of treatment with LMWHs beyond the acute phase may be appropriate in patients with UCAD. The Fragmin and Fast Revascularization during InStability in Coronary artery disease (FRISC II) study was designed to evaluate this hypothesis using the LMWH dalteparin sodium (Fragmin). A factorial design was used to randomize patients enrolled in the FRISC II study to an invasive or noninvasive management strategy, and to treatment with dalteparin sodium or placebo. Treatment with dalteparin sodium significantly reduced incidences of death and/or myocardial infarction (MI) during the first months of treatment (the reduction in the relative risk of double endpoint events was statistically significant at 47.0% at 1 month, and remained so at 2 months, but was no longer statistically significant at the 3-month assessment). However, risk, as defined by the triple endpoint of death, MI, and revascularization, was significantly lower (13.0% relative risk reduction) at 3-month follow-up in the treatment group randomized to dalteparin sodium than among patients receiving placebo. In patients in whom revascularization procedures were carried out, the risk of new, postprocedural events was low in both the placebo and dalteparin sodium arms. Thus, dalteparin sodium appears to protect patients from cardiac events until they undergo invasive procedures, and it can therefore be used as a bridge to revascularization.
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Lars Wallentin (2000) studied this question.
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