BACKGROUND: Short-term treatment with subcutaneous low-molecular-mass heparin in addition to aspirin is effective in unstable coronary-artery disease. We assessed the efficacy of long-term treatment with dalteparin in patients managed with a non-invasive treatment strategy. METHODS:2267 patients from three Scandinavian countries (median age 67 years, 68% men) with unstable coronary-artery disease were randomly assigned to continue double-blind subcutaneous dalteparin twice daily or placebo for 3 months, after at least 5 days' treatment with open-label dalteparin. The composite primary endpoint was death or myocardial infarction. Analysis was by intention to treat. FINDINGS: During the 3 months of double-blind treatment, there was a non-significant decrease in the composite endpoint of death or myocardial infarction of 6.7% and 8.0% in the dalteparin and placebo groups, respectively (risk ratio 0.81 [95% CI 0.60-1.10], p=0.17). At 30 days, this decrease was significant (3.1 vs 5.9%, 0.53 [0.35-0.80]; p=0.002). In the total cohort there was at 3 months a decrease in death, myocardial infarction, or revascularisation (29.1 vs 33.4%, 0.87 [0.77-0.99]; p=0.031). The initial benefits were not sustained at 6-month follow-up. INTERPRETATION: Long-term dalteparin lowers the risk of death, myocardial infarction, and revascularisation in unstable coronary-artery disease at least during the first month of therapy. These early protective effects could be used to lower the risk of events in patients waiting for invasive procedures.
RCT Entities:
BACKGROUND: Short-term treatment with subcutaneous low-molecular-mass heparin in addition to aspirin is effective in unstable coronary-artery disease. We assessed the efficacy of long-term treatment with dalteparin in patients managed with a non-invasive treatment strategy. METHODS: 2267 patients from three Scandinavian countries (median age 67 years, 68% men) with unstable coronary-artery disease were randomly assigned to continue double-blind subcutaneous dalteparin twice daily or placebo for 3 months, after at least 5 days' treatment with open-label dalteparin. The composite primary endpoint was death or myocardial infarction. Analysis was by intention to treat. FINDINGS: During the 3 months of double-blind treatment, there was a non-significant decrease in the composite endpoint of death or myocardial infarction of 6.7% and 8.0% in the dalteparin and placebo groups, respectively (risk ratio 0.81 [95% CI 0.60-1.10], p=0.17). At 30 days, this decrease was significant (3.1 vs 5.9%, 0.53 [0.35-0.80]; p=0.002). In the total cohort there was at 3 months a decrease in death, myocardial infarction, or revascularisation (29.1 vs 33.4%, 0.87 [0.77-0.99]; p=0.031). The initial benefits were not sustained at 6-month follow-up. INTERPRETATION: Long-term dalteparin lowers the risk of death, myocardial infarction, and revascularisation in unstable coronary-artery disease at least during the first month of therapy. These early protective effects could be used to lower the risk of events in patients waiting for invasive procedures.
Authors: D J Blackman; N R Clarke; W P Orr; E Wilkinson; A Beswick; D Coppock; D C Sprigings; A P Banning Journal: Heart Date: 2002-04 Impact factor: 5.994