Long-term low-molecular-mass heparin in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. FRagmin and Fast Revascularisation during InStability in Coronary artery disease. Investigators.
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.


RESULTS
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.


CONCLUSIONS
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.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000188:drug therapy* / Q000401:mortality; D015331:Cohort Studies; D017985:Dalteparin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D011446:Prospective Studies; D012537:Scandinavian and Nordic Countries; D015996:Survival Rate
D017985:Dalteparin