FRISC II invasive研究课件.ppt

FRISC II: Fragmin and fast Revascularization during InStability in Coronary artery disease- INVASIVE TREATMENT - Purpose To compare early invasive with non-invasive treatment in unstable coronary artery disease Reference FRISC II Investigators. Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. Lancet 1999;354:708-15. FRISC II: Fragmin and fast Revascularization during InStability in Coronary artery disease - INVASIVE TREATMENT: TRIAL DESIGN - Design Randomized, multicenter, open: invasive arm of trial also investigating long-term low molecular mass heparin (dalteparin) Patient selection Hospitalized with ischemia symptoms for 48h before start of heparin/dalteparin increasing or at rest (chest pain with ST depression, T inversion or raised biochemical markers) Pre-randomization therapy Aspirin 300–600 mg; b-blockade unless contraindicated; organic nitrates, Ca++ antagonists as required; statins, ACE inhibitors, aggressive antidiabetic treatment according to guidelines Dalteparin 120 U/kg every 12h or infusion of standard heparin FRISC II: Fragmin and fast Revascularization during InStability in Coronary artery disease - INVASIVE TREATMENT: TRIAL DESIGN cont. - Randomization Up to 72h after start of open-label dalteparin, patients randomized to: early invasive or non-invasive treatment (in absence of contraindications for invasive treatment) or dalteparin or placebo for 90 days (all patients) All patients received open-label dalteparin 120 U/kg every 12h for at least 5 days until: non-invasive double-blind dalteparin/placebo treatment started or revascularization and double-blind dalteparin/placebo started FRISC II: Fragmin and fast Revascularization during InStability in Coronary artery disease - INVASIVE TREATMENT: TRIAL DESIGN cont. - Patients 2457 (median age 66 years) entered invasive vs. non-invasive arm Follow up and primary endpoint