GISSI-1研究课件.ppt

GISSI-1: Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico Purpose To determine whether streptokinase (SK) reduces mortality when given shortly after onset of acute MI, and whether benefit, if present, depends on interval from pain onset to SK treatment Reference Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico. Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1986;i:397–402. GISSI-1: Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico - TRIAL DESIGN - Design Multicenter, randomized, open, parallel group Patients 11,806 patients with onset of acute MI within previous 12 h Follow up and primary endpoint Primary endpoint: all-cause mortality. 14–21 days follow up Treatment Patients randomized to treatment group (IV SK, 1.5 million U over 60 min) or control (no infusion) GISSI-1: Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico - RESULTS - 21-day mortality significantly reduced in SK group (relative risk 0.81, P=0.0002) compared with control For SK given at 6 h, the shorter the interval between pain onset and treatment, the bigger the reduction in mortality For SK given at 6 h, no significant difference between treatment and control SK judged safe in view of low incidence of adverse effects (major bleeds in 0.3% of SK group, anaphylactic shock in 0.1%) GISSI-1: Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico - RESULTS continued - GISSI-1: Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico - RESULTS continued - GISSI-1: Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico - SUMMARY - Given within 6 h of onset of pain in acute MI, intravenous SK: Reduced mortality Conferred greater benefit when administered earlier * Control (n=5852) P Mortality and causes of death GISSI. Lancet 1986; i:397–402. SK (n=5860) R