GISSI-3研究课件.ppt

GISSI-3: Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarcto Miocardico Purpose To determine whether the ACE inhibitor lisinopril, transdermal glyceryl nitrate or a combination of both improve survival and ventricular function after acute MI Reference Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarcto Miocardico. GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6-week mortality and ventricular function after acute myocardial infarction. Lancet 1994;343:1115–22. GISSI-3: Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarcto Miocardico - TRIAL DESIGN - Design: Multicenter, randomized, open, controlled Patients: 18,895 patients within 24h of onset of acute MI Follow up and primary endpoint: Primary endpoint: all-cause mortality. Six weeks follow up Treatment: Patients randomized to one of four groups: Lisinopril 5 mg initially, increased over 48 h to 10 mg daily Glyceryl nitrate 5 μg/min IV initially, increasing by 5–20 μg/min every 5 min for first 30 min or until systolic BP fell by 10%; infusion replaced after 24h by patch providing 10 mg/day Lisinopril and glyceryl nitrate, as above No trial therapy GISSI-3: Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarcto Miocardico - RESULTS - With lisinopril, mortality was significantly reduced compared with control (odds ratio 0.88, 95% CI 0.79–0.99, 2P=0.03), as was combined endpoint of mortality and severe ventricular dysfunction (odds ratio 0.90, 95% CI 0.84–0.98, 2P=0.009) With nitrate, no significant reduction in these endpoints compared with control With combination nitrate and lisinopril, significant reduction in both endpoints compared with control (for mortality: odds ratio 0.83, 95% CI 0.70–0.97, 2P=0.021), with some evidence of additive effect Despite significant excess persistent hypotension and renal dysfunction with lisinopril, these did not result in increased mortality or severe renal failure GISS