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1、,ISIS-2: Second International Study of Infarct Survival,Purpose To assess the effects of intravenous streptokinase (SK) and oral aspirin, alone and in combination, shortly after suspected acute MI Reference The ISIS-2 collaborative group. Randomized trial of intravenous streptokinase, oral aspirin,
2、both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988;ii: 34960.,ISIS-2: Second International Study of Infarct Survival - TRIAL DESIGN -,Design: Multicenter, multinational, randomized, double-blind, placebo-controlled Patients: 17,187 patients with suspect
3、ed MI in previous 24h; patients with history of stroke or GI hemorrhage/ulcer were excluded Follow up and primary endpoint: Median 15 months follow up. Primary endpoint vascular mortality Treatment Patients randomized to one of four groups SK (1.5 million U over 60 min) and aspirin (160 mg/day for 1
4、 month) SK (1.5 million U over 60 min) and placebo matching aspirin Placebo matching SK and aspirin (160 mg/day for 1 month) Placebo matching SK and placebo matching aspirin,ISIS-2: Second International Study of Infarct Survival - RESULTS -,Significant reduction in 5-week vascular mortality for: SK
5、or aspirin compared with matched placebo, regardless of therapy with the other agent or its placebo Combination therapy compared with SK alone, aspirin alone or combination placebo Effects of SK and aspirin on 5-week vascular mortality appeared additive and independent Reduction in all-cause mortali
6、ty significant at median 15 months for each agent and for combination (2P0.001) With SK, greater benefit if therapy given early (04h) rather than late (524h) With SK, excess reinfarction and major/minor bleeds; with aspirin, excess minor bleeds but reduced reinfarction and stroke Combination associa
7、ted with excess major/minor bleeds but with greater reduction in reinfarction and stroke than either agent alone,ISIS-2: Second International Study of Infarct Survival - RESULTS continued -,Days after randomization,Cumulative,no. of,vascular,deaths,0,7,14,21,28,35,50,600,400,200,800,1000,Vascular mo
8、rtality over 35 days: individual therapies,Odds reduction:,25%, SD 4,2P0.00001,1029,(12.0%),Placebo,infusion,SK,The ISIS-2 collaborative group.,Lancet 1988; ii: 34960.,791,(9.2%),0,7,14,21,28,35,50,600,400,200,800,1000,Odds reduction:,23%, SD 4,2P0.00001,1016,(11.8%),Placebo,tablets,Aspirin,804,(9.4
9、%),ISIS-2: Second International Study of Infarct Survival - RESULTS continued -,Vascular mortality at 35 days in four treatment arms and combination,The ISIS-2 collaborative group.,Lancet 1988; ii: 34960.,Streptokinase,8.0,Vascular mortality (%) at 35 days,Aspirin,Placebo,Placebo,13.2,ISIS-2: Second
10、 International Study of Infarct Survival - RESULTS continued -,Months after randomization,Estimated % surviving,0,12,24,70,100,95,90,85,80,Estimates of 12- and 24-month survival,Placebo,infusion,SK,The ISIS-2 collaborative group.,Lancet 1988; ii: 34960.,0,12,24,70,100,95,90,85,80,0,12,24,70,100,95,9
11、0,85,80,Placebo,tablets,Aspirin,Placebo,infusion,and tablets,ISIS-2: Second International Study of Infarct Survival - RESULTS continued -,Reduction in odds of vascular death in days 035, by time from pain onset,Odds ratio and 95%CI*,01,2,3,4,Subtotal for 04,512,1324,Subtotal for 524,Total for 024,Th
12、e ISIS-2 collaborative group.,Lancet 1988; ii: 34960.,0.5,1.0,1.5,0.5,1.0,1.5,Time of randomization,(hours from pain onset),SK,better,Placebo,better,Aspirin,better,Placebo,better,ISIS-2: Second International Study of Infarct Survival - RESULTS continued -,Reinfarction,Major bleed,(transfused),Minor
13、bleed,(not transfused),Stroke,(excluding TIA),202,18,81,67,238,46,297,61,284,33,163,81,156,31,215,47,123,11,33,45,77,24,167,25,Effects of SK and aspirin on clinical events,The ISIS-2 collaborative group.,Lancet 1988; ii: 34960.,Placebo,infusion,(n=8595),SK allocation,Clinical,event,Placebo,tablets,(
14、n=8600),SK,(n=8592),Aspirin,(n=8587),Both,placebos,(n=4300),SK and,aspirin,(n=4292),Aspirin allocation,Combination therapy,ISIS-2: Second International Study of Infarct Survival - SUMMARY -,Early therapy with SK and aspirin in patients with MI: Individually and in combination significantly reduced all-cause mortality In combination demonstrated additive effect,
