ISIS-2 - 10-YEAR SURVIVAL AMONG PATIENTS WITH SUSPECTED ACUTE MYOCARDIAL-INFARCTION IN RANDOMIZED COMPARISON OF INTRAVENOUS STREPTOKINASE, ORAL ASPIRIN, BOTH, OR NEITHER
C. Baigent et al., ISIS-2 - 10-YEAR SURVIVAL AMONG PATIENTS WITH SUSPECTED ACUTE MYOCARDIAL-INFARCTION IN RANDOMIZED COMPARISON OF INTRAVENOUS STREPTOKINASE, ORAL ASPIRIN, BOTH, OR NEITHER, BMJ. British medical journal, 316(7141), 1998, pp. 1337-1343
Objective: To assess effects of intravenous streptokinase, one month o
f oral aspirin, or both, on long term survival after suspected acute m
yocardial infarction. Design: Randomised, ''2 x 2 factorial,'' placebo
controlled trial. Setting: 417 hospitals in 16 countries. Subjects: 1
7 187 patients with suspected acute myocardial infarction randomised b
etween March 1985 and December 1987. Follow up of vital status complet
e to at least 1 January 1990 for 95% of all patients and to mid-1997 f
or the 6213 patients in United Kingdom. Interventions: Intravenous str
eptokinase (1.5 MU in 1 hour) and oral aspirin (162 mg daily for 1 mon
th) versus matching placebos. Main outcome measures: Mortality from al
l causes during up to 10 years' follow up, with subgroup analyses base
d on 4 year follow up. Results: After randomisation, 1841 deaths were
recorded in days 0-35, 991 from day 36 to end of year 1, 1478 in years
2-4, and 1230 in Years 5-10. Allocation to streptokinase was associat
ed with 29 (95% confidence interval 20 to 38) fewer deaths per 1000 pa
tients during days 0-35. This early benefit persisted (death rate rati
o 0.98 (0.92 to 1.04) for additional deaths between day 36 and end of
year 10), so that there were 28 (14 to 42) and 23 (2 to 44) fewer deat
hs per 1000 patients treated with streptokinase after 4 years and 10 y
ears respectively There was no evidence that absolute survival benefit
increased with prolonged follow up among an) category of patient incl
uding those presenting early after symptoms started or with anterior S
T elevation. Nor did the early benefits seem to be lost in any categor
y (including those aged over 70). Allocation to one month of aspirin w
as associated with 26 (16 to 35) fewer deaths per 1000 during first 35
days, with little further benefit or loss during subsequent years (de
ath rate ratio 0.99 (0.93 to 1.06) between day 36 and end of year 10).
The early benefit obtained with combination of streptokinase and ope
month of aspirin also seemed to persist long term. Conclusions: The ea
rly survival advantages produced by fibrinolytic therapy and one month
of aspirin started in acute myocardial infarction seem to be maintain
ed for at least 10 years.