Effect of hyaluronidase on mortality and morbidity in patients with early peaking of plasma creatine kinase MB and non-transmural ischaemia. Multicentre investigation for the limitation of infarct size (MILIS).
Key result
Hyaluronidase had no effect on mortality or infarct size overall, but reduced total mortality by 45% compared to placebo in patients with early peaking of plasma creatine kinase MB.
Why the study?
Does hyaluronidase reduce mortality and infarct size in patients with acute myocardial infarction?
Population
730 patients with acute myocardial infarction admitted within 18 hours of onset of symptoms.
Comparison
Hyaluronidase or propranolol. vs Placebo.
Design
RCT, Randomised to group A or group B., Blind
Follow-up
4 years
Authors
Discussion
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Implication
No overall AMI benefit; leaves open targeted use in early CK-MB peak subgroup for confirmation trials.
Study Design
Type
RCT (n=730)
Blinding
blind
Randomization
randomised
Multicenter
Yes
Structured PICO
Does hyaluronidase reduce mortality and infarct size in patients with acute myocardial infarction?
P
Population
730 patients with acute myocardial infarction admitted within 18 hours of symptom onset, followed for up to four years.
I
Intervention
Hyaluronidase (500 U/kg given every six hours for 48 hours) or propranolol.
C
Comparator
Placebo.
O
Outcome
Mortality and infarct size.hard clinical
While hyaluronidase did not improve outcomes in the overall AMI population, it was associated with improved survival in a subgroup of patients with early peaking of plasma creatine kinase MB.
Limitations
- Post-hoc subgroup analysis
Cite This Study
Roberts et al. (1988) conducted an RCT in acute myocardial infarction (n=730). Hyaluronidase vs. placebo was evaluated on mortality or infarct size. Hyaluronidase had no effect on mortality or infarct size overall, but reduced total mortality by 45% compared to placebo in patients with early peaking of plasma creatine kinase MB.