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. 2016 Mar 10;2016(3):MR000043. doi: 10.1002/14651858.MR000043.pub2

OASIS‐2 1999.

Methods RCT comparing the effects of recombinant hirudin (lepirudin) versus heparin on death, myocardial infarction, refractory angina, and revascularisation procedures in patients with acute myocardial ischaemia without ST elevation.
Data 10,141 patients randomised (5058/5083, respectively in each treatment group).
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was myocardial infarction at 7 days or cardiovascular death.
Notes The study was identified because it was included in a pooled analysis of 10 RCTs (Pogue 2009). Data related to the number of events in each treatment group resulting from onsite‐assessor and AC assessments were extracted from this meta‐analysis on the primary outcomes of the included studies.
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? No All suspect events adjudicated were identified by onsite assessor who was blinded to allocated treatment.