Review Article

Novel Antiplatelet Agent Use for Acute Coronary Syndrome in the Emergency Department: A Review

Table 2

Risk of bias assessment of key trials.

TRITON-TIMI 38TRILOGY ACSPLATO
Authors judgementSupport for judgementAuthors judgementSupport for judgementAuthors judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk of biasNo information provided on randomization protocol aside from stratification based on presenting symptomsUnclear risk of biasNo information provided on randomization protocol aside from stratification by age, country, and prior clopidogrel treatment statusLow risk of biasPatients randomised using computer software (treating physician could not influence) operating on a randomisation schedule managed by a group not involved in the trial
Allocation concealment (selection bias)Low risk of biasDouble-dummy trial method usedLow risk of biasDouble-dummy trial method usedLow risk of biasDouble-dummy trial method used
Blinding of participants and personnel (performance bias)Unclear risk of biasTrial is “double blinded" but does not refer explicitly who is blindedUnclear risk of biasTrial is “double blinded" but does not refer explicitly who is blindedUnclear risk of biasTrial is “double blinded" but does not refer explicitly who is blinded
Blinding of outcome assessment (detection bias)Unclear risk of biasTrial is “double blinded" but does not refer explicitly who is blindedUnclear risk of biasTrial is “double blinded" but does not refer explicitly who is blindedUnclear risk of biasTrial is “double blinded" but does not refer explicitly who is blinded
Incomplete outcome data (attrition bias)Low risk of biasIntention to treat analysis, only 0.1% of patients lost to followup, raw data for safety and efficacy endpoints provided for overall cohortLow risk of biasA similar proportion of the prasugrel and clopidogrel groups (76% versus 78%, resp.) continued to receive the study drug throughout the followup. A small proportion (120 patients from 4 sites) were excluded from analysis due to breaking protocol, this was done prior to unblinding, and therefore the effects were unknown to the authors. Low risk of biasAnalysis carried out on entire prespecified stratum. Similar proportions of study drug (14.6) and control drug (14.0) treated patients dropped out of the study. Intention to treat analysis
Selective reporting (reporting bias)Low risk of biasStudy protocol available and all primary, secondary and safety outcomes are reportedLow risk of biasStudy protocol available and all primary, secondary, and safety outcomes are reportedLow risk of biasStudy protocol available and all primary, secondary, and safety outcomes are reported
Other sources of biasLow risk of biasThe study appears to be free of other sources of bias Low risk of biasThe study appears to be free of other sources of bias Low risk of biasThe study appears to be free of other sources of bias