The primary drug measurement required a stent procedure
The PACIFY trial randomized 212 people undergoing coronary angiography to receive intravenous fentanyl or no planned fentanyl. Ticagrelor was given to the 70 who went on to coronary stenting. Only those patients could contribute to the comparison of ticagrelor exposure and platelet inhibition after the oral loading dose.
Two patients changed groups in the as-treated analysis
Two people assigned to no fentanyl received it for pain. An analysis by assignment retains them in their original group. An as-treated comparison counts them with the patients who received fentanyl. The study reported lower ticagrelor exposure with fentanyl. For case review, identify which analysis produced the quoted estimate and whether the claim concerns concentrations, platelet testing or a clinical outcome.
Keep the outcome tied to its denominator
The 212-person figure describes enrollment and randomization. The 70-person figure describes the group with the relevant drug exposure. Using the larger number to characterize precision for the ticagrelor result would overstate the amount of direct evidence. The trial’s concentration and platelet findings also do not quantify the clinical outcome for a particular patient.
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