Table 1.

Questions that the clinician treating unprovoked VTE may ask in light of the EMA Recommendations

Is there adequate evidence to adhere to the EMA recommendation and refrain from selecting a DOAC among all patients with a diagnosis of APS?

Does the EMA recommendation imply that all patients with acute unprovoked VTE be tested for APS prior to prescribing a DOAC for initial anticoagulation?

Are there medico‐legal ramifications for the clinician if a DOAC is selected for treatment of acute VTE, yet the patient experiences recurrent VTE and is subsequently diagnosed with APS?

Is there a subset of patients with unprovoked VTE that is more likely to have APS and should be evaluated for APS prior to prescription of acute anticoagulant therapy? What are the characteristics of patients with unprovoked VTE that are likely to have APS? Is there evidence justifying a workup for APS among patients with unprovoked VTE? What is the false‐positive rate of APS evaluation among patients with unprovoked VTE? What harm (eg, psychological disutility) would be associated with a false‐positive diagnosis?

Is it feasible to evaluate all or select patients with unprovoked VTE for APS?

Would evaluation of all or select patients with unprovoked VTE for APS be cost effective?

What is the number needed to test to inform choice of anticoagulant that would prevent 1 VTE recurrence?

Abbreviations: APS, antiphospholipid syndrome; DOAC, direct oral anticoagulant; VTE, venous thromboembolism.