Use of DOACs in real-world challenging settings: a Delphi Consensus from Italian cardiologists.

Background: Direct oral anticoagulants (DOACs) represent the first therapeutic option for stroke prevention in patients with non-valvular atrial fibrillation (AF). However, phase 3 trials that demonstrated higher safety and at least similar efficacy of DOACs compared to Warfarin, included a selected population, not entirely representative of real-world. The present Consensus document was aimed at overcoming the uncertainties about DOAC use in challenging setting where data are conflicting or sparse or where a gap between trials and real world exists.

Methods: The Delphi method was used to achieve consensus on DOAC use in AF patients throughout 104 Cardiologists in Piedmont, Italy. A questionnaire on 6 commonly encountered clinical settings was administered: 1) the elderly; 2) the "frail" patient; 3) interactions with food/drugs; 4) low-dosages; 5) cancer patients; 6) patients with acute coronary syndrome.

Results: DOAC use over Warfarin was investigated in the elderly population, in the frail patients and in those with cancer, and clinical consensus was reached on its preferential use. Drug interactions should always be considered when a DOAC is prescribed and dosage should respect the Summary of Product Characteristics. No consensus was reached in patients with severe renal impairment and in those with dynamic clinical characteristics ("borderline patients"). DOACs should be considered as the first-line anticoagulation therapy in patients with high intracranial bleeding risk.

Conclusions: DOACs should represent the first-line anticoagulation therapy in non-valvular AF patients in the majority of challenging settings, underexplored by literature. Caution in their prescription is needed in case of severe renal impairment. Dose choice should follow the SmPC, although this is matter of debate in borderline patients.