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Use of DOACs in real-world challenging settings: a Delphi Consensus from Italian cardiologists
Roberta Rossini1, Giorgio Quadri2, Andrea Rognoni3
1Division of Cardiology, S. Croce e Carle Hospital, Cuneo, Italy.
Insights
Direct oral anticoagulants (DOACs) are recommended for stroke prevention in non-valvular atrial fibrillation (AF) patients, especially in challenging real-world settings. Consensus supports DOACs over warfarin in elderly, frail, and cancer patients, with caution in severe renal impairment.
Area of Science:
- Cardiology
- Pharmacology
- Internal Medicine
Background:
- Direct oral anticoagulants (DOACs) are first-line for stroke prevention in non-valvular atrial fibrillation (AF).
- Phase 3 trial populations were selected, limiting real-world applicability.
- This consensus addresses uncertainties in challenging clinical settings for DOAC use.
Purpose of the Study:
- To achieve expert consensus on DOAC utilization in specific, challenging AF patient populations.
- To reconcile trial data with real-world clinical practice.
- To provide guidance on DOAC prescription in complex cases.
Main Methods:
- Delphi method employed with 104 cardiologists in Piedmont, Italy.
- Questionnaire focused on 6 clinical scenarios: elderly, frail, drug/food interactions, low-dosing, cancer, and acute coronary syndrome.
- Consensus building on DOAC versus warfarin use and management strategies.
Main Results:
- Clinical consensus favors DOACs over warfarin in elderly, frail, and cancer patients.
- Consideration of drug interactions and adherence to Summary of Product Characteristics (SmPC) for dosage is crucial.
- No consensus on DOAC use in severe renal impairment or "borderline" patients; DOACs recommended for high intracranial bleeding risk.
Conclusions:
- DOACs are recommended as first-line therapy in most challenging non-valvular AF settings.
- Prescribing DOACs requires caution in severe renal impairment.
- Dosing decisions should follow SmPC, though debated in borderline cases.
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.
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