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This paper describes the rationale and methods entailed in developing the Inventory of Depressive Symptomatology (IDS) in both clinician‐rated (IDS‐C) and self‐reported (IDS‐SR) formats. Psychometric features of the both the IDS‐C and IDS‐SR are presented. These scales are compared to the Hamilton Rating Scale for Depression (HRS‐D) in the detection of symptom change in patients with major depressive (n = 184) or bipolar disorder (n = 141). The face validity and established psychometric features of the IDS‐C and IDS‐SR indicate that either may be useful in detecting symptom change, as well as in detecting residual symptoms in depressed patients. Further efforts to shorten each measure are indicated. Copyright © 2000 Whurr Publishers Ltd.

Aims Edoxaban is a direct factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF). Uninterrupted edoxaban therapy in patients undergoing AF ablation has not been tested. Methods and results The ELIMINATE-AF trial, a multinational, multicentre, randomized, open-label, parallel-group study, was conducted to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for dose reduction) vs. vitamin K antagonists (VKAs) in AF patients undergoing catheter ablation. Patients were randomized 2:1 to edoxaban vs. VKA. The primary endpoint (per-protocol population) was time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding during the period from the end of the ablation procedure to end of treatment (90 days). Overall, 632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent brain magnetic resonance imaging to assess silent cerebral infarcts. The primary endpoint (only major bleeds occurred) was observed in 0.3% (1 patient) on edoxaban and 2.0% (2 patients) on VKA [hazard ratio (95% confidence interval): 0.16 (0.02–1.73)]. In the ablation population (modified intent-to-treat population including patients with ablation), the primary endpoint was observed in 2.7% of edoxaban (N = 10) and 1.7% of VKA patients (N = 3) between start of ablation and end of treatment. There were one ischaemic and one haemorrhagic stroke, both in patients on edoxaban. Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62). Conclusion Uninterrupted edoxaban therapy represents an alternative to uninterrupted VKA treatment in patients undergoing AF ablation.

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The ENTRUST-AF PCI trial tests the hypothesis that an edoxaban-based antithrombotic strategy reduces the risk of bleeding complications after PCI compared with VKA plus conventional dual-antiplatelet therapy in patients with AF in need of oral anticoagulation. The relative risk of ischemic events between groups will be compared.

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Aim Non-vitamin K oral anticoagulants (NOACs) are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report one-year outcomes in patients with AF treated with edoxaban in routine care. Methods and results ETNA-AF-Europe is a prospective, multi-centre, post-authorisation, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban’s post-approval safety plan. Altogether 13,092 patients in 852 sites completed the one-year follow-up (mean age: 73.6 ± 9.5 years; 57% male, mean follow-up: 352 ± 49 days [median: 366 days]). Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualised event rate: 0.82%/year), and major bleeding events was reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low (30 patients [0.24%/year]). Death occurred in 442 patients (3.50%/year); cardiovascular death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and cardiovascular mortality were higher in patients receiving edoxaban 30 mg versus 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg versus 60 mg. Conclusion The rates of stroke, systemic embolism and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.