Comparative non-persistence in the first year of treatment with oral anticoagulants in patients with atrial fibrillation: A French comprehensive nationwide study.

BACKGROUND: Direct oral anticoagulants (DOACs) were developed as an alternative to vitamin K antagonists (VKAs) and are commonly used for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Unlike VKAs, DOACs do not require Internal Normalized Ratio (INR) monitoring, but regular intake is as important for effective anticoagulation. OBJECTIVES: This study examined treatment persistence among patients receiving oral anticoagulants (OACs) for NVAF. METHODS: Within the French healthcare claims database (SNDS), we assessed and compared the rates of non-persistence (≥ 30-day treatment gap) among patients with NVAF initiating an OAC between January 2014 and December 2016. The time-to-event of non-persistence was computed and plotted using a cumulative incidence function accounting for the competing risk of mortality. After adjusting on confounding factors, the risk for non-persistence was compared between apixaban and each other OACs using a Cox proportional hazard model, or Fine and Gray models. RESULTS: In a cohort of 321,501 OAC-naive patients with NVAF, the cumulative incidence of non-persistence at 12 months considering competing risk was 44.3%, 31.0%, 41.3% and 46.8% for VKAs, apixaban, rivaroxaban and dabigatran, respectively. Median therapy duration before non-persistence ranged between 70 and 121 days. Non-persistence was lower with apixaban compared with VKAs (HR=0.63, 95%CI=[0.62-0.64]), rivaroxaban (HR=0.71, 95%CI=[0.70-0.73]), and dabigatran (HR=0.60, 95%CI=[0.59-0.62]). CONCLUSIONS: In this nationwide observational study, non-persistence rates of oral anticoagulant treatment were high in patients treated for NVAF. Apixaban-treated patients seem to experience lowest discontinuation rates 12 months after treatment initiation compared to patients treated with any other OAC.

Comparative Safety and Effectiveness of Oral Anticoagulants in Nonvalvular Atrial Fibrillation: The NAXOS Study.

BACKGROUND AND PURPOSE: The effects of direct oral anticoagulants in nonvalvular atrial fibrillation should be assessed in actual conditions of use. France has near-universal healthcare coverage with a unified healthcare information system, allowing large population-based analyses. NAXOS (Evaluation of Apixaban in Stroke and Systemic Embolism Prevention in Patients With Nonvalvular Atrial Fibrillation) aimed to compare the safety, effectiveness, and mortality of apixaban with vitamin K antagonists (VKAs), rivaroxaban, and dabigatran, in oral anticoagulant-naive patients with nonvalvular atrial fibrillation. METHODS: This was an observational study using French National Health System claims data and including all adults with nonvalvular atrial fibrillation who initiated oral anticoagulant between 2014 and 2016. Outcomes of interest were major bleeding events leading to hospitalization (safety), stroke and systemic thromboembolic events (effectiveness), and all-cause mortality. Four approaches were used for comparative analyses: matching on propensity score (PS; 1:n); as a sensitivity analysis, matching on high-dimensional PS; adjustment on PS; and adjustment on known confounders. For each outcome, cumulative incidence rates accounting for competing risks of death were estimated. RESULTS: Overall, 321 501 patients were analyzed, of whom 35.0%, 27.2%, 31.1%, and 6.6% initiated VKAs, apixaban, rivaroxaban, and dabigatran, respectively. Apixaban was associated with a lower PS-matched risk of major bleeding compared with VKAs (hazard ratio [HR], 0.43 [95% CI, 0.40-0.46]) and rivaroxaban (HR, 0.67 [95% CI, 0.63-0.72]), but not dabigatran (HR, 0.93 [95% CI, 0.81-1.08]). Apixaban was associated with a lower risk of stroke and systemic thromboembolic event compared with VKAs (HR, 0.60 [95% CI, 0.56-0.65]), but not rivaroxaban (HR, 1.05 [95% CI, 0.97-1.15]) or dabigatran (HR, 0.93 [95% CI, 0.78-1.11]). All-cause mortality was lower with apixaban than with VKAs, but not lower than with rivaroxaban or dabigatran. CONCLUSIONS: Apixaban was associated with superior safety, effectiveness, and lower mortality than VKAs; with superior safety than rivaroxaban and similar safety to dabigatran; and with similar effectiveness when compared with rivaroxaban or dabigatran. These observational data suggest potentially important differences in outcomes between direct oral anticoagulants, which should be explored in randomized trials.

Influence of sociodemographic factors on quality of life during pollen season in seasonal allergic rhinitis patients.

BACKGROUND: Quality of life (QOL) is an important outcome in asthma and seasonal allergic rhinitis (SAR), and its determinants are imperfectly understood. More specifically, the influence of sociodemographic factors on QOL in patients with SAR has been so far little investigated. OBJECTIVE: To examine the changes of QOL during the pollen season in patients with isolated SAR or SAR associated with asthma. METHODS: A prospective cohort study was conducted in southern France. Outpatients aged 18 to 60 years and regularly treated by respiratory physicians for SAR (with or without associated asthma) were identified. Patients were recruited before the grass or ragweed pollination period. At peak pollination, patients completed the French versions of the Mini Rhino-conjunctivitis Quality of Life Questionnaire (mini-RQLQ) and the 12-item Short-Form Health Survey (SF-12) physical component summary (PCS) and mental component summary (MCS). RESULTS: A total of 135 patients was included, 83 with isolated SAR and 52 with associated asthma (mean age, 35.4 years; SD, 10.6 years; 56% female). At pollen peak, QOL scores were lower in women for all instruments, with significant effects on SF-12 MCS and PCS scores in multivariate analyses. Likewise, a university-level education was an independent predictor of higher SF-12 PCS and MCS scores. Patients who lived in rural areas had significantly poorer QOL at pollen peak, as measured by the mini-RQLQ (P = .002) and SF-12 PCS (P = .008). No influence of age, presence of an animal at home, or smoking status could be identified on any QOL scores. CONCLUSIONS: Being a woman, living in the countryside, and having a lower education level were all independent predictors of poorer QOL of SAR patients. These factors must be taken into account when interpreting QOL of patients with SAR. Further studies are needed to confirm these results.

Quality of life during pollen season in patients with seasonal allergic rhinitis with or without asthma.

OBJECTIVES: We studied the evolution of generic and rhinoconjunctivitis-specific quality of life (QOL) during pollen season in patients with isolated seasonal allergic rhinitis (SAR) and those with asthma and concomitant SAR (AS+SAR). Generic QOL between groups was also compared at pollen peak. METHODS: A prospective cohort study was conducted in Southern France in 2002. Outpatients aged 18-60, regularly visiting respiratory physicians for SAR, were recruited before the grass (grass cohort) or ragweed pollination period (ragweed cohort). Before the pollination period (baseline) and at peak pollination, patients completed French versions of the Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini-RQLQ) and physical and mental Short Form-12 (SF-12) scores (PCS and MCS) to determine rhinoconjunctivitis and generic QOL. RESULTS: Totals of 83 and 52 patients were included in the SAR and AS+SAR groups, respectively (mean age=35.4; 56.4% females). Mini-RQLQ scores indicated slightly worse QOL in the A+SAR group at inclusion, which significantly deteriorated at the time of pollen peak, both in the SAR (p<0.0001) and AS+SAR groups (p=0.003). In univariate analysis, significantly higher SF-12 PCS (meaning better QOL) were observed at pollen peak in the SAR compared with the AS+SAR group (p=0.0008), while the difference for SF-12 MCS was more limited (p=0.05). Results were confirmed in multivariable analyses adjusting for gender, allergy medication use at pollen peak, cohort of inclusion (grass/ragweed) and comorbid conditions. CONCLUSIONS: Significant deterioration in rhinoconjunctivitis-specific QOL was observed through the pollination period in patients with SAR and AS+SAR. At pollen peak, AS+SAR patients experienced significantly worse physical functioning than patients with SAR alone.