Methods
This cross-sectional study was conducted after receiving approval by Nova Southeastern University’s Institutional Review Board. The survey consisted of 16 items divided into 4 domains: demographics, clinical experience, use of BRTs, and treatment preferences based on cases where bleed risk was lower than or equal to stroke risk (Figure 1). Queries were multiple choice and allowed for free-text input when “Other” was selected. Licensed pharmacists ≥ 18 years of age who routinely provided care to patients with NVAF were eligible to participate in the study. Participants who reported using a BRT (users) completed all study domains, while participants who reported not using a BRT (nonusers) completed domains 1 through 3 only.
An invitation containing the survey link was sent to the American College of Clinical Pharmacy ambulatory care (n = 2237) and cardiology (n = 1318) pharmacists listed in the organization’s Practice-based Research Networks. The survey was administered in the United States between April and June 2016 via Research Electronic Data Capture (REDCap) software, a secure Web application for building and managing online surveys designed to support data collection for research studies.18
Survey responses were downloaded, and data were analyzed using NCSS 2019 Statistical Software, LLC (Kaysville, UT). Descriptive statistics were calculated for all study variables. Demographic and clinical experience data for the group that used a BRT versus the group that did not were compared using Pearson’s chi-square, ANOVA, or the Cochran-Armitage test for trends. Logistic regression with hierarchical forward selection with switching was used to identify predictors of drug selection and use of gastroprotection.
Results
Of 230 respondents who completed the survey (response rate 6.5%), 165 (72%) used a BRT and 65 (28%) did not. No significant differences were found for age, gender, duration in clinical practice, the percentage of time spent in patient care, or practice specialty between users and nonusers (Table). The median age of users was 32 years; 68% were females; the median duration in clinical practice was 6 years; 75% of their time was spent in clinical practice; and clinical settings included ambulatory care, cardiology, and internal medicine. A significant difference was found for practice region between users versus nonusers (P = 0.014). Respondents who managed more than 200 NVAF patients per year used a BRT more often than those who managed fewer than 100 NVAF patients per year (P = 0.001).
Of those who used a BRT, 97% utilized the HAS-BLED tool (n = 160). The remainder used HEMORR2HAGES (n = 3), ATRIA (n = 1), and mOBRI (n = 1). Reasons for choosing HAS-BLED included “familiarity/ease-of-use,” “preference by institution/clinical team,” and the fact that it was a “validated tool for NVAF.”
When bleed risk was lower than stroke risk, 151 of 165 users (92%) chose a treatment option (Figure 2). Of those, 65% chose a DOAC and 35% chose warfarin. Fourteen respondents chose “other” and explained that they “would initiate OACT after weighing patient factors and preferences.” When a DOAC was selected, 9% (n = 9) chose PPI co-therapy and 4% (n = 4) chose a H2RA. When warfarin was selected, 13% (n = 7) chose PPI co-therapy and 4% (n = 2) chose a H2RA. Respondents who chose gastroprotection did not provide reasons for doing so, but those who did not add it explained that they “would add gastroprotection only if patient is also on an NSAID or has a history of GI bleed” or cited “patient preference.” Specific to warfarin, some respondents would not add gastroprotection, as anticoagulation with warfarin is “easily reversed.”
When bleed risk was equal to stroke risk, 141 of 165 users (85%) chose a treatment option (Figure 3). Fifty percent chose DOACs, 45% chose warfarin, and 5% chose aspirin. Logistic regression analysis (outcome DOAC versus warfarin area-under-ROC curve, 0.67) showed that as the number of NVAF patients seen in 12 months increased, respondents were more likely to select a DOAC over warfarin (odds ratio, 1.7; 95% CI, 1.1-2.5). Therefore, for every 50-patient increase per year, the probability of recommending a DOAC increased 1.7-fold.
Of respondents who selected either a DOAC or warfarin, 38% (n = 50) also added gastroprotection (Figure 3). When a DOAC was selected, 34% (n = 24) favored PPI co-therapy and 7% (n = 5) chose a H2RA. When warfarin was selected, 19% (n = 12) favored PPI co-therapy, while 13% (n = 8) chose a H2RA. Rationale for choosing gastroprotection, regardless of OACT selection, included “stroke is more devastating, so if patient wants to continue treatment, but knew risks of bleeding were similar, would recommend gastroprotection to help minimize bleeding risk” and “patient-specific consideration.” Rationales for not choosing gastroprotection included “would add gastroprotection only if patient is on dual antiplatelet therapy or has another indication”; “in most patients, stroke risk outweighs bleed risk so no need for gastroprotection unless there is a stated reason”; “would use apixaban as has lowest bleeding rate of all DOACs in clinical trials”; and “gastroprotection has not been shown to be beneficial in large scale trials.”
Eight respondents chose aspirin because it was “easy and relatively low cost.” Twenty-four respondents chose “other” and explained that the choice of OACT depended on patient preference after they had discussed stroke and bleed risk with the patient and/or determined the etiology driving bleed risk.