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Comparative Clinical Effectiveness of Population-Based Atrial Fibrillation Screening Using Contemporary Modalities: A Decision-Analytic Model.

ABSTRACT: Background Atrial fibrillation (AF) screening is endorsed by certain guidelines for individuals aged ≥65 years. Yet many AF screening strategies exist, including the use of wrist-worn wearable devices, and their comparative effectiveness is not well-understood. Methods and Results We developed a decision-analytic model simulating 50 million individuals with an age, sex, and comorbidity profile matching the United States population aged ≥65 years (ie, with a guideline-based AF screening indication). We modeled no screening, in addition to 45 distinct AF screening strategies (comprising different modalities and screening intervals), each initiated at a clinical encounter. The primary effectiveness measure was quality-adjusted life-years, with incident stroke and major bleeding as secondary measures. We defined continuous or nearly continuous modalities as those capable of monitoring beyond a single time-point (eg, patch monitor), and discrete modalities as those capable of only instantaneous AF detection (eg, 12-lead ECG). In total, 10 AF screening strategies were effective compared with no screening (300-1500 quality-adjusted life-years gained/100 000 individuals screened). Nine (90%) effective strategies involved use of a continuous or nearly continuous modality such as patch monitor or wrist-worn wearable device, whereas 1 (10%) relied on discrete modalities alone. Effective strategies reduced stroke incidence (number needed to screen to prevent a stroke: 3087-4445) but increased major bleeding (number needed to screen to cause a major bleed: 1815-4049) and intracranial hemorrhage (number needed to screen to cause intracranial hemorrhage: 7693-16 950). The test specificity was a highly influential model parameter on screening effectiveness. Conclusions When modeled from a clinician-directed perspective, the comparative effectiveness of population-based AF screening varies substantially upon the specific strategy used. Future screening interventions and guidelines should consider the relative effectiveness of specific AF screening strategies.

SUBMITTER: Khurshid S

PROVIDER: S-EPMC8649502 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients.This is a retrospective cohort study of patients with paroxysmal or persistent nonvalvular AF. We updated an Atrial Fibrillation Decision Support Tool (AFDST) to include DOACs as treatment options. The tool generates patient-specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding using quality-adjusted life-years (QALYs) calculated for each treatment strategy by a decision analytic model. The setting included inpatient and ambulatory sites in an academic health center in the midwestern United States. The study involved 5,121 adults with nonvalvular AF seen for any ambulatory visit or inpatient hospitalization over the 1-year period (January through December 2016). Outcome measure was net clinical benefit in QALYs.When DOACs are a therapeutic option, the AFDST recommends OAT for 4,134 (81%) patients and no antithrombotic therapy or aspirin for 489 (9%). A strong recommendation for OAT could not be made in 498 (10%) patients. When warfarin is the only option, OAT is recommended for 3,228 (63%) patients and no antithrombotic therapy or aspirin for 973 (19%). A strong recommendation for OAT could not be made in 920 (18%) patients. In total, 1,508 QALYs could be gained if treatment were changed to that recommended by the AFDST.Availability of DOACs increases the proportion of patients for whom oral anticoagulation therapy is recommended in a real-world cohort of AF patients and increased projected QALYs by more than 1,500 when all patients are receiving thromboprophylaxis as recommended by the AFDST compared with current treatment.

Project description:Background Optimal management of asymptomatic Brugada syndrome (BrS) with spontaneous type I electrocardiographic pattern is uncertain. Methods and Results We developed an individual-level simulation comprising 2 000 000 average-risk individuals with asymptomatic BrS and spontaneous type I electrocardiographic pattern. We compared (1) observation, (2) electrophysiologic study (EPS)-guided implantable cardioverter-defibrillator (ICD), and (3) upfront ICD, each using either subcutaneous or transvenous ICD, resulting in 6 strategies tested. The primary outcome was quality-adjusted life years (QALYs), with cardiac deaths (arrest or procedural-related) as a secondary outcome. We varied BrS diagnosis age and underlying arrest rate. We assessed cost-effectiveness at $100 000/QALY. Compared with observation, EPS-guided subcutaneous ICD resulted in 0.35 QALY gain/individual and 4130 cardiac deaths avoided/100 000 individuals, and EPS-guided transvenous ICD resulted in 0.26 QALY gain and 3390 cardiac deaths avoided. Compared with observation, upfront ICD reduced cardiac deaths by a greater margin (subcutaneous ICD, 8950; transvenous ICD, 6050), but only subcutaneous ICD improved QALYs (subcutaneous ICD, 0.25 QALY gain; transvenous ICD, 0.01 QALY loss), and complications were higher. ICD-based strategies were more effective at younger ages and higher arrest rates (eg, using subcutaneous devices, upfront ICD was the most effective strategy at ages 20-39.4 years and arrest rates >1.37%/year; EPS-guided ICD was the most effective strategy at ages 39.5-51.3 years and arrest rates 0.47%-1.37%/year, and observation was the most effective strategy at ages >51.3 years and arrest rates <0.47%/year). EPS-guided subcutaneous ICD was cost-effective ($80 508/QALY). Conclusions Device-based approaches (with or without EPS risk stratification) can be more effective than observation among selected patients with asymptomatic BrS. BrS management should be tailored to patient characteristics.

Project description:Background and purposeComparative effectiveness and safety of oral anticoagulants in patients with atrial fibrillation and high polypharmacy are unknown.MethodsWe used Medicare administrative data to evaluate patients with new atrial fibrillation diagnosis from 2015 to 2017, who initiated an oral anticoagulant within 90 days of diagnosis. Patients taking ≤3, 4 to 8, or ≥9 other prescription medications were categorized as having low, moderate, or high polypharmacy, respectively. Within polypharmacy categories, patients receiving apixaban 5 mg twice daily, rivaroxaban 20 mg once daily, or warfarin were matched using a 3-way propensity score matching. Study outcomes included ischemic stroke, bleeding, and all-cause mortality.ResultsThe study cohort included 6985 patients using apixaban, 3838 using rivaroxaban, and 6639 using warfarin. In the propensity-matched cohorts there was no difference in risk of ischemic stroke between the 3 drugs in patients with low and moderate polypharmacy. However, among patients with high polypharmacy, the risk of ischemic stroke was higher with apixaban compared with warfarin (adjusted hazard ratio 2.34 [95% CI, 1.01-5.42]; P=0.05) and similar to rivaroxaban (adjusted hazard ratio, 1.38 [95% CI, 0.67-2.84]; P=0.4). There was no difference in risk of death between the 3 drugs in patients with low and moderate polypharmacy, but apixaban was associated with a higher risk of death compared with rivaroxaban (adjusted hazard ratio, 2.03 [95% CI, 1.01-4.08]; P=0.05) in the high polypharmacy group. Apixaban had lower bleeding risk compared with warfarin in the low polypharmacy group (adjusted hazard ratio, 0.54 [95% CI, 0.32-0.90]; P=0.02), but there was no difference in bleeding between the 3 drugs in the moderate and high polypharmacy groups.ConclusionsOur study suggests that among patients with significant polypharmacy (>8 drugs), there may be a higher stroke and mortality risk with apixaban compared with warfarin and rivaroxaban. However, differences were of borderline significance.

Project description: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.

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Comparative Clinical Effectiveness of Population-Based Atrial Fibrillation Screening Using Contemporary Modalities: A Decision-Analytic Model.

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