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Sanders GD, Lowenstern A, Borre E, et al. Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Oct. (Comparative Effectiveness Reviews, No. 214.)

Cover of Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update

Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update [Internet].

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Table 2Major therapeutic options for stroke prevention in atrial fibrillation

PICOTS ElementInclusion CriteriaExclusion Criteria
Populations
  • Adults (≥18 years of age)
  • Patients with nonvalvular AF (including atrial flutter):
    • Paroxysmal AF (recurrent episodes that self-terminate in less than 7 days)
    • Persistent AF (recurrent episodes that last more than 7 days until stopped)
    • Permanent AF (continuous)
    • Patients with AF who experience acute coronary syndrome
  • Subgroups of interest for KQ 3 include (but are not limited to):
    • Age
    • Sex
    • Race/ethnicity
    • Presence of heart disease
    • Type of AF
    • Comorbid conditions (such as moderate to severe chronic kidney disease (eGFR<60), dementia)
    • When in therapeutic range
    • When non-adherent to medication
    • Previous thromboembolic event
    • Previous bleed
    • Pregnant
  • Patients who have known reversible causes of AF (including but not limited to postoperative, hyperthyroidism)
  • All subjects are <18 years of age, or some subjects are under <18 years of age but results are not broken down by age
InterventionsKQ 1: Clinical and imaging tools and associated risk factors for assessment/evaluation of thromboembolic risk:
  • Clinical tools include:
    • CHADS2 score
    • CHA2DS2-VASc score
    • Framingham risk score
    • ABC stroke risk score
  • Individual risk factors include:
    • INR level
    • Duration and frequency of AF
    • Age
    • Prior stroke
    • Type of AF
    • Cognitive impairment
    • Falls risk
    • Presence of heart disease
    • Presence and severity of CKD
    • DM
    • Sex
    • Race/ethnicity
    • Cancer
    • HIV
  • Imaging tools include:
    • Transthoracic echo (TTE)
    • Transesophageal echo (TEE)
    • CT scans
    • Cardiac MRIs
KQ 2: Clinical tools and individual risk factors for assessment/evaluation of intracranial hemorrhage bleeding risk:
  • Clinical tools include:
    • HAS-BLED score
    • HEMORR2HAGES score
    • ATRIA score
    • Bleeding Risk Index
    • ABC Bleeding Risk score
  • Individual risk factors include:
    • INR level
    • Duration and frequency of AF
    • Age
    • Prior stroke
    • Type of AF
    • Cognitive impairment
    • Falls risk
    • Presence of heart disease
    • Presence and severity of CKD
    • DM
    • Sex
    • Race/ethnicity
    • Cancer
    • HIV
KQ 3: Anticoagulation, antiplatelet, and procedural interventions:
  • Anticoagulation therapies:
    • VKAs: Warfarin
    • Newer anticoagulants (direct oral anticoagulants [DOACs])
      ▪

      Direct thrombin Inh-DTI: Dabigatran

      ▪

      Factor Xa inhibitors:

      • Rivaroxaban
      • Apixaban
      • Edoxaban

  • Antiplatelet therapies:
    • Clopidogrel
    • Aspirin
    • Dipyridamole
    • Combinations of antiplatelets
      ▪

      Aspirin+dipyridamole

  • Procedures:
    • Surgeries (e.g., left atrial appendage occlusion, resection/removal)
    • Minimally invasive (e.g., Atriclip, LARIAT)
    • Transcatheter (WATCHMAN™, AMPLATZER™, PLAATO)
None
Comparators
  • KQ 1: Other clinical or imaging tools listed for assessing thromboembolic risk
  • KQ 2: Other clinical tools listed for assessing bleeding risk
  • KQ 3: Other anticoagulation therapies, antiplatelet therapies, or procedural interventions for preventing thromboembolic events
For KQ 3, studies that did not include an active comparator
Outcomes
  • Assessment of clinical and imaging tool efficacy for predicting thromboembolic risk and bleeding events (KQs 1 and 2):
    • Diagnostic accuracy efficacy
    • Diagnostic thinking efficacy (defined as how using diagnostic technologies help or confirm the diagnosis of the referring provider)
    • Therapeutic efficacy (defined as how the intended treatment plan compares with the actual treatment pursued before and after the diagnostic examination)
    • Patient outcome efficacy (defined as the change in patient outcomes as a result of the diagnostic examination)
Patient-centered outcomes for KQ 3 (and for KQ 1 [thromboembolic outcomes] and KQ 2 [bleeding outcomes] under “Patient outcome efficacy”):
  • Thromboembolic outcomes:
    • Cerebrovascular infarction
    • TIA
    • Systemic embolism (excludes PE and DVT)
  • Bleeding outcomes:
    • Hemorrhagic stroke
    • Intracranial hemorrhage (intracerebral hemorrhage, subdural hematoma)
    • Major and minor bleed (stratified by type and location)a
  • Other clinical outcomes:
    • Mortality
      ▪

      All-cause mortality

      ▪

      Cardiovascular mortality

    • Myocardial infarction
    • Infection
    • Heart block
    • Esophageal fistula
    • Cardiac tamponade
    • Dyspepsia
    • Health-related quality of life
    • Functional capacity
    • Health services utilization (e.g., hospital admissions, outpatient office visits, ER visits, prescription drug use)
    • Long-term adherence to therapy
    • Cognitive function
Study does not include any outcomes of interest
Timing
  • Timing of followup not limited
None
Setting
  • Inpatient and outpatient
Studies which were conducted exclusively in Asia, Africa, or the Middle Eastb
Study design
  • Original peer-reviewed data
  • N ≥20 patients
  • RCTs, prospective and retrospective observational studies
  • Not a clinical study (e.g., editorial, nonsystematic review, letter to the editor, case series, case reports)
  • Abstract-only or poster publications; articles that have been retracted or withdrawn
  • Because studies with fewer than 20 subjects are often pilot studies or studies of lower quality,86,87 we excluded them from our review
  • Systematic reviews, meta-analyses, or methods articles (used for background and component references only)
  • Observational studies that are only relevant to KQ 3 (treatment), have fewer than 1000 patients, and only target pharmacological interventionsc
Publications
  • English-language publications
  • Published on or after January 1, 2000
  • Non–English-language publicationsd
  • Relevant systematic reviews, meta-analyses, or methods articles (will be used for background only)
a

Different classification systems are used for bleeding (e.g., International Society on Thrombosis and Haemostasis [ISTH], Global Utilization Of Streptokinase And Tpa For Occluded Arteries [GUSTO], and Thrombolysis In Myocardial Infarction [TIMI]). Systems of classification used across studies vary. We report data based on the studies’ classification system(s) and incorporate this information into any quantitative synthesis of the data. We did not expect studies to provide enough granular data to classify the events ourselves.

b

This criterion excludes areas of the world where clinical practice differs significantly from standards in the United States.

c

Observational studies with fewer than 1000 patients targeting only pharmacological interventions were considered by the investigators to be insufficiently powered to modify decisionmaking relative to other evidence available to be searched. Note this exclusion does not restrict observational studies that target nonpharmacologic interventions where evidence is more sparse and smaller studies may have a larger impact on the review findings.

d

Due to (1) the high volume of literature available in English language publications, (2) the focus of our review on applicability to populations in the United States, and (3) the scope of our KQs, it is the opinion of the investigators that the resources required to translate non-English articles was not justified by the low potential likelihood of identifying relevant data unavailable from English-language sources.

Abbreviations: ABC=age, biomarkers, clinical history; AF=atrial fibrillation; ATRIA=age, female, diabetes, congestive heart failure, hypertension, proteinuria, eGFR <45 or ESRD; CHADS2=congestive heart failure, hypertension, age >75, diabetes, stroke/TIA; CHA2DS2-VASc=congestive heart failure/left ventricular ejection fraction ≤40%, hypertension, age ≥75, diabetes, stroke/TIA/thromboembolism, vascular disease, age 65-74, sex; CKD=chronic kidney disease; CT=computed tomography; DM=diabetes mellitus; DTI=direct thrombin inhibitor; DVT=deep vein thrombosis; eGFR=estimated glomerular filtration rate; ER=emergency room; ESRD=end-stage renal disease; HAS-BLED=hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly (>65), drugs/alcohol concomitantly; HEMORR2HAGES=hepatic or renal disease, ethanol (alcohol) abuse, malignancy, older (>75), reduced platelet count or function, rebleeding risk, hypertension (uncontrolled), anemia, genetic factors, excessive fall risk, stroke history; HIV=human immunodeficiency virus; INR=international normalized ratio; KQ=Key Question; MRI=magnetic resonance imaging; PE=pulmonary embolism; PICOTS=Populations, Interventions, Comparators, Outcomes, Timing, Settings; PLAATO=Percutaneous Left Atrial Appendage Transcatheter Occlusion; RCT=randomized controlled trial; TIA=transient ischemic attack; VKA=Vitamin K antagonists

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