Recommendation 1 – Stratification of patients using a predictive index for stroke risk (2014)
We recommend that all patients with AF or AFL (paroxysmal, persistent or permanent), should be stratified using a predictive index for stroke risk (for example, the “CCS algorithm” based on the CHADS2 model) (Strong Recommendation, High Quality Evidence).
Values and preferences (2014)
Use of a modified version of the CHADS2 schema (the “CCS algorithm”) is recommended to facilitate the choice of appropriate antithrombotic therapy by incorporating the substantial risk of stroke conferred by age 65-74 to the well validated CHADS2 risk stratification scheme. However, it excludes female sex or vascular disease alone for the reasons detailed above.
Recommendation 2 – OAC therapy for patients ≥ 65 years or CHADS2 ≥ 1 (2014)
We recommend that OAC therapy be prescribed for most patients with age ≥ 65 years or CHADS2 ≥ 1 (the “CCS algorithm”) – see Figure 1. (Strong Recommendation, Moderate Quality Evidence) Values and preferences (2014) This recommendation places relatively greater weight on the absolute reduction of stroke risk with OACs compared to aspirin in patients aged >65 or with CHADS2 ≥ 1 and less weight on the increased risk of major hemorrhage with OACs compared to aspirin.
Recommendation 3 – ASA for patients with no risks besides arterial vascular disease (2014)
We suggest that ASA (81 mg/day) be prescribed for patients with none of the risks outlined in the “CCS algorithm” (age < 65 years and no CHADS2 risk factors) who have arterial vascular disease (coronary, aortic, or peripheral). (Conditional Recommendation, Moderate Quality Evidence)
Values and preferences (2014)
This recommendation for places greater weight on the inconvenience, costs and risks of major hemorrhage with OAC compared to ASA patients whose risk of stroke is relatively low versus the strokes prevented. The recommendation for aspirin rather than no antithrombotic therapy places greater weight on the strokes prevented in this low risk group and less weight on the risks of major bleeding.
Recommendation 4 – No antithrombotic therapy for patients with no major risks (2014)
We suggest no antithrombotic therapy for patients with none of the risks outlined in the “CCS algorithm” (age < 65 years and no CHADS2 risk factors) and free of arterial vascular disease (coronary, aortic, peripheral) (Conditional Recommendation, Low Quality Evidence).
Values and preferences (2014)
This recommendation places greater weight on the inconvenience, costs and risks (major hemorrhage) with both OAC and ASA compared to no antithrombotic therapy and relatively less weight on the strokes prevented in this group of patients whose risk of stroke is very low.
Recommendation 5 – Most patients should receive NOAC (2014)
We recommend that when OAC-therapy is indicated for patients with non-valvular AF, most patients should receive dabigatran, rivaroxaban, apixaban or edoxaban (when approved) in preference to warfarin (Strong Recommendation, High Quality Evidence).
Values and preferences (2014)
This recommendation places a relatively high value on the greater ease of use of the NOACs in comparison to warfarin, and the results of large RCTs showing that the NOACs are either non-inferior or superior to warfarin in stroke prevention; the drugs have no more major bleeding or less bleeding vs warfarin and especially less intracranial hemorrhage. The recommendation places less value on the shorter clinical experience, lack of a specific antidote, and lack of a simple test for intensity of anticoagulant effect with the NOACs. The preference for one of the NOACs over warfarin is less marked among patients already receiving warfarin with stable therapeutic INRs, no bleeding complications, and who are not requesting a change in OAC therapy.
Recommendation 6 – Warfarin when mechanical valve, mitral stenosis or renal dysfunction (2014)
We recommend that when OAC is indicated, warfarin be used rather than one of the NOACs for those patients with a mechanical prosthetic valve, those with rheumatic mitral stenosis and those with a CrCl of 15 - 30 mL/min (Strong Recommendation, Moderate Quality Evidence).
Values and preferences (2014)
This recommendation places high value on the evidence from one RCT of the inferiority of dabigatran compared to warfarin for the prevention of thromboemboli in patients with a mechanical prosthetic valve. It places relatively high value on the long experience and clinical reports of the use of warfarin in patients with rheumatic mitral stenosis and patients with CrCl 15 – 30 mL/min and the absence of such information for NOACs.
Recommendation 7 – Patients who refuse OAC should receive ASA plus clopidogrel (2014)
We recommend that patients whose risk of stroke warrants OAC therapy, but who refuse any OAC, should receive ASA 81 mg/ day plus clopidogrel 75 mg/ day (Strong Recommendation, High Quality Evidence).
Values and preferences (2014)
This recommendation places high value on the superiority of the combination of ASA and clopidogrel over ASA alone in the ACTIVE-A trial. However, bleeding risk of combined antiplatelet therapy may not be very different from OAC monotherapy.
Recommendation 8– OAC therapy for highly selected patients with subclinical AF (2014)
We suggest that it is reasonable to prescribe OAC therapy for patients with age ≥ 65 years or CHADS2 ≥ 1 (“CCS algorithm”) who have episodes of SCAF lasting more than 24 hours, or for shorter episodes in high risk patients (such as those with a recent cryptogenic stroke) (Conditional Recommendation, Low Quality of Evidence).
Recommendation 9 –OAC for 3 weeks before and at least 4 weeks post cardioversion (2010)
We recommend that hemodynamically stable patients with AF or AFL for whom electrical or pharmacological cardioversion is planned should receive therapeutic OAC therapy for 3 weeks before and at least 4 weeks post cardioversion. Following attempted cardioversion:
Recommendation 10 – Annual renal function assessment (2012)
We recommend that patients with AF who are receiving OAC should have their renal function assessed at least annually by measuring serum creatinine and calculating CrCl (Strong Recommendation, Moderate Quality Evidence) and should be regularly considered for the need for alteration of OAC drug and/or dose changes based on CrCl (Strong Recommendation, Moderate Quality Evidence).
Recommendation 11 – Antithrombotic therapy should relate to CrCl (2012)
For antithrombotic therapy of CKD patients, therapy should relate to CrCl as follows:
CrCl >30 mL/min: We recommend that such patients receive antithrombotic therapy according to their risk as determined by the “CCS algorithm” as detailed in recommendations for patients for patients with normal renal function (Strong Recommendation, High Quality Evidence).
CrCl 15-30 mL/min and not on dialysis: We suggest that such patients receive antithrombotic therapy according to their risk as determined by the “CCS algorithm” as for patients with normal renal function. The preferred agent for these patients is warfarin (Conditional Recommendation, Low Quality Evidence).
CrCl<15mL/min (on dialysis): We suggest that such patients not routinely receive either OAC (Conditional Recommendation, Low Quality Evidence) or ASA for stroke prevention in AF (Conditional Recommendation, Low Quality Evidence).
Values and preferences (2016, updated from 2012)
Recommendation 11 places a relatively higher value on prevention of ischemic stroke than on bleeding complications associated with antithrombotic therapy, as well as the limited data available for new OACs in CKD patients. They also place a relatively higher weight on observational data linking warfarin and ASA use with mortality in patients on dialysis, and relatively lower weight on the potential for these agents to prevent ischemic stroke. Patients on renal dialysis who have atrial fibrillation continue to be at high risk of both stroke and major bleeding complications. This population has been largely excluded from clinical trials evaluating stroke prevention therapies, and there have been no substantial new advances in the management of these individuals. Such studies are being planned, but until they can be completed, clinicians must continue to balance the risks of stroke against the risk of bleeding complications.
Recommendation 12 – LAA closure devices to be used only in research and, exceptional cases (2014)
We suggest these non-approved LAA closure devices not be used, except in research protocols or in systematically documented use protocols in patients who are at high risk of stroke (CHADS2 ≥ 2) and yet antithrombotic therapy is precluded (Conditional Recommendation, Low Quality Evidence).
Values and preferences (2014)
This recommendation places relatively great weight on the absence of RCTs showing clear benefit to risk in favor of these devices and on the need for further research and careful case series.
Recommendation 13 – Acute management of stroke patients as per AHAASA guidelines (2010)
We recommend that patients with AF or AFL who experience a stroke be managed acutely according to the published guidelines of the American Heart and American Stroke Associations (Strong Recommendation, Moderate Quality Evidence).
Recommendation 14 – Hemorrhage on OAC to be managed per AACP guidelines (2010)
We suggest that patients with AF or AFL who experience hemorrhage while on OAC be managed according to the published practice guidelines of the American College of Chest Physicians (Conditional Recommendation, Low Quality Evidence).
Practical tip (2012)
No antithrombotic therapy may be appropriate for some patients with CrCl 15-30 mL/min (not on dialysis), with a stronger preference for avoiding bleeding complications than preventing ischemic stroke.
Practical tip (2016, updated from 2010)
Therapy with OACs or antiplatelet drugs may be appropriate for some patients with AF and CrCl<15 mL/min (on dialysis) in whom there is a stronger preference to avoid ischemic stroke despite uncertain benefit and likely greater bleeding risk.
Recommendation 15 – Idarucizimab for emergency reversal of dabigatran's anticoagulant effect (2016)
We recommend administering idarucizimab for emergency reversal of dabigatran's anticoagulant effect in patients with uncontrollable or potentially life-threatening bleeding and/or in patients requiring urgent surgery for which normal hemostasis is necessary (Strong Recommendation, Moderate Quality Evidence).
Values and Preferences
This recommendation places relatively greater value on the ability of idarucizimab to reverse coagulation parameters indicative of dabigatran’s effect, its potential to decrease bleeding-related outcomes and risks of urgent surgery and its safety and tolerability profile, and less value on the absence of a control group in the RE-VERSE AD trial and the cost of the drug.
Practical Tips (2016)
In the acute, life-threatening bleeding situation where standard resuscitation (such as local measures, transfusion, etc) is not anticipated to be sufficient (e.g. ICH), or in the situation where it has not stabilized the patient, idarucizumab, should be administered as soon as possible. Although dilute thrombin time and ecarin clotting time were used to identify the presence of dabigatran in REVERSE-AD, these tests are not widely available. Thrombin time (TT) and activated partial thromboplastin time (aPTT) are widely available and can qualitatively identify the presence of active dabigatran in a patient,65 however obtaining these tests should not delay the administration of idarucizumab. In many instances of life-threatening bleeding, clinicians have to base a treatment decision on a history of dabigatran use rather than laboratory evidence. Renal function and timing of the last dose of dabigatran provide key information regarding the likely extent of remaining dabigatran effect. The timing of surgery may permit clinicians to obtain coagulation parameters like stat TT or aPTT to identify patients who no longer have dabigatran present, and who would be unlikely to benefit from idarucizumab. No dose adjustment for idarucizumab is required in patients with renal impairment. In some patients, coagulation parameters may rise between 12-24 hours after initial administration of idarucizumab, possibly reflecting redistribution of extravascular dabigatran into the intravascular space.64 Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. OAC should be reintroduced as soon as medically appropriate.