Table 1.

Monitoring of warfarin/vitamin K antagonists in patients with antiphospholipid syndrome

Monitoring testType of assayTarget rangePoints to note
PT-INR
(venous) 
Clotting assay
INR  =  PT/MNPT 
2.0-3.0
3.0-4.0 
• Venous (laboratory) INR standard test to monitor VKA anticoagulation intensity in APS patients
• Ensure new thromboplastins have low sensitivity to LA before using to monitor VKA
• Define MNPT and ISI for reagent/instrument combination
• Check baseline PT before anticoagulation, if possible
• If baseline PT prolonged, check for acquired factor II deficiency (LA-hypoprothrombinemia syndrome) 
PT-INR
(point-of-care) 
Clotting assay
INR  =  PT/MNPT 
2.0-3.0
3.0-4.0 
• Reliable, accurate INRs versus venous INRs in general population
• Interpret with caution in APS patients - may be discordant versus venous INRs
Pragmatic approach for APS patients:
In patients using POC INRs (including self-testing/self-monitoring), via an anticoagulation clinic, ensure:
• Check for concordance versus venous INRs (ie, <0.5 INR unit difference) before use for monitoring: initially on three occasions when venous INR in therapeutic range, thereafter, suggest check concordance once every 6-12 months
• Regular internal quality control: run at minimum when testing a new batch of test strips or if unexpectedly high or low INR
• Regular external quality assessment 
Chromogenic factor X Chromogenic assay ~40%–20%  =   INR 2.0-3.0 • LA-independent measure of anticoagulant intensity
• Therapeutic ranges not established
• Poor utility at INRs >3.0 (equivalent to chromogenic factor X  <  12 IU/dL; ie, inverse relationship)
• Not widely available or practicable for routine use
• Could assist (1) in INR monitoring when prolonged INR before warfarin/VKA; or (2) if recurrent thrombotic event while on apparently therapeutic VKA anticoagulation 
Thrombin generation Fluorogenic substrate, continuous measurement of TG Therapeutic range not established • ETP and peak TG showed significant inverse correlations with INR in non-APS and APS patients24
• A subgroup of APS patients with increased peak TG, despite therapeutic INR and CFX, suggests that TG might identify an ongoing prothrombotic state24
• The use of TG remains limited to specialized laboratories due to lack of standardization and established therapeutic ranges 
Monitoring testType of assayTarget rangePoints to note
PT-INR
(venous) 
Clotting assay
INR  =  PT/MNPT 
2.0-3.0
3.0-4.0 
• Venous (laboratory) INR standard test to monitor VKA anticoagulation intensity in APS patients
• Ensure new thromboplastins have low sensitivity to LA before using to monitor VKA
• Define MNPT and ISI for reagent/instrument combination
• Check baseline PT before anticoagulation, if possible
• If baseline PT prolonged, check for acquired factor II deficiency (LA-hypoprothrombinemia syndrome) 
PT-INR
(point-of-care) 
Clotting assay
INR  =  PT/MNPT 
2.0-3.0
3.0-4.0 
• Reliable, accurate INRs versus venous INRs in general population
• Interpret with caution in APS patients - may be discordant versus venous INRs
Pragmatic approach for APS patients:
In patients using POC INRs (including self-testing/self-monitoring), via an anticoagulation clinic, ensure:
• Check for concordance versus venous INRs (ie, <0.5 INR unit difference) before use for monitoring: initially on three occasions when venous INR in therapeutic range, thereafter, suggest check concordance once every 6-12 months
• Regular internal quality control: run at minimum when testing a new batch of test strips or if unexpectedly high or low INR
• Regular external quality assessment 
Chromogenic factor X Chromogenic assay ~40%–20%  =   INR 2.0-3.0 • LA-independent measure of anticoagulant intensity
• Therapeutic ranges not established
• Poor utility at INRs >3.0 (equivalent to chromogenic factor X  <  12 IU/dL; ie, inverse relationship)
• Not widely available or practicable for routine use
• Could assist (1) in INR monitoring when prolonged INR before warfarin/VKA; or (2) if recurrent thrombotic event while on apparently therapeutic VKA anticoagulation 
Thrombin generation Fluorogenic substrate, continuous measurement of TG Therapeutic range not established • ETP and peak TG showed significant inverse correlations with INR in non-APS and APS patients24
• A subgroup of APS patients with increased peak TG, despite therapeutic INR and CFX, suggests that TG might identify an ongoing prothrombotic state24
• The use of TG remains limited to specialized laboratories due to lack of standardization and established therapeutic ranges 

ETP, endogenous thrombin potential.

Adapted from Table 1 in Cohen et al.52 

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