What question did this study set out to answer?

To determine whether a 10-mg warfarin initiation nomogram achieves therapeutic anticoagulation more rapidly than a 5-mg nomogram in outpatients receiving low-molecular-weight heparin for acute venous thromboembolism.

May 6, 2003Annals of Internal Medicine

Comparison of 10-mg and 5-mg Warfarin Initiation Nomograms Together with Low-Molecular-Weight Heparin for Outpatient Treatment of Acute Venous Thromboembolism

Q: What is the clinical evidence from this study?

Study design: RCT. Population: acute venous thromboembolism (n=201). Intervention: 10-mg warfarin initiation nomogram vs. 5-mg warfarin initiation nomogram. Primary outcome: time in days to therapeutic INR (1.4 days earlier, p=<0.001).

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Key result

A 10-mg warfarin initiation nomogram achieved a therapeutic INR 1.4 days earlier than a 5-mg nomogram (P < 0.001), with 83% vs 46% reaching therapeutic INR by day 5.

Why the study?

Does a 10-mg warfarin initiation nomogram reduce time to therapeutic INR compared to a 5-mg nomogram in outpatients with acute venous thromboembolism?

Population

201 outpatients with objectively confirmed diagnoses of acute venous thromboembolism

Comparison

10-mg warfarin initiation nomogram, with… vs 5-mg warfarin initiation nomogram, with…

Design

RCT, Randomly assigned

Authors

MKMichael J. KovacsVascular Medicine MRMarc RodgerVascular Medicine DADavid R. AndersonGeneral / Preventive / Lipids

Discussion

Member takes

Implication

Supports 10-mg over 5-mg nomogram for faster therapeutic INR in acute VTE outpatients; extends RCT evidence for nomogram-guided initiation.

Key Points

To determine whether a 10-mg warfarin initiation nomogram achieves therapeutic anticoagulation more rapidly than a 5-mg nomogram in outpatients receiving low-molecular-weight heparin for acute venous thromboembolism.
Randomized controlled trial conducted across outpatient venous thromboembolism services at four tertiary care hospitals.
Consecutive patients with acute venous thromboembolism (N=201) received subcutaneous low-molecular-weight heparin for at least 5 days and were randomly assigned to a 10-mg (n=104) or 5-mg (n=97) initial warfarin dosing nomogram.
Patients in the 10-mg group achieved a therapeutic international normalized ratio (INR) 1.4 days earlier than those in the 5-mg group (P < 0.001).
Therapeutic INR was achieved by day 5 in 83% of patients in the 10-mg group versus 46% in the 5-mg group (P < 0.001), with fewer total INR assessments required (8.1 vs. 9.1; P = 0.04).
No significant differences were observed between the groups in major bleeding, recurrent venous thromboembolism, survival, or INR values exceeding 5.0.

Study Design

Type

RCT (n=201)

Randomization

randomly assigned

Multicenter

Yes

Structured PICO

Does a 10-mg warfarin initiation nomogram reduce time to therapeutic INR compared to a 5-mg nomogram in outpatients with acute venous thromboembolism?

Population

201 outpatients with objectively confirmed diagnoses of acute venous thromboembolism

Intervention

10-mg warfarin initiation nomogram, with subcutaneous low-molecular-weight heparin for a minimum of 5 days until therapeutic INR

Comparator

5-mg warfarin initiation nomogram, with subcutaneous low-molecular-weight heparin for a minimum of 5 days until therapeutic INR

Outcome

Time in days to therapeutic INRsurrogate

Main Result

Effect estimate: 1.4 days earlier

p-value: p=<0.001

A 10-mg warfarin initiation nomogram allows more rapid achievement of a therapeutic INR compared to a 5-mg nomogram without increasing the risk of over-anticoagulation or bleeding.

Cite This Study

Kovacs et al. (2003) conducted an RCT in acute venous thromboembolism (n=201). 10-mg warfarin initiation nomogram vs. 5-mg warfarin initiation nomogram was evaluated on time in days to therapeutic INR (1.4 days earlier, p=<0.001). A 10-mg warfarin initiation nomogram achieved a therapeutic INR 1.4 days earlier than a 5-mg nomogram (P < 0.001), with 83% vs 46% reaching therapeutic INR by day 5.

synapsesocial.com/papers/6a0f429e42feb5cfcf9bc5a2 https://doi.org/10.7326/0003-4819-138-9-200305060-00007

Topics

Pulmonary embolism Anticoagulation in AF

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Implication

Supports 10-mg over 5-mg nomogram for faster therapeutic INR in acute VTE outpatients; extends RCT evidence for nomogram-guided initiation.