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. 2021 Feb 20;5(2):326-341.
doi: 10.1002/rth2.12482. eCollection 2021 Feb.

Provoked versus unprovoked venous thromboembolism: Findings from GARFIELD-VTE

Walter Ageno  1 , Alfredo Farjat  2 , Sylvia Haas  3 , Jeffrey I Weitz  4 , Samuel Z Goldhaber  5 , Alexander G G Turpie  6 , Shinya Goto  7 , Pantep Angchaisuksiri  8 , Joern Dalsgaard Nielsen  9 , Gloria Kayani  2 , Sebastian Schellong  10 , Henri Bounameaux  11 , Lorenzo G Mantovani  12   13 , Paolo Prandoni  14 , Ajay K Kakkar  2   15
Affiliations

Provoked versus unprovoked venous thromboembolism: Findings from GARFIELD-VTE

Walter Ageno et al. Res Pract Thromb Haemost. .

Abstract

Introduction: Venous thromboembolism (VTE) has a long-term risk of recurrence, dependent on the presence or absence of provoking risk factors at the time of the event.

Objective: To compare clinical characteristics, anticoagulant patterns, and 12-month outcomes in patients with transient provoking factors, active cancer, and unprovoked VTE.

Methods: The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE is a prospective, observational study that enrolled 10 207 patients with objectively diagnosed VTE from 415 sites in 28 countries.

Results: Patients with transient provoking factors were younger (53.0 years) and more frequently women (61.2%) than patients with unprovoked VTE (60.3 years; 43.0% women) or active cancer (63.6 years; 51.7% women). After 6 months, 59.1% of patients with transient provoking factors remained on anticoagulation, compared to 71.3% with unprovoked VTE and 47.3% with active cancer. At 12 months, this decreased to 36.7%, 51.5%, and 25.4%, respectively. The risk of mortality (hazard ratio [HR], 1.21; 95% confidence interval [CI], 0.90-1.62), recurrent VTE (HR, 0.84; 95% CI, 0.62-1.14), and major bleeding (HR, 1.26; 95% CI, 0.86-1.85) was comparable in patients with transient provoking factors and unprovoked VTE. Patients with minor and major transient provoking factors had a similar risk of recurrent VTE (HR, 0.99; 95% CI, 0.59-1.66), but those with major transient risk factors had a lower risk of death (HR, 0.61; 95% CI, 0.38-0.98).

Conclusion: At 1 year, nearly 40% of patients with transient provoking factors and slightly over half of patients with unprovoked VTE were on anticoagulant treatment. Event rates were comparable between the two groups. Risk of death was higher in patients with minor transient factors than in those with major transient factors.

Keywords: anticoagulants; deep vein thrombosis; pulmonary embolism; risk factors; venous thromboembolism.

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Figures

FIGURE 1
FIGURE 1
Study population flowchart. AC, anticoagulant; DOAC, direct oral anticoagulant; PAR, parenteral; VKA, vitamin K antagonist
FIGURE 2
FIGURE 2
Anticoagulation treatment patterns for (A) persistent provoked VTE (B) transient provoked VTE, and (C) unprovoked VTE over time. AC, anticoagulant; DOAC, direct oral anticoagulant; LTFU, lost to follow‐up; PAR, parenteral therapy, VKA, vitamin K antagonist
FIGURE 3
FIGURE 3
Cumulative incidence curves for primary outcomes over 12 months of follow‐up in patients with persistent or transient provoking risk factors or unprovoked VTE. (A) All‐cause mortality; (B) recurrent VTE; (C) major bleeding. Data are shown as percentage of patients with event and 95% confidence intervals. VTE, venous thromboembolism
FIGURE 4
FIGURE 4
Adjusted hazard ratios for mortality with 95% confidence intervals for 12‐month outcomes after VTE diagnosis between patients with persistent provoked VTE vs unprovoked VTE (reference group) and transient provoked VTE vs unprovoked VTE (reference group). Hazard ratios were adjusted for age, gender, ethnicity, body mass index, type of VTE, recent bleeding or anaemia, chronic heart failure, chronic immobilization, family history of VTE, history of cancer, known thrombophilia, prior episode of VTE, chronic kidney disease stage, and treatment at baseline. VTE, venous thromboembolism
FIGURE 5
FIGURE 5
Anticoagulant treatment patterns over 12 months of follow‐up in patients with major or minor transient provoking risk factors. DOAC, direct oral anticoagulant; LTFU, lost to follow‐up; PAR, parenteral therapy; VKA, vitamin K antagonist
FIGURE 6
FIGURE 6
Cumulative incidence curves for primary outcomes in patients with major or minor transient provoking risk factors. (A) All‐cause mortality; (B) recurrent VTE; (C) major bleeding. Data are shown as percentage of patients with event. VTE, venous thromboembolism
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