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. 2021 Jan 27;5(1):e24-e34.
doi: 10.1055/s-0040-1722611. eCollection 2021 Jan.

Pregnancy-Associated Venous Thromboembolism: Insights from GARFIELD-VTE

Carlos Jerjes-Sánchez  1 , David Rodriguez  1 , Alfredo E Farjat  2 , Gloria Kayani  2 , Peter MacCallum  2   3 , Renato D Lopes  4 , Alexander G G Turpie  5 , Jeffrey I Weitz  5   6 , Sylvia Haas  7 , Walter Ageno  8 , Shinya Goto  9 , Samuel Z Goldhaber  10 , Pantep Angchaisuksiri  11 , Joern Dalsgaard Nielsen  12 , Sebastian Schellong  13 , Henri Bounameaux  14 , Lorenzo G Mantovani  15   16 , Paolo Prandoni  17 , Ajay K Kakkar  18 ; GARFIELD-VTE investigators
Affiliations

Pregnancy-Associated Venous Thromboembolism: Insights from GARFIELD-VTE

Carlos Jerjes-Sánchez et al. TH Open. .

Abstract

Introduction The risk of venous thromboembolism (VTE) increases during pregnancy and the puerperium such that VTE is a leading cause of maternal mortality. Methods We describe the clinical characteristics, diagnostic strategies, treatment patterns, and outcomes of women with pregnancy-associated VTE (PA-VTE) enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE. Women of childbearing age (<45 years) were stratified into those with PA-VTE ( n = 183), which included pregnant patients and those within the puerperium, and those with nonpregnancy associated VTE (NPA-VTE; n = 1,187). Patients with PA-VTE were not stratified based upon the stage of pregnancy or puerperium. Results Women with PA-VTE were younger (30.5 vs. 34.8 years), less likely to have pulmonary embolism (PE) (19.7 vs. 32.3%) and more likely to have left-sided deep vein thrombosis (DVT) (73.9 vs. 54.8%) compared with those with NPA-VTE. The most common risk factors in PA-VTE patients were hospitalization (10.4%), previous surgery (10.4%), and family history of VTE (9.3%). DVT was typically diagnosed by compression ultrasonography (98.7%) and PE by chest computed tomography (75.0%). PA-VTE patients more often received parenteral (43.2 vs. 15.1%) or vitamin K antagonists (VKA) (9.3 vs. 7.6%) therapy alone. NPA-VTE patients more often received a DOAC alone (30.2 vs. 13.7%). The risk (hazard ratio [95% confidence interval]) of all-cause mortality (0.59 [0.18-1.98]), recurrent VTE (0.82 [0.34-1.94]), and major bleeding (1.13 [0.33-3.90]) were comparable between PA-VTE and NPA-VTE patients. Uterine bleeding was the most common complication in both groups. Conclusion VKAs or DOACs are widely used for treatment of PA-VTE despite limited evidence for their use in this population. Rates of clinical outcomes were comparable between groups.

Keywords: deep vein thrombosis; pregnancy; pulmonary embolism; registry; venous thromboembolism.

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Conflict of interest statement

Conflict of Interest C.J.-S. received consultancy fees from Bayer, Pfizer, Actelion, Boehringer, and Meranini. P.M. received personal fees from Bayer Pharma AG. R.D.L. received research grants and personal fees from Bristol-Myers Squibb and Pfizer, personal fees from Boehringer Ingelheim and Bayer AG, and research grants from Amgen Inc, GlaxoSmithKline, Medtronic PLC, and Sanofi Aventis outside the submitted work. A.G.G.T. received personal fees from Bayer Pharma AG and Janssen. J.I.W. received research support from Canadian Institutes of Health Research, Heart and Stroke Foundation, and the Canadian Fund for Innovation; honoraria from Bayer Pharma AG, Boehringer-Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Ionis, Janssen, Merck, Portola, Pfizer, Servier, Novartis, Anthos, and Tetherex. S.H. received honoraria from Bayer Pharma AG, Bristol Myers Squibb, Daiichi-Sankyo, Pfizer, and Portola. W.A. received honoraria from Boehringer Ingelheim, Bayer Pharma AG, Bristol Myers Squibb, Pfizer, Daiichi-Sankyo, Portola, Aspen, Sanofi. S.G. got research funding from Ono, Bristol Myers Squibb, Sanofi, and Pfizer; personal fees from Thrombosis Research Institute and the American Heart Association. S.Z.G. received research support from Bayer Pharma AG, Boehringer-Ingelheim, BMS, BTG EKOS, Daiichi-Sankyo, Janssen, NHLBI, Thrombosis Research Institute; consultancy fees from Bayer Pharma AG, Boehringer-Ingelheim. J.D.N. received honoraria from Bayer Pharma AG, Boehringer-Ingelheim, Bristol Myers Squibb, Merck Sharp & Dohme, Leo Pharma, and Pfizer. S.S. received speaker fees from Bayer Pharma AG, Boehringer-Ingelheim, Bristol Meyer Squibb, Daiichi-Sankyo, Sanofi Aventis, and Pfizer; consultancy fees from Bayer Pharma AG, Boehringer-Ingelheim, Daiichi-Sankyo, Sanofi Aventis, Aspen, and Pfizer. H.B. received honoraria from Bayer Pharma (Switzerland) AG. L.G.M. received grants and personal fees from Bayer Pharma AG, Boehringer-Ingelheim, Pfizer, and Daiichi-Sankyo. P.P. received personal fees from Bayer Pharma AG, Pfizer, Daiichi-Sankyo, and Sanofi. A.K.K. received research grants from Bayer Pharma AG; personal fees from Bayer Pharma AG, Sanofi S.A., Janssen Pharma, Verseon, and Pfizer. D.R. , P.A., A.E.F., and G.K. declare that they have no conflict of interest in the research.

Figures

Fig. 1
Fig. 1
Anticoagulant treatment at baseline (up to 30 days after VTE diagnosis). Percentages are calculated from all patients receiving AC treatment, including those who received AC in combination with other modalities of treatment. AC, anticoagulant; DOAC, direct oral anticoagulant; NPA-VTE, nonpregnancy-associated venous thromboembolism; PA-VTE, pregnancy-associated venous thromboembolism; VKA, vitamin K antagonist.
Fig. 2
Fig. 2
Unadjusted time-to-event curves for ( A ) all-cause mortality ( B ) recurrent VTE, and ( C ) major bleeding. Data are shown as percentage of patients and 95% confidence intervals. NPA-VTE, nonpregnancy-associated venous thromboembolism; PA-VTE, pregnancy-associated venous thromboembolism.
Fig. 3
Fig. 3
Forest plots for hazard ratios (HRs) with 95% CIs for 12-month outcomes . Reference group: nonpregnant women. HRs were adjusted for age, ethnicity, and BMI. BMI, body mass index; PA-VTE, pregnancy-associated venous thromboembolism.
See this image and copyright information in PMC

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