Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups: pregnancy, elderly and obese patients

Abstract

BackgroundVenous thromboembolism (VTE) accounts for an estimated 900,000 cases per year in the US alone and constitutes a considerable burden on healthcare systems across the globe.ObjectiveTo understand why the burden is so high, qualitative and quantitative research was carried out to gain insights from experts, guidelines and published studies on the unmet clinical needs and therapeutic strategies in VTE prevention and treatment in three populations identified as being at increased risk of VTE and in whom VTE prevention and treatment were regarded as suboptimal: pregnant women, the elderly and obese patients.MethodologyA gap analysis methodology was created to highlight unmet needs in VTE management and to discover the patient populations considered most at risk. A questionnaire was devised to guide qualitative interviews with 44 thrombosis and haemostasis experts, and a review of the literature on VTE in the specific patient groups from 2015 to 2017 was completed. This was followed by a Think Tank meeting where the results from the research were discussed.ResultsThis review highlights the insights gained and examines in detail the unmet needs with regard to VTE risk-assessment tools, biomarkers, patient stratification methods, and anticoagulant and dosing regimens in pregnant women, the elderly and obese patients.ConclusionsSpecifically, in pregnant women at high risk of VTE, low-molecular-weight heparin (LMWH) is the therapy of choice, but it remains unclear how to use anticoagulants when VTE risk is intermediate. In elderly patients, evaluation of the benefit of VTE prophylaxis against the bleeding risk is particularly important, and a head-to-head comparison of efficacy and safety of LMWH versus direct oral anticoagulants is needed. Finally, in obese patients, lack of guidance on anticoagulant dose adjustment to body weight has emerged as a major obstacle in effective prophylaxis and treatment of VTE.

Management of prepregnancy, pregnancy, and postpartum obesity from the FIGO Pregnancy and Non‐Communicable Diseases Committee: A FIGO (International Federation of Gynecology and Obstetrics) guideline

“…High maternal BMI is a risk factor for venous thromboembolism during pregnancy and postpartum 61,112 . Prophylactic management should be considered for women with obesity in accordance with local and national guidance documents 103,113–115 .…”

Trombosis de la vena ovárica posparto

“…Los casos asintomáticos son los más comunes y su evolución generalmente es benigna, con una incidencia del 30% de trombosis de las venas (ilíacas y ováricas) (4) . Esta condición es clásicamente un proceso asociado al embarazo, pero también puede surgir en contextos no puerperales, como endometritis, enfermedad pélvica inflamatoria, neoplasias malignas, trombofilia, enfermedad inflamatoria intestinal y cirugías pélvicas y ginecológicas (4)(5)(6) . Los factores de riesgo para esta condición son la multiparidad, tabaquismo, obesidad, bacteriemia puerperal y trombofilia, tanto heredada como adquirida.…”

“…El embarazo es un estado de hipercoagulabilidad caracterizado por aumento de la adhesión plaquetaria y disminución de la fibrinólisis. La masa de eritrocitos aumenta aproximadamente 30%, mientras que el volumen plasmático aumenta 50% (6) . La hipercoagulabilidad, estasis venosa y lesión endotelial (tríada de Virchow) son las causas más frecuentes de la trombosis de las venas ováricas y el embarazo es un ejemplo de esta tríada (7) .…”

Missed opportunities for venous thromboembolism prophylaxis during pregnancy and the postpartum period: evidence from mainland China in 2019

“…These strategies have been recommended; however, the specific effects of their implementation are unclear. There is still a lack of related epidemiological evidence [ 18 , 19 ].…”