A blood clot may form in any vein in the body. Blood clots can break off and can block the flow of blood between organs and lead to death. Compared to people without cancer, people with cancer are more likely to develop blood clots, they are more like to have recurring blood clots and are more likely to have side effects to drugs such as bleeding. People with blood clots are often treated with “blood thinning” medication in an effort to reduce the possibility of having another blood clot. In the past it has been necessary to monitor blood thinning treatment with regular blood tests. New blood thinning tablets have been developed which have a lower risk of bleeding and do not require regular monitoring Real world evidence, utilising the Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics dataset, can provide additional insight on the role of long term blood thinning medication in patients suffering a blood clot and cancer. This research will help inform doctors on the safety and success of blood thinning medication and thereby help improve the clinical care of these patients. .
Venous thromboembolism (VTE) is characterised by the formation of blood clots in blood vessels, and includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients with cancer are six times more likely to develop VTE compared with their non-cancer counterparts, and cancer-related VTE is associated with an increased risk of developing recurrent VTE and major bleeding compared to VTE in non-cancer patients. Common VTE treatment options include the use of anticoagulants. Traditional treatment involves warfarin, and low molecular weight heparin (LMWH). However, direct oral anticoagulants (DOACs) are likely to replace warfarin given the evidence of non-inferiority in randomised trials, and their association with reductions in the risk of bleeding. However, evidence on the effectiveness of DOACs compared with LWMH/warfarin therapy for patients with VTE and cancer is lacking. The aim of the current study is to describe patient characteristics, treatment patterns and healthcare resource utilisation in VTE patients with cancer in Europe receiving anticoagulant medication , and compare the effectiveness and safety of DOACs vs warfarin and LMWH. The main effectiveness outcome will be VTE recurrence, whilst the main safety outcome will be major bleeding. The study will be conducted in two groups: one group of patients with VTE and active cancer, and another group of patients with VTE and history of cancer.
Outcomes to be measured
• Baseline characteristics: demographics; clinical characteristics (i.e., comorbidities); transient risk factors for VTE; other risk factors for VTE; previous procedures; prior medications; cancer-related variables.
• Treatment patterns: discontinuation (includes complete discontinuation, interruptions and switches); persistence.
• Health care resource use: inpatient visits (day and overnight stay); outpatient visits; primary care visits (GP and nurse visits) length of hospital stay. These visits will be presented as all-cause, VTE-related and bleeding-related.
• Safety outcomes: major bleeding (overall and stratified by site: gastrointestinal (GI), intracerebral hemorrhage and other); clinically relevant non-major (CRNM) bleeding (overall and stratified by site: GI and other).
• Effectiveness outcome: VTE recurrence. The definition of VTE recurrence will be explored during Phase I. It is expected that a VTE recurrence will be identified if it occurs after a certain time window after the VTE index date. In addition, there is likely to be a requirement for a diagnostic scan (e.g., CT, ultrasound) scan within a certain time window of the VTE code.
Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Sophie Graham - Corresponding Applicant - Evidera, Inc
Aaron Jenkins - Collaborator - Pfizer Ltd - UK
Beth Nordstrom - Collaborator - Evidera, Inc
Binglin Yue - Collaborator - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Mireia Raluy Callado - Collaborator - Evidera, Inc
Raza Alikhan - Collaborator - University Hospital of Wales
Robert Donaldson - Collaborator - Evidera Ltd - UK
Sophie Graham - Collaborator - Evidera, Inc
HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation