Prevalence of risk factors for VTE in hospitalized medical and surgical patients

1. COmparison of Methods for thromboembolic risk assessment with clinical Perceptions and AwareneSS in real life Surgical and Medical patients COMPASS study • Prevalence of risk factors for VTE in hospitalized medical and surgical patients

2. Unmet needs for VTE risk stratification • The identification of hospitalized patients at VTE risk is a major chalenge since it will protect from underuse or misuse of thromboprophylaxis. • Most of the available risk assessment models (RAM) have been constructed on a disease or surgical act based approach • RAMs include the most relevant risk factors for VTE in order to stratify hospitalized patients to three risk levels (low, moderate and high). • However they do not take into account the most frequent VTE risk factors as well as risk factors related to bleeding or other comorbidities that might influence treating physician’s decision making in real-life clinical practice.

3. COMPASSAim • The primary aim of the COMPASS registry was to evaluate the prevalence of the known risk factors for VTE and bleeding described in the literature in real-life surgical and medical patients which are hospitalised in different medical or surgical departments.

4. COMPASS Patients • COMPASS: a prospective multicenter cross-sectional observational study • Conducted in 8 hospitals (7 in Greece and one in France) • All patients aged >40 years hospitalised for serious medical disease • Inpatients aged >18 years admitted due to a surgical condition requiring operation and hospitalisation for a period exceeding three days were included in the study • Patients and their treating physicians were interviewed with standardised questionnaire including all VTE risk factors described in literature (120 items) • Patients charts were also analysed

5. COMPASS Methods • Patients were assessed on the third day of hospitalisation. Main exclusion criteria • Patients not giving informed consent • Patients receiving anticoagulant treatment for any reason • Patients hospitalised in order to undergo diagnostic tests without need for further therapeutic intervention were excluded from the study.

6. COMPASS patients

7. COMPASS Causes of hospitalisation in medical patients

8. COMPASS Causes of hospitalisation in surgical patients

9. Frequency of thromboprophylaxis

10. Type of thromboprophylaxis

11. Predicted duration of thromboprophylaxis

12. Monitoring of platelet count

13. COMPASSFrequency of VTE and bleeding risk factors in hospitalised medical and surgical patients *p<0,05

14. Risk Assessment model for VTE in surgical patients according to the ACCP

15. Classification of surgical patients to VTE risk according to ACCP 76,53% of patients are classified as moderate or highrisk 87% of patients receivedprophylaxiswith LMWH

16. Classification of medical patients according to ACCP RAM

17. COMPASS RAM for medical patients

18. Classification of medical patients according to ACCP ad COMPASS RAM

19. Comparison of classification of medical patients wt risk levels according to COMPASS and ACCP RAM

20. Prophylaxis administration and risk level according to ACCP and COMPASS RAM 60% of medical patients receivedprophylaxiswith LMWH

21. COMPASSConlusion • COMPASS is the first registry that provides key data on the prevalence of all known VTE and bleeding risk factors in real life medical and surgical patients hospitalised in two countries of European Union • The analysis of the data shows that in addition to risk steming from the disease or surgical act both medical and surgical patients share common VTE risk factors • The careful analysis of the most frequent and relevant VTE risk factors will allow the derivation of a practical VTE and bleeding risk assessment model taken into account these factors

22. Prospective COmparison of Methods for thromboembolic risk assessment with clinical Perceptions and AwareneSS in real life Cancer patients. • COMPASS – Cancer

23. Background • the identification of cancer patients at VTE risk and the optimization of thromboprophylaxis is a puzzling exercise • VTE risk may vary according • to patient grounds, • to cancer evolution, • histological type and stage of cancer • Type and intensity of chemotherapy and other adjuvant treatments • drawbacks for the application of pharmacological thromboprophylaxis • thrombocytopenia or thrombocytopathia due to the myelotoxic effect of chemotherapy • other acquired coagulopathies related to cancer (i.e. consumption coagulopathy or liver impairment, acquired von Willebrand disease...)

24. Background • 5% to 7% of cancer patients suffer symptomatic VTE of approximately • similar or greater than that reported in hospitalized or postoperative patients for whom VTE prophylaxis has been shown to be highly effective.

25. COMPASS – CancerAims • Primary aim • prospective evaluation of the 4T’s RAM, the Khorana RAM and the established RAMs (i.e. Caprini and ACCP) to predict symptomatic or objectively diagnosed VTE in hospitalised patients and ambulatory/outpatients with cancer. • Secondary aim • evaluation of the actual level of awareness of oncologists for VTE risk and the actual perception on the use of thromboprophylaxis. This information will be used as baseline for comparing the efficacy of eventual future initiatives in order to optimize VTE prophylaxis in cancer patients.

26. COMPASS Cancer Centers

27. COMPASS-Cancer histology or localisation • types of cancer • gynaecological • lung • gastrointestinal • pancreatic breast • hematological • …

28. COMPASS-Cancer studied population • Expected 6 months cumulative incidence of symptomatic VTE • 3,3% for ovarian cancer, • 1,4% for lung cancer, • 0,9% for breast cancer

29. COMPASS-Cancer studied population Surgical pts (n= 1000) Medical pts (n=2500) at distance from any surgical intervention, receivinge the indicated chemotherapy, or targeted treatment or combination of any of these treatments with radiotherapy. Control group : 500 acutely ill medical patient

30. COMPASS-Cancerend-points • symptomatic and objectively diagnosed VTE episodes (DVT and/or PE). • symptomatic and documented arterial thrombosis (ischemic stroke, acute coronary syndrome or other site) • superficial venous thrombosis • central catheter thrombosis • thrombosis in rare localizations • all cause mortality • combined clinical end-point (symptomatic VTE, arterial thrombosis superficial venous thrombosis, central catheter thrombosis, thrombosis in rare localizations) • Severe bleeding (according to the definition given by the ISTH)

31. COMPASS-Cancerinclusion criteria • consecutive newly diagnosed out-patients with histologically confirmed ovarian, lung or breast cancer (OR OTHER according to PROMETHEE Centers) before any treatment administration • consecutive out-patients with ovarian, lung or breast cancer, hospitalised in one day clinics for daily administration of anticancer treatment • consecutive patients with ovarian, lung or breast cancer hospitalized for administration of anticancer treatment • patients receiving anticancer treatment should have a perspective to receive at least 2 cycles of this treatment • acutely ill patients hospitalized for at least 2 days for acute medical disease other than cancer (control group) • Patients with known cardiovascular disease receiving treatment with antiplatelet agents (aspirin, clopidogrel or prasugrel or combination of aspirin and clopidogrel or prasugrel) will not be excluded from the study

32. COMPASS-Cancerexclusion criteria • age< 18 years • pregnant or lactating women • any kind of anticoagulant treatment (vitamin K antagonists, or rivaroxaban or dabigatran or unfractionated heparin or low molecular weight heparin of fondaparinux) for any indication until one moth before the interview • For the non surgical pts: any kind of surgery during the last 3 months prior inclusion

33. COMPASS-CancerData recruitment and follow-up Local Investigator Data entry in the web-site data base Telephone interview, or out-patient interview, or analysis of medical records CRF for patient 3 months 3 months 6 months CRF for treating physician Laboratory data

34. COMPASS-Cancerschedule • 750 patients per center (?) • Interim analysis of the data will be done when recruitment of patients will reach 25%, 50% and 75% of the total size • In three months after the end of the study final data analysis and report of the study will be completed

35. COMPASS-CancerPublication policy • GG and IE will sign as first and last and corresponding authors in at least two major publications. All members of the national PROMETHEE boards (national and local investigators and their assistants) will participate in these two publications • In addition to the scheduled central publications, articles and abstracts for international or national congresses will be produced by PROMETHEE members using data from the COMPASS-Cancer data base after information of the steering committee • The coordinating center and the steering committee will be responsible for the data management and the quality control of the data collection • Statistical analysis of the data regarding the endpoints of the study described above will be done by a biostatistitian based in the coordinating center • All data will be available for the members of PROMETHEE network for additional analysis and all additional publications will be done after the authorisation of the steering committee.