Personalizing risk-assessment in THROMBOSIS

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1 Personalizing risk-assessment in THROMBOSIS

2 OUR SERVICE PHYSICIAN Clinical data DNA sample Saliva Clinical data Genetic result 2 variants (in 7 genes) Based on the 2 most relevant (a) genetic variants (in 7 genes) related to VTE 2 Thrombosis risk score Through a unique algorithm that calculates the risk score for Thrombosis based on genetic clinical data 3 Recommendations report Personalized Management of risk situations Promote healthy lifestyle Advice on conducting a family study (a) Based on internal or published meta-analyses (3,3). Concordance with Thombosis risk >95% in serval publications.

3 ASSESSING GENETIC RISK IN THROMBOSIS Every year, approximately Million people in the United States develop Venous Thromboembolism (VTE). () Among these individuals, the risk of recurrence within years is 3%. (2) It is estimated that genetics is responsible for 6% of the total risk for thromboembolic events. (3) Identifying patients at risk could reduce the incidence and the complications of Venous Thromboembolism. CANDIDATE PATIENT PROFILE FOR GENETIC ANALYSIS (4,5) CANDIDATE PATIENT BENEFIT. Personal history of thromboembolic disease (6) Thromboprophylaxis in risk situations. Detection of potential relatives affected With pregnancy (7,8,9) Type and duration of thromboprophylaxis during pregnancy/postpartum period 2. Family history of thromboembolic disease With prothromboembolic risk situation* (6,9,) Type and duration of the most appropriate thromboprophylaxis With the intention to start therapy with oral contraceptives () Recommendation / No recommendation 3. Repeated miscarriages (8,9) Implantation failures Pre-eclampsia Rule out genetic basis (due to microthrombi in placenta or embryo implantation zone) Note: With 3rd/4th generation contraceptives genetic analysis is recommended even with no family history of thrombosis (2) *Surgery, venous catheter, traumatism, immobilization, medication, cancer, heart failure, nephrotic syndrome, inflammatory bowel disease, antiphospholipid syndrome, unexplained arterial thrombosis

4 THE 2 GENETIC VARIANTS STUDIED (a) VARIANT GENE/PROTEIN PREVALENCE IN VTE PATIENTS RELATIVE RISK (c) OF VTE Arg56Gln (FV Leiden) Factor V (FV) (4-2) 5-25% 5 G22A Factor II (7,8,2-22) 6-6% C>T Factor XII (23,24) 6% (b) 5 rs87679 rs rs rs87675 ABO group (25-27) (A carriers) nd 2-4 (+ FV Leiden: 6,7,4-3) Arg67Stop Serpin A (28) 4,4% 3,3 Ala384Ser (Cambridge II) Serpin C (29),7% Arg36Thr (FV Cambridge) nd nd Factor V (FV) (4-2) Arg36Gly (FV Hong Kong) nd nd Val34Leu Factor XIII (8,3,3) 2% (b),7 (b) Homozygotic value (c) Data obtained from literature and diverse meta-analyses VTE: Venous Thromboembolism IMPROVED IDENTIFICATION OF GENETIC RISK (d) significantly improves (d) the percentage of patients in whom genetic risk factors for Thrombosis were detected; and enhances management of VTE risks. FV Leiden Factor II ABO (A) FXII Serpin C Serpin A FV Cambridge FV Hong Kong FXIII OR (e) 7.2 (e).7 Carriers 2% (f) 85% (f) (d) Soria JM et al. Multilocus genetic risk scores for venous thromboembolism risk assessment. Presented at the XXIV congress of ISTH, Amsterdam 23. Accepted in JAHA 24 (in print) (e) Equivalent to FV Leiden (resistance to activated protein C) (f) % patients with Venous Thromboembolism in whom at least one genetic risk factor for thrombosis is detected (p<,5)

5 ALGORITHM FOR CALCULATING THE RISK SCORE FOR THROMBOSIS Without With VALUES INDIVIDUAL VALUES INDIVIDUAL Gender M= F=2 2 Gender M= F=2 2 Age Years 35 Age Years 35 Clinical Data Smoker Type II Diabetes Family history Yes= No= Pregnancy Clinical Data Smoker Type II Diabetes Family history Yes= No= Pregnancy Oral contraceptives Oral anticonceptives BMI Kg/m 2 25 BMI Kg/m 2 25 Genetic Data FV Leiden Prothrombin No= Hetero= Homo=2 Genetic Data FV Leiden Prothrombin Serpin A FXII FXIII No= Hetero= Homo=2 Serpin C A Carrier FV Cambridge FV Hong Kong Clinical-genetic risk of thrombosis: 2.5% Clinical-genetic risk of thrombosis*: 6.8% * Clinical-genetic risk of thrombosis: 6.8 % means that 7 out of every patients with the same clinical-genetic conditions will suffer VTE within years.

6 Personalizing risk-assessment in THROMBOSIS Identifies 2 genetic variants related to VTE risk Defines clinical-genetic thrombosis risk score Useful to manage thrombotic risk situations References:. Deitelzweig SB et.al. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol. 2; 86(2): Heit JA et al. The epidemiology of venous thromboembolism in the community. Thromb Haemost. 2; 86(): Souto JC et al. Genetic susceptibility to thrombosis and its relationship to physiological risk factor: The GAIT study. Am J. Hum. Genet 2; 67: Antithrombotic Therapy and the Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-based Guidelines. Chest. 22 Feb;4(2 Suppl). 5. Tait C et al. Guidelines on the investigation and management of venous thrombosis at unusual sites. Brit Jour Haema, 22, 59, Couturaud F, Kearon C. Predictors of thrombosis in relatives of patients with venous thromboembolism. Curr Opin Pulm Med. 2 Sep;6(5): Cochery-Nouvellon E et al. Homozygosity for the C46T polymorphism of the F2 gene is a risk factor for venous thrombosis during the first pregnancy. J Thromb Haemost. 27; 5(4): Sarig G, Younis JS, Hoffman R, Lanir N, Blumenfeld Z, et al. Thrombophilia is common in women with idiopathic pregnancy loss and is associated with late pregnancy wastage. Fertil Steril. 22 Feb;77(2): Wu O, Robertson L, Twaddle S, Lowe GD, Clark P, et al. Screening for thrombophilia in high-risk situations: systematic review and cost-effectiveness analysis. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) study. Health Technol Assess. 26 Apr;():-.. Rickles FR, Levine MN. Epidemiology of thrombosis in cancer. Acta Haematol. 2;6(-2):6-2.. Blickstein D, Blickstein I. Oral contraception and thrombophilia. Curr Opin Obstet Gynecol. 27 Aug;9(4): Lidegaard Ø et al. Hormonal contraception and risk of venous thromboembolism: national follow-up study.bmj. 29 Aug 3;339:b I.D. Bezemer et al. Predictive genetic variants. Semin Hematol 44: Bertina RM et al. Mutation in blood coagulation factor V associated with resistance to activated protein C. Nature 994; 369(6475): Williamson D et al. Factor V Cambridge: a new mutation (Arg36>Thr) associated with resistance to activated protein C. Blood. 998; 9(4): Chang WP et al. A novel mutation of Arg36 of factor V gene in Hong Kong Chinese. Blood. 998; 9(4): Dölek B et al. Molecular analysis of factor V Leiden, factor V Hong Kong, factor II G22A, methylenetetrahydrofolate reductase C677T, and A298C mutations related to Turkish thrombosis patients. Clin Appl Thromb Hemost. 27;3(4): Renner W et al. Prothrombin G22A, factor V Leiden, and factor XIII Val34Leu: common mutations of blood coagulation factors and deep vein thrombosis in Austria. Thromb Res. 2; 99(): Emmerich J et al. Combined effect of factor V Leiden and prothrombin 22A on the risk of venous thromboembolism--pooled analysis of 8 case-control studies including 23 cases and 324 controls. Study Group for Pooled-Analysis in Venous Thromboembolism. Thromb Haemost. 2; 86(3): Young G et al. Influence of the factor II G22A variant or the factor V G69A mutation on symptomatic recurrent venous thromboembolism in children: an international multicenter cohort study. J Thromb Haemost. 29 Jan;7(): Corral J et al. Antithrombin Cambridge II (A384S): an underestimated genetic risk factor for venous thrombosis. Blood. 27; 9(): Souto JC et al. The prothrombin 22A allele is the most prevalent genetic risk factor for venous thromboembolism in the Spanish population. Thromb Haemost. 998; 8(3): Soria JM et al. A quantitative-trait locus in the human factor XII gene influences both plasma factor XII levels and susceptibility to thrombotic disease. Am J Hum Genet. 22; 7(3): Tirado I et al. Association after linkage analysis indicates that homozygosity for the 46C-->T polymorphism in the F2 gene is a genetic risk factor for venous thrombosis. Thromb Haemost. 24; 9: Morelli VM et al. ABO blood group genotypes and the risk of venous thrombosis: effect of factor V Leiden. J Thromb Haemost. 25; 3(): Ohira T et al. ABO blood group, other risk factors and incidence of venous thromboembolism: the Longitudinal Investigation of Thromboembolism Etiology (LITE). J Thromb Haemost. 27; 5(7): Tirado I et al. The ABO blood group genotype and factor VIII levels as independent risk factors for venous thromboembolism. Thromb Haemost. 25; 93(3): Corral J et al. A nonsense polymorphism in the protein Z-dependent protease inhibitor increases the risk for venous thrombosis. Blood. 26; 8(): Tait RC et al. Prevalence of antithrombin deficiency in the healthy population. Br J Haematol. 994 May;87(): Ariëns RA et al. The factor XIII V34L polymorphism accelerates thrombin activation of factor XIII and affects cross-linked fibrin structure. Blood. 2; 96(3): Catto AJ et al. Association of a common polymorphism in the factor XIII gene with venous trombosis. Blood. 999; 93(3):96-8. Healthcare Professionals Use Only - TIC4 - v.9/4 Tel

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