Haemostasis, thrombosis risk and hormone replacement therapy

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1 Haemostasis, thrombosis risk and hormone replacement therapy Serge Motte Brussels

2 MY TALK TODAY The coagulation cascade and its regulation Effects of hormone replacement therapy on haemostasis and risk of venous thrombosis Association of hormone therapy with risk factors for venous thrombosis Changes in haemostasis and risk of ischemic stroke and coronary heart disease 2

3 THE COAGULATION CASCADE IN VIVO 3 Versteeg HH et al. Physiol Rev 93: , 2013

4 NEGATIVE REGULATION OF THE COAGULATION CASCADE Versteeg HH et al. Physiol Rev 93: ,

5 ORAL HT INCREASES PLASMA CONCENTRATIONS OF MARKERS FOR IN VIVO THROMBIN GENERATION AND FIBRINOLYSIS Complexe TAT Prothrombin Fragment Antithrombin Prothrombin Xa Ca++, PL Va Thrombin (IIa) Fibrinogen Fibrin Fibrinolysis D-Dimers 5

6 EFFECT OF ORAL ESTROGENS ON FACTORS AND INHIBITORS OF COAGULATION AND FIBRINOLYSIS Coagulation factors Fibrinogen Prothrombin, thrombin Factor VII, VIII Coagulation inhibitors TFPI Antithrombin Protein S Protein C Fibrinolysis factors Tissue plasminogen activator Plasminogen Effect of oral estrogens No clear effect Significant decrease in most of the studies No clear effect Fibrinolysis inhibitors Antiplasmin Plasminogen activator inhibitor 1 Significant decrease 6

7 ENDOGENOUS THROMBIN TEST Initiation Propagation Terminaison Brummel-Ziedins KE et al. J Thromb Haemost 2005; 3:

8 ORAL CONTRACEPTIVE USE IS ASSOCIATED WITH ACQUIRED RESISTANCE TO ACTIVATED PROTEIN C (APC) 8 J Rosing and G Tans. Am J Obstet Gynecol 1999;180:S375-82

9 HORMONE REPLACEMENT THERAPY IS ASSOCIATED WITH A LARGE INCREASE IN RESISTANCE TO APC Randomized, placebo controlled study in healthy post-menopausal women E2: oestradiol 2 mg/d D: dydrogesterone 10 mg/d T: trimegestone: 0,5 mg/d. napc-sr :([ETP+APC/ETP APC]plasma/[ETP+APC/ETP APC]normal plasma 9 MS Post et al.br J of Haematol 2002;119,

10 EFFECT OF ORAL AND TRANSDERMAL ESTROGEN REPLACEMENT THERAPY ON APC RESISTANCE Randomized, double-blind study te 2 : 50µg daily oe 2 1mg G: 25µg napc-sr :([ETP+APC/ETP APC]plasma/[ETP+APC/ETP APC]normal plasma 10 Post MS et al. Arterioscler Thromb Vasc Biol. 2003;23:

11 THROMBOTIC RISK AMONG USERS OF ORAL AND TRANSDERMAL OESTROGEN: A META-ANALYSIS Canonino M et al. Br Med J 2008 ; 336:

12 RISK OF VENOUS THROMBOSIS IN USERS OF CONJUGATED EQUINE ESTROGENS VERSUS ORAL ESTRADIOL A population-based case-control study Venous thrombosis Reference Estradiol Use CEE use Adjusted OR (95% CI) * P Value ( ).045 Significant higher normalized activated protein C sensitivity ratios in CEEs users compared with estradiol users *Adjusted for age, race/ethnicity, cancer history, body mass index, current statin use, estrogen daily dose, current progestogen use, current smoking status, treated hypertension, treated diabetes mellitus, prevalent cardiovascular disease, and the number of GHC visits in the year before the index date NL Smith et al. JAMA Intern Med. 2014;174:

13 ROLE OF THE PROGESTOGEN COMPONENTS: VTE RISK GREATER WITH ORAL ESTROGEN-PROGESTIN THAN ORAL ESTROGEN ONLY The Million Women Study (UK) Relative risk (RR) of venous thromboembolism, by use of hormone therapy Sweetland S et al. J Thromb Haemost 2012; 10:

14 ROLE OF THE PROGESTOGEN COMPONENTS IN HORMONE THERAPY E3N (Etude Epidémiologique de femmes de l Education Nationale) French prospective cohort Hazard Ratios of VTE Multivariable adjusted (95% CI) Current use of oral estrogens 1.7 ( ) Current use of transdermal estrogens 1.1 ( ) Current use of micronized progesterone 0.9 ( ) Current use of pregnane derivatives 1.3 ( ) Current use of norpregnane derivatives 1.8 ( ) Current use of nortestosterone derivatives 1.4 ( ) Canonino M et al. Arterioscler Thromb Vasc Biol. 2010;30:

15 ROLE OF THE PROGESTOGEN COMPONENTS IN HORMONE THERAPY French Study of Norpregnanes on Coagulation Cross sectional study among healthy postmenopausal volunteer women napcsr, mean values (SD) No hormone therapy 1.00 (0.63) Transdermal estrogens + progesterone 0.98 (0.72) Transdermal estrogens + norpregnanes 1.64 (1.17) Norpregnanes: nomegestrol acetate and promegestone Canonino M et al. Menopause 2010;17:

16 MY TALK TODAY The coagulation cascade and its regulation Effects of hormone replacement therapy on haemostasis and risk of venous thrombosis Association of hormone therapy with risk factors for venous thrombosis Changes in haemostasis and risk of ischemic stroke and coronary heart disease 16 16

17 GENETIC THROMBOPHILIA, HORMONE USE AND THE RISK OF VENOUS THROMBOSIS OR* (95% CI) Thrombophilia No hormone use, no thrombophilia HT use, no thrombophilia HT use, thrombophilia Family history of VT No hormone use, no family history HT use, no family history HT use, family history Reference 0.8 ( ) 2.9 ( ) Reference 1.3 ( ) 2.4 ( ) *Adjusted for age, smoking and BMI REJ Roach, J Thromb Haemost 2013; 11:

18 RISK FACTORS FOR VENOUS THROMBOSIS AND ASSOCIATION OF HORMONE THERAPY Nested case-control study based on data drawn from the WHI study Annualized rate/1000 person-years Baseline Age, y Body Mass Index < > 30 Placebo Estrogen + Progestin M Cushman el al. JAMA. 2004;292:

19 MY TALK TODAY The coagulation cascade and its regulation Effects of hormone replacement therapy on haemostasis and risk of venous thrombosis Association of hormone therapy with risk factors for venous thrombosis Changes in haemostasis and risk of ischemic stroke and coronary heart disease 19 19

20 DO CHANGES IN HEMOSTASIS EXPLAIN THE INCREASED RISK OF STROKE AND CHD WITH USE OF HORMONE THERAPY? WHI study: Estrogen plus progestin increased APC resistance compared with placebo Changes in APC-R did not seem to modify or mediate the effect of estrogen plus progestin on: the risk of ischemic stroke 1 the risk of coronary heart disease 2 1 JE Rossouw, Stroke 2012;43: K Johnson, Arterioscler Thromb Vasc Biol. 2016;36:

21 IMPACT OF DOSE AND ROUTE OF ESTROGEN ADMINISTRATION ON ISCHEMIC STROKE A case-control,united Kingdom s General Practice Research Database Type of HT Adjusted rate ratio 1 (95% CI) None 1 Transdermal route Low dose ( 50μg) High dose (>50 μg) Oral route Low dose High dose 0.81 (0.62 to 1.05) 1.89 (1.15 to 3.11) 1.25 (1.12 to 1.40) 1.48 (1.16 to 1.90) Low dose of oral HRT defined by mg of equine oestrogen or 2 mg of estradiol and high dose of oral HRT defined by >0.625 mg of equine oestrogen or >2 mg of estradiol. 1 Adjusted for age, body mass index, smoking status, alcohol misuse, diabetes, hyperlipidaemia, hypertension, atrial fibrillation, cardiovascular disease, transient ischaemic attack, aspirin or other NSAID use, and history of hysterectomy or oophorectomy. C Renoux, BMJ 2010;340:c

22 RISK OF ISCHEMIC STROKE ACCORDING TO ESTROGEN DOSE BY ROUTE OF ADMINISTRATION Nested case control study: French women aged 51 to 62 years with a first hospitalization for a stroke between 2009 and 2011 Estrogen dose: low: 1 mg/d of oral estrogens or <50 μg/d of transdermal estrogens; intermediate: 1.5 mg/d of oral estrogens or 50 μg/d of transdermal estrogens; high: 2 mg/d of oral estrogens or >50 μg/d of transdermal estrogens 22 M Canonico et al. Stroke 2016;47:

23 IMPACT OF ROUTE OF ESTROGEN ADMINISTRATION AND PROGESTAGENS ON ISCHEMIC STROKE A case control study of ischemic stroke within French women aged 51 to 62 years Non users OR of Ischemic Stroke (95% C I)* 1 (reference) Current use of oral estrogens 1.58 ( ) Current use of transdermal estrogens 0.83 ( ) Current use of micronized progesterone 0.78 ( ) Current use of pregnane derivatives 1.00 ( ) Current use of norpregnane derivatives 2.25 ( ) Current use of nortestosterone derivatives 1.26 ( ) *Adjusted for antidiabetic medication, antihypertensive medication, antidyslipidemia medication, and long-term chronic disease M Canonico et al. Stroke. 2016;47:

24 CONCLUSIONS HT induces an acquired resistance to the natural anticoagulant activated protein C (APC R) APC R and Risk of venous thromboembolism with HT vary by HT formulation, route of administration HT increases the risk associated with age, overweight or obesity, family history of VT or thrombophilia 24

25 CONCLUSIONS Role of hypercoagulable state in the pathogenesis of ischemic stroke not yet clear Both route of estrogen administration and progestogens may be determinants of ischemic stroke 25

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