Il laboratorio: verso una migliore definizione dei test
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1 Il laboratorio: verso una migliore definizione dei test Armando Tripodi Angelo Bianchi Bonomi Hemophilia and Thrombosis Center Dept. of Clinical Sciences and Community Health University of Milano
2 Laboratory & DOAC When to measure DOAC reach (Cmax) approximately 2 hours after ingestion DOAC reach Ctrough approximately 12h (bid) or 24h (od) after ingestion Timing of blood draw is essential for results interpretation
3 Which Test for Dabigatran APTT Thrombin Time (TT) PT INR Ecarin clotting time (ECT) Anti FIIa activity
4 APTT & Dabigatran Van Ryn et al, 2010
5 Commercial APTT & Dabigatran Hawes EM et al, 2013
6 ECT & Dabigatran Van Ryn et al, 2010
7 Stangier et al, 2007
8 Van Ryn et al, 2010
9 Which Test for Rivaroxaban Anti Xa PT APTT HepTest dilute Russell Viper Venom Time (drvvt) Others (whole blood monitors, TG, etc.)
10 Rivaroxaban Prothrombin Time
11 Corresponding to 20 mg once daily Samama et al, 2010
12 Order of thromboplastin responsiveness to rivaroxaban Thromboplastin Neoplastin Plus Recombiplastin Neoplastin Triniclot Thromborel S Innovin et al. JTH 2011 Riva SI
13 Between-thromboplastin variability according to results expression A. Tripodi et al, JTH 2011 CV% CV=29.6% CV=14.0% CV=2.1% PT-ratio INR Riva-PT-ratio
14 Which Test for Apixaban Anti FXa APTT PT Others A. Tripodi
15 Apixaban & PT (Douxifils et al, 2013)
16 Apixaban & Anti Fxa (Douxifils et al, 2013)
17 Alternatives for PT (and other tests) Standardization
18 Clotting time Normal plasma + Drug at increasing concentration Drug Concentration
19 clotting times for calibration plasmas depend on: Pro-coagulant activity of the normal plasma plus The effect of the drug
20 normal plasmas are not equal in terms of procoagulant activity
21 Clotting time Normal plasma 1 Normal plasma 2 Drug Concentration
22 Expected Therapeutic Dabigatran Concentrations Peak 175 ng/ml ( ) Trough 91 ng/ml (61 143)
23 Expected Therapeutic Rivaroxaban Concentrations Peak 215 ng/ml (22 535) Trough 32 ng/ml (6 239)
24 Expected Therapeutic Apixaban Concentrations Peak 162 ng/ml (range??) Trough 19 ng/ml (range??)
25 Conclusions (1) How to measure the effect of Dabigatran Dilute TT or ECT Ratio (patient/normal) Results Expression Drug concentration from calibration curve
26 Conclusions (2) How to measure the effect of Rivaroxaban anti-fxa or PT Results expression Anti-FXa - Drug concentration from calibration curve PT - Ratio (patient/normal) - No INR - Riva-PT-ratio is an alternative
27 Conclusions (3) How to measure the effect of Apixaban Anti-FXa Results expression Anti-FXa - Drug concentration from calibration curve
28 Conclusions (4) Usefulness of measuring the effect of DOAC Useful - At baseline (before initiation of treatment) - Before surgical/invasive procedures - Adverse events (hemorrhage or thrombosis) - Need for reversal of anticoagulation Potentially useful - When chronic anticoagulation is achieved (1-2 weeks after initiation) - At regular intervals during clinical visits - Soon before and after introducing additional drugs - Extreme body weight
29 Cosa fare subito Attrezzarsi prima possibile con i test consigliati Valutare il comportamento dei test di base (PT, APTT) mediante la loro esecuzione su plasmi calibranti a titolo noto del farmaco Organizzare riunioni aziendali con tutti i soggetti coinvolti, per stabilire linee di comportamento condivise In una prima fase eseguire alla bisogna test specifici ma anche di base per capire meglio il loro comportamento
30 Antidotes & Reversal
31
32
33
34 Circulation 2011; 124 : Conclusions PCC immediately and completely reverses the effect of rivaroxaban, but has no influence on dabigatran when assessed by lab tests
35 Rivaroxaban & PT Placebo PCC
36 Dabigatran & thrombin time Placebo PCC
37 If different DOAC have different antidote/reversal strategy Knowledge of the drug being taken by patients is essential for management of reversal
38 DOAC effect of the most common hemostatic parameters Antithrombin Fibrinogen APC resistance Factor assay Protein C anticoagulant activity Protein S anticoagulant activity Lupus anticoagulant Factor XIII
39 Conclusions Although DOAC do not require doseadjustment based on lab testing, assessment of their anticoagulant effect is useful in many circumstances Caution should be exerted when interpreting results of hemostatic parameters in patients taking DOAC
40 Blood 2013;121:4032-5
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