Terapia Anticoagulante Oggi: Il Valore Aggiunto Dei Noacs Versus La Terapia Standard; Gli Eventi Avversi In PS Noemi Renzi PS/OBI NOA (MS); ATNO.

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1 Terapia Anticoagulante Oggi: Il Valore Aggiunto Dei Noacs Versus La Terapia Standard; Gli Eventi Avversi In PS Noemi Renzi PS/OBI NOA (MS); ATNO. Consiglio Regionale SIMEU Toscana

2 Stato dell arte..

3 La storia

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5 Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation Patel M et al. NEJM 211; 365:

6 Granger CB et al. NEJM 211; 365:

7 Giual. NEJM 213gliano RP et; 39:

8 Connolly S et al. NEJM 211; 364:

9 VTE Treatment Trials With NOACs According to the ACCP 212 guidelines, the framework of anticoagulation for VTE treatment includes initial ( to ~7 days), long-term (~7 days to ~3 months) and extended treatment (~3 months to indefinite) 1 Initial 5 Days of Parenteral Required? Study Drug Initial/Long-term Treatment Trial Name Extended Treatment Trial Name No (Single-agent approach) Yes Apixaban AMPLIFY 2 AMPLIFY-EXT 8 Rivaroxaban EINSTEIN-DVT 3 EINSTEIN-EXT 3 EINSTEIN-PE 4 Dabigatran RE-COVER 5 RE-MEDY 9 RE-COVER II 6 RE-SONATE 9 Edoxaban Hokusai-VTE 7 ACCP=American College of Chest Physicians. 1. Kearon et al. Chest. 212;141(2):e419S-e494S. 2. Agnelli G et al. N Engl J Med. 213;369: Bauersachs R et al. N Engl J Med. 21;363: Büller HR et al. N Engl J Med. 212;366: Schulman S et al. N Engl J Med. 29;361: Schulman S et al. Circulation. 214;129: Büller HR et al. N Engl J Med. 213;369: Agnelli G et al. N Engl J Med. 213;368: Schulman S et al. N Engl J Med. 213;368:

10 Paulus Kirchhof et al. ESC Guidelines 216, European Heart Journal (216) 37,

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14 Lip GYH et al. Int J Clin Prat 216; Sep 7:

15 Barco S et al. Best Practice & Research Clinical Haematology 213; 26:

16 Barco S et al. Best Practice & Research Clinical Haematology 213; 26:

17 Survey pazienti con eventi emorragici PS Ospedale Apuane 1 8 % 1 G a s t r o I n t r a H a e m a t E p i s t G y n e c o H e m o p t E y e b l e v Total Bleeding Major Bleeding Gli eventi avversi in PS

18 Age Partial Thrombin Time Creatinine Cumulated risk of events about variables of Major clinical interest on presentation according to Kaplan-Meier analysis. Risk of Events Risk of Events Heart Rate Systolic Arterial Pressure Risk of Events International Normalized Ratio White Blood Cells Glucose Risk of Events Risk of Events Risk of Events Risk of Events Risk of Events Risk of Events D-Dymer Glucose Risk of Events

19 The chart of time to clinical evaluation, management, short- and long-term death in patients presenting with any bleeding events enrolled in the study (n=429). P<.1 P<.1 P<.1 P=.45 P=.27 P=.32 P=<.1 P=.5 P<.1 Mean Age 82±13 year CHA 2 D 2 VASC 2 5 (69%) Female 36 (5%) Major Hemorrhage 23(89%) Reversal Treatment 24 (92%) Heart Rate 23(89%) Additional Bleedings 23(89%) Haemoglobin 11 ± 3 Glucose 161 ± 67 One-year Death n=72 (16.8%) Patients with any bleeding events n=3,5 (1.8%) Propensity-matched patients n=429(8.1%) One-month Death n=26 (6.1%) Mean Age 81±12 year CHA 2 D 2 VASC 2 21 (81%) Female 17 (65%) P<.1 Major Hemorrhage 23(89%) Reversal Treatment 62 (86%) Partial Thrombin Time 29 ± 6 Glucose 163 ± 56 P=.48 P=.16 P=.19 P<.1 P<.38 P<.1 P=.21 Ischemic vascular disease 24(3%)

20 p <. 1 p <. 1 p <. 1 p Antiplatelets 388 (33%) Low Molecular Wheight Heparin 127 (11%) Warfarin 13 (11%) Direct Oral Antcoagulants 33 (3%) Aspirin 37 (26%) p <. Clopidogrel 118 (1%) Admission 188 (92%) Anticoagulants 287 (24%) One-month Death 3 (3%) T h e CHA 2 D 2 VASc score (64%) c h a r Major Bleeding t o(39%) f t Out of 3.48 i patients with any mbleeding events e to the Emergency t Department o c l i n i c a p <.1 Ischemic Vascular Disease p 329 (28%) < One-year Death 68 (6%). Kidney Disease 76 (6%) 1 Pulmonary Embolism or Deep Venous Thrombosis 75 (3%) Chronic Obstructive p Pulmonary Disease < 128 (11%). Dilated Cardiomyopathy 9 (8%) 1 p Reversal Treatment < 13 (1.1%) =. Blood Transfusion 1821(7%) p < p. Cancer 24 (17%)

21 CHA 2 D 2 VASc score (64%) p <.1 p < Antiplatelets 388 (33%) Low Molecular Wheight Heparin 127 (11%) Warfarin 13 (11%) Direct Oral Antcoagulants 33 (3%) Aspirin 37 (26%) Clopidogrel 118 (1%) Anticoagulants 287 (24%) Major Bleeding (39%) Out of 3.48 patients with any bleeding events to the Emergency Department Ischemic Vascular Disease 329 (28%) p < Kidney Disease. 76 (6%) Pulmonary Embolism or Deep 1 Venous Thrombosis 75 (3%) Chronic Obstructive Pulmonary Disease 128 (11%) p <. 1 Dilated Cardiomyopathy 9 (8%) Cancer 24 (17%) Reversal Treatment p 13 (1.1%) Admission < 188 (92%) Blood Transfusion = 182 (7%) One-month Death One-year Death. 68 (6%) p 3 (3%) 1 <

22 Other Anticoagulants 287 (24%) Antiplatelets 388 (33%) Aspirin 37 (26%) Direct Oral Antcoagulants 33 (3%)

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24 Conclusions Bleeding events to the emergency department accounts for 2% visits in a population based large survey. Death rate was substantially high at short- and long-term. Death rate was driven by major bleeding, female gender, white blood cells on short-term and older age on long-term, regardless of any treatment strategy. Patients presenting with gastrointestinal bleeding, intracranial bleeding or haematuria were more likely to die at one-month. Among dead patients mortality was approximately 4% on one-month; up to 6% in older patients, and up to 8% in female gender associated with CHA2D2VASC-score 2.

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