Oral anticoagulant agent-associated bleeding events reporting system (ORANGE study)

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1 Oral anticoagulant agent-associated bleeding events reporting system (ORANGE study) Laura Green 1,2,3, Joan Morris 1, Raza Alikhan 4, Nicola Curry 5, Rhona Maclean 6, Khalid Saja 7, Simon Stanworth 3,5, Campbell Tait 8, Joachim Tan 1, Peter MacCallum 1,2 1 Barts and the London School of Medicine and Dentistry, Queen Mary University of London; 2 Barts Health NHS Trust; 3 NHS Blood and Transplant; 4 University Hospital of Wales, Cardiff and Vale University Health Board; 5 Oxford University Hospitals NHS Trust; 6 Sheffield Teaching Hospitals NHS Foundation Trust; 7 Barking, Havering and Redbridge University Hospitals NHS Trust; 8 Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde

2 Summary Background Study Objectives Study progress

3 Background NICE Commissioning Guide (2013) extrapolated to UK Prevalence of AF about 2% of adult population of UK Currently 500,000 on oral a/c therapy Likely to increase towards 1 million with new initiatives Reflects efficacy of warfarin and NOACs in stroke prevention (2/3 reduction)

4 Background New cases of VTE 100,000 per year in UK Additional 0.1% of adult population - 50,000 - need long-term oral a/c therapy Prosthetic heart valves 100,000 Other indications 100,000 Total 2.4% of adult population 1.2 million people on oral a/c therapy

5 Overview of anticoagulant therapy properties Laura Green

6 Safety Budnitz et al (NEJM 2011) 100, 000 emergency admissions for adverse drug events in adults 65 years (2007-9) 50% in adults 80 years Warfarin 33% Insulin 14% Antiplatelet agents 13%

7 Safety Bleeding Major bleeding 1-3% per year If 1.2 million people on oral a/c therapy 24,000 major bleeds per year in UK 500 per week, 2 or 3 per week per acute Trust

8 Safety Warfarin-related bleeds management guidelines so must be ok?? how good are we at managing warfarin- or NOAC- related bleeds??

9 Correction of warfarin-associated major bleeding (Toth et al; Blood Transf 2013) Retrospective audit of emergency warfarin reversal 131 consecutive patients Median PCC dose 26.8 IU/kg, INR reduced 3.1 to 1.2 Vitamin K (5 mg) given in 91.6% Median time from presentation to INR result 2.0 h (1.3 h in ICH) Vit K administration 3.6 h (2.7 h in ICH) PCC administration 5.2 h (3.0 h in ICH) Mortality 7.6% (ICH 22.8%) Thrombosis by 7 days 1.5%

10 Meta-analysis of bleeding on NOACs Chai-Adisaksopha et al. Blood 2014;124:2450-8

11 Intracranial bleeds Meta-analysis of bleeding on NOACs Chai-Adisaksopha et al. Blood 2014;124:2450-8

12 Fatal bleeds Meta-analysis of bleeding on NOACs Chai-Adisaksopha et al. Blood 2014;124:2450-8

13 30-day mortality after major bleeding Dabigatran v warfarin (Majeed et al Circulation 2013;128: )

14 Management of major bleeding dabigatran v warfarin (Majeed et al Circulation 2013;128: )

15 Mortality in warfarin-related major bleeding PCC v FFP Johansen M et al. Cochrane Review 2015

16 Safety in clinical practice Outcomes of major bleeding Dresden NOAC registry (Bayer-Westendorf J et al. Blood 2014;124:955-62) 1776 patients (67.5% AF; 32.5% VTE) Major bleeding per 100 py 3.1% AF; 4.1% VTE 1082 all bleeds 59% minor, 35% clinically relevant, 6% major 66 major bleeds 25 (38%) procedural intervention 6 PCC 5 showed stabilisation, 1 death from ICH with delayed and underdosed PCC Bleeding mortality at 90 days after major bleed 5.1% (15-20% for VKA in literature)

17 Design ORANGE study Prospective, multicentre, observational 3-year study Collect data on the current management and outcomes of patients who develop major bleeding while on OAC o warfarin, rivaroxaban, dabigatran, apixaban and others (as they become available) Primary Objectives Proportion of patients who develop major bleeding and: o present with ICH o die within 30 days of presentation

18 Secondary Objectives Estimate the effectiveness of products (PCC, rfviia or FEIBA, FgC) in treating major bleeding Characterise coagulation abnormalities of major bleeding associated with the new OAC Examine associations between clinical outcomes and: o transfusion requirements (RBC to FFP ratio) o correction of coagulation abnormalities resulting from blood transfusion and/or other products

19 ORANGE study Major bleeding Bleeding leading to hospital admission and resulting in Death Transfusion of 2 units red cells Transfusion of FFP Administration of other products (PCC, rfviia, FEIBA, fibrinogen) Bleeding into a critical organ

20 Milestones REC approval obtained (REC reference: 12/EE/0431) NIHR CRN Portfolio adopted (UKCRN ID: 15322) Recruitment began: October 2013 Study ends: December 2016 Number of sites: 31 recruiting; 2 pending R&D Quarterly newsletter Yearly reporting of results at BSH meetings

21 Demographics 1059 cases have been reported between October 2013 and August 2015 Characteristics N = 1059 Female / Male 520/539 Median age (yrs) 79 [IQR 70-85] N (%) Warfarin(Vitamin K antagonists) 909 (85.8) NOAC 150 (14.2) - Rivaroxaban 106 (10.0) - Apixaban 24 (2.3) - Dabigatran 20 (1.9)

22 Indications for OAC (% of total indications, not patients) DVT 11% Heart valve 10% PE 10% AF 59% Other 5% Stroke 5%

23 Age distribution by gender

24 Site of bleeding by OAC type Warfarin/VKA N = 909 % NOAC N = 150 Intracranial Gastrointestinal Other

25 Hb (g/dl)

26 INR

27 Management of Bleeding 1 Intervention Number Vitamin K mg 86 IV 254 Tranexamic acid 25 Haemodialysis 3 Dose 10 mg 145 Route Oral 8 Other 26 unspec. 7 unspec. 12 Surgery/Procedure 63 Neuro-surgical intervention GI tract endoscopic investigation/procedure Other 18

28 Management of Bleeding 2 PCC, FEIBA

29 Management of Bleeding 3 RBC, FFP, Platelets & Cryoprecipitate

30 Died 19.8% Outcomes at 30 days Pending 5.5% Discharged 62.2% Still inpatient 12.5% % Discharged Inpatient Died Report pending* VKA (n= 909) NOAC (n=150) Overall (n=1059)

31 Length of hospitalisation (for discharged patients)

32 Summary 85.8% warfarin; 14.2% NOAC. Median age: 79 yrs 41% ICH; 32.2% G-I bleeds overall, however: o Rate of ICH is higher with VKA than NOAC o Rate of G-I bleed is higher with NOAC than VKA Overall mortality rate at 30 days is 19.8%.

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