Patient safety with oral anticoagulation are we on the right track?

Transcription

1 Patient safety with oral anticoagulation are we on the right track? Sotiris Antoniou, Consultant Pharmacist, Cardiovascular, Barts Health and UCL Partners Peter MacCallum, Consultant Haematologist, Barts Health 1 Acknowledgements - Joan Morris and Alana Ysmay Cavadino, Barts and the London School of Medicine and Dentistry, Queen Mary University of London

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3 Delayed adoption: wasted opportunities; lost lives On the 20th of May 1747, I selected twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of their knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; Lind s Trial and had Findings Routine adoption: one Published Lemon juice issued on diet common to all, viz. water-gruel lemon juice to non-stop voyage to India whole fleet sweetened with sugar in the morning; fresh mutton-broth often times for dinner; at other times light puddings, boiled biscuit with sugar, &c. and for supper, barley and raisins, rice and currants, sago and wine, or the like. Two of these were ordered each a quart of 3 cyder a-day. Two others took twenty-five drops of elixir vitriol.

4 How fast do useful new treatments get to patients? Research into routine practice = 17 years Average annual rate of adoption = 3.2 % Clinical Procedure Landmark Trial Rate of Use study Rate of Use % Annual increase in Rate of Use % Flu Vaccination Thrombolytic therapy Pneumococcal vaccination Diabetic eye exam Beta Blockers after MI Mammography Diabetic footcare Cholesterol screening Fecal occult blood test Balas, 4 E. A., & Boren, S. A. (2000). Yearbook of Medical Informatics: Managing Clinical Knowledge for Health Care Improvement. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbh. 4

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8 45 40 % NOAC prescribing by Area Team Quarter April-June

9 How fast do useful new treatments get to patients? Research into routine practice = 17 years Average annual rate of adoption = 3.2 % Clinical Procedure Landmark Trial Rate of Use study Rate of Use % Annual increase in Rate of Use % Flu Vaccination Thrombolytic therapy Pneumococcal vaccination Diabetic eye exam Beta Blockers after MI Mammography Diabetic footcare Cholesterol screening Fecal occult blood test Balas, 9 E. A., & Boren, S. A. (2000). Yearbook of Medical Informatics: Managing Clinical Knowledge for Health Care Improvement. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbh. 9

10 How fast do useful new treatments get to patients? Research into routine practice = 17 years Average annual rate of adoption = 3.2 % Clinical Procedure Landmark Trial Rate of Use study Rate of Use % Annual increase in Rate of Use % Flu Vaccination Thrombolytic therapy Pneumococcal vaccination Diabetic eye exam Beta Blockers after MI NICE costing model suggest 35% NOAC Mammography Diabetic footcare Cholesterol screening Fecal occult blood test NOAC Balas, E. A., & Boren, S. A. (2000). Yearbook of Medical Informatics: Managing Clinical Knowledge for Health Care Improvement. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbh. 10

11 So what 11 11

12 Jan March 2015 Total strokes 18,839 Known AF prior to admission 4100 (20.1%) On oral antiplatelets 6,612 (35.1%) On oral anticoagulation 8,346 (44.3%) Contra-indicated to anticoagulation 258 (13.7%) 12

13 So what 13 13

14 Implications on lack of antidote? Bleeding on warfarin Bleeding on NOAC

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

16 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

17 ORANGE STUDY Main Objectives Examine the current management and clinical outcomes of patients who develop major bleeding while on OAC o Warfarin (or other Vitamin K antagonists), o Rivaroxaban, Dabigatran, Apixaban (and others as they become available) Proportion of patients who develop major bleeding and: o present with ICH o die within 30 days of presentation

18 Methods Multicentre, observational, 3-year study (October 2013 October 2016) Definition of Major bleeding o Bleeding leading to hospital admission and resulting in Death Transfusion of 2 units red cells Transfusion of FFP or cryoprecipitate Administration of other products (PCC, rfviia, FEIBA, fibrinogen) Bleeding into a critical organ

19 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)

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

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

22 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)

23 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%.

24 Thank You UKCRN ID: 15322