Anticoagulation Care

Improving the evidence base for anticoagulation care

Researchers at the Centre for Evidence Based Medicine have been leading a programme of work to optimise the use of anticoagulants. The work includes a suite of systematic reviews, several of which have influenced national and international health policy, clinical guidelines, and pharmaceutical companies.

Underpinning research and indicative impact

Date Activity Summary
Aug 2006 Underpinning research Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367:404–11.
Nov 2008 Underpinning research Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C, Xu Y. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circulation: Cardiovascular Quality and Outcomes. 2008 Nov;1(2):84-91.
Apr 2010 Underpinning research Garcia‐Alamino JM, Ward AM, Alonso‐Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ. Self‐monitoring and self‐management of oral anticoagulation. Cochrane Database of Systematic Reviews. 2010(4).
Dec 2010 Impact Liberating the NHS white paper – Department of Health’s white paper on “Equity and Excellence: Liberating the NHS” Cites 2010 Cochrane review as a strategy for involving more patients in their own care. 
Dec 2010 Underpinning research Heneghan C, Tyndel S, Bankhead C, Wan Y, Keeling D, Perera R, Ward A. Optimal loading dose for the initiation of warfarin: a systematic review. BMC cardiovascular disorders. 2010 Dec;10(1):18.
Jun 2011 Impact British Society of Haematology Guidelines on Anticoagulation (4th edition) cites 2010 systematic review on the optimal loading dose of warfarin, cite also 2010 review on self-monitoring. These guidelines remain current BSH guidance.
Jan 2012 Underpinning research Heneghan C, Ward A, Perera R, Bankhead C, Fuller A, Stevens R, Bradford K, Tyndel S, Alonso-Coello P, Ansell J, Beyth R. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. The Lancet. 2012 Jan 28;379(9813):322-34. – funded by the National Institute of Health Research, included a meta-analysis of individual participant data involving over 30 international collaborators (“Self-Monitoring Triallist Collaboration”). The Individual patient data analysis, with 12,800 person-years of follow-up, showed that self-monitoring was effective in the long term and across a wide age range of participants.
Feb 2012 Impact Evidence-Based Management of Anticoagulant Therapy Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines – cite 2006 self monitoring review, 2011 Lancet review and 2010 optimal loading dose review. These guidelines remain the current version.
April 2012 Underpinning research Mahtani KR, Heneghan CJ, Nunan D, Bankhead C, Keeling D, Ward AM, Harrison SE, Roberts NW, Hobbs FDR, Perera R. Optimal loading dose of warfarin for the initiation of oral anticoagulation. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: CD008685. DOI: 10.1002/14651858.CD008685.pub2.
Nov 2012 Underpinning research Plüddemann A, Thompson M, Wolstenholme J, Price CP, Heneghan C. Point-of-care INR coagulometers for self-management of oral anticoagulation: primary care diagnostic technology update. Br J Gen Pract. 2012 Nov 1;62(604):e798-800.
Apr 2014 Underpinning research Mahtani KR, Heneghan CJ, Nunan D, Roberts NW. Vitamin K for improved anticoagulation control in patients receiving warfarin. Cochrane Database of Systematic Reviews. 2014(5).
July 2014 Impact AntiCoagulation Europe (ACE) (UK) is a charity dedicated to supporting patients who take anticoagulant and antiplatelet therapies. The charity partnered with three other UK charities to form the AntiCoagulation Self-Monitoring Alliance and submitted written evidence, citing the reviews, to the Parliamentary Health Select Committee’s inquiry into the Management of Long-Term Conditions (2014). They cite the 2006 and 2010 systematic reviews on self-monitoring.
July 2014 Impact Anticoagulation services and patient access to INR self-monitoring in the NHS in England – A report by the AntiCoagulation Self-Monitoring Alliance (July 2014) cite 2006 Lancet review. 
Aug 2014 Impact British Society of Haematology – Patient self‐testing and self‐management of oral anticoagulation with vitamin K antagonists: guidance from the British Committee for Standards in Haematology. The guidance cites the 2012 Lancet review on self-monitoring. Heneghan invited as co-author of the guideline.
Apr 2015 Impact Royal College of Obstetricians and Gynaecologists – Thromboembolic Disease in Pregnancy and the Puerperium: Acute Management Green-top Guideline. Cite 2010 systematic review of the optimal loading dose of warfarin.
April 2016 Impact NHS Healthcall – An NHS collaboration driving improved care and technology innovation across the North East of England – produce patient information sheets citing 2012 Lancet review on self-monitoring.
May 2016 Impact Roche launches the CoaguChek® INRange system in countries accepting the CE Mark. Cite 2006 and 2012 systematic reviews on self-monitoring.

Roche also makes these related statements:

  • “CoaguChek meters have been offered in the U.S. for more than 20 years and there are more than one million CoaguChek XS devices in use around the world
  • Over 250,000 CoaguChek XS PT test strips are used globally per day
  • Nine of the top 10 U.S. integrated health networks (IHNs) choose CoaguChek technology
Jul 2016 Underpinning research Heneghan CJ, Garcia‐Alamino JM, Spencer EA, Ward AM, Perera R, Bankhead C, Alonso‐Coello P, Fitzmaurice D, Mahtani KR, Onakpoya IJ. Self‐monitoring and self‐management of oral anticoagulation. Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD003839. DOI: 10.1002/14651858.CD003839.pub3
July 2016 Impact Above review is press released. Lead author statement: “There are more than 1.2 million people in the UK on warfarin therapy, of whom fewer than 2 per cent self-monitor their INR levels despite mounting evidence that self-monitoring alone can cut the risk of death by nearly two fifths and more than half the risk of strokes.”
Sep 2016 Lead editorial in the BMJ Novel oral anticoagulants for atrial fibrillation Mahtani, K.R. and Heneghan, C., 2016. Novel oral anticoagulants for atrial fibrillation.(2016): i5187. BMJ

Picked up by:

BMJ: More Questions on Faulty INR Device Used in ROCKET AF
Medscape, 30 Sep 2016
The manufacturer of rivaroxaban ( Xarelto, Bayer/Johnson

Oxford academics question NOAC’s safety
6 Minutes, 30 Sep 2016
Two Oxford academics have called for more research into the the safety and efficacy of the anticoagulant rivaroxiban.

Drug company withheld information about faulty device in key trial of best selling anti-clotting drug
Medical News Today, 29 Sep 2016
An investigation published by The BMJ today reveals that Janssen, the pharmaceutical arm of Johnson and Johnson, withheld data…

Pharma withheld faulty device info in rivaroxaban trial
OnMedica, 29 Sep 2016
Janssen withheld data from the US Food and Drug Administration (FDA) about a faulty device used during one of the crucial…

Were Problems With the Point-of-Care Device Used in ROCKET AF Kept From the FDA? BMJ Says Yes
TCTMD, 29 Sep 2016
Soon after the ROCKET AF trial evaluating rivaroxaban began enrolling patients, study investigators started expressing concerns…

Drug company withheld information about faulty device in key trial of best selling anti-clotting drug
Today Topics , 28 Sep 2016
An investigation published by The BMJ today reveals that Janssen, the pharmaceutical arm of Johnson and Johnson, withheld data…

May 2017 Impact Roche develop patient facing material to support self-monitoring of INR – “I know my value – Be an active part of your anticoagulation therapy with INR self-monitoring” – citing 2012 systematic review
Aug 2017 Impact ESC/EACTS Guidelines for the management of valvular heart disease – Cite 2012 Lancet review on self-monitoring
Sep 2017 Impact Inhealthcare launches an INR self-testing service for NHS patients in Manchester – citing 2012 Cochrane systematic review. “Inhealthcare is supplying the pioneering technology for the service, which is being delivered by staff from The Pennine Acute Hospitals NHS Trust, which runs North Manchester General Hospital.

It is available for up to 200 patients with Atrial Fibrillation in North Manchester. Their respective clinics will still be their first point of contact if they have any problems or concerns.”

Nov 2017 Impact NICE Clinical Knowledge summaries – What is the starting dose when warfarin therapy is initiated? – Recommendations from 2011 BSH guidance which cites 2006 and 2010 systematic review
Nov 2017 Impact NICE Clinical Knowledge Summaries (Anticoagulation) – Are self-testing and self-management as safe and effective as routine management? – Recommendations include:

“For selected and successfully trained people, self-testing or self-management are as effective and safe as usual care for long-term oral anticoagulation therapy and can improve the quality of oral anticoagulation therapy in this group of people.
However, in the UK, self-testing is unlikely to be more cost-effective than usual care, because of the increased frequency of testing and subsequent cost of test strips.”

The basis for the recommendation – heavily reference 2016 Cochrane systematic review – on self-monitoring

Jan 2018 Impact The self-testing point of care coagulation market is one of the largest sectors in the global point-of-care industry. In 2011, the market was valued at $1.0bn. By 2017, the global coagulation analyzer market was valued at $1.8bn.

Global Coagulation Analyzer Market to Surpass US$ 13.17 Billion by 2025

May 2018 Impact Department of Health and Social Care Reviews Facility – To support national policy development and implementation “The effective, safe and appropriate use of anticoagulation medicines.
A systematic overview of reviews” – cite 2016 Cochrane systematic review
Jun 2018 Impact Roche introduces first self-testing device for Warfarin monitoring with built-in Bluetooth® technology. “Patient self-testing with the Bluetooth-enabled CoaguChek Vantus system allows for a new level of patient monitoring. Patients can use their tablet or smartphone with a compatible app to send their results automatically via wireless connectivity which enables healthcare providers to receive patient INR results rapidly and accurately, while also reducing visits to the lab.” citing 2016 Cochrane systematic review on self-monitoring.
Jun 2018 Blog NOACs: good for some perhaps, but not for all
Oct 2018 Impact Roche – “In vitro diagnostics: enabling better health decisions” cite Lancet 2012 review
Nov 2018 Impact American College of Chest Physicians – Antithrombotic Therapy for Atrial Fibrillation – CHEST Guideline and Expert Panel Report – cites 2016 Cochrane review on self-monitoring. REACH – The website of CHEST states “CHEST is the global leader in prevention, diagnosis and treatment of chest diseases. Its mission is to champion advanced clinical practice, education communication and research in chest medicine. It serves as an essential connection to clinical knowledge and resources for its 19,000+ members from around the world who provide patient care in pulmonary, critical care and sleep medicine.”
Jun 2019 Impact The global Point of Care (PoC) Diagnostics market was valued at USD 23.98 Billion in 2018 and is expected to reach USD 50.51 Billion by year 2026, at a CAGR of 9.6%.” includes PT/INR Testing Products

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