Page 200 - Haematologica-April 2018

L. Green et al.
practice than those observed in the randomized clinical trials. Patients in the latter were more highly selected, and the management of major bleeding in the trials appears different from current recommended practice; for exam- ple, among those with major bleeding in the open-label warfarin arm of the RELY trial only 27% received vitamin K and 1% received a prothrombin complex concentrate27 in contrast to over 70% for both in our study.
We identified patients who developed major bleeding on OAC and were admitted to hospital, but it is possible that not every case was captured, because they were not triaged to emergency departments, and thus could have been missed by the research team. The upshot is that we may have collected data on the more severe bleeding cases with consequently worse outcomes, although we expect the numbers affected to be relatively small. Furthermore, it could be argued that warfarin cases would have been easier to capture through the prescription of prothrombin complex concentrate. However, the methods of case iden- tification were designed to capture all cases of major bleeding from hospitals, independently of the type of OAC, but we recognize that some cases could have been inadvertently missed.
It is also possible that we may have missed some cases of fatal bleeding who died suddenly in the community; however, we think these numbers will likely be small because the majority would be taken to their local emer- gency department because of acute deterioration. Furthermore, we might have missed the outcome of patients who were discharged before 30 days; however, it seems a reasonable stipulation that patients were dis- charged from hospital if and when major bleeding had been successfully treated or resolved, and hence restricting follow-up to within the hospital is justifiable on the grounds that any post-discharge deaths would not be “fol- lowing from the bleeding event”.
In conclusion, for clinicians who are responsible for counseling patients about oral anticoagulation our find- ings indicate that mortality from major bleeding on OAC that requires hospitalization is high, with one in five patients likely to die within 30 days. This is of concern given the widening use of these agents in an increasingly elderly and frail population. As far as DOAC are con- cerned, our results provide reassurance, in that they are
not associated with worse outcomes compared to war- farin despite the lack of antidotes at the time of the study. As the DOAC antidotes emerge, it would be important for future studies to investigate their impact on patients’ out- comes compared to current practice.
Funding
This study was funded by the British Society for Haematology Early Stage Researcher Fellowship awarded to Dr Laura Green. The views expressed in this publication are those of the authors and not those of the funder. The funder had no role in the study design, data collection/analysis or preparation of this article.
Acknowledgments
We would like to acknowledge all hospitals, NHS trusts and principal investigators who reported to the study: Newham University Hospital (Dr Olivia Kreze), Whipps Cross University Hospital (Dr Peter MacCallum); The Royal London Hospital (Dr Laura Green); Barking Havering and Redbridge University Hospitals (Dr Khalid Saja); John Radcliffe Hospital (Dr Nicola Curry); Glasgow Royal Infirmary (Dr Campbell Tait); University Hospital of Wales (Dr Raza Alikhan); Sheffield Teaching Hospitals (Dr Rhona Maclean); Basingstoke & North Hampshire Hospital and Salisbury District Hospital (Dr Tamara Everington); Ulster Hospital (Dr Margaret Bowers); Wexham Park Hospital (Dr Sarah Wilson); Withybush General Hospital (Dr Sumant Kundu); Newcastle upon Tyne Hospitals (Dr John Hanley); North Middlesex University Hospital (Dr John Luckit); Basildon and Thurrock Hospitals (Dr Godwin Simon); Torbay Hospital (Dr Nichola Rymes); University College Hospital (Dr Hannah Cohen); St George's Healthcare NHS Trust (Dr James Uprichard); Birmingham Heartlands Hospital (Dr Charalampos Kartsios); Royal Bournemouth Hospital (Dr Jason Mainwaring); Hull and East Yorkshire Hospitals NHS Trust (Dr Salama Abosaad); Northern Lincolnshire and Goole NHS Foundation Trust (Dr Sanjeev Jalihal); Dumfries and Galloway Royal Infirmary (Dr Mohamed Khan); University Hospitals of North Midlands (Dr Deepak Chandra); Gloucestershire Hospitals (Dr Oliver Miles); South Tees Hospitals (Dr Jamie Maddox); Glangwili General Hospital (Dr Saran Nicholas); Royal Berkshire NHS Foundation Trust (Dr Liza Keating); University Hospital Southampton (Dr Sara Boyce); Northumbria Healthcare NHS Foundation Trust (Dr Charlotte Bomken) and North Cumbria University Hospitals (Dr Roderick Oakes).
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