Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Terence William Sullivan who died on 10th August 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 13th March 2024 concerning the death of Terence William Sullivan on 10th August 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Terence’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Terence’s care have been listened to and reflected upon. 

Your Report raised the concern that the current guidance from the National Institute for Health and Care Excellence (NICE) and the guidance from the British Society for Gastroenterology (BSG) may not reflect best practice for patients on a single anticoagulant medication (in this case Rivaroxaban) with coronary stents and requiring a therapeutic endoscopic procedure.

The British Society of Gastroenterology (BSG) and the European Society of Gastrointestinal Endoscopy issued updated guidance in 2021 on ‘Endoscopy in patients on antiplatelet and anticoagulant therapy’. This update followed “an extensive revision” and “evidence-based update”. The guidance clearly states that for patients undergoing a high-risk procedure (such as polypectomy) and taking a direct oral anticoagulants (DOAC), such as Rivaroxaban, they should take their ‘last dose 3 days before endoscopy [and] … restart DOAC 2-3 days after the procedure.’ This is clearly set out in Figure 2 of the guidance.

As part of NHS England’s review of your Report, a cardiovascular expert was also consulted. They advised that it was difficult to comment without further details of Terence’s medical history but that a conversation with a cardiologist would have been warranted in Terence’s case to agree on a strategy for the procedure and that it was possible that antiplatelet therapy with aspirin could have been given during the period that DOAC was withheld.

As your Report references, NICE and the BSG publish the relevant clinical guidance on the issues raised. This does not come under NHS England’s remit. We note that you have also addressed your Report to both organisations and refer you to their National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

26th April 2024

responses. We have engaged with the BSG on the concerns raised and understand that they are intending to provide some updated guidance on this issue. It is our understanding that this will be a communication to all BSG members initially, followed by a published letter in a journal and formal guidelines in due course. We have asked that the BSG keep us updated on this. NHS England will support on the implementation of any changes.

NHS England has also shared your Report with the Chief Medical Officers for Worcestershire Acute Hospital Trust and Herefordshire and Worcestershire Integrated Care Board.

I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Mr Reid, Re: Regulation 28 Prevention of Future Deaths Report in respect of Terence William Sullivan I write in response to your regulation 28 report dated 14 March 2024 regarding the sad death of Terence William Sullivan. I would like to express my sincere condolences to Mr Sullivan's family. We have reflected on the circumstances surrounding Mr Sullivan's death and the concerns raised in your report. We note your concerns that guidance from NICE and the British Society of Gastroenterology on temporarily pausing anticoagulant medications prior to therapeutic endoscopy may not reflect current best practice. Following receipt of your report, senior clinical advisors within the patient safety team here at NICE have reviewed the concerns raised. They have highlighted that although it has not been stated when Mr Sullivan underwent his stent insertion, it is understood, based on experience, that if this procedure was undertaken less than a year prior to the endoscopy, temporary cessation of anticoagulation would need discussion with the patient's cardiologist. Within your report you have outlined that Worcestershire Acute Hospitals NHS Trust based their own guidance on the Clinical Knowledge Summary (CKS) anticoagulation - oral and the scenario on rivaroxaban. This scenario outlines specific recommendations under the title should rivaroxaban be stopped if surgery or dental treatment is required? outlining timings on when anticoagulants should be stopped based on the bleeding risk of the surgical procedure. The CKS are developed by an external company called Agilio Software and are designed to summarise the evidence on the treatment of specific health conditions. They use a variety of sources and may include NICE guidance, if there is any that is relevant, but they use many other sources too. We publish them on our website as a source of advice and information for health professionals working in primary care, but they do not constitute NICE guidance.

NICE

As part of this process, we have shared this report with Agilio Software for their awareness and understand that they are going to update this specific CKS shortly. If further detail is required on the changes to the content of the CKS topic, Agilio Software can ~e contacted directly. In addition to the CKS, there are some potentially relevant recommendations in the NICE guideline, acute coronary syndromes (NG185] under the title, antiplatelet therapy for people with an ongoing separate indication for anticoagulation. We acknowledge that there are no definitive recommendations in this guideline on when it is safe to temporarily stop anticoagulants for a patient who has had stent insertion and when advice should be sought from the cardiologist caring for the patient, as our recommendations do not cover all clinical circumstances. _The recommendations in our guidelines represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take our guidelines fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guidelines do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian. N~vertheless, NICE will consider the issues raised through our guideline's surveillance team and process, and update or issue new guidance recommendations, accordingly, depending on the outcome of these considerations. I hope this response has helped 01,1tline our role and the guidance that exists in this topic area.

Dear Mr Reid Regulation 28 Prevention of Future Deaths report regarding Terence Willian Sullivan Thank you for bringing to our attention the circumstances leading to the death of Mr Sullivan. The report does not mention how long ago the coronary stents were inserted, but I assume that he was treated with dual antiplatelet therapy for at least the minimum required period, and at a later date was switched to rivaroxaban alone to cover his atrial fibrillation. You are correct that this scenario was not covered in the guideline "Endoscopy ·in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology {BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update Veitch AM et al Gut 2021 ;70:1611-28", although the scenario of a DOAC plus aspirin was considered in patients with stents. At that time the published evidence did not support sole therapy with a DOAC for patients with coronary stents and atrial fibrillation, but it is apparent that this is now a more common scenario, and is indeed supported by European cardiology guidelines. I took advice from the cardiology co-author on the 2021 guidelines, , who was aware of a similar case, and we plan to issue the following statement to all BSG members: "Addendum to BSG/ESGE Endoscopy in patients on antiplatelet or anticoagulant therapy guideline 2021 We thank the Senior Coroner for Worcestershire for bringing to our attention the death of a patient due to a myocardial infarction who had previous coronary stents, but had atrial fibrillation in addition, and at the time of colonoscopy was on sole therapy with rivaroxaban. The rivaroxaban was stopped at least 48 hours prior to the procedure. This particular scenario is not covered by the BSG/ESGE guidelines, and I am grateful to the cardiology author on the guidelines, , for providing interim guidance. We are aware of at least one other similar case with catastrophic consequences. Many clinicians increasingly stop all antiplatelets in patients with prior coronary stents when there is a need for long-term anticoagulation for other reasons (e.g. AF), as per the current European Society of Cardiology guidelines. These patients will be at an increased risk of stent thrombosis when anticoagulants are stopped, and they are on no antithrombotic medication at all. We recommend that all patients on anticoagulants alone with a history of prior coronary stents must either be switched to aspirin (provided there are no contraindications) or discussed with an interventional cardiology consultant first. When switching to aspirin patients should be loaded with 300mg the day prior to anticoagulant cessation and prescribed 75mg daily thereafter. Patients should remain on aspirin British Society of Gastroenterology: Company No. 8124892 Charity No. 1149074 / VAT No. 347 4214 61

until they are re-established on anticoagulants and within therapeutic range, after which the aspirin can be stopped. It is important to remember that particular care must be taken in any patients with a prior history of having coronary stents. We would encourage discussion with a consultant interventional cardiologist in patients in whom interruption of either antiplatelets or anticoagulants is being considered. We also plan to publish this guidance as a journal letter prior to a formal update of the BSG/ESGE guideline." As indicated in the message to BSG members, we plan to publish this advice in a peer-reviewed journal prior to scheduled five year revision of the whole guideline. It is important to note that the reported scenario occurred prior to a therapeutic endoscopic procedure, but the principles will apply prior to any therapeutic intervention which requires temporary cessation or modification of anticoagulant therapy in a patient with coronary stents.