Terence Sullivan

BRITISH SOCIETY OF 
GASTROENTEROLOGY 

3 St Andrews Place 
Regent's  Park 
London  NW, 4LB 

www.bsg.org.uk

3 May 2024 

MrD DW Reid 
HM Senior Coroner 
Coroner's Court 
Martins Way 
Stourport-on-Severn 
Worcestershire 
DY13 8UN 

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, 
, for providing interim 
and  I am grateful to  the cardiology author on the guidelines, 
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. 

Yours sincerely 

President, British  Society of Gastroenterology 

British Society of Gastroenterology: Company No. 8124892 
Charity No.  1149074 / VAT No. 347 4214 61

David Donald William Reid 
Worcestershire Coroner’s Court 
The Civic 
Martins Way 
Stourport-on-Severn 
Worcestershire  
DY13 8UN 

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

26th April 2024  

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 

                                                                                                                       
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 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.  

Yours sincerely,  

National Medical Director

NICE National Institute for 

Health and Care Excellence 

2nd  Floor 
2 Redman Place 
London 
E20 1JQ 
United Kingdom 

2 May2024 

MrD OW Reid 

His  Majesty's Senior Coroner for Worcestershire 

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 

www.nice.org.uk I nice@nice.org.uk

 
 
 
 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 . 

Yours sincerely, 

Chief Executive 

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