Risk assessment in UGIB: recent PCI & ACS Dr Martin James PhD FRCP October 20 th 2016 Nottingham Endoscopy Masterclass
Clinical scenario 65 yr male Previous smoker, hyperlipidaemia, DM PCI < 48 hours Dual antiplatelet therapy & LMWH Active bleeding melaena, hypotension, tachycardia GBS 12; pre-endo Rockall score 5
ECG
Glasgow-Blatchford Bleeding Score Requires FBC, U&E and basic clinical assessment Simple Ready within 1 hour Assessed against composite end-point of: Clinical intervention (transfusion, endoscopic treatment or surgery) Death 30d
Rockall et al 1996
Glasgow-Blatchford Bleeding Score Stanley Lancet 2009
Stanley Lancet 2009
Rockall Score Risk Score Rebleed % Mortality % 0 5 0 1 3 0 2 5 0.2 3 11 3 4 14 5 5 24 11 6 33 17 7 44 27 8+ 42 41 Rockall et al 1996
Key questions How common & what causes GI bleeding after ACS/PCI? Efficacy & risks of conservative measures? Likelihood of therapeutic intervention? What is the clinical outcome? Risks associated with endoscopy post ACS? Should antiplatelets/anticoagulation be stopped?
Key questions How common & what causes GI bleeding after ACS/PCI? Efficacy & risks of conservative measures Likelihood of therapeutic intervention? What is the clinical outcome? Risks associated with endoscopy post ACS? Should antiplatelets/anticoagulation be stopped?
Secondary prevention - evidence Study Year n Follow up Drugs CVS event Bleeding COGENT (dual therapy) 2010 NEJM 3800 6m ASA/Clopi +Omeprazole ASA/Clopi +placebo 4.9% 1.1% 5.7% 2.9% CHARISMA (ACS pts) 2010 NEJM 15,600 28m Aspirin 75 7.3% 1.7% OASIS-7 (PCI) PROFESS (CVA) Aspirin 75/ Clopi 75 2010 NEJM 25,000 30d Clopi HD/ Aspirin 75 Clopi LD /aspirin 2008 NEJM 20,000 2.5y Aspirin/ dipyridamole 6.8% 1.3% 4.2% 2.5% 4.4% 2.0% 9.0% 4.1% Clopidogrel 8.8% 3.6%
Bleeding events post PCI Koscinas ; Circ Cardiovent Intervent 2015
Causes of UGIB after ACS/PCI COMMON (90%): Peptic ulceration Gastritis, duodenitis Oesophagitis UNCOMMON (10%): Variceal haemorrhage UGI malignancy Dieulafoy Lesion Mallory Weiss tear Shalev Int J Cardiol 2012 Ng Am J Gastro 2008 Yachimski Dig Dis Sci 2011
Key questions How common & what causes GI bleeding after ACS/PCI? Efficacy & risks of conservative measures Likelihood of therapeutic intervention? What is the clinical outcome? Risks associated with endoscopy post ACS? Should antiplatelets/anticoagulation be stopped?
Rebleed rates Rebleed <5 days; PPI alone 11-34% Rebleed <5 days; following endoscopic therapy 9% in high risk lesion 3% in low risk lesion Khurooo NEJM 1997 Jung AM J Gastro 2002 Bleau GIE 2002 Bini GIE 2003 Yachimski Dig Dis Sci 2011
Stigmata of Bleeding Risks of Re-bleeding and Prevalence Clean base 49% bleeder 7% NBVV 8% 100 80 60 40 dot 23% clot 13% 20 0 Active bleeder NBVV Clot Dot Clean base
Key questions How common & what causes GI bleeding after ACS/PCI? Efficacy & risks of conservative measures Likelihood of therapeutic intervention? What is the clinical outcome? Risks associated with endoscopy post ACS? Should antiplatelets/anticoagulation be stopped?
Clinical outcomes UGIB in ACS Findings in acute severe overt GI bleeding: Identify bleeding source 90% Need for endoscopic intervention: 39% Procedure related mortality 1% 30d mortality in ACS and UGIB 10-33% Cappell Am J Med 1999 Cappell Dig Dis Sci 2005 Lin Dig Dis Sci 2005 Yachimski Dig Dis Sci 2011
Haemoglobin targets? Villaneuva NEJM 2013
NEJM; VILLANAEUVA NEJM 2013
TRIGGER STUDY; Jairath LANCET 2015
TRIGGER Subgroup analyses Hb <12 g/dl Outcome Liberal (n=383) Restrictive (n=257) Difference and 95% CI P-value Ischaemic heart disease Further bleeding (Day 28) no. (%) 6/66 (9) 3/46 (7) -2.7 (-20.8 to 15.4) 0.85 Mortality no. (%) 2/67 (3) 6/49 (12) -10.7 (-9.8 to 31.2) 0.11 Variceal bleeding Further bleeding (Day 28) no. (%) 7/51 (14) 4/22 (18) -0.7 (-40.2 to 41.6) 0.73 Mortality no. (%) 6/55 (11) 1/23 (4) -7.1 (-20.3 to 6.0 0.18
Anaesthetic Support in Major Upper Gastrointestinal Bleeding?
Current NUH Algorithm NICE 2012 Cardio-respiratory support not specifically addressed SIGN 2008 Highlights risk of airway compromise and need for appropriately trained staff but no specific guidelines regarding use of anaesthetic support BSG 2006 Anaesthetic support recommended for large UGIB where there is depressed LOC or reduced patient co-operation. Also considers those who may be at risk of oversedation and aspiration pneumonia Yes to any Perform endoscopy in emergency theatre Initial patient assessment indicates urgent endoscopy is required Exsanguinating (ongoing haemodynamic compromise after initial resuscitation) Active fresh haematemesis with haemodynamic compromise Risk of airway compromise (reduced consciousness, vomiting, agitation, uncooperative) Urgent endoscopy needed out of office hours No Stabilise and endoscopy <12 hours
Principal recommendations: Hospitals must provide 24/7 access to on-site endoscopy, IR, GI surgery and critical care anaesthesia Patients with major GIB should be discussed with duty on-call endoscopist within 1 hour GIB + haemodynamic instability require OGD within 2 hours of optimal resuscitation Ongoing management of major bleeds rests with named consultant Gastroenterologist Clearly documented re-bleed plans
Patient Characteristics NUH UGIB GA cases 2015 Gender Male:Female ratio 60:35 Age (years) mean ± SD Males 59.2 ± 19.1 Females 55.2 ± 28.4 ASA (%) Grade 1 7.4 Grade 2 10.5 Grade 3 44.2 Grade 4 34.7 Grade 5 3.2 Urgency Code (%) 1 64.2 3 25.3 6 4.2 12 4.2 24 2.1 GBS Score Yes (%) 17 (18%) Median (range) 12 (1 19)
Post-OGD complications MI: n=5 (5.3%) ARF: n=24 (25%) Respiratory failure: n=15 (15.8%) Heart failure: n= 11 (11.6%) Sepsis: n=22 (23.2%) Mortality: n=20 (21 %)
Key questions How common & what causes GI bleeding after ACS/PCI? Efficacy & risks of conservative measures Likelihood of therapeutic intervention? What is the clinical outcome? Risks associated with endoscopy post ACS? Should antiplatelets/anticoagulation be stopped?
Risks of endoscopy post ACS/MI Overall 30% Mostly self-limiting Hypotension arrhythmia 16% evidence of myocardial ischaemia Procedure related mortality 1%
Key questions How common & what causes GI bleeding after ACS/PCI? Efficacy & risks of conservative measures Likelihood of therapeutic intervention? What is the clinical outcome? Risks associated with endoscopy post ACS? Should antiplatelets/anticoagulation be stopped?
Methods Patients on aspirin for secondary prophylaxis Bleeding controlled endoscopically All had 72h PPI then po pantoprazole 40mg Randomised to aspirin 80mg or placebo for 8 weeks RCDBT 2003-2006 Single institution Follow-up at 30 and 56 days No Hp eradication
Primary outcome Aspirin re-bleeding (n=8): 1 GU/ 7DU Same site as index bleed 6 within 10 days Placebo (n=4) 4 DU re-bleeds (2 others likely re-bleed but too unwell for OGD) 3 within 10 days
Secondary Outcomes
NICE UGIB 2012
Conclusions 2% ACS/PCI patients have acute UGIB & are high risk 90% will have OGD findings Mostly UGI ulceration or inflammatory changes 40% require endo therapy Monitoring & anaesthetic support Blood transfusion targets? Post-procedure monitoring & re-bleed plans
Algorithmic approach? PCI/ACS & significant UGIB bleed Resuscitate & stabilise Hb 10g/L Risk assess GBS/ Pre-endo Rockall Anaesthetic support and monitoring Upper GI endoscopy -identify source -dual endo therapy Post endoscopy PPI, anti-platelets, monitoring Close liaison with cardiologists & patient