Who is the High Bleeding Risk Patient (And Why Does it Matter)? - - PowerPoint PPT Presentation
Who is the High Bleeding Risk Patient (And Why Does it Matter)? Eric A. Secemsky, MD, MSc Director | Vascular Intervention | Beth Israel Deaconess Medical Center Assistant Professor of Medicine | Harvard Medical School Investigator | Richard A.
Eric A. Secemsky, MD, MSc Director | Vascular Intervention | Beth Israel Deaconess Medical Center Assistant Professor of Medicine | Harvard Medical School Investigator | Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology #SCAI19
Genereaux, Giustino, et al. JACC 2015. ADAPT-DES: Prospective registry of 8,582 “all-comers” who underwent PCI with DES *6.2% had post-discharge bleeding within 2 years
Valle, Shetterly, et al. Circ Cardiovasc Interv 2016. HMORN-Stent Registry: 8,137 pts who underwent PCI with DES at 3 large health systems *4.8% had bleeding-related hospitalization after discharge
Chhatriwalla, Amin, et al. JAMA 2013. NCDR CathPCI Registry: 3,386,688 PCIs in US between 2004-2011, in-hospital bleeding *3.39% absolute risk increase of in-hospital death, NNH 29
Ndrepepa, Berger, et al. JACC 2008. 5,384 pts from 4 PCI RCTs of abciximab; bleeding events w/in 30 days; mortality at 1 yr *0.8% bleeding at 30 days
Kazi, Leong, et al. JACC 2015. 32,906 pts from Kaiser; adverse events 7-365 days post-PCI; median f/u 4.42 years
Secemsky, Yeh, et al. JAMA Cardiology 2017. DAPT Study: 11,648 post-PCI pts wo bleeding/ischemia at 12 mos; events 12-33 mos
Vranckx, White, et al. JACC 2016.
Vranckx, White, et al. JACC 2016.
severe only captured ~80% of BARC 3 bleeds
Urban, Mehran, et al. In Press
Urban, Mehran, et al. 2019. In Press
year.
Major Minor
Age ≥75 years Long term oral anticoagulation* Severe or end-stage CKD (eGFR <30 ml/min) Moderate CKD (eGFR 30-59 ml/min) Hemoglobin <11 g/dL for both men and women Hemoglobin 11-12.9 g/dL for men and 11-11.9 g/dL for women Spontaneous bleeding requiring hospitalization and/or transfusion in the past 6 months or at any time if recurrent Spontaneous bleeding requiring hospitalization and/or transfusion within the past 12 months not meeting the major criterion Moderate or severe thrombocytopenia (platelet count <100 x 109 per liter) Chronic bleeding diathesis Liver cirrhosis with known or suspected portal hypertension Chronic use of oral NSAIDs or steroids Active malignancy‡ (excluding non-melanoma skin cancer) within the past 12 months Previous spontaneous ICH (at any time) Previous traumatic ICH within the past 12 months Presence of a bAVM Moderate or severe ischemic stroke within the past 6 months Any ischemic stroke at any time not meeting the major criterion Non-deferrable major surgery on DAPT Recent major surgery or major trauma within 30 days prior to PCI
Urban, Mehran, et al. 2019. In Press
Urban, Mehran, et al. 2019. In Press
REACH Dutch ASA score DAPT* PARIS PRECISE-DAPT BleeMACS Year of publication 2010 2014 2016 2016 2017 2018 Development dataset REACH registry Dutch ASA registry DAPT randomized trial PARIS registry Pooled analysis of 8 randomized trials BleedMACS registry Development dataset, n 56,616 235,531 11,648 4,190 14,963 15,401 Patient population Risk of atherothrombosis† New low-dose aspirin users Stable and event-free pts 12 mos post-PCI Stable & unstable pts undergoing PCI Stable and unstable patients undergoing PCI ACS patients undergoing PCI Bleeding outcome Serious bleeding at 2 years Upper GI bleeding at a median follow- up of 530 days Major bleeding between 12 and 30 months after PCI Major bleeding at 2 years Out-of-hospital bleeding at a median follow-up of 552 days Serious spontaneous bleeding at 1 year Bleeding definition used Protocol-defined‡ First episode of upper GI bleeding GUSTO moderate or severe(144) BARC 3 or 5(13) TIMI major or minor(145,146) Protocol-defined Proportion of HBR pts 25% (score >11) 83.1% (score >1) 23.4% (score -2 to 0) 8% (score >8) 25% (score ≥25) 25% (score >26) Rate of bleeding in the HBR subgroup 2.76% (at 2 years) 1% to 35% for scores from 2 to 13 2.7% (between 13 and 30 months) 10.7% (at 2 years) 1.8-4.2% (at 1 year) 8.03% (at 1 year) Also evaluates thrombotic risk No No Yes Yes No No Score range 0 to 23 0 to 15
0 to 14 0 to 100 0 to 80 Development discrimination AUC 0.68 AUC 0.64 AUC 0.68 AUC 0.72 AUC 0.73 AUC 0.71 (0.72 in internal validation) Validating dataset CHARISMA Dutch health insurance database PROTECT ADAPT-DES PLATO and Bern PCI registry SWEDEHEART Validating dataset, n 15,603 32,613 8,136 8,130 8,595 and 6,172 96,239 (ACS+PCI) Validation AUC 0.64 AUC 0.63 AUC 0.64 (bleeding) AUC 0.64 AUC 0.70 and 0.66 AUC 0.65
esecemsk@bidmc.harvard.edu @EricSecemskyMD
Richard and Susan Smith Center for Outcomes Research in Cardiology 375 Longwood Avenue, 4th Floor Boston, Massachusetts 02215