Are the minor high bleeding risk criteria of the academic research consortium truly minor? Insights from a high-volume tertiary care pci centre

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Chandiramani ◽  
D Cao ◽  
B Claessen ◽  
S Sartori ◽  
J Nicolas ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Cox Regression ◽  
Tertiary Care ◽  
Academic Research ◽  
High Volume ◽  
Bleeding Risk ◽  
Minor Criterion ◽  
Research Consortium ◽  
High Bleeding Risk ◽  
Minor Criteria

Abstract Background The Academic Research Consortium (ARC) has recently published a consensus-based definition to identify patients at high bleeding risk (HBR), reflected by a BARC 3 or 5 bleeding rate of ≥4% at 1 year after percutaneous coronary intervention (PCI). The HBR criteria included in the definition are divided into minor and major categories, with patients deemed to be at HBR if they fulfill at least one major or two minor criteria. As a result, patients who present with only one minor criterion are categorized as non-HBR. Purpose To compare the differences in baseline characteristics and 1-year bleeding and ischaemic outcomes between non-HBR patients undergoing PCI that present with only one minor HBR criterion versus those that do not fulfill any HBR criteria. Methods The study population consisted of all consecutive patients who underwent PCI with stent implantation in a single high-volume centre from January 2014 to December 2017. Patients were classified as non-HBR if they did not fulfill at least one major or two minor ARC-HBR criteria. The outcomes of interest were major bleeding (composite of peri-procedural and post-discharge bleeding), all-cause death, and myocardial infarction (MI) at 1 year. The Kaplan-Meier method was used for time-to-event analyses, with comparative risks being assessed using Cox regression. Results Of the 9,623 patients included in the analysis, 5,345 were classified as non-HBR. Within the non-HBR patients, 2,078 (38.9%) presented with only one minor HBR criterion and 3,267 (61.1%) presented with no HBR criteria. Non-HBR patients with one minor criterion were more often female, significantly older, with a higher burden of comorbidities such as diabetes mellitus, hypertension and hyperlipidaemia, and more likely to have multivessel disease as well as a history of prior MI and revascularisation, while non-HBR patients with no criteria were more likely to be smokers and have a higher BMI. Distribution of the minor HBR criteria within the group presenting with one minor criterion are illustrated in the figure. Non-HBR patients with only one minor criterion had a numerically higher rate of major bleeding compared to non-HBR patients with no criteria (3.6% vs. 2.9%, p=0.09). While the rate of all-cause death was significantly higher in the group with only one minor criterion (1.2% vs. 0.4%, p=0.004), there was no difference in the rate of MI between the two groups (2.1% vs. 1.9%, p=0.83). Hazard ratios comparing the two groups are presented in the figure. Conclusions Non-HBR patients presenting with only one minor criterion had a numerically higher rate of post-PCI bleeding and significantly higher mortality compared to those without any criteria. Nonetheless, the major bleeding rates of both groups at 1 year were less than the 4% cutoff to qualify as HBR according to the ARC definition, thereby supporting their inclusion as “minor” criteria in the recent ARC-HBR definition. Figure 1 Funding Acknowledgement Type of funding source: None

Intersection of the Academic Research Consortium – high bleeding risk criteria in patients undergoing PCI for acute coronary syndromes: insights from a high-volume single centre registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Nicolas ◽  
D Cao ◽  
B Claessen ◽  
S Sartori ◽  
A Roumeliotis ◽  
...  
Keyword(s):  
Acute Coronary Syndromes ◽  
Academic Research ◽  
High Volume ◽  
Bleeding Risk ◽  
Severe Anemia ◽  
Mild Anemia ◽  
Coronary Syndromes ◽  
Research Consortium ◽  
High Bleeding Risk ◽  
Minor Criteria

Abstract Introduction Patients presenting for percutaneous coronary intervention (PCI) with acute coronary syndromes (ACS) often have overlapping bleeding and ischaemic risk factors that offset the long-term success of PCI and limit the post stenting therapeutic options. Aiming at improving outcomes following PCI, the Academic Research Consortium (ARC) recently published a set of major and minor criteria that identify, a priori, patients at high bleeding risk (HBR). Indeed, knowledge of these risk factors will help in optimization of pre-procedural therapy and minimization of post intervention complications. Nonetheless, the actual prevalence of these criteria among patients undergoing PCI for ACS is not well known. Purpose To determine the intersection and distribution of ARC-HBR major and minor criteria in a real-world ACS population presenting for PCI. Methods In this analysis, we included all patients who presented with ACS to a high-volume PCI centre from 2012 to 2017 and underwent PCI with 2nd generation drug-eluting stent (DES) implantation. Patients were then classified as HBR if they met ≥1 major or ≥2 minor criteria according to the ARC-HBR definition. Baseline clinical and procedural characteristics were extracted from each patient electronic health records. The most common exclusive intersections of ARC-HBR major and minor criteria were quantitatively visualized using an Upset Plot. Results Only 44.6% (n=2,717) of ACS patients (n=6,097) fulfilled the ARC-HBR definition. There were significant differences in baseline clinical characteristics between HBR and non-HBR groups: age (71.4±11.5 vs. 60.9±10.3 years, p<0.001), females (40.7% vs. 25.5%, p<0.001), cerebrovascular disease (19.5% vs. 3.9%, p<0.001), and diabetes (55.4% vs. 42.1%, p<0.001). The prevalence of active smoking, a major risk factor for bleeding, was higher in the non-HBR group (20.6% vs. 9.9%, p<0.001). The most frequent major and minor criteria were severe anemia (n=1,072) and age ≥75 (n=1,264), respectively. The top five criteria intersections were: severe anemia (n=215), age ≥75 and moderate chronic kidney disease (CKD) (n=145); moderate CKD and mild anemia (n=142); age ≥75 and mild anemia (n=140); age ≥75, moderate CKD, and mild anemia (n=130) (Figure 1). Conclusion Among patients who have undergone PCI for ACS, a significant proportion of individuals fulfilled the ARC-HBR definition. Severe anemia was the most prevalent major criteria. Different combinations of minor criteria, mainly age ≥75, moderate CKD and mild anemia, represented the most common intersections. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals 600 Validation of the academic research consortium high bleeding risk criteria in patients undergoing percutaneous coronary intervention: a systematic review and meta-analysis of 10 studies and 67 862 patients

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Angelo Silverio ◽  
Marco Di Maio ◽  
Sergio Buccheri ◽  
Giuseppe De Luca ◽  
Luca Esposito ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
High Bleeding Risk ◽  
Minor Criteria

Abstract Aims The Academic Research Consortium for High Bleeding Risk (ARC-HBR) has recently proposed, by consensus, 20 clinical criteria for the assessment of the bleeding risk after percutaneous coronary intervention (PCI). A major criterion was defined as any individual clinical condition conferring in isolation a risk for major bleeding ≥4% up to 1 year after PCI; instead, a minor criterion was considered to confer a bleeding risk of < 4%. The aim of this meta-analysis was to assess the performance of the ARC-HBR criteria in stratifying the risk of bleeding and ischaemic events after PCI. Methods and results MEDLINE, COCHRANE, Web of Sciences, and SCOPUS were searched for studies aimed at validating the ARC-HBR criteria in patients treated with PCI. The primary outcome measure of this meta-analysis was major bleeding. The analysis included 10 studies encompassing 67 862 patients undergoing PCI; the HBR definition was fulfilled in 44.7% of the cases. The risk of major bleeding was significantly higher in HBR vs. Non-HBR group (RR: 2.56, 95% CI: 2.28–2.89). The average C-statistic was 0.64 (95% CI: 0.60–0.68), indicating modest discrimination. The risk of intracranial haemorrhage, gastrointestinal bleeding, fatal bleeding, ischaemic stroke, cardiac death and all-cause death was higher in HBR vs. Non-HBR group. Despite a higher incidence of myocardial infarction and stent thrombosis in patients deemed at HBR, the rate of target lesion revascularization was comparable between groups (RR, 1.01, 95% CI: 0.88–1.16). When assessed in isolation, the mean cumulative incidence of major bleeding at 1 year exceeded the cut-off value of 4% for all the major criteria and for two out of six minor criteria, including age ≥75 years and moderate chronic kidney disease (CKD) (Figure). Conclusions The ARC-HBR definition identifies patients at higher risk of major bleeding and other adverse cardiovascular events after PCI. Almost all major criteria, but also two of the minor criteria, were individually associated with rates of major bleeding above 4% thus fulfilling the definition of major HBR criteria. These findings corroborate the ability of ARC-HBR major criteria in identifying PCI patients who are more likely to develop adverse events, but also suggest caution in the decision making of patients with isolated minor criteria, including age ≥ 75 years and moderate CKD.

Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk

2020 ◽  
Vol 41 (38) ◽  
pp. 3743-3749 ◽  
Author(s):  
Noé Corpataux ◽  
Alessandro Spirito ◽  
Felice Gragnano ◽  
Lukas Vaisnora ◽  
Roberto Galea ◽  
...  
Keyword(s):  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
University Hospital ◽  
Minor Criterion ◽  
Complete Arc ◽  
Risk Patients ◽  
Research Consortium ◽  
High Bleeding Risk ◽  
Minor Criteria

Abstract Aims To validate the set of clinical and biochemical criteria proposed by consensus by the Academic Research Consortium (ARC) for High Bleeding Risk (HBR) for the identification of HBR patients. These criteria were categorized into major and minor, if expected to carry in isolation, respectively, ≥4% and <4% Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding risk within 1-year after percutaneous coronary intervention (PCI). High bleeding risk patients are those meeting at least 1 major or 2 minor criteria. Methods and results All patients undergoing PCI at Bern University Hospital, between February 2009 and September 2018 were prospectively entered into the Bern PCI Registry (NCT02241291). Age, haemoglobin, platelet count, creatinine, and use of oral anticoagulation were prospectively collected, while the remaining HBR criteria except for planned surgery were retrospectively adjudicated. A total of 16 580 participants with complete ARC-HBR criteria were included. After assigning 1 point to each major and 0.5 point to each minor criterion, we observed for every 0.5 score increase a step-wise augmentation of BARC 3 or 5 bleeding rates at 1 year ranging from 1.90% among patients fulfilling no criterion, through 4.01%, 5.98%, 7.42%, 8.60%, 12.21%, 12.29%, and 17.64%. All major and five out of six minor criteria, conferred in isolation a risk for BARC 3 or 5 bleeding at 1 year exceeding 4% at the upper limit of the 95% confidence intervals. Conclusion All major and the majority of minor ARC-HBR criteria identify in isolation patients at HBR.

Acute coronary syndrome patients with two minor high-bleeding risk criteria have the same bleeding rate that patients with one major criteria

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Cordero ◽  
J.M Garcia-Acuna ◽  
M Rodriguez-Manero ◽  
B Cid ◽  
B Alvarez Alvarez ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Academic Research ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Post Discharge ◽  
Bleeding Rate ◽  
Coronary Syndrome ◽  
All Cause Mortality ◽  
High Bleeding Risk ◽  
Minor Criteria

Abstract Background In 2019 the Academic Research Consortium of high-bleeding risk (ARC-HBR) proposed a new and binary definition of high-bleeding risk (HBR) patients based on the presence of 1 major or 2 minor criteria. Methods Prospective study of all consecutive patients admitted for ACS in two different centers. We analyzed bleeding incidence in patients with 1 major criteria (1MC) vs. 2 minor criteria (2mC) using the 2019 ARC-HBR consensus. Bleeding events were collected according those fitting definitions 3 or 5 of the BARC consortium. Results We included 8,724 patients included and 40.9% we classified as HBR; 20.9% for 1MC and 20.0% for 2mC. In-hospital mayor bleeding rate was 8.6%; no-HBR patients had 0.3%, 2mC 15.1% and 1MC 29.7% (p<0.001 for the comparison). In contrast, the statistically highest in-hospital mortality was observed in patients with 2mC (11.4%), followed by patients with 1MC (8.0%) and no-HBR patients (2.0%). During follow-up (median time 57.8 months) all-cause mortality rate was 21.0% and cardiovascular dead 14.2%. The incidence of post-discharge major bleeding was 10.5%. No-HBR patients had the lowest bleeding rate (7.4%) and no difference was observed in patients with 1MC (14.6%) or 2mC (15.8%) (figure). The multivariate analysis, adjusted by age, gender, medical treatment, atrial fibrillation and revascularization and considering all-cause mortality as competing risk, showed independent association of 1MC (sHR: 1.46, 95% 1.22–1.75) and 2mC (sHR: 1.31, 95% CI 1.05–1.63) with post-discharge major bleeding. Conclusions HBR patients according to the 2019 ARC-HBR containing 2mC or 1MC are at similar and higher risk of in-hospital or post-discharge bleeding events Funding Acknowledgement Type of funding source: None

Risk stratification based on academic research consortium high bleeding risk criteria for long-term bleeding event after everolimus-eluting stent implantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Miura ◽  
T Shimada ◽  
M Ohya ◽  
R Murai ◽  
H Amano ◽  
...  
Keyword(s):  
Risk Stratification ◽  
Major Bleeding ◽  
Stent Implantation ◽  
Academic Research ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Drug Eluting Stent ◽  
Research Consortium ◽  
High Bleeding Risk

Abstract Background Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria has been suggested as the standard definition of HBR. Purpose We aimed to investigate the risk stratification based on ARC-HBR Criteria for long-term bleeding event after everolimus-eluting stent implantation Methods The study population comprised 1193 patients treated with EES without in-hospital event between 2010 and 2011. Individual ARC-HBR criteria was retrospectively assessed. Major bleeding were defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleeding event. The mean follow-up period was 2996±433 days. Results There were 656 patients (55.0%) in HBR-groups. Cumulative incidence of major bleeding was significantly higher in HBR-group (8.1% vs 3.4% at 4 year, and 16.2% vs 5.7% at 8 year, P<0.001). Cumulative rate of major bleeding tend to be higher as the number of ARC-HBR criteria increased (≥2 Majors: 24.3%, 1 Major: 17.0%, ≥2 Minors:11.7%, and Non-HBR: 5.7%, P<0.001). Conclusion ARC-HBR criteria successfully stratified the long-term bleeding risk after drug-eluting stent implantation in real-world practice. Funding Acknowledgement Type of funding source: None

Abstract 16570: Systemic Inflammation Alters the Bleeding-Ischemic Balance in High-Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Johny Nicolas ◽  
Davide Cao ◽  
Bimmer E Claessen ◽  
Mauro Chiarito ◽  
Samantha Sartori ◽  
...  
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Academic Research ◽  
Bleeding Risk ◽  
Lesion Length ◽  
Syntax Score ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Percutaneous Coronary ◽  
High Bleeding Risk

Introduction: Prognosis in high-bleeding risk (HBR) patients after percutaneous coronary intervention (PCI) is largely dependent on risk of ischemic/bleeding events. Inflammation is known to increase the ischemic risk following PCI in the general population, yet its impact on HBR patients remains unknown. Hypothesis: We assessed the hypothesis that inflammation, as reflected by elevated high-sensitivity C - reactive protein (hsCRP), increases the risk of ischemic and bleeding events in HBR patients undergoing PCI. Methods: We included patients who underwent PCI at a tertiary care center between 2014 and 2017. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the Academic Research Consortium (ARC)-HBR consensus. Patients were then stratified into high (≥3 mg/l) and low (<3 mg/ml) baseline hsCRP level; those presenting with myocardial infarction (MI) or hsCRP >10 mg/l were excluded. The main outcomes of interest were major adverse cardiac events (MACE) (composite of all-cause death, MI, and target vessel revascularization) and bleeding events. Results: Out of 7,186 patients included, 3,403 (42.3%) fulfilled the ARC-HBR definition of whom 1,046 (34.4%) had high hsCRP. These patients were frequently female, younger, and had more cardiovascular risk factors (diabetes, kidney disease, and peripheral artery disease) yet similar angiographic features (multivessel disease, syntax score, and lesion length) than those with low hsCRP. Although risk of MACE at 1 year was similar in HBR patients with either high or low hsCRP, mortality risk was significantly higher in the former group ( Figure 1 ). In addition, HBR patients with high hsCRP were more likely to have periprocedural bleeding (OR 1.72, 95% CI [1.14-2.58], p=0.01) but similar risk of 1-year major bleeding as HBR patients with low hsCRP ( Figure 1 ). Conclusion: In conclusion, inflammation is associated with periprocedural bleeding and 1-year mortality in HBR patients undergoing PCI.

scholarly journals PERFORMANCE OF THE ACADEMIC RESEARCH CONSORTIUM FOR HIGH BLEEDING RISK CRITERIA ACCORDING TO SEX

2020 ◽  
Vol 75 (11) ◽  
pp. 1414
Author(s):  
Davide Cao ◽  
Roxana Mehran ◽  
Rishi Chandiramani ◽  
Samantha Sartori ◽  
George D. Dangas ◽  
...  
Keyword(s):  
Academic Research ◽  
Bleeding Risk ◽  
Risk Criteria ◽  
Research Consortium ◽  
High Bleeding Risk
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