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

scholarly journals Prevalence and impact of ischemic risk on long-term bleeding and ischemic event for high bleeding risk patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Shima ◽  
K Miura ◽  
T Tada ◽  
H Tanaka ◽  
Y Fuku ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Academic Research ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Diabetic Patients ◽  
Kaplan Meier ◽  
Research Consortium ◽  
High Bleeding Risk ◽  
Ischemic Events

Abstract Background Impact of ischemic risk (IR) on long term outcomes in patients at high bleeding risk (HBR) after everolimus-eluting stent (EES) implantation remains unclear. Purpose We aimed to evaluate long term bleeding and ischemic events in patient with HBR or IR after EES implantation. Methods The study population comprised 1219 patients treated with EES without in-hospital events between 2010 and 2011. The follow-up period was 2996±433 days. HBR was defined as Academic research consortium. IR defined as high-risk features of stent-driven recurrent ischemic events in Europe society of cardiology guidelines in 2019: prior stent thrombosis on adequate antiplatelet therapy, diffuse multivessel disease especially in diabetic patients, creatinine clearance <60 ml/min, at least three stents implanted, bifurcation two stents implanted, total stent length >60 mm, and treatment of a chronic total occlusion. Major bleeding (MB) was defined as defined as the occurrence of a Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding event. Primary ischemic events included myocardial infarction, definite stent thrombosis, and cardiac death. The Kaplan-Meier method was used for time-to-event analyses. Results Of the 1219 patients, 317 (26.0%) patients had no risk, 114 (9.4%) patients had only HBR, 288 (23.6%) patients had only IR, and 500 (41.0%) patients had both risks. The 81.4% of HBR patients had IR. The figure of Kaplan-Meier showed MB and CE for 7–8 years. Both risk groups had higher bleeding risk and Ischemic events (log rank p=0.0039, 0.0001). Conclusion HBR patients with EES had a high incidence of IR. Patients who had both HBR and IR are especially at risk for both ischemic events and bleeding compared to those who had no or only one risk. Funding Acknowledgement Type of funding source: None

scholarly journals PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY

2020 ◽  
Author(s):  
Felice Gragnano ◽  
Dik Heg ◽  
Anna Franzone ◽  
Eugène P McFadden ◽  
Sergio Leonardi ◽  
...  
Keyword(s):  
Risk Prediction ◽  
Stent Implantation ◽  
Academic Research ◽  
Treatment Strategies ◽  
Bleeding Risk ◽  
Coronary Stenting ◽  
Drug Eluting Stent ◽  
Net Benefit ◽  
Research Consortium ◽  
Reference Strategy

Abstract Aims The five-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally adjudicated bleeding endpoints. Methods and results The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict Bleeding Academic Research Consortium 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally adjudicated in GLOBAL LEADERS and GLASSY, respectively. At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 [95% confidence interval (CI): 0.63–0.71] vs. 0.63 (95% CI: 0.59–0.67) in GLOBAL LEADERS (P = 0.27), and 0.67 (95% CI: 0.61–0.73) vs. 0.66 (95% CI: 0.61–0.72) in GLASSY (P = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified four-item PRECISE-DAPT. Conclusion The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.

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.

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

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

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

Abstract 12614: Total Thrombus Formation Analysis System Can Predict High Bleeding Risk in Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Nobuhiro Nakanishi ◽  
Koichi Kaikita ◽  
Kenichi Tsujita
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Thrombus Formation ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Bleeding Events ◽  
Percutaneous Coronary ◽  
Analysis System ◽  
Research Consortium ◽  
High Bleeding Risk

Introduction: Antithrombotic therapy is established for the treatment in various cardiovascular events, however, it has shown to increase the bleeding risk. Total Thrombus-formation Analysis System (T-TAS) is reported to be useful for evaluating thrombogenicity. Hypothesis: We examined whether T-TAS might predict 1-year bleeding risk in patients undergoing percutaneous coronary intervention (PCI). Methods: This was a retrospective, observational study at Kumamoto University Hospital between April 2017 and March 2019. Blood samples obtained on the day of PCI were used in T-TAS to compute the thrombus formation area under the curve (AUC) (AR10-AUC30, AUC for AR chip). We divided the study population into 2 groups according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) (182 patients in ARC-HBR positive, 118 in ARC-HBR negative). The primary endpoint was 1-year bleeding events that were defined by Bleeding Academic Research Consortium type2, 3, or 5. Results: The AR10-AUC30 levels were significantly lower in the ARC-HBR positive group than in the ARC-HBR negative group (median [interquartile range] 1568.1 [1258.5-1744.1] vs. 1723.1 [1567.0-1799.5], p<0.001). The combination of ARC-HBR and AR10-AUC30 could discriminate the bleeding risk, and improved predictive capacity compared with ARC-HBR by c-statistics and integrated discrimination improvement. In multivariate Cox hazards analyses, combining ARC-HBR and lower AR10-AUC30 levels were significantly associated with 1-year bleeding events. Decision curve analysis revealed that combining AR10-AUC30 with ARC-HBR ameliorated risk-prediction of bleeding events. Conclusions: The results highlighted that AR10-AUC30 could be a potentially useful marker for predicting high bleeding risk in patients undergoing PCI.

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