scholarly journals Ischemic and Bleeding Outcomes According to the Academic Research Consortium High Bleeding Risk Criteria in All Comers Treated by Percutaneous Coronary Interventions

2021 ◽  
Vol 8 ◽  
Author(s):  
Daphné Doomun ◽  
Ianis Doomun ◽  
Sara Schukraft ◽  
Diego Arroyo ◽  
Selma Cook ◽  
...  
Keyword(s):  
Risk Factors ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
High Bleeding Risk

Background: The Academic Research Consortium have identified a set of major and minor risk factors in order to standardize the definition of a High Bleeding Risk (ACR-HBR).Aims: The aim of this study is to stratify the bleeding risk in patients included in the Cardio-Fribourg registry, according to the Academic Research Consortium for High Bleeding Risk (ACR-HBR) definition, and to report ischemic and hemorrhagic events at 2-year of clinical follow-up.Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. Patients were considered high (HBR) or low (LBR) bleeding risk depending on the ARC-HBR definition. Primary endpoints were hierarchical major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) grade 3–5, and ARC patient-oriented major adverse cardiac events (POCE) at 2-year follow-up.Results: Follow-up was complete in 1,080 patients. There were 354 patients in the HBR group (32.7%) and 726 patients in the low-bleeding risk (LBR) group (67.2%). At 2-year follow-up, cumulative BARC 3–5 bleedings were higher in HBR (10.5%) compared to LBR patients (1.5%, p < 0.01) and the impact of HBR risk factors was incremental. At 2-year follow-up, POCE were more frequent in HBR (27.4%) compared to LBR group (18.2%, <0.01). Overall mortality was higher in HBR (14.0%) vs. LBR (2.9%, p < 0.01).Conclusions: ARC-HBR criteria appropriately identified a population at a higher risk of bleeding after percutaneous coronary intervention. An increased risk of bleeding is also associated with an increased risk of ischemic events at 2-year follow-up.

scholarly journals Bleeding Risk Profile in Patients on Oral Anticoagulation Undergoing Percutaneous Coronary Interventions: A Prospective 24 Months Cohort Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Sara Schukraft ◽  
Tibor Huwyler ◽  
Cindy Ottiger-Mankaka ◽  
Sonja Lehmann ◽  
Ezia Cook ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Primary Endpoint ◽  
Oral Anticoagulation ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Risk Of Bleeding ◽  
Percutaneous Coronary ◽  
High Bleeding Risk

Background: The Academic Research Consortium has identified a set of major and minor risk factors in order to standardize the definition of a high bleeding risk (ACR-HBR). Oral anticoagulation is a major criterion frequently observed.Aims: The objective of this study is to quantify the risk of bleeding in patients on oral anticoagulation with at least one additional major ACR-HBR criteria in the Cardio-Fribourg Registry.Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. The study population included patients with ongoing long-term oral anticoagulation (OAC) and planned to receive triple antithrombotic therapy. Patients were divided in two groups: patients on OAC with at least one additional major ACR-HBR criteria vs. patients on OAC without additional major ACR-HBR criteria. The primary endpoint was any bleeding during the 24-month follow-up. Secondary bleeding endpoint was defined as Bleeding Academic Research Classification (BARC) ≥3.Results: Follow-up was completed in 142 patients at high bleeding risk on OAC, of which 33 (23%) had at least one additional major ACR-HBR criteria. The rate of the primary endpoint was 55% in patients on OAC with at least one additional ACR-HBR criteria compared with 14% in patients on OAC without additional ACR-HBR criteria (hazard ratio, 3.88; 95%CI, 1.85–8.14; p < 0.01). Patients with additional major ACR-HBR criteria also experienced significantly higher rates of BARC ≥ 3 bleedings (39% at 24 months).Conclusion: The presence of at least one additional ACR-HBR criterion identifies patients on OAC who are at very high risk of bleeding after percutaneous coronary intervention.

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.

scholarly journals Sex-Related Differences in the Prevalence and Prognostic Value of the Academic Research Consortium for High Bleeding Risk Criteria

2021 ◽  
Author(s):  
Matteo Nardin ◽  
Davide Cao ◽  
Roxana Mehran ◽  
Rishi Chandiramani ◽  
Mauro Chiarito ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Percutaneous Coronary Intervention ◽  
Prognostic Value ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Severe Anemia ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
High Bleeding Risk

Background: Bleeding events after percutaneous coronary intervention are associated with substantial morbidity and mortality. Female patients undergoing percutaneous coronary intervention are often older and present with a higher burden of comorbidities, which in turn increases their risk of adverse events, including bleeding complications. The Academic Research Consortium (ARC) have proposed a list of clinical criteria to define high bleeding risk (HBR). Our aim was to evaluate the prevalence and predictive value of the ARC-HBR criteria according to sex in a contemporary cohort of patients undergoing percutaneous coronary intervention. Methods: All consecutive patients receiving coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they fulfilled at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding end point was the composite of periprocedural in-hospital or postdischarge bleeding up to 1 year. Individual components of the primary bleeding end point, all-cause mortality, and myocardial infarction were also evaluated. Results: Of the total 9623 patients, 6979 (72.5%) were male and 2644 (27.5%) female. The prevalence of HBR was significantly higher in females compared with males (56.5% versus 39.9%, P <0.001). With regard to the individual criteria, moderate/severe anemia and moderate chronic kidney disease were more common in females, while oral anticoagulation and mild anemia were more frequent among males. The presence of HBR was associated with an increased risk of bleeding in both females (10.0% versus 4.4%; hazard ratio, 2.57 [95% CI, 1.80–3.67]; P <0.001) and males (8.7% versus 2.9%; hazard ratio, 3.19 [95% CI, 2.50–4.08]; P <0.001)(p interaction =0.344).The ARC-HBR criteria associated with the highest bleeding risk at 1 year were severe/end-stage chronic kidney disease and thrombocytopenia in females, and moderate/severe anemia in males. Conclusions: In a real-world cohort of percutaneous coronary intervention patients, females were more often at HBR than males. The prognostic value of the ARC-HBR definition was consistent between female and male patients, despite sex-related differences in the prevalence and bleeding risk associated with individual ARC-HBR criteria.

scholarly journals Sex‐Based Differences in Bleeding Risk After Percutaneous Coronary Intervention and Implications for the Academic Research Consortium High Bleeding Risk Criteria

2021 ◽  
Author(s):  
Alessandro Spirito ◽  
Felice Gragnano ◽  
Noé Corpataux ◽  
Lukas Vaisnora ◽  
Roberto Galea ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Creatinine Clearance ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Access Site ◽  
Female Sex ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
High Bleeding Risk

Background Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. Methods and Results Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access‐site (adjusted hazard ratio, 2.14; 95% CI, 1.22–3.74; P =0.008) but not with overall or non–access‐site 1‐year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c‐index 0.644 versus 0.688; P =0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. Conclusions Female sex is an independent predictor for access‐site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02241291.

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 &lt; 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.

scholarly journals Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

2019 ◽  
Vol 40 (31) ◽  
pp. 2632-2653 ◽  
Author(s):  
Philip Urban ◽  
Roxana Mehran ◽  
Roisin Colleran ◽  
Dominick J Angiolillo ◽  
Robert A Byrne ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Clinical Decision Making ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Clinical Decision ◽  
Consensus Document ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
High Bleeding Risk

Abstract Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

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