Academic Research Consortium For High Bleeding Risk Research Articles

Clinical impact of Academic Research Consortium for High Bleeding-Risk scores on clinical outcomes in patients with stable coronary artery disease undergoing percutaneous coronary intervention.

High bleeding risk (HBR), as defined by the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria, has been recently reported to be associated with an increased risk of major bleeding events and cardiovascular events. We investigated the association between the ARC-HBR score and clinical outcomes in patients with stable coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). We assessed 328 consecutive patients with stable CAD who underwent PCI between January 2017 and December 2020. We scored the ARC-HBR criteria by assigning 1 point to each major criterion and 0.5 points to each minor criterion. Patients were stratified into low (ARC-HBR score < 1), intermediate (1 ≤ ARC-HBR score < 2), and high (ARC-HBR score ≥ 2) bleeding-risk groups. The primary outcome measure was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and nonfatal stroke. We compared the discriminative abilities of the ARC-HBR score with the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2°P) and ARC-HBR score with Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) thrombotic risk score. The mean patient age was 70.1 ± 10.2years (males, 76.8%). During the median follow-up period of 983 (618-1338) days, 44 patients developed MACE. Kaplan-Meier curves showed that a stepwise significant increase in the cumulative incidence of MACE as the ARC-HBR score increased (log-rank p < 0.001). In the time-dependent receiver-operating characteristic curve analysis for predicting MACE within 2years, the area under the curve (AUC) of the ARC-HBR score was significantly higher than that of the TRS2°P (AUC: 0.825 vs. 0.725, p value for the difference = 0.023) and similar to that of CREDO-Kyoto thrombotic risk score (AUC: 0.825 vs. 0.813, p value for the difference = 0.627). Conclusions: The ARC-HBR score adequately stratified future risk of MACE in patients with stable CAD who underwent PCI. The ARC-HBR score showed a higher discriminative ability for predicting mid-term MACE than the TRS2°P.

Application of the Academic Research Consortium High Bleeding Risk criteria in patients treated with coronary bioresorbable polymer everolimus-eluting stents: Insights from the POEM trial

BackgroundPrevious studies have investigated a 1 to 6-month short dual antiplatelet therapy (S-DAPT) after percutaneous coronary intervention (PCI) with modern drug eluting-stents to reduce bleeding events. ObjectivesTo investigate cardiovascular outcomes in patients at high bleeding risk (HBR) according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria after PCI with the Synergy bioresorbable-polymer everolimus-eluting stents (EES). MethodsWe applied ARC-HBR criteria in the population of the prospective, single-arm, multicenter POEM (Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy Stent in Patients at HBR Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy) trial. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 12 months. ResultsThe original POEM cohort included 356 patients (80.4 %) fulfilling ARC-HBR criteria. Oral anticoagulant (OAC) usage and age ≥75 years were the most frequent major and minor ARC-HBR criteria, respectively. The ARC-HBR group was mainly represented by men (71.1 %), with 74.4 ± 9.3 years and a high burden of cardiovascular risk factors. DAPT was prescribed in 79.3 %, and single antiplatelet (SAPT) with OAC in 18.7 %. 12-month follow-up was completed in 96.2 %. The primary endpoint occurred in 5.2 % (95 % CI 3.29–8.10) of patients, whereas bleeding Academic Research Consortium type 3–5 occurred in 2.7 % (95 % CI, 1.39 %–5.05 %). ConclusionPrevious results of the POEM trial showed positive outcomes regarding ischemic and bleeding events with an S-DAPT regimen after Synergy EES. These results are also confirmed in sub-group analysis when ARC-HBR criteria are applied.

Comparison of Discriminative Ability of Bleeding Risk Criteria and Scores for Predicting Short- and Mid-Term Major Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention.

Background: This study aimed to compare the discriminative ability of the Japanese Version of High Bleeding Risk (J-HBR), Academic Research Consortium for High Bleeding Risk (ARC-HBR), and Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) scores for predicting major bleeding events. Methods and Results: Between January 2017 and December 2020, 646 consecutive patients who underwent successful percutaneous coronary intervention (PCI) were enrolled. We scored the ARC-HBR and J-HBR criteria by assigning 1 point to each major criterion and 0.5 point to each minor criterion. The primary outcome was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5 bleeding events. According to the J-HBR, ARC-HBR, and PRECISE-DAPT scores, 428 (66.3%), 319 (49.4%), and 282 (43.7%) patients respectively had a high bleeding risk. During the follow-up period (median, 974 days), 44 patients experienced major bleeding events. The area under the curve (AUC) using the time-dependent receiver operating characteristic curve for major bleeding events was 0.84, 0.82, and 0.83 within 30 days and 0.86, 0.83, and 0.80 within 2 years for the J-HBR, ARC-HBR, and PRECISE-DAPT scores, respectively. The AUC values did not differ significantly among the 3 bleeding risk scores. Conclusions: The J-HBR score had a discriminative ability similar to the ARC-HBR and PRECISE-DAPT scores for predicting short- and mid-term major bleeding events.

Clopidogrel vs. aspirin in the chronic maintenance period following percutaneous coronary intervention in high thrombotic and high bleeding risk patients:sub-analysis of the HOST-EXAM Extended study

Abstract Background The HOST-EXAM Extended study evaluated the long-term follow-up results of the original HOST-EXAM trial, which demonstrated that clopidogrel monotherapy was associated with a lower risk of thrombotic and bleeding events compared to aspirin monotherapy. However, the optimal single antiplatelet agent during the chronic maintenance period in patients with high thrombotic risk and/or high bleeding risk has not been assessed. Purpose This study aimed to compare the efficacy of clopidogrel versus aspirin monotherapy in patients with high thrombotic risk and/or high bleeding risk who were stabilized after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods A post-hoc subgroup analysis of the HOST-EXAM Extended study was conducted. High thrombotic risk was defined as patients who had at least one of the following procedural features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length &amp;gt;60 mm, or chronic total occlusion. High bleeding risk was defined according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium bleeding type 3 or 5. Clinical outcome was analyzed according to the patients’ initial thrombotic and bleeding risk. Results Among the total population, 28.2% had high thrombotic risk and 27.0% had high bleeding risk. Patients with high thrombotic risk was not associated with a higher risk of primary endpoint, whereas those of high bleeding risk was associated with a increased risk of the clincical event (Hazard ratio [HR] 2.70, 95% Confidence interval [CI] 2.29-3.18, Log-rank p &amp;lt; 0.001). Clopidogrel consistently reduced the risk of primary endpoint, regardless of the presence of high thrombotic risk or high bleeding risk (Absolute risk difference [ARD] 7.5%, 95% CI 2.7-12.3, HR 0.59, 95% CI 0.43-0.82, Log-rank p=0.001 vs ARD 4.1%, 95% CI 1.5-6.7, HR 0.78, 95% CI 0.66-0.92, Log-rank p=0.004 with or without high thrombotic risk, respectively. P-interaction=0.133; ARD 9.2%, 95% CI 2.4-16.0, HR 0.71, 95% CI 0.55-0.92, Log-rank p=0.008 vs ARD 4.0%, 95% CI 1.6-6.4, HR 0.74, 95% CI 0.60-0.90, Log-rank p=0.003 with or without high bleeding risk, respectively. P-interaction=0.860; Figure 1). The beneficial effect of clopidogrel was consistent across patients divided into four groups based on the presence or absence of high thrombotic risk and high bleeding risk (Figure 2). Conclusion In chronic maintenance period of patients who received PCI with DES, the beneficial effect of clopidogrel was maintained in patients regardless of the presence or absence of high thrombotic risk and high bleeding risk.

Association between High Bleeding Risk and 2-Year Mortality in Patients with Chronic Limb-Threatening Ischemia.

Patients with chronic limb-threatening ischemia (CLTI) have a high bleeding risk (HBR) and mortality rate. The 2-year life expectancy is an important factor in deciding the appropriate treatment strategy. This study aimed to assess the influence of HBR on the prognosis of patients with CLTI. A total of 259 patients with CLTI who underwent endovascular therapy (EVT) (mean age, 76.2 years; male, 62.9%) between January 2018 and December 2019 were evaluated. The Academic Research Consortium for HBR (ARC-HBR) criteria were applied to each patient, and the ARC-HBR scores were calculated. The cut-off score for predicting all-cause mortality within two years was derived using a survival classification and regression tree (CART) model. Causes of death and the association between ARC-HBR scores and major bleeding events within two years were also investigated. Based on the CART model, patients were divided into three groups (low HBR score 0-1.0, 48 patients; moderate HBR score 1.5-3.0, 176 patients; and high HBR score ≥ 3.5, 35 patients). During the study period, 82 patients (39.6%) died due to cardiac (n=23) and non-cardiac causes (n=59). All-cause mortality increased significantly with increasing ARC-HBR scores. Cox multivariate analysis revealed a significant association between high ARC-HBR scores and the risk of all-cause mortality within two years. Major bleeding events increased significantly with increasing ARC-HBR scores. The ARC-HBR score could predict 2-year mortality in patients with CLTI who underwent EVT. Thus, this score can help determine the best revascularization strategy for patients with CLTI.

Temporal variations in ischemic and bleeding event risks after acute coronary syndrome during dual antiplatelet therapy

BackgroundThis study estimates the temporal risk variations of ischemic and bleeding events during dual antiplatelet therapy (DAPT) among patients stratified according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria, suggesting the optimal period for DAPT after acute coronary syndrome (ACS). MethodsA total of 1264 ACS patients receiving either clopidogrel or prasugrel with aspirin were classified by ARC-HBR; HBR (n = 574) and non-HBR groups (n = 690). This study was designed as a multicenter observation to evaluate the primary endpoints of ischemic, including cardiovascular death, myocardial infarction, or ischemic stroke, and bleeding events, defined as Bleeding Academic Research Consortium type 3/5. The temporal risk variations were estimated using the Cox hazard and Royston-Parmar models. ResultsIschemic and bleeding events were observed in 9.4% and 7.4%, respectively, during an average observation period of 313 days. The HBR group had a higher incidence of both events than the non-HBR group (15.3% vs. 4.5%, P < 0.01 for ischemic; 11.9% vs. 3.8%, P < 0.01 for bleeding). The estimated risk curves for both events revealed peaks and steep declines in the first few days, followed by constant declines. The peak of risk was higher for bleeding than for ischemic events, but this relationship reversed early, with ischemic events displaying a higher risk in both the HBR and non-HBR groups until at least 60 days. ConclusionsA 60-day period of DAPT is appropriate to balance the risks of adverse events after ACS, regardless of ARC-HBR criteria.

High Bleeding Incidence in Unselected Hospitalized Suspected Non–ST-Segment Elevation Myocardial Infarction Patients Aged Under 65 Years

High bleeding risk (HBR) is commonly encountered among patients with acute coronary syndrome (ACS), and bleeding complications are associated with worse prognosis. Data on bleeding events of patients with ACS are based almost exclusively on percutaneous coronary intervention registries. Enrolling only patients suitable for invasive procedures might have skewed the observed bleeding incidence. We sought to investigate bleeding incidence in unselected patients with ACS. Patients were retrospectively enrolled between January and June 2019 from the emergency department of a tertiary hospital. All consecutive hospitalized adults with suspected non-ST-segment elevation myocardial infarction were included. Data was gathered by a database search and verified using electronic patient records. Bleeding risk was assessed according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definition. The primary end point was a composite of post- discharge Bleeding Academic Research Consortium type 2, 3, and 5 bleeding during 1-year follow-up. Of the 209 included patients, 15 (7.2%) suffered a bleeding event. There were more bleeding events among dual antiplatelet therapy (DAPT) users as compared with those without DAPT (10.7% vs 3.1%, p=0.033). Among HBR patients, 6.1% and in non-HBR patients 8.1% suffered a bleeding event (p=0.579). Notably, major bleeding (Bleeding Academic Research Consortium type 3) incidence was highest in patients <65years and without DAPT use. In conclusion, unselected suspected non-ST-segment elevation myocardial infarction patients aged <65years had surprisingly high bleeding incidence, regardless of ARC-HBR status or DAPT use.

Comparison of Clinical Outcomes Between Ticagrelor and Clopidogrel in East-Asian Patients with Acute Coronary Syndrome: Large Cohort Study.

A high risk of bleeding is observed in East Asian patients with acute coronary syndrome (ACS). Therefore, the choice between two antiplatelet therapy drugs, ticagrelor and clopidogrel, remains controversial in this population with ACS. This study aimed to use a large cohort database to assess the clinical outcomes of ticagrelor and clopidogrel therapy, including major bleeding, recurrent ACS, and mortality, in this population. Between January 2009 and December 2019, 43,696 patients were diagnosed with ACS based on the medical history (International Classification of Diseases [ICD] code) of the Chang Gung Research Database. After excluding patients without percutaneous coronary intervention, with concurrent medical problems, and on non-standard dual antiplatelet therapy (DAPT) or a single antiplatelet agent, 18,046 patients were recruited for analysis. Ticagrelor- and clopidogrel-based DAPT were administered to 3666 patients and 14,380 patients, respectively. Baseline characteristics and clinical outcomes were compared between the two groups. A total of 4225 patients were defined as a high-bleeding-risk subgroup according to Academic Research Consortium for High Bleeding Risk (ARC-HBR) score (met one major or two minor criteria), of which 466 and 3759 patients received ticagrelor- and clopidogrel-based DAPT, respectively. Before propensity score matching (PSM), younger age, higher prevalence of male sex, and higher body mass index were noted in the ticagrelor-based DAPT group in the whole cohort and high-bleeding-risk subgroup. After PSM, no difference in baseline characteristics and comorbidities between ticagrelor-based and clopidogrel-based DAPT groups in the whole cohort and high-bleeding-risk subgroup was noted. The Kaplan-Meier curves of recurrent ACS and major bleeding were significantly lower in the ticagrelor-based DAPT group than in the clopidogrel-based DAPT group, and that of cardiovascular (CV) and all-cause mortality showed no significant differences. After PSM, in the high-bleeding-risk subgroup, the Kaplan-Meier curve of recurrent ACS was significantly lower in the ticagrelor-based DAPT group than in the clopidogrel-based DAPT group, and that of major bleeding, CV, and all-cause mortality showed no significant differences. In this large cohort study, patients receiving ticagrelor-based DAPT were at lower risk of recurrent ACS compared to those receiving clopidogrel-based DAPT, especially in the patients with myocardial infarction. Ticagrelor-based DAPT did not result in a higher risk of major bleeding in the whole ACS population and high-bleeding-risk subgroup. The rate of CV and all-cause mortality were similar between both the groups.

Clinical characteristics and outcomes of patients with intracerebral hemorrhage after acute myocardial infarction

Data regarding patients with intracranial hemorrhage (ICH) following acute myocardial infarction (AMI) is scarce. This study aims to investigate the incidence, clinical characteristics, prevention, treatment, and prognosis of ICH in patients with AMI.Among 5257 patients with AMI, 14 cases (0.27%) experienced ICH following AMI, including 11 males and three females. In-hospital mortality occurred in eight patients (57.1%), all of whom experienced sudden loss of consciousness. Six patients (42.6%) were classified as high or very high risk according to CRUSADE score, and seven patients (50.0%) were classified as high risk according to Academic Research Consortium for High Bleeding Risk (ARC-HBR). The CRUSADE and ARC-HBR scores can complement each other in risk assessment. All in-hospital deaths occurred within four days of ICH onset; The volume of ICH in patients who died in the hospital was significantly higher than in those who survived and were discharged, with 30 ml possibly serving as a threshold.The incidence of ICH following myocardial infarction is low; however, the mortality rate is extremely high, presenting considerable challenges for clinical treatment. Prevention, early detection, and prompt symptomatic management are essential for improving patient outcomes.

Clinical Outcomes Based on High Bleeding Risk in Patients With Lower Extremity Peripheral Artery Disease Who Have Undergone Endovascular Therapy.

Endovascular therapies (EVTs) for symptomatic lower extremity peripheral artery disease (PAD) are efficient and minimally invasive. However, patients with PAD tend to have high bleeding risk (HBR), and there are limited data regarding the HBR for patients with PAD after EVT. In this study, we investigated the prevalence and severity of HBR, as well as its association with clinical outcomes in the patients with PAD who underwent EVT. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria were applied to 732 consecutive patients with lower extremity PAD post-EVT to assess the prevalence of HBR, and its association with major bleeding events, all-cause mortality, and ischemic events. The ARC-HBR scores (1 point for each major criterion and 0.5 points for each minor criterion) were obtained and the patients were divided into four groups (score: 0-0.5; low risk, score: 1-1.5; moderate risk, score: 2-2.5; high risk, and score: ≥3; very high risk) according to the score. Major bleeding events were defined as Bleeding Academic Research Consortium type-3 or type-5 bleeding, and ischemic events were defined as the composite of myocardial infarction, ischemic stroke, and acute limb ischemia within 2 years. High bleeding risk occurred in 78.8% of the patients. Major bleeding events, all-cause mortality, and ischemic events occurred in 9.7%, 18.7%, and 6.4% of the study cohort, respectively, within 2 years. During the follow-up period, major bleeding events significantly increased with the ARC-HBR score. The severity of the ARC-HBR score was significantly associated with an increased risk of major bleeding events (high risk: adjusted hazard ratio [HR] 5.62; 95% confidence interval [CI]: [1.28, 24.62]; p=0.022; very high risk: adjusted HR: 10.37; 95% CI: [2.32, 46.30]; p=0.002). All-cause mortality and ischemic events also significantly increased with higher ARC-HBR score. High bleeding risk patients with lower extremity PAD can be at a high risk of bleeding events, mortality, and ischemic events after EVT. The ARC-HBR criteria and its associated scores can successfully stratify HBR patients and assess the bleeding risk in patients with lower extremity PAD who undergo EVT. Endovascular therapies (EVTs) for symptomatic lower extremity peripheral artery disease (PAD) are efficient and minimally invasive. However, patients with PAD tend to have high bleeding risk (HBR), and there are limited data regarding the HBR for patients with PAD after EVT. Post EVT, most of the patients with PAD were classified as having HBR using the Academic Research Consortium for HBR (ARC-HBR) criteria and the rate of bleeding events as well as mortality and ischemic events within 2 years increased as the ARC-HBR score increased in this retrospective study of 732 participants. HBR patients with PAD can be at high risk of not only bleeding events but also mortality and ischemic events in the mid-term. The ARC-HBR criteria and its associated scores can successfully stratify HBR patients and assess the bleeding risk in patients with PAD who underwent EVT.

High thrombotic risk is associated with higher prevalence of suboptimal stent results in patients with high bleeding risk

Abstract Funding Acknowledgements Type of funding sources: None. Background Shorter duration of dual antiplatelet therapy after drug-eluting stent implantation is required in patients with high bleeding risk (HBR) irrespective of the presence of concomitant high thrombotic risk (HTR). The prevalence of post-stent suboptimal findings in patients with HBR remains unclear. Purpose To clarify the prevalence of post-stent suboptimal findings assessed by optical coherence tomography (OCT) in patients with HBR according to the presence of HTR. Methods A total of 607 consecutive patients with stable coronary disease, who underwent OCT imaging of the culprit lesion were included. HBR was defined based on the Academic Research Consortium for High Bleeding Risk (ARC-HBR). HTR was defined as lesions with diffuse long (≧60 mm), treated with more than three stents, chronic total occlusion or diffuse long lesion (≧32 mm) in patients with diabetes mellitus. Post-stent suboptimal OCT criteria was defined as minimum stent area (MSA) &amp;lt;4.5 mm2, edge dissection and stent malapposition. Results The prevalence of HBR was 55.8%. The prevalence of HTR was significantly higher in patients with HBR than in those without HBR (35.0 vs. 26.6%, p=0.028) (Figure A). Among patients with HBR, the prevalence of post-stent suboptimal OCT criteria was significantly higher in patients with HTR than in those without HTR (86.2 vs. 64.7%, p&amp;lt;0.001), mainly due to the higher prevalence of MSA &amp;lt;4.5 mm2 (Figure B) in patients with HTR. Conclusions HTR was associated with a higher prevalence of post-stent suboptimal findings among patients with HBR. The present results may suggest the importance of optimal stenting in patients with HBR, particularly in those with concomitant HTR.

Association between the number of Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and clinical outcomes in patients with acute coronary syndrome

BackgroundAcademic Research Consortium for High Bleeding Risk (ARC-HBR) criteria have been used to identify high-risk patients undergoing percutaneous coronary intervention (PCI) in current clinical practice. This study aimed to evaluate the association between the number of ARC-HBR criteria and clinical outcomes in patients with acute coronary syndrome (ACS) after an emergent PCI. MethodsWe assessed 338 consecutive patients with ACS who underwent successful emergent PCI between January 2017 and December 2020. The ARC-HBR score was calculated by assigning 1 point to each major criterion and 0.5 points to each minor criterion. The patients were classified into low (ARC-HBR score<1), intermediate (1≤ARC-HBR score<2), and high (ARC-HBR score≥2) bleeding risk groups. We investigated the association between the ARC-HBR score and major adverse cardiovascular events (MACEs), defined as a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke. We also compared the diagnostic ability of the ARC-HBR score and Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) risk score. ResultsThe mean age of the patients was 67.6±12.4years, and 78.4% were men. During the median follow-up of 864 (557–1309) days, 70 patients developed MACEs. Kaplan–Meier curves showed that the cumulative incidence of MACE was significantly higher as the ARC-HBR score increased in a stepwise manner (log-rank p<0.001). There were no significant differences in the area under the receiver operating characteristic curve (AUC) for predicting MACE within two years after an emergent PCI between the ARC-HBR and CADILLAC risk scores (AUC: 0.763 vs. 0.777). ConclusionsARC-HBR score was independently associated with an increased risk of MACE in patients with ACS after an emergent PCI. Moreover, it had a similar diagnostic ability for predicting MACE within two years compared to the CADILLAC risk score.

Estimation of adverse events associated with P2Y12 receptor inhibitors stratified by academic research consortium for high bleeding risk criteria in acute coronary syndrome

BackgroundThe usefulness of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in the selection of P2Y12 receptor inhibitors for acute coronary syndrome is unknown. This study investigated whether the selection of antiplatelet agents according to the ARC-HBR criteria could improve clinical outcomes. MethodsThis multicenter retrospective study included 1261 patients with acute coronary syndrome who received dual antiplatelet therapy, namely clopidogrel (75 mg, n = 529) or prasugrel (3.75 mg, n = 732) in addition to aspirin. The primary endpoint was net adverse clinical events (NACE) after hospital admission, including ischemic (death, myocardial infarction, ischemic stroke) and bleeding events (Bleeding Academic Research Consortium 3 or 5). Secondary outcomes were ischemic and bleeding events. For each patient, the observation period was defined as the duration of dual antiplatelet therapy after admission. ResultsDuring the observation period (average: 313 days), the rate of NACE was lower in the prasugrel group than the clopidogrel group (20.6% vs. 12.6%, respectively, P < 0.01). In patients who satisfied or did not satisfy the ARC-HBR criteria, prasugrel was associated with a 3.7% and 2.1% lower incidence of NACE, respectively, versus clopidogrel. Ischemic and bleeding events were less frequent in the prasugrel group than the clopidogrel group (11.5% vs. 7.9%, respectively, P = 0.03; 10.6% vs. 5.2%, respectively, P < 0.01). The estimated incidence models for NACE suggested that the difference between clopidogrel and prasugrel was greater in patients who satisfied the ARC-HBR criteria than in those who did not. ConclusionsPrasugrel is preferable to clopidogrel regardless of the ARC-HBR.

PRECISE-DAPT and ARC-HBR Predict in-Hospital Outcomes in Patients Who Underwent Percutaneous Coronary Intervention

Bleeding events result in morbidity and mortality in patients who underwent percutaneous coronary intervention (PCI). There are limited data on the predicting bleeding complications in patients who underwent stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) and Academic Research Consortium for High Bleeding Risk (ARC-HBR) scores' ability to predict in-hospital outcomes in patients who underwent PCI. Consecutive patients who underwent PCI at tertiary centers from January 2016 to March 2018 were identified and the bleeding risk scores were calculated. The primary end point was the National Cardiovascular Data Registry-defined in-hospital bleeding stratified by low versus high predicted bleeding risk. The major and net adverse cardiovascular events were also examined. The discriminatory ability of the risk models was determined using receiver operating characteristic curves. Among 3,659 patients studied, the in-hospital major bleeding was 3.3% (n=121). The patients characterized as high bleeding risk by either criterion had significantly higher bleeding rates than those meeting the low-risk criteria (ARC-HBR 5.4% vs 3.3%, p <0.001; PRECISE-DAPT 5.8% vs 2.4%, p <0.001), and higher major adverse cardiovascular events and net adverse clinical events. These risk estimates showed moderate and similar predictive ability (ARC-HBR high-risk area under the receiver operating characteristic curve [AUC] 0.62, PRECISE-DAPT ≥25 AUC 0.61, p=0.49), with no incremental benefit to adding the estimates (AUC 0.60). The subgroup analysis revealed that women had higher bleeding rates than men (5.53% vs 2.39%, p <0.001); however, the predictive ability of the criteria were similar in women and men. The patients identified as having a high bleeding risk by the PRECISE-DAPT and the ARC-HBR criteria before PCI are at high risk for in-hospital bleeding and adverse outcomes independent of gender. The 2 scores have moderate predictive ability for bleeds. Further study is needed to determine strategies to reduce risk in this population.

512 ACADEMIC RESEARCH CONSORTIUM HIGH BLEEDING RISK CRITERIA ASSOCIATED WITH ONE-YEAR NACES IN A MULTICENTER COHORT OF OLDEST OLD STEMI PATIENTS

Abstract Introduction The balance between thrombotic and bleeding events after myocardial revascularization is of paramount importance. Patients with higher bleeding risk are at high risk for complications. Age and frailty are also major risk factors for complications. We sought to evaluate the incidence of major bleeding events (BE) and their impact on prognosis in a real life oldest old (i.e. &amp;gt;85 years) ST elevation myocardial infarction (STEMI) patients population. Methods We evaluated all consecutive oldest old STEMI patients hospitalized in two hub-centers between January 2010 and June 2021. Patients were stratified according to Academic Research Consortium for High Bleeding Risk (ARC-HBR) in high bleeding risk (HR) and non-HR (nHR) patients. BE were defined according to the Bleeding Academic Research Consortium (BARC) criteria, BARC 3 or 5. Patients were also divided in groups according to anti-thrombotic therapy (AT) regimens at discharge: single antiplatelet therapy (SAPT), dual antiplatelet therapy (DAPT) or triple therapy (DAPT plus oral anticoagulation) (TT). Net adverse clinical event (NACE) was defined as a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding. Follow-up data were determined from local clinical records during a twelve-months period. Results 340 oldest old (mean age 88.6 ± 2.9 years, 52.6% female) STEMI patients were eligible for the analysis. 161 patients (47.4%) were categorized as nHR and 179 patients (52.6%) as HR. AT regimens at discharge were: 28 patients with SAPT (8.2%), 276 with DAPT (81.2%) and 36 with TT (10.6%). The overall incidence of BE was 4.6% within 12 months, without difference between nHR and HR patients (3.0% vs 5.9%, p=0.16). No BE were found in the SAPT group while the incidence of BE in the HR group was not statistically different between the DAPT and TT regimens (11.2% vs 9.5%; p=0.8). The incidence of NACE was statistically higher in HR than nHR patients (40.9% vs 25.5%, p&amp;lt;0.01) at 1-year. In addition, time-to-NACE was statistically inferior in HR group than nHR group (256.2 days vs 294.2 days, p&amp;lt;0.01) (Figure). Conclusions Our oldest old STEMI population was characterized by a large proportion of HR patients according to ARC-HBR criteria. This population experienced a higher rate of NACE in a shorter time when compared to nHR patients in the same age group.

Abstract 12411: Validation of Academic Research Consortium for High Bleeding Risk (ARC-HBR) Definition in East-Asian Patients

Introduction: Clinical applicability of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in East-Asian patients receiving potent antiplatelet therapy for acute coronary syndromes (ACS) is still undetermined Methods: Using individual patient data from the TICAKOREA trial, which is a multicenter trial randomly compared ticagrelor and clopidogrel in Korean patients with ACS, we determined the prognostic effect of ARC-HBR criteria on bleeding and ischemic events. The primary safety outcome was bleeding of academic research consortium (BARC) type 3 or 5 and primary efficacy outcome was major adverse cardiovascular events (MACE; a composite of cardiovascular death, myocardial infarction, or stroke). Results: HBR patients compared with non-HBR patients had a higher incidence of BARC type 3 or 5 bleeding (10.0% vs. 3.61%; hazard ratio [HR], 2.98; 95% confidence interval [CI], 1.52 to 5.86) and MACE (14.3% vs. 6.1%; HR 2.35; 95% CI, 1.35-4.10). Among HBR patients, there was no significant difference in bleeding events between ticagrelor and clopidogrel (10.2% vs. 9.8%; HR 1.15; 95% CI, 0.38-3.44). However, the efficacy endpoint of MACE tended to be higher in the ticagrelor group than in the clopidogrel group (19.1% vs. 8.1%; HR 2.31; 95% CI, 0.91-5.83) Conclusions: In Korean patients with ACS intended to receive early invasive management, ARC-HBR criteria is sufficiently applicable to predict both bleeding and ischemic risk. We also observed differential safety and effectiveness of ticagrelor compared with clopidogrel according to presence or absence of ARC-HBR criteria.

Gastrointestinal and Intracranial Bleeding Events After Second-Generation Drug-Eluting Stent Implantation - Their Association With High Bleeding Risk, Predictors, and Clinical Outcomes.

Gastrointestinal bleeding (GIB) and intracranial bleeding (ICB) are frequently observed as major bleeding events after percutaneous coronary intervention (PCI); however, there are few reports on these predictors and their association with the Academic Research Consortium for High Bleeding Risk (ARC-HBR).Methods and Results: The study included 3,453 patients who underwent PCI with second-generation drug-eluting stents between 2010 and 2013. Mean follow up was 2,663±596 days. The cumulative incidences of GIB and ICB were significantly higher in the HBR group than in the non-HBR group (6.3% vs. 1.9%, P<0.001, 5.5% vs. 2.3%, P<0.001). Older age, oral anticoagulant (OAC), and severe chronic kidney disease were independent predictors of GIB (hazard ratios [HR], 1.64; 95% confidence intervals [CI], 1.11-2.41; P=0.012; HR, 1.94; 95% CI, 1.23-3.05; P=0.004; HR, 1.80; 95% CI, 1.02-3.19, P=0.043 respectively), and low body weight, OAC, and left main coronary artery stenting were independent predictors of ICB by multivariate logistic regression analysis (HR, 1.83; 95% CI, 1.20-2.80; P=0.005; HR, 2.04; 95% CI, 1.31-3.19; P=0.002; HR, 1.79; 95% CI, 1.18-2.70; P=0.006 respectively). ARC-HBR was consistently associated with GIB and ICB within a 7-year period. GIB and ICB had three predictors each. Of these, only OAC administration was common, and the other two were different.

Comparison of original and modified Academic Research Consortium for High Bleeding Risk definitions in real-world practice

BackgroundThe Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined high bleeding risk (HBR) in patients undergoing percutaneous coronary intervention. We have reported a simplified HBR (S-HBR), excluding six items with prevalences under 1% from ARC-HBR. The Japanese Circulation Society developed an HBR specific to Japanese (J-HBR), adding three items to ARC-HBR in consideration of ethnicity. Data comparing each HBR are scarce. MethodsPatients treated with second-generation drug-eluting stents between January 2010 and December 2013 were enrolled, in whom all items of ARC-HBR, and the incidences of major bleeding and ischemic events were examined. Also, the diagnostic values of ARC-HBR, S-HBR, and J-HBR at 1 and 7 years post procedure were compared by using receiver-operating characteristic curves. ResultsThe study sample consisted of 3430 patients. Mean follow-up period was 2299 ± 904 days. The incidence of major bleeding at 1 and 7 years in each definition was as follows: ARC-HBC, 3.3% and 10.6%; S-HBR, 3.3% and 10.7%; and J-HBR, 2.9% and 10.0%. The diagnostic value of J-HBR for major bleeding at 1 year was lower than that of ARC-HBR (C statistics 0.64 vs. 0.68, p < 0.001). Other diagnostic values of S-HBR and J-HBR were comparable to those of ARC-HBR. ConclusionsS-HBR was as useful as ARC-HBR in predicting both short- and long-term HBR, and J-HBR is useful for predicting long-term HBR.

B-type natriuretic peptide is associated with the occurrence of bleeding events in heart failure patients with a history of coronary artery disease

Background: Bleeding risk in heart failure (HF) patients with coronary artery disease (CAD) has not yet been fully investigated. Methods: We analyzed the data of 677 patients with a previous history of CAD who were hospitalized for HF. The patients were divided into three groups based on the tertiles of B-type natriuretic peptide (BNP) levels: Low, Middle, and High BNP groups (n = 225, 226, and 226, respectively). The primary endpoint was post-discharge bleeding events, which was defined as hemorrhagic stroke and gastrointestinal bleeding. Results: The High BNP group was the oldest (Low, Middle, High, 67.0, 74.0, and 75.0 years, respectively; p < 0.001), showed the lowest left ventricular ejection fraction (56.0%, 50.7%, and 40.3%, respectively; p < 0.001), and contained more patients at high bleeding risk (HBR) defined by the simplified version of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definition (65.3%, 85.4%, and 93.8%, respectively, p < 0.001). Kaplan-Meier analysis demonstrated that post-discharge bleeding events occurred most frequently in the High BNP group (log-rank p = 0.008). In the Cox proportional hazard analysis, compared to the Low BNP group as a reference, the High BNP group was independently associated with bleeding events after adjustment for age, sex, simplified ARC-HBR definition, and left ventricular ejection fraction (hazard ratio 3.208, 95% confidence interval 1.078–9.544, p = 0.036). Conclusions: High BNP is associated with bleeding events in HF patients with a history of CAD.

Aspirin vs. Clopidogrel as a Chronic maintenance monotherapy after PCI in patients with high ischemic risk and high bleeding risk: Subgroup analysis of the HOST-EXAM trial

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf on behalf of the HOST-EXAM investigators Background The HOST-EXAM randomized clinical trial recently performed a comparison of clopidogrel monotherapy vs. aspirin monotherapy in patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention (PCI). This study randomized 5,438 patients who maintained dual antiplatelet therapy without clinical events for 6–18 months after PCI with drug-eluting stents (DES) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. During the 24-month follow-up, the primary outcome (a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater) rate was significantly lower in the clopidogrel group (hazard ratio [HR] 0.73 [95% CI 0.59–0.90]; p = 0.0035). However, it is uncertain whether the beneficial effect of clopidogrel will be consistent in patients with high ischemic risk or those with high bleeding risk. Methods This is a post-hoc analysis of the HOST-EXAM trial. A high ischemic risk was defined as those who had at least 1 of the following procedural features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length &amp;gt;60 mm, or left main PCI. Patients with high bleeding risk were defined according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The co-primary outcome were thrombotic endpoints (a composite of cardiac death, non-fatal myocardial infarction, ischemic stroke, readmission due to acute coronary syndrome, and definite or probable stent thrombosis) and bleeding endpoints (BARC type ≥2 bleeding events) at 24-month follow-up. Results Among the total population, 22.1% had high ischemic risk and 21.4% had high bleeding risk. Complex PCI was not associated with a higher risk of thrombotic endpoints, nor bleeding endpoints. For patients with a high bleeding risk, these patients had a higher risk of both thrombotic endpoints (HR 1.545, 95% CI 0.141-2.092, p = 0.005) and bleeding endpoints (HR 3.418, 95% CI 2.413-4.840, p &amp;lt; 0.001). The primary results focusing on the interaction between high ischemic risk, high bleeding and the antiplatelet regimen will be presented. Conclusion The current post-hoc analysis of the HOST-EXAM trial will evaluate the efficacy of clopidogrel monotherapy vs. aspirin monotherapy during the chronic maintenance period after PCI, in patients with high ischemic risk or those with high bleeding risk.