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

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.

615 Characterization of actionable bleeding and thrombotic trade-offs in patients undergoing percutaneous coronary intervention

Aims Patients undergoing percutaneous coronary intervention (PCI) are at risk of developing bleeding and/or thrombotic complications. Bleeding and thrombotic risk characteristics may overlap in some patients, which makes decision-making for dual antiplatelet therapy duration a clinical challenge. The actual proportion of PCI patients who have an increased bleeding risk and/or an increased thrombotic risk is unclear. The aim of this study is to identify sizeable and actionable proportions of patients at high bleeding risk (HBR) and/or at high thrombotic risk (HTR) in a contemporary cohort of PCI patients. Methods and results We retrospectively included all patients undergoing PCI at our Institution from November 2019 to April 2020 and identified those at HBR or HTR based on criteria from the Academic Research Consortium for High Bleeding Risk (ARC-HBR) or criteria from Giustino et al., respectively. Since belonging to the HBR and HTR groups was non-mutually exclusive, patients were further stratified into four mutually exclusive subgroups: (1) HBR/HTR; (2) HBR, non-HTR; (3) non-HBR, HTR; and (4) non-HBR, non-HTR. In addition, the new ARC-HBR trade-off model (integrating patients’ characteristics to define the individual risks of bleeding and thrombotic events) was applied to rank patients based on their computed risk scores for bleeding and thrombosis. Patients were categorized based on the ratio between the ARC-HBR thrombotic and the bleeding risk scores [i.e. high (1.5), intermediate (0.75–1.5), and low (<0.75)]. A total of 312 patients (mean age 68 ± 11 years, female 29%) were included, of which 93 (30%) presented with HBR and 116 (37%) presented with HTR. Among patients with HBR, 41% presented with HTR. Among patients with HTR, 33% presented with HBR. Overall, 12.2% of patients had HBR/HTR, 17.6% had HBR, non-HTR, 25.0% had non-HBR, HTR, and 45.2% had non-HBR, non-HTR. Based on the ARC-HBR trade off score, 16.3% of patients had a higher risk of thrombosis than the risk of bleeding, 45.9% had similar risks, and 37.8% had a higher risk of bleeding than the risk of thrombosis. Among patients who had HBR/HTR, the trade-off model identified 8% as having a higher risk of thrombosis than the risk of bleeding and 18.4% as having a higher risk of bleeding than the risk of thrombosis. Conclusions Characterizing the risk of bleeding and thrombotic complications is an important prerequisite for tailoring strategies to individual patients, hence minimizing the risks and improving the outcome of PCI. More than half of patients undergoing PCI presented with HBR, HTR, or both. About 40% of patients present with characteristic of high risk, which make them actionable (e.g. by using shorter durations of dual antiplatelet therapy in patients at HBR and non-HTR or using longer durations in patients at non-HBR and HTR). The ARC-HBR trade off model score is an additional useful tool that may be used to identify an additional quarter of actionable patients in the HBR/HTR category.

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

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.

Dual Antiplatelet Therapy after PCI: When Could We Go Shorter?

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) remains an important clinical question in interventional cardiology. Several clinical and angiographic variables are associated with an increased risk for thrombotic events, and prolonged DAPT duration may improve long term clinical outcome. However, some patients also present high bleeding risk (HBR) characteristics and may require a shorter DAPT duration. The guidelines recommendations consider the data from randomized clinical trials, however numerous exclusion criteria may create gaps in the evidence leading to uncertainties, the need for expert opinion and patient level decision making. Furthermore, the stent platforms have evolved in such way that opportunities now exist to shorten duration of DAPT. This chapter will review the variables associated with ischemic and bleeding risks as well as different stent platforms to help clinicians optimize DAPT duration in patients undergoing PCI.

Sports and Children with Hemophilia: Current Trends

Hemophilia is a sex-linked recessive disorder characterized by a lack of blood factors necessary for clotting. This review aims to investigate the benefits of sports activities in children with hemophilia in terms of both physical and psychological wellness. Sports activity is necessary for children with hemophilia to preserve joints’ range of motion, reduce joint bleeding, improve muscle mass and strength, enhance proprioception and prevent secondary chronic diseases. In the past, high-impact sports were usually forbidden in children with hemophilia because of their high bleeding risk. Recent studies, however, have shown that prophylaxis therapy can allow a hemophilic child to take part in vigorous activities or high-impact sports. The benefits of sports activity in children with hemophilia are expressed by a better muscular trophism and an improved bone mineral density. Moreover, physical activity has a positive impact on children’s psychosocial well-being. Due to prophylaxis therapy, the quality of life of children with hemophilia is similar to their peers, and this has allowed an improvement in sports participation, including team sports.

Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after Transcatheter Aortic Valve Replacement Discharge: A Japanese Multicentre Prospective OCEAN-TAVI Registry Study

Aims To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and results We enrolled 2,514 patients who underwent successful TAVR during 2013–2017. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischemic stroke in the first 2 years was evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score=2–4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR): 1.19; 95% confidence interval (CI): 1.07–1.31; p = 0.001] and all-cause mortality (adjusted HR: 1.24; 95% CI: 1.17–1.32; p < 0.001). Conclusions The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.