scholarly journals Impact of ESC-endorsed high ischemic risk features and ARC-high bleeding risk criteria on clinical outcomes in all-comer patients undergoing PCI

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
HY Wang ◽  
D Yin ◽  
YJ Yang ◽  
B Xu ◽  
KF Dou

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Beijing Municipal Health Commission (Grant number: 2020-1-4032). Background Whether the underlying risk of high bleeding risk (HBR) influences the relationship of high ischemic risk (HIR) features with adverse events after drug-eluting stent implantation remains unclear. The purpose of this study was to evaluate (1) the prognostic effect of ESC guideline-endorsed HIR features on long-term clinical outcomes and (2) whether the outcomes of HIR versus non-HIR features vary by HBR status. Methods Ten thousand one hundred sixty-seven consecutive patients who underwent percutaneous coronary intervention between January 2013 and December 2013 were prospectively enrolled in Fuwai PCI Registry. Patients who are at HIR were defined as: diffuse multivessel disease in diabetic patients, chronic kidney disease, at least three stents implanted, at least three stents lesions treated, bifurcation with two stents implanted, total stent length > 60 mm, or treatment of chronic total occlusion. The definition of HBR was based on the Academic Research Consortium (ARC) for HBR criteria. The primary ischemic outcome was major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization and stent thrombosis. The primary bleeding outcome was clinically relevant bleeding, defined according to Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. Results With a 2.4-year median follow-up, 4430 patients (43.6%) having HIR experienced a significantly higher risk of MACE (hazard ratio [HR] adjust : 1.56, 95% confidence interval [CI]: 1.34–1.82; P < 0.001) and device-oriented composite endpoint (composite of cardiac death, target-vessel MI, and target lesion revascularization) (HRadjust : 1.52 [1.27–1.83]; P < 0.001), compared to those having non-HIR. The risk of clinically relevant bleeding did not differ between groups (HRadjust : 0.85 [0.66–1.08]; P = 0.174). Associations between HIR and adverse events were similar in HBR and non-HBR groups, without evidence of interaction (all P interaction > 0.05); however, adverse event rates were highest among subjects with both HIR and HBR. Conclusions ESC guideline-endorsed HIR was associated with significantly increased risk of MACE without any significant differences in clinically relevant bleeding. The presence of ARC-HBR does not emerge as a modifier of cardiovascular risk for patients at HIR, suggesting more potent and longer antiplatelet therapy may be beneficial for this patient population.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Shima ◽  
K Miura ◽  
T Tada ◽  
H Tanaka ◽  
Y Fuku ◽  
...  

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


2021 ◽  
Vol 8 ◽  
Author(s):  
Daphné Doomun ◽  
Ianis Doomun ◽  
Sara Schukraft ◽  
Diego Arroyo ◽  
Selma Cook ◽  
...  

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.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Miura ◽  
T Shimada ◽  
M Ohya ◽  
R Murai ◽  
H Amano ◽  
...  

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


2020 ◽  
Vol 75 (11) ◽  
pp. 1414
Author(s):  
Davide Cao ◽  
Roxana Mehran ◽  
Rishi Chandiramani ◽  
Samantha Sartori ◽  
George D. Dangas ◽  
...  

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Nobuhiro Nakanishi ◽  
Koichi Kaikita ◽  
Kenichi Tsujita

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.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Nicolas ◽  
D Cao ◽  
B Claessen ◽  
S Sartori ◽  
A Roumeliotis ◽  
...  

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&lt;0.001), females (40.7% vs. 25.5%, p&lt;0.001), cerebrovascular disease (19.5% vs. 3.9%, p&lt;0.001), and diabetes (55.4% vs. 42.1%, p&lt;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&lt;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


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