Bleeding events and mid-term mortality in the patients undergoing endovascular interventions for peripheral artery disease of the lower limbs based on the academic research consortium high bleeding risk criteria

2021 ◽  
Author(s):  
Naoki Yoshioka ◽  
Kensuke Takagi ◽  
Yasuhiro Morita ◽  
Yasunori Kanzaki ◽  
Hiroaki Nagai ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Academic Research ◽  
Bleeding Risk ◽  
Lower Limbs ◽  
Peripheral Artery ◽  
Bleeding Events ◽  
Endovascular Interventions ◽  
Artery Disease ◽  
Research Consortium ◽  
High Bleeding Risk

A New Preprocedural Score to Predict Bleeding Complications of Endovascular Interventions for Peripheral Artery Disease

2019 ◽  
Vol 26 (6) ◽  
pp. 816-825 ◽  
Author(s):  
Stavros Spiliopoulos ◽  
Athanasios Tsochatzis ◽  
Georgios Festas ◽  
Lazaros Reppas ◽  
Foteini Christidi ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Peripheral Artery Disease ◽  
Bleeding Risk ◽  
Bleeding Complications ◽  
Peripheral Artery ◽  
Bleeding Events ◽  
Endovascular Interventions ◽  
Hazard Ratios ◽  
Artery Disease ◽  
Bleeding Score

Purpose: To investigate the bleeding complications associated with endovascular therapy (EVT) for peripheral artery disease (PAD) and develop a dedicated peripheral bleeding score (PBS). Materials and Methods: This prospective, single-center study enrolled 530 patients (mean age 67.6±9.8 years; 396 men) undergoing endovascular procedures between August 2016 and July 2018 for chronic PAD. Primary endpoints were the incidence of 30-day bleeding complications [minor and major (prolonging hospitalization, causing permanent sequelae, or resulting in death)], the identification of factors associated with bleeding events, and the development of a dedicated PBS based on univariate and multivariate analysis. Hazard ratios (HR) and 95% confidence intervals (CI) are reported. The HAS-BLED score was compared with the PBS. Results: The overall peripheral bleeding complication rate was 3.8% (20/530), of which 3.2% (17/530) were major and included 4 (0.7%) active retroperitoneal bleeding events and 13 (2.4%) pseudoaneurysms. The annualized incidences of overall bleeding and major bleeding complications were 1.9% and 1.6%, respectively. Multivariable regression analysis identified age ≥75 as a correlate of significantly increased bleeding risk (HR 3.32, 95% CI 1.12 to 9.80, p<0.02). Male gender (HR 0.193, 95% CI 0.49 to 0.75, p<0.001) and statin therapy (HR 0.245, 95% CI 0.08 to 0.71, p=0.01) were correlated with a significantly decreased bleeding risk. Based on the regression analysis findings an 8-point PBS was developed, demonstrating 75.0% sensitivity and 78.4% specificity in detecting bleeding complications. The HAS-BLED score failed to identify 30-day bleeding events. Conclusion: The annualized incidence of bleeding complications associated with peripheral EVT was low. Advanced age and female sex were correlated with increased bleeding risk. The PBS demonstrated satisfactory statistical performance and could be considered for inclusion in the preprocedural endovascular checklist to help optimize intra- and postprocedural care.

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.

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

2021 ◽  
Author(s):  
Kazuki Mizutani ◽  
Gaku Nakazawa ◽  
Tomohiro Yamaguchi ◽  
Mana Ogawa ◽  
Tsukasa Okai ◽  
...  
Keyword(s):  
High Risk ◽  
Transcatheter Aortic Valve Replacement ◽  
Academic Research ◽  
Bleeding Risk ◽  
Severe Bleeding ◽  
Bleeding Events ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Research Consortium ◽  
High Bleeding Risk

Abstract 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 &lt; 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.

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&lt;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

Abstract 16570: Systemic Inflammation Alters the Bleeding-Ischemic Balance in High-Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Johny Nicolas ◽  
Davide Cao ◽  
Bimmer E Claessen ◽  
Mauro Chiarito ◽  
Samantha Sartori ◽  
...  
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Academic Research ◽  
Bleeding Risk ◽  
Lesion Length ◽  
Syntax Score ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Percutaneous Coronary ◽  
High Bleeding Risk

Introduction: Prognosis in high-bleeding risk (HBR) patients after percutaneous coronary intervention (PCI) is largely dependent on risk of ischemic/bleeding events. Inflammation is known to increase the ischemic risk following PCI in the general population, yet its impact on HBR patients remains unknown. Hypothesis: We assessed the hypothesis that inflammation, as reflected by elevated high-sensitivity C - reactive protein (hsCRP), increases the risk of ischemic and bleeding events in HBR patients undergoing PCI. Methods: We included patients who underwent PCI at a tertiary care center between 2014 and 2017. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the Academic Research Consortium (ARC)-HBR consensus. Patients were then stratified into high (≥3 mg/l) and low (<3 mg/ml) baseline hsCRP level; those presenting with myocardial infarction (MI) or hsCRP >10 mg/l were excluded. The main outcomes of interest were major adverse cardiac events (MACE) (composite of all-cause death, MI, and target vessel revascularization) and bleeding events. Results: Out of 7,186 patients included, 3,403 (42.3%) fulfilled the ARC-HBR definition of whom 1,046 (34.4%) had high hsCRP. These patients were frequently female, younger, and had more cardiovascular risk factors (diabetes, kidney disease, and peripheral artery disease) yet similar angiographic features (multivessel disease, syntax score, and lesion length) than those with low hsCRP. Although risk of MACE at 1 year was similar in HBR patients with either high or low hsCRP, mortality risk was significantly higher in the former group ( Figure 1 ). In addition, HBR patients with high hsCRP were more likely to have periprocedural bleeding (OR 1.72, 95% CI [1.14-2.58], p=0.01) but similar risk of 1-year major bleeding as HBR patients with low hsCRP ( Figure 1 ). Conclusion: In conclusion, inflammation is associated with periprocedural bleeding and 1-year mortality in HBR patients undergoing PCI.

461Modulation of ischemic and bleeding risk by peripheral artery disease after an acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Cespon Fernandez ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
S Manzano-Fernandez ◽  
F Dascenzo ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Peripheral Artery Disease ◽  
Cumulative Incidence ◽  
Bleeding Risk ◽  
Peripheral Artery ◽  
Data Set ◽  
Coronary Syndrome ◽  
Artery Disease ◽  
The Impact

Abstract Introduction Peripheral artery disease (PAD) is associated with heightened ischemic and bleeding risk in patients with acute coronary syndrome (ACS). With this study from real-life patients, we try to analyze the balance between ischemic and bleeding risk during treatment with dual antiplatelet therapy (DAPT) after an ACS according to the presence or not of PAD. Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients with and without PAD. The impact of prior PAD in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction (AMI), whereas for bleeding risk we have considered major bleeding (MB) defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 1,600 have PAD (6.1%). Patients with PAD were older, and with more cardiovascular risk factors. DAPT with prasugrel/ticagrelor was less frequently prescribed in patients with PAD in comparison with the rest of the population (8.2% vs 22.8%, p<0.001). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), and 640 AMI (2.5%) and 685 MB (2.6%) were reported. After propensity-score matching, we obtained two matched groups of 1,591 patients. Patients with PAD showed a significant higher risk of both AMI (sHR 2.17, 95% CI 1.51–3.10, p<0.001) and MB (sHR 1.51, 95% CI 1.07–2.12, p=0.018), in comparison with those without PAD. The cumulative incidence of AMI was 63.9 and 29.8 per 1,000 patients/year in patients with and without PAD, respectively. The cumulative incidence of MB was 55.9 and 37.6 per 1,000 patients/year in patients with and without PAD, respectively. The rate difference per 1,000 patient-years for AMI between patients with and without PAD was +34.1 (95% CI 30.1–38.1), and for MB +18.3 (16.1–20.4). The net balance between ischemic and bleeding events comparing patients with and without PAD was positive (+15.8 per 1,000 patients/year, 95% CI 9.7–22.0). Conclusions PAD was associated with higher ischemic and bleeding risk after hospital discharge for ACS treated with DAPT. However, the balance between ischemic and bleeding risk was positive for patients with PAD in comparison with patients without PAD. As summary, ACS patients with PAD had an ischemic risk greater than the bleeding risk.

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