Ischemic and Bleeding Events in PENDULUM Patients With High Bleeding Risk and High Platelet Reactivity

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<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

Download Full-text

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

Circulation ◽

10.1161/circ.142.suppl_3.16570 ◽

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.

Download Full-text

Long-term outcomes in high-bleeding risk patients undergoing PCI for acute coronary syndromes: results from a large single-center pci registry

European Heart Journal ◽

10.1093/ehjci/ehaa946.2563 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

J Nicolas ◽

D Cao ◽

B Claessen ◽

S Sartori ◽

R Chandiramani ◽

...

Keyword(s):

Major Bleeding ◽

Acute Coronary Syndromes ◽

Bleeding Risk ◽

Bleeding Complications ◽

Major Adverse Cardiovascular Events ◽

Bleeding Events ◽

Increased Risk ◽

Risk Patients ◽

Coronary Syndromes ◽

High Bleeding Risk

Abstract Introduction Current clinical guidelines recommend prolonged dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS). However, an extended DAPT duration in high-bleeding risk (HBR) patients amplifies the risk of post procedural complications. Hence, clinicians often face the dilemma of prolonging DAPT duration to prevent recurrent ischaemic events at the expense of increasing the incidence of bleeding in high-risk patients. The actual incidence of ischaemic and bleeding events in this particular population is not well elucidated. Purpose To evaluate one-year ischemic and bleeding outcomes following PCI for ACS in a real-world HBR population as defined by the Academic Research Consortium (ARC) consensus document. Methods We included all patients who presented with ACS to a high-volume single PCI centre from 2012 to 2017 and underwent PCI with 2nd generation drug-eluting stent implantation. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the recent ARC-HBR consensus. The outcomes of interest were major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), and target lesion revascularization (TLR), and major bleeding events, including both peri-procedural and post-discharge bleeding. All outcomes were assessed at 1-year follow-up. The Kaplan-Meier method was used for time-to-event analyses. Results Out of 6,097 ACS patients included in this analysis, 2,717 (44.6%) fulfilled the ARC-HBR definition. Compared to non-HBR group, HBR patients were more frequently female, older, more likely to have cardiovascular risk factors (e.g., diabetes, hypertension, and hyperlipidemia) and complex coronary artery disease (e.g., multi-vessel disease, bifurcation lesions, and calcification). The 1-year incidence of MACE was significantly higher in HBR patients (16.3% vs. 8.1%, HR 2.16, 95% CI [1.81–2.59], p<0.001) (Figure 1A). This finding was driven by higher rates of all-cause death and MI (Figure 1B). The 1-year incidence of major bleeding was also significantly higher in HBR patients compared to non-HBR (11.1% vs. 3.1%, HR: 3.92, 95% CI 3.10–4.95; p<0.001). Conclusions HBR patients undergoing PCI for ACS are not only subject to bleeding complications but are also at an increased risk for ischemic events and all-cause mortality. Figure 1 Funding Acknowledgement Type of funding source: None

Download Full-text

Ticagrelor versus Clopidogrel in high bleeding risk patients presenting with Acute Coronary Syndromes: insights from the multicenter START-ANTIPLATELET registry

European Heart Journal ◽

10.1093/ehjci/ehaa946.1730 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

F Gragnano ◽

E Moscarella ◽

P Calabro' ◽

A Cesaro ◽

P.C Pafundi ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Coronary Syndromes ◽

Bleeding Risk ◽

Coronary Intervention ◽

P Value ◽

Bleeding Events ◽

P2y12 Inhibitors ◽

Coronary Syndromes ◽

High Bleeding Risk

Abstract Background Optimal dual antiplatelet therapy in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) remains debated. Although current guidelines recommend the use of potent P2Y12 inhibitors in these patients (according to the labeled indications), clopidogrel is frequently used in clinical practice based on a perceived advantage in terms of safety in the HBR population. Purpose We sought to investigate the use of clopidogrel versus ticagrelor in consecutive HBR ACS patients and their impact on ischemic and bleeding events at 1 year. Methods ACS patients enrolled in the START-ANTIPLATELET registry with at least 1 HBR criterion were included in the present analysis and stratified according to DAPT type (clopidogrel versus ticagrelor). The primary endpoint was net adverse clinical endpoint (NACE), defined as a composite of all-cause death, myocardial infarction, stroke, and major bleeding. The secondary endpoints were major adverse cardiac and cerebral events (MACE), defined as a composite of all-cause death, myocardial infarction and stroke, each individual component of NACE and MACE, and target vessel revascularization. Results Among a total of 1,209 patients with 1-year follow-up in the registry, 383 patients were considered at HBR, of whom 174 (45.4%) were on clopidogrel and 209 (54.6%) on ticagrelor. Clopidogrel was more likely to be administered in patients at increased ischemic and bleeding risk, while ticagrelor in those undergoing percutaneous coronary intervention. Mean DAPT duration was longer in the ticagrelor group than in the clopidogrel group (10.40±4.29 versus 9.35±5.4; p-value=0.03). At 1-year follow-up, the risk of NACE and MACE events was significantly higher in the clopidogrel than in the ticagrelor group (NACE: HR 1.82; 95% CI 1.07–3.09; p-value=0.02; MACE: HR 1.83; 95% CI 1.04–3.24; p-value=0.03) (Figure). After multivariate adjustment for clinical and procedural characteristics, no difference in NACEs nor MACEs was observed between patients on clopidogrel versus ticagrelor (NACE: adjusted HR 1.27; 95% CI 0.71–2.27; p-value=0.42; MACE: adjusted HR 1.19; 95% CI 0.63–2.24; p-value=0.59) (Figure). Age, number of HBR criteria, and mean DAPT duration were independent predictors of NACEs. Conclusions In a real-world ACS registry, approximately 50% of patients are at HBR and frequently treated with clopidogrel. In HBR ACS patients, no difference was observed in ischemic and bleeding events between clopidogrel and ticagrelor after adjustment for potential confounders. Kaplan-Meier curves at 1-year follow-up. Funding Acknowledgement Type of funding source: None

Download Full-text

P3726Percutaneous left atrial appendage closure and conservative antithrombotic treatment in patients with atrial fibrillation and contraindication to oral anticoagulation: a 5-year follow-up study

European Heart Journal ◽

10.1093/eurheartj/ehz745.0580 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

J P Pouru ◽

S Jaakkola ◽

J Lund ◽

F Biancari ◽

A Saraste ◽

...

Keyword(s):

Antiplatelet Therapy ◽

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Bleeding Risk ◽

Left Atrial Appendage Closure ◽

Bleeding Events ◽

Device Embolization ◽

High Bleeding Risk

Abstract Background Patients with atrial fibrillation (AF) having high thromboembolic risk and either a history of major bleeding or very high bleeding risk form a treatment challenge. Percutaneous left atrial appendage closure (LAAC) offers a feasible option for stroke prevention in these patients. However, the optimal treatment strategy for AF patients with contraindications to oral anticoagulation (OAC) remains unclear. Purpose To study periprocedural and late events after LAAC in AF patients with contraindications to OAC therapy. Methods Data were collected into a prospective registry from all consenting AF patients who underwent LAAC from February 2009 to August 2018. Follow-up data was gathered during scheduled clinical visits, annual phone calls and by reviewing electronic patient records. Only AF patients with contraindications to OAC were considered for the present analysis. Results LAAC using mainly Amplatzer Cardiac Plugs (98.2%) was attempted in a total of 172 patients (mean age 74 years; 60 women). The mean CHA2DS2-VASc score was 3.8±1.5 and HAS-BLED score 4.0±1.0. Contraindications to OAC were prior intracranial bleeding in 112 (65.1%), other major bleeding in 33 (19.2%) and high bleeding risk in 27 patients (15.7%). Procedure was technically successful in 166 (96.5%) patients. Clinically significant in-hospital complications were as follows: two patients (1.2%) had cardiac tamponade, which was fatal in one case, one (0.6%) had device embolization and eight (4.7%) had major access site-related bleeding events. None of the patients had in-hospital thromboembolic complications. After successful implantation, 152 patients (91.6%) were discharged on aspirin. Single antiplatelet therapy was more common than dual or triple antiplatelet therapy (74.7% vs. 18.1% vs. 1.8%, respectively), while 8 patients (4.8%) received no antiplatelet therapy. The length of initial antiplatelet therapy ranged from 0.5 to 12 months and long-term antiplatelet therapy was prescribed in 53 patients (31.9%). After a median follow-up of 33 months (interquartile range 12–49) there were 29 deaths (17.5%), 16 thromboembolic events (9.6%), consisting of 11 strokes (6.6%) and 5 transient ischemic attacks (3.0%). At the time of thromboembolic event, 10 patients (62.5%) were on antithrombotic therapy. Eighteen patients (10.8%) had at least one major bleeding event after the index hospitalization. Intracranial bleeding occurred in 7 patients (4.2%) and 6 of them (85.7%) were on antithrombotic therapy when the event occurred. Most thromboembolic events (68.8%) and intracranial bleedings (57.1%) occurred after one year of follow-up. One patient (0.6%) had an asymptomatic device embolization detected at 3-month control visit. No predictive factors for thromboembolic or major bleeding events were identified. Conclusion The early outcome of this challenging patient group is good after LAAC, but thromboembolic and major bleeding events are not uncommon during later follow-up.

Download Full-text

Abstract 12614: Total Thrombus Formation Analysis System Can Predict High Bleeding Risk in Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention

Circulation ◽

10.1161/circ.142.suppl_3.12614 ◽

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.

Download Full-text

Academic Research Consortium for High Bleeding Risk Definitions for Early, Late, and Very Late Bleeding Events

Circulation Journal ◽

10.1253/circj.cj-21-0120 ◽

2021 ◽

Author(s):

Katsuya Miura ◽

Yuki Shima ◽

Koya Okabe ◽

Yuya Taguchi ◽

Akihiro Ikuta ◽

...

Keyword(s):

Academic Research ◽

Bleeding Risk ◽

Bleeding Events ◽

Research Consortium ◽

High Bleeding Risk ◽

Early Late ◽

Late Bleeding

Download Full-text

Thrombotic and Bleeding Outcomes Following Perioperative Interruption of Direct Oral Anticoagulants and Vitamin K Antagonists in Patients with Non-Valvular Atrial Fibrillation - a Comparative Analysis

Blood ◽

10.1182/blood-2018-99-111698 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 1234-1234

Author(s):

Joseph R. Shaw ◽

Tinghua Zhang ◽

Gregoire Le Gal ◽

James Douketis ◽

Marc Carrier

Keyword(s):

Major Bleeding ◽

Research Funding ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Advisory Board ◽

Bleeding Events ◽

Chads2 Score ◽

High Bleeding Risk

Abstract Background: Atrial fibrillation (AF) is a common disorder that will affect up to 5.6 million patients in the U.S. by 2050. Both direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs), typically warfarin, are used for stroke prevention in AF and such patients frequently undergo invasive procedures requiring anticoagulant interruption. Temporary interruption of anticoagulants can be associated with significant morbidity and mortality in the form of thromboembolic and bleeding complications. DOACs have a short half-life and fast onset of action, thereby facilitating their perioperative management as compared to VKAs. Despite important differences in perioperative management and pharmacokinetics between DOACs and VKAs, there is a paucity of data comparing perioperative outcomes in DOAC and VKA-treated patients. Methods: We undertook a single-center, retrospective chart review that compared consecutive DOAC- or warfarin-treated patients with AF who underwent perioperative anticoagulant interruption for invasive procedures between January 2017 and March 2018. Perioperative warfarin interruption was done as per CHEST guidelines (Douketis et al. Chest 141,2 Suppl). Perioperative bridging with low-molecular-weight heparin was only used for patients with CHADS2 scores of 5-6 or in patients with stroke within the past 6 months. Perioperative interruption of DOACs was done as per Thrombosis Canada guidelines, with anticoagulation held for 3 half-lives prior to low bleeding risk procedures and 5 half-lives for high bleeding risk procedures. Primary outcomes included the 30-day post-operative thromboembolic and major bleeding rates. Secondary outcomes included the 30-day clinically relevant non-major bleeding (CRNMB) andl mortality rates. Major bleeding and CRNMB were defined according to ISTH definitions. Procedural bleeding risk was defined as per Schulman et al (Circulation 2015; 132(3)). Outcome events were independently adjudicated by two investigators. Outcomes from patients on DOACs and VKAs were compared. Demographic data was analyzed on a per-patient basis, p-values were calculated using independent T-Test, Chi-Square/Fisher's Exact Test where appropriate. Outcome data was analyzed on a per-interruption basis. P-values for unadjusted and adjusted comparisons were calculated using generalized estimating equations (GEE) to account for correlation between multiple procedures on the same patients. Results: 325 DOAC patients and 199 warfarin patients underwent 351 and 221 periprocedural interruptions, respectively. Warfarin patients had a significantly higher mean age, CHADS2 score, and proportion with renal dysfunction (Table 1). There was no statistically significant difference in 30-day post-operative rates of thromboembolism, CRNMB, and overall mortality, but warfarin patients had a significantly higher rate of major bleeding (Table 2). This latter result remained statistically significant following multivariate logistic regression correction for age, CHADS2 score and level of renal dysfunction. All bleeding events occurred post-procedure, with major bleeding events occurring from post-operative day 1 to post-operative day 25. None of the warfarin patients with major bleeding received perioperative bridging; the mean international normalized ratio (INR) at the time of major bleeding was 3.3. Most major bleeding events (7/8) in the VKA arm were surgical, with a single non-surgical major-bleed (spontaneous ICH on post-operative day 15 following urological surgery). Conclusions: The perioperative interruption of warfarin was associated with a higher 30-day rate of major bleeding as compared with DOAC interruption. Re-initiation of warfarin should be done judiciously following high bleeding risk procedures, and close INR monitoring may be warranted. Disclosures Shaw: Portola Pharmaceuticals: Research Funding. Douketis:Janssen: Consultancy; Pfizer: Other: Advisory Board; Boehringer-Ingelheim: Consultancy, Other: Advisory Board, Research Funding; Portola: Other: Advisory Board; The Medicines Company: Other: Advisory Board; Daiichi-Sankyo: Other: Advisory Board; Biotie: Other: Advisory Board; Bayer: Other: Advisory Board; Sanofi: Consultancy, Other: Advisory Board; BMS: Other: Advisory Board; Astra-Zeneca: Other: Advisory Board. Carrier:Bayer: Honoraria; Pfizer: Honoraria; BMS: Honoraria, Research Funding; Leo Pharma: Research Funding.

Download Full-text

Predictors for major bleeding in elderly (75 years and over) patients with non-valvular atrial fibrillation at high risk of bleeding: sub-analysis of the ANAFIE Registry

European Heart Journal ◽

10.1093/eurheartj/ehab724.0555 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

K Okumura ◽

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Major Bleeding ◽

Risk Group ◽

Reference Group ◽

Bleeding Risk ◽

High Risk Group ◽

Bleeding Events ◽

All Cause Mortality ◽

High Bleeding Risk

Abstract Background In patients with atrial fibrillation (AF) receiving anticoagulant therapy, bleeding events are associated with reduced survival. Previous studies showed that bleeding events during anticoagulant therapy were more frequent in elderly AF patients than in younger patients. HAS-BLED score has been used to assess the risk of bleeding in AF patients. In patients at high bleeding risk (HAS-BLED score ≥3), we sought to identify other risk factors associated with major bleeding not included in HAS-BLED score in elderly non-valvular AF (NVAF) patients. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study to collect real-world data on clinical status and prognosis in more than 30,000 Japanese patients (aged ≥75 y) with NVAF. This sub-analysis of the ANAFIE Registry assessed the 2-year outcomes and identified predictors for major bleeding in elderly NVAF patients with a high bleeding risk. Methods A total of 32,275 patients from the ANAFIE Registry were divided into 2 groups according to HAS-BLED score (≥3 [high-risk group] and ≤2 [reference group]). The annualized incidence rate, hazard ratio (HR) for clinical outcomes, and independent predictors for major bleeding were analyzed using Kaplan-Meier analysis and the Cox proportional-hazards model. Results A total of 6,826 patients constituted the high-risk group: mean age, 81.8 years old (75–80 years, 37.8%; 81–84 years, 33.9%; ≥85 years, 28.3%); male ratio, 72.2%; mean creatinine clearance (CrCL), 42.7 mL/min; history of major bleeding, 14.2%; presence of non-paroxysmal AF, 62.2%; mean total number of medicines used, 7.8. Anticoagulants were used in 91.2% (warfarin [WF], 29.9%; direct oral anticoagulants [DOACs], 61.2%). Proton-pump inhibitors (PPI) were administered in 46.5%. Compared to the reference group, the high-risk group had higher annualized incidence rates (/100 patient-year) of major bleeding (1.49 vs 0.97), intracranial hemorrhage (0.95 vs 0.70), gastrointestinal (GI) bleeding (2.63 vs 1.73), and all-cause mortality (5.50 vs 3.24). All-cause mortality more frequently occurred in patients aged ≥85 years compared to 75–79 years and those with CrCL <50 mL/min compared to CrCL ≥50 mL/min. In the high-risk group, DOAC subgroup had lower incidences of the above-mentioned outcomes other than GI bleeding than WF subgroup. The following relevant factors for major bleeding not included in HAS-BLED score were identified in the high-risk group: Body mass index (BMI) ≥25.0 kg/m2 (HR, 0.40), heart failure (HF) with reduced left ventricular ejection fraction (LVEF) (HR, 1.38), a fall within 1 year (HR, 2.29), and use of PPI (HR, 0.65). Conclusions Among elderly (≥75 years) Japanese NVAF patients in the high bleeding risk group (HAS-BLED score ≥3), HF with reduced LVEF, and a fall within 1 year were identified as independent predictors of major bleeding. BMI ≥25.0 kg/m2 and PPI use were protective for major bleeding. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

Download Full-text

Abstract 18785: Should We Recommend Triple Therapy for Patients Undergoing Stent Implantation With a High Score HAS-BLED?

Circulation ◽

10.1161/circ.130.suppl_2.18785 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Antonia Sambola

Keyword(s):

Renal Failure ◽

Major Bleeding ◽

Bleeding Risk ◽

Coronary Intervention ◽

Adverse Outcomes ◽

Cardiac Events ◽

Bleeding Events ◽

Risk Of Bleeding ◽

Drug Eluting ◽

High Bleeding Risk

Introduction: Current clinical guidelines recommend the use of HAS-BLED score to assess the risk of bleeding in patients requiring oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stenting (PCI-S). Hypothesis: The use of OAC in patients requiring OAC with a high score HAS-BLED would be not safe. Objective: To evaluate the safety of OAC in patients with indication and a high risk of bleeding (HAS-BLED score ≥ 3) who undergoing PCI-s. Methods: A prospective multicenter study was conducted from 2007 to 2012 to identify patients requiring long-term OAC undergoing PCI-S. All adverse outcomes were analyzed at 1-year follow-up. Results: We identified 828 patients requiring OAC (77.3% male, 72.0±9.3 years) undergoing PCI-S. Five-hundred thirteen (62%) had a HAS-BLED ≥ 3. Of these, 329 (64.8%) received OAC. These patients had a mortality rate (10.1% vs. 10.3%) and major adverse cardiac events rate (MACE) (19.6% vs. 18.8%, p=0:46) similar to those who did not receive OAC. However, bleeding events rate was significantly higher (15.1% vs. 23.7%, p=0.01) with an excess of major bleeding (3.4% vs. 9.2%, p=0.01) in patients treated on OAC. In a multivariate analysis, in patients with a HAS-BLED ≥ 3: age (p=0.02) and renal failure (p <0.001) were predictors of mortality, but OAC was not associated with mortality. The only predictor of bleeding events was the use of OAC (p=0.01), while renal failure and use of drug eluting stents were not. Conclusions: A high percentage of patients undergoing PCI-S have a high bleeding risk (HAS-BLED ≥ 3). In these patients, the use of OAC does not seem to improve prognosis, but increases the incidence of major bleeding.

Download Full-text