Bleeding Academic Research Consortium Definition Research Articles

Abstract 18093: Bleeding Events in Clopidogrel-Treated Patients with STEMI is Associated with a Genetic Risk Score Based on High-Risk Genetic Polymorphisms

Introduction: Gene polymorphisms of ABCB1, CYP2C19, PON1 and P2Y12 may influence pharmacodynamics and clinical events of clopidogrel treatment. Hypothesis: We assessed the hypothesis that a genetic risk score based on identified high-risk single nucleotide polymorphisms (SNPs) would be associated with bleedings in clopidogrel-treated Chinese STEMI patients after percutaneous coronary intervention (PCI). Methods: A total of 503 consecutive patients with STEMI who received an uneventful PCI and were exposed to clopidogrel treatment for 12 months, were enrolled in the single-center registry. There were 38 tag SNPs selected from ABCB1, CYP2C19, PON1 and P2Y12 genes, which were detected by the ligase detection reaction. The primary clinical safety endpoint was the incidence of major bleeding events. Major bleeding was quantified according to bleeding academic research consortium definition (BARC) criteria, including type 3 and 5 in the analysis. The follow-up period was 12 months. Results: Overall, 46 BARC≥3 bleeding events (9.1%) occurred, which included 11 (2.1%) cases of BARC 3b bleedings and 35 (7.0%) cases of BARC 3a bleedings. After adjustment for traditional clinical risk factors, multivariate logistic regression analysis identified SNPs significantly associated with bleedings were ABCB1 (rs1045642, rs2235047, rs7779562), P2Y12 (rs6809699) and CYP2C19*17. A genetic risk score was constructed by summing the number of risk alleles. Bleedings were significantly associated with increased genetic risk score tertile. Patients in the top tertile of the genetic score were estimated to have a 3.268-fold (95%CI=1.198-8.929, p=0.021) increased risk of bleedings compared with those in the bottom tertile. As a continuous variable, the risk score resulted in an OR of 1.326 per unit increase in score (95%CI=1.098-1.601, p=0.003). Conclusions: This genetic score was significantly associated with bleedings after PCI in our study population.

Incidence, Source, Determinants, and Prognostic Impact of Major Bleeding in Outpatients With Stable Coronary Artery Disease

BackgroundAlthough there is evidence that patients who experience major bleeding after an acute coronary event are at higher risk of death in the months after the event, the incidence and impact on outcome of bleeding beyond 1 year of follow-up in patients with stable coronary artery disease (CAD) are largely unknown. ObjectivesThe goal of this study was to assess the incidence, source, determinants, and prognostic impact of major bleeding in stable CAD. MethodsWe prospectively included 4,184 consecutive CAD outpatients who were free from any myocardial infarction (MI) or coronary revascularization for >1 year at inclusion. Follow-up was performed at 2 years, with major bleeding defined as a type ≥3 bleed using the Bleeding Academic Research Consortium (BARC) definition. ResultsThere were 51 major bleeding events during follow-up (0.6%/year). Most events were BARC type 3a bleeds with 12 fatal bleeds (type 5). In most cases (54.9%), the site of bleeding was gastrointestinal. Major bleeding was significantly associated with mortality (adjusted hazard ratio: 2.89; 95% confidence intervals: 1.73 to 4.83; p < 0.0001). The increased risk of bleeding associated with vitamin K antagonist (VKA) treatment was particularly evident when VKA was combined with an antiplatelet therapy (APT). In contrast, the risk of cardiovascular death, MI, or nonhemorrhagic stroke did not differ in patients who received VKA + APT versus patients on VKA alone. ConclusionsIn patients with stable CAD (i.e., >1 year, with no acute events), major bleeding events are rare, but such events are an independent predictor of death. When oral anticoagulation is required, concomitant APT should not be prescribed in the absence of a recent cardiovascular event.

TCT-825 Bleeding events are reduced and survival improved by use of radial access during primary percutaneous coronary intervention for patients receiving glycoprotein inhibitors

access during primary percutaneous coronary intervention for patients receiving glycoprotein inhibitors Control Number: 2917 Submission Type: Abstract Presentation Format: Poster Only New Device/Innovation: No Author(s): Adam J Brown, Nikil K Rajani, Liam M McCormick, Stephen P Hoole, Nick E West Institution(s): University of Cambridge, Cambridge, United Kingdom, Papworth Hospital, Cambridge, United Kingdom Presenter Poster: Dr Adam J Brown, MB BChir View Disclosure University of Cambridge Background: Use of glycoprotein IIb/IIIa inhibitors (GPI) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) is known to improve myocardial perfusion and reduce further ischemic events, but is associated with an increase in bleeding risk. Performing PPCI via radial access (rPPCI) is thought to reduce post-procedural bleeding complications and may improve overall survival. We sought to assess whether rPPCI is associated with improved outcomes in patients receiving GPI at our institution. Methods: Consecutive patients undergoing PPCI for STEMI over a four-year period were included. All patients were preloaded with 600mg clopidogrel and 300mg aspirin en-route to PPCI. Interventional strategy and GPI use were left to operator discretion. Patient data and outcome measures were obtained by interrogation of notes and national databases. Bleeding complications were categorized using Bleeding Academic Research Consortium (BARC) definitions. Results: 2,019 patients were included in the analysis (mean age 64.2±12.4yrs, 75.9% male), with 863 receiving GPI. Patients that received GPI were younger (62.7±11.8yrs vs. 64.8±12.6yrs, p< 0.001), more likely to be male (80.5% vs. 73.9%, p< 0.001) but had a higher incidence of cardiogenic shock (5.6% vs. 2.7%, p=0.002). Other baseline demographics were similar. Overall, BARC defined bleeding was more prevalent in those receiving GPI (BARC ≥2 3.0% vs. 0.7%, p< 0.001; BARC ≥3 2.6% vs. 0.2%, p< 0.001). However, patients undergoing rPPCI with GPI had lower bleeding rates when compared with femoral access (0.8% vs. 3.7%, p=0.05). For patients receiving GPI, rPPCI resulted in a significant improvement in 1-year survival (99.2% vs. 93.5%, p=0.01; OR 0.12, 95%CI 0.02-0.87, p=0.04). However, in patients not receiving GPI, no survival benefit for rPPCI was observed (94.4% vs. 93.7%, p=0.70; OR 0.87, 95%CI 0.44-1.71, p=0.69). Conclusions: rPPCI results in lower rates of bleeding and improved survival in patients receiving GPI during PPCI. rPPCI should be considered in patient groups where subsequent use of GPI is likely. CORONARY: STEMI and NSTEMI

Relationship Between ABCB1 Polymorphisms, Thromboelastography and Risk of Bleeding Events in Clopidogrel-Treated Patients With ST-Elevation Myocardial Infarction

IntroductionThis study sought to investigate the relationship of polymorphisms in ABCB1 and the predictive value of thromboelastography (TEG) on bleeding risk in clopidogrel-treated patients with ST-elevation myocardial infarction (STEMI). Methods467 consecutive patients with STEMI undergoing percutaneous coronary intervention (PCI) were enrolled. Twenty tag single nucleotide polymorphisms (SNPs) selected from ABCB1 gene and CYP2C19*2, *3, *17 were detected by the ligase detection reaction. Platelet reactivity was assessed by TEG. The follow-up period was 12months. ResultsBy receiver operating characteristic curve analysis, the TEG platelet mapping assay value of ADP inhibition had the best predictive value of bleeding academic research consortium definition (BARC) ≥3b bleedings, yielding an area under the curve (AUC) of 0.707 (95% CI 0.662-0.749, p=0.009; cut-off value >93.4%). ADP inhibition can also predict BARC≥3 bleedings with an AUC of 0.594 (95% CI 0.546-0.640, p=0.05; cut-off value >92.5%). After adjustment for established risk factors of bleeding including the gain of function CYP2C19*17 allele, age, female gender, renal function, the multivariable logistic regression model demonstrated that ADP inhibition>92.5% (OR 2.247, 95%CI 1.082-4.665, P=0.03), carriage of rs1045642 (OR 2.943, 95%CI 1.195-7.247, P=0.019) and rs7779562 (OR 0.453, 95%CI 0.219-0.936, P=0.032) were independent predictors of BARC≥3 bleedings. These associations were validated in a second cohort of 504 STEMI patients. ConclusionsIn STEMI patients treated with clopidogrel after PCI, the ABCB1 tag SNP rs1045642 is associated with higher risk of bleedings while rs7779562 is associated with lower bleeding risk, and ADP inhibition in TEG has a predictive value of bleedings.

Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: Design of the randomized antarctic study

Elderly patients are at high risk for both ischemic and bleeding events. Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio. The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy using prasugrel 5 mg without monitoring and without adjustment (Conventional Treatment Arm) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome (ACS). ANTARCTIC is a multicenter, prospective, open-label study with 2 parallel arms. A total of 852 elderly patients (≥ 75 years) undergoing stent percutaneous coronary intervention for ACS are to be enrolled. The primary end point is the time to first occurrence of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, urgent revascularization, and bleeding complications (Bleeding Academic Research Consortium definition 2, 3, or 5). Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment. ANTARCTIC is a nationwide, prospective, open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting.

Impact of in‐hospital bleeding according to the bleeding academic research consortium classification on the long‐term adverse outcomes in patients undergoing percutaneous coronary intervention

The aim of this study was to assess the impact of bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents on long-term clinical events according to the newly proposed Bleeding Academic Research Consortium (BARC) classification. Current evidence about the impact of the BARC classification is limited. Out of a total of 6,166 patients who underwent PCI in a prospective IRIS-DES registry, the impact of in-hospital bleeding defined as the BARC classification on major adverse cardiovascular events (MACE) comprising death, myocardial infarction (MI), or stroke was analyzed. In-hospital bleeding occurred in 235 patients (3.8%) according to BARC classification. During the 2-year follow-up, MACE occurred in 599 patients (9.7%). The 2-year incidence of MACE was significantly higher in patients with bleeding (16.7% vs. 8.3%; adjusted hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.2-2.3; P = 0.002) than in those without bleeding. We observed a higher risk of MI (12.4% vs. 6.4%; adjusted HR, 1.7; 95% CI, 1.2-2.6, P = 0.005), stroke (3.0% vs. 0.6%; adjusted HR, 2.9; 95% CI, 1.4-6.2, P = 0.005) in patients with bleeding. Death (3.8% vs. 1.6%; adjusted HR, 1.6; 95% CI, 0.9-3.0, P = 0.120) and target vessel revascularization (4.3% vs. 1.9%; adjusted HR, 1.6; 95% CI, 0.9-2.9, P = 0.108) were statistically insignificant. Incidence, adjusted HR and P-value were similar between BARC and TIMI classification. In-hospital bleeding events according to the newly proposed BARC definition were significantly associated with an increased risk of adverse long-term events in patients undergoing PCI with drug-eluting stents. © 2014 Wiley Periodicals, Inc.

Clinical utility of new bleeding criteria: A prospective study of evaluation for the Bleeding Academic Research Consortium definition of bleeding in patients undergoing percutaneous coronary intervention

ObjectivesThe aim of this study was to evaluate the clinical utility of the new bleeding criteria, proposed by the Bleeding Academic Research Consortium (BARC), compared with the old criteria for determining the action of physicians in contact with bleeding events, after percutaneous coronary intervention (PCI). BackgroundThe BARC criteria were independently associated with an increased risk of 1-year mortality after PCI, and provided a predictive value, in regard to 1-year mortality. The standardized bleeding definitions will be expected to help the physician to correctly analyze the bleeding events, to select an optimal treatment, and to objectively compare the results of multiple trials and registries. MethodsAll the patients undergoing PCI from June to September 2012 were prospectively enrolled. Patients who experienced a bleeding event were further classified, based on three different bleeding severity criteria: BARC, Thrombolysis In Myocardial Infarction (TIMI), and Global Use of Strategies To Open coronary arteries (GUSTO). The primary outcome was the occurrence of bleeding events requiring interruption of antiplatelet therapy (IAT) by physicians. ResultsA total of 376 consecutive patients were included in this study. Total bleeding events occurred in 46 patients (12.2%). BARC type ≥2 bleeding occurred in 30 patients (8.0%); however, TIMI major or minor bleeding, and GUSTO moderate or severe bleeding occurred in 6 (1.6%) and 11 patients (2.9%), respectively. Of the 46 patients, 28 (60.9% of patients) required IAT. On receiver-operating characteristic curve analysis, bleeding defined BARC type ≥2 effectively predicted IAT, with a sensitivity of 89.3%, and a specificity of 98.5% (p<0.001), compared with TIMI (sensitivity, 21.4%; specificity, 100%; p<0.001), and GUSTO (sensitivity, 39.3%; specificity, 100%; p<0.001). ConclusionsCompared with TIMI and GUSTO, the BARC definition may be a more useful tool for the detection of bleeding with clinical relevance, for patients undergoing PCI.

Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial

Bivalirudin, with selective use of glycoprotein (GP) IIb/IIIa inhibitor agents, is an accepted standard of care in primary percutaneous coronary intervention (PPCI). We aimed to compare antithrombotic therapy with bivalirudin or unfractionated heparin during this procedure. In our open-label, randomised controlled trial, we enrolled consecutive adults scheduled for angiography in the context of a PPCI presentation at Liverpool Heart and Chest Hospital (Liverpool, UK) with a strategy of delayed consent. Before angiography, we randomly allocated patients (1:1; stratified by age [<75 years vs ≥75 years] and presence of cardiogenic shock [yes vs no]) to heparin (70 U/kg) or bivalirudin (bolus 0·75 mg/kg; infusion 1·75 mg/kg per h). Patients were followed up for 28 days. The primary efficacy outcome was a composite of all-cause mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularisation. The primary safety outcome was incidence of major bleeding (type 3-5 as per Bleeding Academic Research Consortium definitions). This study is registered with ClinicalTrials.gov, number NCT01519518. Between Feb 7, 2012, and Nov 20, 2013, 1829 of 1917 patients undergoing emergency angiography at our centre (representing 97% of trial-naive presentations) were randomly allocated treatment, with 1812 included in the final analyses. 751 (83%) of 905 patients in the bivalirudin group and 740 (82%) of 907 patients in the heparin group had a percutaneous coronary intervention. The rate of GP IIb/IIIa inhibitor use was much the same between groups (122 patients [13%] in the bivalirudin group and 140 patients [15%] in the heparin group). The primary efficacy outcome occurred in 79 (8·7%) of 905 patients in the bivalirudin group and 52 (5·7%) of 907 patients in the heparin group (absolute risk difference 3·0%; relative risk [RR] 1·52, 95% CI 1·09-2·13, p=0·01). The primary safety outcome occurred in 32 (3·5%) of 905 patients in the bivalirudin group and 28 (3·1%) of 907 patients in the heparin group (0·4%; 1·15, 0·70-1·89, p=0·59). Compared with bivalirudin, heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI, with no increase in bleeding complications. Systematic use of heparin rather than bivalirudin would reduce drug costs substantially. Liverpool Heart and Chest Hospital, UK National Institute of Health Research, The Medicines Company, AstraZeneca, The Bentley Drivers Club (UK).

66 Comparison Between Transradial and Femoral Approach for Rotational Atherectomy in Contemporary Practice- A Large Single Centre Experience

IntroductionTransradial access is often avoided for rotablation atherectomy (RA) because of concern over limitations of guiding catheter (GC) size. Radial operators have used sheathless GC to overcome this. However, coronary...

Red Cell Distribution Width and Additive Risk Prediction for Major Bleeding in Non–ST-segment Elevation Acute Coronary Syndrome

Introduction and objectivesRed cell distribution width has been linked to an increased risk for in-hospital bleeding in patients with non–ST-segment elevation acute coronary syndrome. However, its usefulness for predicting bleeding complications beyond the hospitalization period remains unknown. Our aim was to evaluate the complementary value of red cell distribution width and the CRUSADE scale to predict long-term bleeding risk in these patients. MethodsRed cell distribution width was measured at admission in 293 patients with non–ST-segment elevation acute coronary syndrome. All patients were clinically followed up and major bleeding events were recorded (defined according to Bleeding Academic Research Consortium Definition criteria). ResultsDuring a follow-up of 782 days [interquartile range, 510-1112 days], events occurred in 30 (10.2%) patients. Quartile analyses showed an abrupt increase in major bleedings at the fourth red cell distribution width quartile (> 14.9%; P=.001). After multivariate adjustment, red cell distribution width >14.9% was associated with higher risk of events (hazard ratio=2.67; 95% confidence interval, 1.17-6.10; P=.02). Patients with values≤14.9% and a CRUSADE score≤40 had the lowest events rate, while patients with values >14.9% and a CRUSADE score >40 points (high and very high risk) had the highest rate of bleeding (log rank test, P<.001). Further, the addition of red cell distribution width to the CRUSADE score for the prediction of major bleeding had a significant integrated discrimination improvement of 5.2% (P<.001) and a net reclassification improvement of 10% (P=.001). ConclusionsIn non–ST-segment elevation acute coronary syndrome patients, elevated red cell distribution width is predictive of increased major bleeding risk and provides additional information to the CRUSADE scale.

Ancho de distribución eritrocitaria y predicción adicional del riesgo de hemorragia mayor en el síndrome coronario agudo sin elevación del ST

Introduction and objectivesRed cell distribution width has been linked to an increased risk for in-hospital bleeding in patients with non–ST-segment elevation acute coronary syndrome. However, its usefulness for predicting bleeding complications beyond the hospitalization period remains unknown. Our aim was to evaluate the complementary value of red cell distribution width and the CRUSADE scale to predict long-term bleeding risk in these patients. MethodsRed cell distribution width was measured at admission in 293 patients with non–ST-segment elevation acute coronary syndrome. All patients were clinically followed up and major bleeding events were recorded (defined according to Bleeding Academic Research Consortium Definition criteria). ResultsDuring a follow-up of 782 days [interquartile range, 510-1112 days], events occurred in 30 (10.2%) patients. Quartile analyses showed an abrupt increase in major bleedings at the fourth red cell distribution width quartile (> 14.9%; P=.001). After multivariate adjustment, red cell distribution width >14.9% was associated with higher risk of events (hazard ratio = 2.67; 95% confidence interval, 1.17-6.10; P=.02). Patients with values≤14.9% and a CRUSADE score≤40 had the lowest events rate, while patients with values >14.9% and a CRUSADE score >40 points (high and very high risk) had the highest rate of bleeding (log rank test, P<.001). Further, the addition of red cell distribution width to the CRUSADE score for the prediction of major bleeding had a significant integrated discrimination improvement of 5.2% (P<.001) and a net reclassification improvement of 10% (P=.001). ConclusionsIn non–ST-segment elevation acute coronary syndrome patients, elevated red cell distribution width is predictive of increased major bleeding risk and provides additional information to the CRUSADE scale.Full English text available from: www.revespcardiol.org/en

Dual Antiplatelet Therapy Over 6 Months Increases the Risk of Bleeding after Biodegradable Polymer‐Coated Sirolimus Eluting Stents Implantation: Insights from the CREATE Study

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains controversial. The primary aim of our study was to evaluate the impact of optimal DAPT duration on bleeding events between 6 and 12 months after biodegradable polymer-coated DES implantation. The secondary aim is to determine the predictors and prognostic implications of bleeding.MethodsThis study is a post hoc analysis of the Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents (CREATE) study population. A total of 2,040 patients surviving at 6 months were studied, including 1,639 (80.3%) who had received 6-month DAPT and 401 (19.7%) who had received DAPT greater than 6 months. Bleeding events were defined according to the bleeding academic research consortium (BARC) definitions as described previously and were classified as major/minor (BARC 2–5) and minimal (BARC 1). A left censored method with a landmark at 6 months was used to determine the incidence, predictors, and impact of bleeding on clinical prognosis between 6 and 12 months.ResultsAt 1-year follow-up, patients who received prolonged DAPT longer than 6 months had a significantly higher incidence of overall (3.0% vs. 5.5%, P = 0.021) and major/minor bleeding (1.1% vs. 2.5%, P = 0.050) compared to the patients who received 6-month DAPT. Multivariate analysis showed that being elderly (OR = 1.882, 95% CI: 1.109–3.193, P = 0.019), having diabetes (OR = 1.735, 95% CI: 1.020–2.952, P = 0.042), having a history of coronary artery disease (OR = 2.163, 95% CI: 1.097–4.266, P = 0.026), and duration of DAPT longer than 6 months (OR = 1.814, 95% CI: 1.064–3.091, P = 0.029) were independent predictors of bleeding. Patients with bleeding events had a significantly higher incidence of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis.ConclusionsProlonged DAPT (greater than 6 months) after biodegradable polymer-coated DES increases the risk of bleeding, and is associated with adverse cardiac events at 1-year follow-up.

Sex‐Based Differences in Outcomes After Percutaneous Coronary Intervention for Acute Myocardial Infarction: A Report From TRANSLATE‐ACS

BackgroundData regarding sex‐based outcomes after percutaneous coronary intervention (PCI) for myocardial infarction are mixed. We sought to examine whether sex differences in outcomes exist in contemporary practice.Methods and ResultsWe examined acute myocardial infarction patients undergoing PCI between April 2010 and October 2012 at 210 US hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE‐ACS) observational study. Outcomes included 1‐year risk of major adverse cardiac events and bleeding according to Global Utilization of Strategies To Open Occluded Arteries (GUSTO) and Bleeding Academic Research Consortium (BARC) definitions. Among 6218 patients, 27.5% (n=1712) were female. Compared with men, women were older, had more comorbidities, and had lower functional status. Use of multivessel PCI and drug‐eluting stents was similar between sexes, while women received less prasugrel. Unadjusted cumulative incidence of 1‐year major adverse cardiac events was higher for women than for men (15.7% versus 13.6%, P=0.02), but female sex was no longer associated with higher incidence of major adverse cardiac events after multivariable adjustment (hazard ratio 0.98, 95% CI 0.83 to 1.15). Female sex was associated with higher risks of post‐PCI GUSTO bleeding (9.1% versus 5.7%, P<0.0001) and postdischarge BARC bleeding (39.6% versus 27.9%, P<0.0001). Differences persisted after adjustment (GUSTO: hazard ratio 1.32, 95% CI 1.06 to 1.64; BARC: incidence rate ratio 1.42, 95% CI 1.27 to 1.56).ConclusionsFemale and male myocardial infarction patients undergoing PCI differ regarding demographic, clinical, and treatment profiles. These differences appear to explain the higher observed major adverse cardiac event rate but not higher adjusted bleeding risk for women versus men.

917

Introduction: Oral antithrombotic agents are used to treat thromboembolic conditions and prevent thromboembolism secondary to atrial fibrillation and orthopedic surgery. The incidence of bleeding secondary to oral antithrombotic agents can only be inferred from well controlled clinical trials. The true frequency of oral antithrombotic bleeding is poorly defined. Methods: A retrospective review was performed of patients diagnosed with an adverse event related to an antithrombotic agent from January to December 2012. Patients were identified through discharge diagnosis coding reports provided by the health-system's Health Information Management department. Patients receiving antithrombotic agents and experiencing a bleeding event were included in the final sample. Data collected included demographics, antithrombotic used, concomitant therapy, site, bleed severity and management, disposition of the patient, and coagulation lab results. Data was analyzed to determine the incidence of anticoagulant-related bleeding, patient specific factors contributing to the event, and management of the bleed. Results: Of the 1,083 patients discharged with a diagnosis of an adverse drug event, 92 (8.5%) patients bled secondary to an antithrombotic agent; 84 (7.7%) of those patients received an oral antithrombotic. Using the Bleeding Academic Research Consortium Definition for Bleeding, 54 (64.3%) patients receiving an oral antithrombotic experienced a bleeding event. The average INR on admission was 4.17 (SD ± 3.19); 53 (98.1%) of the patients received warfarin prior to or during their inpatient stay. Concomitant antiplatelet therapy was identified in 29 (53.7%) patients. Conclusions: The rate of overall bleeding secondary to oral antithrombotic use was higher in our study population than what is currently reported in the literature. The bleeding rate may be even higher as we only included patients with diagnosis codes for adverse events related to an antithrombotic agent and not those discharged with a diagnosis of a specific bleeding event.

Bleeding outcomes in patients given clopidogrel within 5 days of robotic coronary artery bypass graft procedure.

Current guidelines recommend that clopidogrel should be held for 5 days prior to coronary artery bypass graft (CABG) procedure. However, it is unknown if this recommendation should apply to robotic-assisted (rCABG), which is less invasive because it does not involve sternotomy and thus reduces the risk of bleeding. To compare postoperative bleeding for rCABG patients who were taking clopidogrel within 5 days of the procedure with those who were not taking clopidogrel. This was a retrospective cohort study conducted between January 1, 2012 and December 31, 2012 of consecutive patients undergoing rCABG. Patients were categorized into 2 groups based on whether or not clopidogrel was administered within 5 days prior to the date of surgery. The primary outcome measure was the occurrence of the Bleeding Academic Research Consortium (BARC) definition for CABG-related bleeding. The secondary outcome measure was a comparison of chest tube output during the first 24-hour postoperative period. A total of 136 rCABG patients were included in the final analyses. Of these, 39 (29%) received clopidogrel within 5 days of surgery. CABG-related bleeding using the BARC definition occurred in 26% of patients who received clopidogrel and 8% of patients who did not (P = .011). Median chest tube output during the first 24-hour postoperative period was also greater in patients who received clopidogrel (900 vs 735 mL, P = .002). The use of clopidogrel within 5 days of rCABG is associated with greater postoperative bleeding and chest tube output, as defined by the BARC criteria.

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COMPARISON OF CLINICAL UTILITY BETWEEN NEW AND OLD BLEEDING CRITERIA : A PROSPECTIVE STUDY OF EVALUATION FOR THE BLEEDING ACADEMIC RESEARCH CONSORTIUM DEFINITION OF BLEEDING IN PATIENTS WITH UNDERGOING PERCUTANEOUS INTERVENTION

The Bleeding Academic Research Consortium (BARC) definition of bleeding was suggested to be a predictive value in regard to 1-year mortality that is comparable to that provided by traditional bleeding definitions. We evaluated for clinical utility of the new bleeding criteria, proposed by BARC,

Simple Risk Algorithm to Predict Serious Bleeding in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Bleeding is a potentially catastrophic complication after primary percutaneous coronary intervention (PPCI). It occurs most frequently within the first 30 days following the intervention. The aim of this study was to generate a simple and accurate risk model for the prediction of bleeding after PPCI. The training set included 2,096 patients enrolled in the RISK-PCI trial. The model was validated using a database of 961 patients enrolled in the ART-PCI trial. Bleeding was defined as type ≥3a bleeding according to the Bleeding Academic Research Consortium definition. Multivariate logistic regression was used to evaluate the predictors of outcome. A sum of weighted points for specific predictors was calculated to determine the final score. The model included 5 independent predictors of 30-day bleeding: gender (female); history of peptic ulcer; creatinine clearance at admission (<60 ml/min); hemoglobin at presentation (<125 g/dl); and Killip class >1 heart failure at admission. The model showed good discrimination and calibration for the prediction of bleeding in the derivation set (C-statistic, 0.79; goodness of fit, P=0.12) and in the validation set (C-statistic, 0.76; goodness of fit, P=0.37). Patients were classified into 3 risk classes and the observed incidence of 30-day bleeding of 1.0%, 3.5% and 10.7% corresponded to the low-, intermediate- and high-risk classes, respectively. A simple risk model was developed that has a reasonably good capacity for the prediction of 30-day bleeding after PPCI.

Abstract 18402: Impact of the Use of Different Bleeding Scales on the Rate of 6-Month Bleeding After PCI: Results from the PARIS Registry

Background: Multiple definitions have been used to classify bleeding, which is an important safety metric in cardiovascular clinical studies. We investigated the impact of different scales on apparent 6-month bleeding rates in a real-world registry of patients on dual antiplatelet therapy following percutaneous coronary intervention (PCI). Methods: PARIS is an ongoing multicenter, multinational, observational study of 5033 patients examining the modes and clinical correlates of medication non-adherence. All bleeding events were independently adjudicated according to the TIMI (Thrombolysis in Myocardial Infarction), BARC (Bleeding Academic Research Consortium) and ACUITY Acute Catheterization and Urgent Intervention Triage Strategy) bleeding classification schemes. In this analysis, we compared the bleeding rates using these bleeding scales. BARC &lt;3 bleeding was considered minor; BARC ≥3 bleeding was considered major. Results: The overall incidence of minor and major bleeding at 6 months using the ACUITY classification scheme was 4.71% (n=237).; overall bleeding rates defined by the TIMI, and BARC scales were 1.21% and 4.67%, respectively (Figure). Rates of minor bleeding were 0.5%, 3.28%, and 3.18% using the TMI, BARC and ACUITY definitions; rates of major bleeding were 0.74%, 1.49% and 1.65%, respectively. Agreement between the ACUITY and BARC definitions yielded a high level of correlation (kappa 0.86, p&lt; 0.001). TIMI bleeding, rates were excluded from this analysis do the low number of TIMI bleeds. Conclusions: In this real-world contemporary PCI registry, the overall incidence of any, major and minor bleeding at 6 months varied substantially between different classification schemes. These findings highlight the importance of bleeding definition selection and emphasize the problem of cross trial comparison when different definitions of bleeding are used.