Abstract 19660: Scoring System to Predict Major Bleeding Complications in Atrial Fibrillation Patients With Oral Anticoagulant After Drug-eluting Stent Implantation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Norihiro Kobayashi ◽  
Yoshiaki Ito ◽  
Keisuke Hirano ◽  
Masahiro Yamawaki ◽  
Motoharu Araki ◽  
...  

Background: We aimed to introduce scoring system to predict major bleeding complications after triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) and drug-eluting stent (DES) implantation. Methods: Between April 2007 and December 2011, 119 patients with AF and DES implantation were enrolled in this study. All of these patients received oral anticoagulant therapy and dual antiplatelet therapy (DAPT). We investigated the incidence of major bleeding complications including intracranial and gastrointestinal bleeding. Each variables which seem to be associated with major bleeding complications were analyzed using the univariate logistic regression model. All variables tested in univariate analysis with p<0.10 were included in multivariate logistic regression model. The scores for each variables were transformed from regression coefficients and computed in a total score. Results: The mean follow-up period was 43.6 ± 25.5 month. The incidence of major bleeding was 17.6%. In multivariate analysis, age > 75 (OR 3.67, 95%CI 1.01-13.3, p = 0.048), continuation of DAPT (OR 7.85, 95%CI 1.50-41.2, p = 0.015), INR > 2.2 (OR 9.19, 95%CI 2.65-31.9, p < 0.001) were predictors of major bleeding complications. Each item’s score ranged from 0 to 2 and the total score ranged from 0 to 5. The area under the receiver operating characteristics curve revealed that there was 82.8% accuracy in the total scores predicting the likelihood of major bleeding complications. The rate of major bleeding complications was 2.3% in low-risk group (scores 0-1), 20.0% in moderate-risk group (scores 2-3), and 53.3% in high-risk group (scores 4-5) (p<0.001). Conclusions: This scoring system is useful for the risk stratification of major bleeding complications in AF patients with TAT after DES implantation.

2020 ◽  
Vol 26 (44) ◽  
pp. 5739-5745
Author(s):  
Jieqiong Guan ◽  
Wenjing Song ◽  
Pan He ◽  
Siyu Fan ◽  
Hong Zhi ◽  
...  

Objective: The aim was to evaluate the efficacy and safety of duration of dual antiplatelet therapy (DAPT) for patients who received percutaneous coronary intervention (PCI) with a drug-eluting stent. Background: The optimal duration of DAPT to balance the risk of ischemia and bleeding in CAD patients undergoing drug-eluting stent (DES) implantation remains controversial. Methods: PubMed, Cochrane Library, Web of Science, Clinicaltrials.gov, CNKI and Wanfang Databases were searched for randomized controlled trials of comparing different durations of DAPT after DES implantation. Primary outcomes were major adverse cardiac and cerebrovascular events (MACCE), and major bleeding, and were pooled by Bayes network meta-analysis. Net adverse clinical and cerebral events were used to estimate the surface under the cumulative ranking (SUCRA) curves. The subgroup analysis based on clinical status, follow-up and area was conducted using traditional pairwise meta-analysis. Results: A total of nineteen trials (n=51,035) were included, involving six duration strategies. The network metaanalysis showed that T2 (<6-month DAPT followed by aspirin, HR:1.51, 95%CI:1.02-2.22), T3 (standard 6-month DAPT, HR:1.47, 95%CI:1.14-1.91), T4 (standard 12-month DAPT, HR:1.41, 95%CI:1.15-1.75) and T5 (18-24 months DAPT, HR:1.47, 95%CI:1.09-1.97) was associated with significantly increased risk of MACCE compared to T6 (>24-month DAPT). However, no significant difference was found in MACCE risk between T1 (<6-month DAPT followed by P2Y12 monotherapy) and T6. Moreover, T5 was associated with significantly increased risk of bleeding compared to T1(RR:3.94, 95%CI:1.66-10.60), T2(RR:3.65, 95%CI:1.32-9.97), T3(RR:1.93, 95%CI:1.21-3.50) and T4(RR:1.89, 95%CI:1.15-3.30). The cumulative probabilities showed that T6(85.0%), T1(78.3%) and T4(44.5%) were the most efficacious treatment compared to the other durations. In the ACS (<50%) subgroup, T1 was observed to significantly reduce the risk of major bleeding compared to T4, but not in the ACS (≥50%) subgroup. Conclusions: Compared with other durations, short DAPT followed by P2Y12 inhibitor monotherapy showed non-inferiority, with a lower risk of bleeding and not associated with an increased MACCE. In addition, the risk of major bleeding increased significantly, starting with DAPT for 18-month. Compared with the short-term treatment, patients with ACS with the standard 12-month treatment have a better prognosis, including lower bleeding rate and the decreased risk of MACCE. Due to study's limitations, the results should be verified in different risk populations.


2021 ◽  
Vol 14 ◽  
pp. 175628482199735
Author(s):  
Steven Deitelzweig ◽  
Allison Keshishian ◽  
Amiee Kang ◽  
Amol D. Dhamane ◽  
Xuemei Luo ◽  
...  

Background: Gastrointestinal (GI) bleeding is the most common type of major bleeding associated with oral anticoagulant (OAC) treatment. Patients with major bleeding are at an increased risk of a stroke if an OAC is not reinitiated. Methods: Non-valvular atrial fibrillation (NVAF) patients initiating OACs were identified from the Centers for Medicare and Medicaid Services ( CMS) Medicare data and four US commercial claims databases. Patients who had a major GI bleeding event (hospitalization with primary diagnosis of GI bleeding) while on an OAC were selected. A control cohort of patients without a major GI bleed during OAC treatment was matched to major GI bleeding patients using propensity scores. Stroke/systemic embolism (SE), major bleeding, and mortality (in the CMS population) were examined using Cox proportional hazards models with robust sandwich estimates. Results: A total of 15,888 patients with major GI bleeding and 833,052 patients without major GI bleeding were included in the study. Within 90 days of the major GI bleed, 58% of patients discontinued the initial OAC treatment. Patients with a major GI bleed had a higher risk of stroke/SE [hazard ratio (HR): 1.57, 95% confidence interval (CI): 1.42–1.74], major bleeding (HR: 2.79, 95% CI: 2.64–2.95), and all-cause mortality (HR: 1.29, 95% CI: 1.23–1.36) than patients without a major GI bleed. Conclusion: Patients with a major GI bleed on OAC had a high rate of OAC discontinuation and significantly higher risk of stroke/SE, major bleeding, and mortality after hospital discharge than those without. Effective management strategies are needed for patients with risk factors for major GI bleeding.


2014 ◽  
Vol 112 (08) ◽  
pp. 276-286 ◽  
Author(s):  
Carlos Martinez ◽  
Anja Katholing ◽  
Saul Freedman

SummaryIt was the aim of this study to determine prognosis of incidentally detected ambulatory atrial fibrillation (IA-AF) and its response to antithrombotic therapy. We performed a cohort study of 5,555 patients with IA-AF (mean age 70.9 ± 10.1, 38.4% female) and 24,705 age- and gender-matched controls without AF followed three years using UK Clinical Practice Research Datalink. We measured incidence rates of stroke, all-cause mortality, myocardial infarction, major bleeding, and effect of antithrombotic therapy. Patients with IA-AF had mean CHA2DS2VASc score 2.5 ± 1.5, 73% with score ≥2. The stroke incidence rate (IR) was 19.4 (95% confidence interval 17.1 – 21.9)/1,000 person-years vs 8.4 (7.7 – 9.1) in controls (p<0.001), mortality 40.1 (36.8 – 43.6)/1,000 person-years vs 20.9 (19.8 – 22.0) in controls (p<0.001), and myocardial infarction 9.0 (7.5 – 10.8)/1,000 person-years vs 6.5 (5.9 – 7.2) in controls (p<0.001). IRs of all endpoints increased with age. Oral anticoagulant ± antiplatelet therapy received by 51.0% in year following IA-AF was associated with adjusted hazard ratio (HR) of 0.35 (0.17 – 0.71) for stroke, and 0.56 (0.36 – 0.85) for death compared to no therapy, while antiplatelet treatment was associated with a non-significant reduction of HR: 0.81 (0.51 – 1.29) for stroke, and 0.80 (0.55 – 1.15) for death, though both carried a similar small non-significant adjusted excess IR of major bleeding. In conclusion, asymptomatic AF detected incidentally is associated with a significant adverse effect on stroke and death, with reduction in both associated with oral anticoagulant but not antiplatelet treatment. This provides justification to assess cost-effectiveness of community screening to detect unknown AF.


Author(s):  
David R Walker ◽  
Jasmina Ivanova ◽  
Keith A Betts ◽  
Sapna Rao ◽  
Eric Q Wu

Background and Objective: Dabigatran etexilate (DE) and warfarin, both oral anticoagulants used for stroke risk reduction in patients with non-valvular atrial fibrillation (NVAF), have been or are being compared in several comparative effectiveness studies. Understanding patient characteristics of those prescribed DE vs. warfarin are important for interpreting such studies. The objective of this study is to identify the characteristics that differentiate NVAF patients prescribed DE versus warfarin as first-line anticoagulation. Methods: An online survey was administered in October 2012 to an established panel of cardiologists and primary care physicians (PCPs) in the US. Physicians were asked to identify medical charts of their patients diagnosed with NVAF and who had at least one prescription for DE or warfarin between 1/1/2011 and 6/30/2012. Patients were further required to be anticoagulant naïve prior to the first prescription of DE or warfarin. A computer generated random dice was applied to direct the random selection of the patients. Patient characteristics, comorbidities and clinical risk measures were compared between DE and warfarin patients using Chi-square tests for categorical variables and t-tests for continuous variables. A logistic regression model was utilized to evaluate patient characteristics associated with DE vs. warfarin use among anticoagulant naïve NVAF patients. Results: A total of 288 physicians (144 cardiologists and 144 PCPs) completed the survey. 262 medical records for DE patients and 247 for warfarin patients were randomly selected. The mean age of the DE and warfarin patients, respectively were 61.6 and 65.8 years (p < 0.01). The proportion of females was 20.6% and 41.7% in the DE and warfarin patients respectively (p<0.01). 86.3% of DE patients vs. 68.4% of warfarin patients were Caucasian (p<0.01). Other differences between DE and warfarin patients respectively included: previous myocardial infarction (3.8%, 9.3%; p<0.05), previous transient ischemic attack (8.4%, 16.2%; p <0.01), and CHA 2 DS 2 -VASc stroke risk score (2.21, 2.98; p<0.01). The logistic regression model found age (OR = 0.96; p=0.001), female gender (OR=0.46; p = 0.002), Hispanic/Latino (OR = 0.33; p=.007), Black (OR= 0.37; p = 0.006), and > 6 months and < 1 year for time from first NVAF diagnosis to first prescription date (OR = 0.38; p = 0.02) were associated with initiation of DE vs. warfarin. However, CHA 2 DS 2 -VASc was not found to be a significant predictor of anticoagulant prescription. Conclusions: Patients who are younger, male, Caucasian, and recently diagnosed with NVAF were significantly more likely to be initiated by their physician on DE vs. warfarin. These findings should be considered when doing comparative analyses of outcomes between patients on DE vs. warfarin.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19508-e19508
Author(s):  
Mohammad Ammad Ud Din ◽  
Samarthkumar Thakkar ◽  
Harsh P. Patel ◽  
Syed Ather Hussain ◽  
Aneeqa Zafar ◽  
...  

e19508 Background: With the increased use of novel agents like Bruton tyrosine kinase inhibitors (BTKi) for the treatment of chronic lymphocytic leukemia (CLL), the incidence of atrial fibrillation (AF) is on the rise in these patients. However, the excess burden added by AF to the morbidity and mortality of CLL patients is unclear. Methods: Using the appropriate ICD-9 and ICD-10 codes, the National Inpatient Sample (NIS) database was accessed to gather data of hospitalized CLL patients with AF from 2008 to 2019. Propensity-score matching (PSM) and logistic regression model were performed to control for baseline patient factors like age, sex, income, and the relevant co-morbidities to match 7265 CLL patient admissions with AF and 7265 CLL patient admissions without AF. The primary outcome was all-cause mortality (ACM), while secondary outcomes included stroke, acute heart failure (AHF), and total cost of hospital stay. Results: The mean age of the cohorts was 82 years. Females made up 44% of both groups. The AF group had similar prevalence of systemic hypertension (62.38% vs 62.10%; p= 0.73), diabetes mellitus (5.09% vs 5.43%; p= 0.35), congestive heart failure (5.57% vs 5.36%; p= 0.58), valvular heart disease (1.17% vs 1.44%; p= 0.14), and pulmonary hypertension (0.21% vs 0.14%; p= 0.31) compared to the group without AF. PSM revealed CLL patients with AF had a higher rate of ACM (6.06% vs 4.47%; p= <0.0001), AHF (7.50% vs 3.85%; p= <0.001), and stroke (3.09% vs 1.65%; p= <0.0001). Admission in the AF group also had a higher median total cost of hospital stay ($9097 vs $7646). A logistic regression model was done to adjust for confounders which revealed similar results for the AF group with increased adjusted odd’s ratio (aOR) of ACM (aOR:1.39, 95% confidence interval (CI): 1.19-1.61; p= <0.001), AHF (aOR: 2.16, 95% CI: 1.85-2.52; p= <0.001), and stroke (aOR:1.94, 95% CI: 1.54-2.44; P= <0.001) (Table). Conclusions: Our data suggest that hospitalized CLL patients with AF are at a significantly increased risk of all-cause mortality, AHF, and stroke. Several limitations like the inability to establish the temporal relationship between CLL and AF and the lack of data regarding medications of individual patients are important to keep in mind while interpreting the results.[Table: see text]


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Yoshitaka Ito ◽  
Kazuhiro Naito ◽  
Katsuhisa Waseda ◽  
Hiroaki Takashima ◽  
Akiyoshi Kurita ◽  
...  

Background: While anticoagulant therapy is standard management for atrial fibrillation (Af), dual antiplatelet therapy (DAPT) is needed after stent implantation for coronary artery disease. HAS-BLED score estimates risk of major bleeding for patients on anticoagulation to assess risk-benefit in Af care. However, it is little known about usefulness of HAS-BLED score in Af patient treated with coronary stents requiring DAPT or DAPT plus warfarin (triple therapy: TT). The aim of this study was to evaluate the role of HAS-BLED score on major bleeding in Af patients undergoing DAPT or TT. Methods: A total of 837 consecutive patients were received PCI in our hospital from Jan. 2007 to Dec. 2010, and 66 patients had Af or paroxysmal Af at the time of PCI. Clinical events including major bleeding (cerebral or gastrointestinal bleeding) were investigated up to 3 years. Patients were divided into 2 groups based on HAS-BLED score (High-risk group: HAS-BLED score≥4, n=19 and Low-risk group: HAS-BLED score<4, n=47). DAPT therapy was required for a minimum 12 months after stent implantation and warfarin was prescribed based on physicians’ discretion. Management/change of antiplatelet and anticoagulant therapy during follow-up periods were also up to physicians’ discretion. Results: Baseline characteristics were not different between High-risk and Low-risk group except for age. Overall incidence of major bleeding was observed in 8 cases (12.1%) at 3 years follow-up. Major bleeding event was significantly higher in High-risk group compared with Low-risk group (31.6% vs. 4.3%, p=0.002). However, management of DAPT and TT was not different between the 2 groups. Among component of HAS-BLED score, renal dysfunction and bleeding contributed with increased number of the score. Conclusion: High-risk group was more frequently observed major bleeding events compared with Low-risk group in patients with Af following DES implantation regardless of antiplatelet/anticoagulant therapy.


2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Hong Seok Lee

Background: Oral anticoagulants known as a novel oral anticoagulant have been used for the management of non -valvular atrial fibrillation. There was no enough study regarding the efficacy and safety of three major new oral anticoagulants. We assessed major three oral anticoagulants in terms of major bleeding complication and stroke prevention by meta-analyses studies comparing those drugs. Method: Relevant studies were identified through electronic literature searches of MEDLINE, EMBASE, Cochrane library, and clinicaltrials.gov (from inception to February 24, 2016). RevMan and ITC software were used for direct comparisons, respectively. Results: Apixaban (N=6020), versus dabigatran(N=12038), apixaban versus rivaroxaban(N=8503) and rivaroxaban versus dabigatran were analyzed directly. There was significantly higher major bleeding risks in apixaban compared to dabigatran (both 110mg and 150mg) after adjusting baseline bleeding risk (Relative risk 3.41, 95% confidence interval(2.61 to 4.47) in 110mg, (5.62, 4.83 to 6.54) in 150mg. Intracranial bleeding risk in apixaban was significantly higher than in dabigatran (10.5, 6.10 to18.01). However, apixaban had less GI bleeding risk compared to dabigatran (0.80 , 0.65 to 0.98) and also had less ischemic stroke risk (0.31,0.22 to 0.42). Rivaroxaban showed higher major bleeding risk than dabigatran 110mg (2.34 , 1.81 to 3.03), however, Rivaroxaban had less bleeding risk compared to dabigatran 150mg (0.41, 0.35 to 0.46). Dabigatran 110mg and 150mg had less GI bleeding risk compared to rivaroxaban (0.31 , 0.24 to 0.39) and (0.23,0.17 to 0.29) respectively. Ischemic stroke risk was also decreased in dabigatran110mg (0.46, 0.38 to 0.57). and 150mg (0.66 ,0.52 to 0.83). Conclusion: Observed oral anticoagulants were associated with various complications. Overall, apixaban had higher intracranial bleeding risk than dabigatran. The highest GI bleeding risk in rivaroxaban compared to apixaban and dabigatran. Ischemic stroke risk was the highest in dabigatran. In conclusion, we may use those oral anticoagulant based on risks rates, however, a larger study with longer follow-up is needed to corroborate findings.


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