scholarly journals Clinical factors associated with safety and efficacy in patients receiving direct oral anticoagulants for non-valvular atrial fibrillation

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Hiroshi Yamato ◽  
Koichiro Abe ◽  
Shun Osumi ◽  
Daisuke Yanagisawa ◽  
Shinya Kodashima ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Oral Anticoagulant Therapy ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Factors Associated ◽  
Cerebrovascular Events ◽  
Low Dose Aspirin ◽  
Positive Correlations

AbstractAlthough patients suffering from atrial fibrillation have increased worldwide, detailed information about factors associated with bleeding during direct oral anticoagulant therapy remains insufficient. We studied 1086 patients for whom direct oral anticoagulants were initiated for non-valvular atrial fibrillation between April 2011 and June 2017. Endpoints were clinically relevant bleeding or major adverse cardiac and cerebrovascular events until the end of December 2018. Incidences of bleeding and thrombosis were 4.5 per 100 person-years and 4.7 per 100 person-years, respectively. Most bleeding events represented gastrointestinal bleeding. Multivariate analysis revealed initiation of anticoagulants at ≥ 85 years old as significantly associated with bleeding, particularly gastrointestinal bleeding, but not major cardiac and cerebrovascular events. Other significant factors included chronic kidney disease, low-dose aspirin and nonsteroidal anti-inflammatory drugs. For gastrointestinal bleeding alone, histories of gastrointestinal bleeding and malignancy also showed positive correlations, in addition to the above-mentioned factors. Clinicians should pay greater attention to the risk of gastrointestinal bleeding when considering prescription of anticoagulants to patients ≥ 85 years old with atrial fibrillation.

scholarly journals Gastrointestinal Bleeding During Direct Oral Anticoagulants Therapy in Patients With Nonvalvular Atrial Fibrillation and Risk of Polypharmacy

2022 ◽  
Author(s):  
Taku Honda ◽  
Koichiro Abe ◽  
Minoru Oda ◽  
Fumito Harada ◽  
Kyohei Maruyama ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Significant Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Oral Medications ◽  
Cerebrovascular Events ◽  
Concomitant Medications ◽  
Inverse Probability Weighted

Abstract Although concomitant medications have been raised as a factor affecting hemorrhage during direct oral anticoagulants (DOACs) therapy, details remain unelucidated. This study was conducted to clarify the relationship between concomitant medications with possible pharmacokinetic interactions and number of concomitant medications, and bleeding and embolism in patients with nonvalvular atrial fibrillation on DOACs. The subjects were 1,010 patients prescribed DOACs between April 2011 and June 2018. The study investigated their course between the first prescription and December 2018, including the presence or absence of clinically relevant bleeding, gastrointestinal bleeding (GIB), and major cardiovascular and cerebrovascular events (MACCE). Impacts of medications were evaluated by the general linear model with inverse probability-weighted propensity score. The observation period was 2,272 patient-years. The rate of bleeding was 4.7%/year, GIB was 2.8%/year, and MACCE was 2.0%/year. Taking 10 or more oral medications concurrently was a significant risk for GIB (hazard ratio, 2.046 [1.188–3.526]; p = 0.010). Nonsteroidal anti-inflammatory drugs (NSAIDs) was the only significant risk for GIB. Clinicians should be aware of gastrointestinal bleeding when using DOACs with patients taking more than 10 medications and/or NSAIDs.

scholarly journals Clinical significances of prothrombin time-international normalized ratio and activated partial thromboplastin time in patients with atrial fibrillation treated with direct oral anticoagulants

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Randomized Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
International Normalized Ratio ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Factors Associated ◽  
Funding Sources

Abstract Background Although the measurements of PT-INR or aPTT were not performed for patients with atrial fibrillation (AF) taking direct oral anticoagulants (DOACs) in randomized trials, these tests were commonly used and familiar to clinical physicians. We aimed to test whether there is an association between PT-INR or aPTT ratio and risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding among AF patients taking rivaroxaban or dabigatran, respectively. Methods This multi-center cohort study included 3,192 AF patients taking rivaroxaban and 958 patients taking dabigatran for stroke prevention whose data about PT-INR and aPTT were available. Results For patients treated with rivaroxaban, a higher INR level was not associated with a higher risk of major bleeding compared to an INR level <1.1. The risk of IS/SE was lower for patients having an INR ≥1.5 compared to those with an INR <1.1 (aHR: 0.57; [95% CI: 0.37–0.87]; P=0.0088) (Figure). On-label dosing of rivaroxaban and use of digoxin were independent factors associated with an INR ≥1.5 after taking rivaroxaban. For patients taking dabigatran, a higher aPTT ratio was not associated with a higher risk of major bleeding. The risk of IS/SE was lower for patients having an aPTT ratio of 1.1–1.2 and 1.3–1.4 than those with an aPTT ratio <1.1. Conclusions In Asian AF patients, PT-INR or aPTT ratios were not associated with the occurrences of bleeding events for rivaroxaban or dabigatran. Patients taking rivaroxaban with an INR ≥1.5 were associated with a lower risk of IS/SE. Appropriate dosages of DOACs and the compliances of patients should be confirmed for patients taking rivaroxaban with an INR <1.5. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Treatment Patterns and Clinical Outcomes in Korean Cancer Patients With Venous Thromboembolism: A Retrospective Cohort Study

2021 ◽  
Vol 27 ◽  
pp. 107602962097957
Author(s):  
Soo-Mee Bang ◽  
Jin-Hyoung Kang ◽  
Min Hee Hong ◽  
Jin-Seok Ahn ◽  
So Yeon Oh ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Factors Associated ◽  
Vein Thrombosis ◽  
Medical Chart Review ◽  
Deep Vein

This study assessed epidemiologic data and clinical outcomes, including venous thromboembolism (VTE) recurrence and bleeding events, in patients with cancer-associated VTE, and assessed factors associated with clinical outcomes. Data were extracted from retrospective medical-chart review of adult patients diagnosed with cancer-associated deep vein thrombosis or pulmonary embolism who received anticoagulation treatment for ≥3 months. Patients were classified by: low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs), and other anticoagulants. First VTE recurrence and bleeding events, and factors associated with their occurrence, were assessed during the initial 6 months of treatment. Overall, 623 patients (age: 63.7 ± 11.3 years, 49.3% male) were included (119, 132, and 372 patients in LMWH, DOACs and other anticoagulants groups, respectively). The cumulative 6-month incidence of VTE recurrence was 16.6% (total), 8.3% (LMWH), 16.7% (DOACs), and 20.7% (other); respective bleeding events were 22.5%, 11.0%, 12.3%, and 30.7%). VTE recurrence and bleeding rates differed only between LMWH and other anticoagulants (HR 2.4, 95% CI: 1.2-5.0 and 3.6, 1.9-6.8, respectively). These results highlight the importance of initial VTE treatment choice for preventing VTE recurrence and bleeding events. LMWH or DOACs for ≥3 months can be considered for effective VTE management in cancer patients.

scholarly journals Evaluation of Direct Oral Anticoagulant Prescribing in Patients With Moderate to Severe Renal Impairment

2021 ◽  
Vol 27 ◽  
pp. 107602962098790
Author(s):  
Clara Ting ◽  
Megan Rhoten ◽  
Jillian Dempsey ◽  
Hunter Nichols ◽  
John Fanikos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Impairment ◽  
Severe Renal Impairment ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Increase Risk ◽  
Severe Chronic Kidney Disease ◽  
Dosing Strategies ◽  
Require Dose

Patients with renal impairment require dose adjustments for direct oral anticoagulants (DOACs), though there is uncertainty regarding their use in severe chronic kidney disease. Inappropriately dosed DOACs may increase risk of ischemic events when under-dosed, or risk of bleeding when over-dosed. The purpose of this study was to describe DOAC selection, dosing strategies, and associated clinical outcomes in patients with moderate to severe renal impairment at our institution. This was a single-center retrospective analysis of adult outpatients with moderate to severe renal impairment (estimated creatinine clearance <50 mL/min, including need for hemodialysis) who were prescribed a DOAC by a cardiologist between June 1, 2015 and December 1, 2018. Outcomes evaluated included the percentage of patients who received appropriate and inappropriate DOAC dosing, prescriber reasons for inappropriate DOAC dosing if documented, and incidence of thrombotic and bleeding events. A total of 207 patients were included. Overall, 61 (29.5%) patients received inappropriate dosing, with 43 (70.5%) being under-dosed and 18 (29.5%) being over-dosed as compared to FDA-labeled dosing recommendations for atrial fibrillation or venous thromboembolism (VTE). By a median follow-up duration of 20 months, stroke occurred in 6 (3.3%) patients receiving DOACs for atrial fibrillation, and VTE occurred in 1 (4.3%) patient receiving a DOAC for VTE. International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding occurred in 25 (12.1%) patients. Direct oral anticoagulants were frequently prescribed at off-label doses in patients with moderate to severe renal impairment, with a tendency toward under-dosing.

scholarly journals Anticoagulation Challenges in Hematogeriatrics: Effectiveness and Safety of Direct Oral Anticoagulants Vs Vitamin k Antagonist in Elderly with Atrial Fibrillation

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1162-1162
Author(s):  
Desirée Campoy ◽  
Gonzalo Artaza ◽  
César A Velasquez ◽  
Tania Canals ◽  
Erik A Johansson ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Vitamin K ◽  
Major Bleeding ◽  
Frail Elderly ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Bleeding Events

BACKGROUND Direct oral anticoagulants (DOAC) are increasingly used in patients with Non Valvular Atrial Fibrillation (NVAF) for stroke prevention. However, Follow-Up (FU) and dosing these agents in the elderly can be challenging due to different factors, such as chronic kidney disease, frailty, falls, multifactorial anemia and concomitant polypharmacy. These factors in elderly patients predisposes to both thromboembolic and bleeding events once atrial fibrillation occurs. Therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. Despite recent increases in DOAC use in NVAF, there are still limited data regarding DOACs effectiveness and safety in frail elderly patients. AIM To assess the effectiveness and safety according to DOAC or Vitamin K Antagonist (VKA) in a cohort of elderly patients with NVAF. METHODS From April 2016 to April 2019, we consecutively included NVAF elderly patients (≥80 years-old) treated with DOAC or VKA in a prospective multicenter registry. Demographic, laboratory, frailty risk stratification and antithrombotic therapy data were collected. Patients had a minimum FU of 6 months. VKA patients had a standard FU through digital international normalized ratio (INR) control and the efficacy of therapy was determined by the time in therapeutic range (TTR) values from the preceding 6 months of treatment using Rosendaal's method. FU in DOAC patients was performed through structured and integral assessment following the Tromboc@t Working Group recommendations for management in patients receiving DOAC (Olivera et al, Med Clin 2018). Key practical management aspects are listed in the flow chart (Figure 1). Clinical Frailty Scale (CFS score) was assigned to each patient at the beginning and during the FU; patients were classified into three categories: non-frail (CFS 1-4), mild-to-moderately frail (CFS 5-6), and severely frail (CFS 7-9). RESULTS From a total of 1040 NVAF patients, 690 (63.5%) were treated with DOAC (61 dabigatran, 95 rivaroxaban, 254 edoxaban and 280 apixaban) and 350 with VKA. In the VKA group, the mean TTR was 52.8%. Demographic characteristics and CFS score are summarized in table 1. Kaplan-Meier analysis (median FU: 16.5 months) showed a significantly high incidence of stroke/systemic embolism among VKA patients vs DOAC patients (4.2 vs 0.5 events per 100 patient-years, p<0.001). Major bleeding in the DOAC group was significantly infrequent compared with VKA group (2.2 vs 8.9 events, p=0.001). In the DOAC group, 90% (n=20/22) of the major bleedings were gastrointestinal [16 rivaroxaban and 4 edoxaban]. However, in the VKA group 64% (n = 20/31) were gastrointestinal, 25.8% (n= 8/31) intracranial and 9.7% (n = 3/31) urogenital bleedings. We identified 365 very elderly patients (aged ≥ 90 years) of which 270 (39.1%) were DOAC patients and 95 (27.1%) VKA patients. In this subgroup of patients, after a multivariate regression analysis, the stroke/systemic embolism incidence was similar in both treatment groups regardless of the age, but major bleeding decreased significantly in DOAC group (adjusted HR 0.247, 95% CI 0.091-0.664). CONCLUSIONS Our data indicate that DOACs can be a good therapeutic option for stroke/systemic embolism prevention in frail elderly patients, showing low rates of stroke as well as bleeding events when a structured and integral FU is applied to anticoagulated patients. Further investigations are necessary to analyze the impact in the quality of life and net clinical benefit of anticoagulant therapy when a FU program is applied in elderly patients. Disclosures Sierra: Novartis: Honoraria, Research Funding, Speakers Bureau; Astellas: Honoraria; Pfizer: Honoraria; Daiichi-Sankyo: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Roche: Honoraria; Jazz Pharmaceuticals: Honoraria.

scholarly journals Safety and timing of resuming dabigatran after major gastrointestinal bleeding reversed by idarucizumab

2018 ◽  
Vol 6 ◽  
pp. 2050313X1775333 ◽  
Author(s):  
Gian Galeazzo Riario Sforza ◽  
Francesco Gentile ◽  
Fabio Stock ◽  
Francesco Caggiano ◽  
Enrica Chiocca ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Case Report ◽  
Major Bleeding ◽  
Acute Treatment ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Oral Vitamin ◽  
Bleeding Events ◽  
Massive Rectal Bleeding

The recent introduction of direct oral anticoagulants, including rivaroxaban, dabigatran, apixaban, and edoxaban, for the acute treatment and secondary prevention of venous thromboembolism and in atrial fibrillation has been shown to provide greater clinical benefit than oral vitamin K antagonists. However, direct oral anticoagulants are associated with adverse events, the most common being major bleeding; such events require the reversal of the anticoagulant effects by specific agents. In this case report, we describe an 87-year-old female with atrial fibrillation treated with dabigatran who had massive rectal bleeding. Idarucizumab 5 g (2 × 2.5 g/50 mL) was successfully used to reverse dabigatran effect; subsequent to this, treatment with dabigatran was resumed, and there were no further bleeding events. This suggests that dabigatran can be safely restarted after major bleeding, but this outcome needs to be confirmed in studies involving larger groups of patients.

P1860Unfractionated heparin dose and complication rate in catheter ablation of atrial fibrillation, a comparison between uninterrupted therapy with phenprocoumon and direct oral anticoagulants

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Poci ◽  
D Gjermeni ◽  
V Kuehlkamp
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
Anticoagulation Management ◽  
Significant Difference ◽  
The Mean ◽  
Initial Bolus

Abstract Background Catheter ablation of atrial fibrillation is known for the combining risks of thromboembolism (TE) and major bleedings. This urges a better understanding and optimization of the intraprocedural anticoagulation management. Differences in unfractionated heparin (UFH) requirements and anticoagulation time (ACT) levels between patients on different uninterrupted oral anticoagulation (OAC) agents have been studied. However, the clinical relevance, in terms of periprocedural TE and bleeding events, of UFH administration according to ACT monitoring among patients on different OAC agents, needs to be addressed. Objective To evaluate how the ACT monitoring and differences in intraprocedural UFH requirements among different anticoagulant agents, may translate to clinical outcome, in terms of periprocedural incidence of thromboembolic and bleeding events. Methods We retrospectively studied 1571 cases who underwent catheter ablation for atrial fibrillation between January 2011 and May 2017. Cases were on an uninterrupted oral OAC therapy of Vitamin K Antagonists (VKA)(713), Rivaroxaban (RG)(385), Dabigatran (DG)(260), Apixaban (AG)(192) and Edoxaban (EG)(21). First ACT measurements after the initial bolus of UFH (1ehz748.0610U), mean ACT measurements, total UFH doses/kg (Body Weight)/min (duration of procedure) and incidence of major periprocedural events were compared among the above OAC groups. Results The mean ACT (sec) was significantly lower in the AG and greater in the VKA (313,7±47 vs 340,5±49, p<0,001). Significantly lower UFH doses (U/kg/min) were required to reach the target ACT in VKA compared to RG, DG, AG and EG (0,69±0,4 vs 1,41±0,76; 1,42±0,7; 1,63±0,8; 1,37±0,4 respectively, p<0,001) The proportion of patients who achieved a target ACT value within 30 minutes after the fixed first UFH Bolus of 10 000 U was significantly lower in DG and AG compared to VKA, EG and RG group (51,5% and 49% vs 53%, 71,4%, and 61,8% respectively p=0,005). The incidence of periprocedural TE events and bleedings showed no significant difference among OAC groups. However, the 22 patients with a periprocedural TE event had significantly lower UFH doses (U)/ Duration of catheter ablation (min) compared to the ones without periprocedural TE (62,71±44,5 vs 94,4±66,4, p=0,026), despite equivalent mean ACT values between these two groups. Patients with a periprocedural TE had also a significantly older Age (69,6±10 vs 64±10 p=0,01, higher CHADSVASC Score (3,64±1,76 vs 2,63±1,7 p=0,006), longer duration of procedure (188,9±79,1 vs 144,9±57 p=0,0001) and higher pre-Ablation INR values (2,2±0,6 vs 1,7±0,6 p=0,002). Conclusions The average UFH doses required to reach the target ACT were lower in VKA than in NOAC- groups. The incidence of periprocedural TE events and bleedings was equivalent among OAC groups. Patients with TE showed a lower UFH requirement compared to no-TE group, with both groups having mean ACT ≥300 sec.

P675Current status of anticoagulation in patients with breast cancer and atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Pardo Sanz ◽  
L M Rincon ◽  
P Guedes Ramallo ◽  
L Belarte ◽  
G De Lara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Atrial Fibrillation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Patients With Cancer ◽  
Oncologic Patients

Abstract Aims Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. We further evaluated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with cancer. Methods The AMBER-AF registry is an observational multicentre study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain. 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. Mean follow-up was 3.1 years. Results Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. Lack of guidelines recommended therapies was more frequent among patients with cancer. Compared with patients without cancer, adjusted rates of stroke (hazard ratio [95% confidence interval]) in cancer patients were higher (1.56 [1.04–2.35]), whereas bleeding rates remained similar (1.25 [0.95–1.64]). Within the group of patients with cancer, the use of DOACs vs VKAs did not entail differences in the adjusted rates of stroke (0.91 [0.42–1.99]) or severe bleedings (1.53 [0.93–2.53]). Follow-up events Conclusions Antithrombotic management of AF frequently differs in patients with breast cancer. While breast cancer is associated with a higher risk of incident stroke, bleeding events remained similar. Patients with cancer treated with DOACs experienced similar rates of stroke and bleeding as those with VKAs.

Efficacy and Safety of Direct Oral Anticoagulants in Extremes Weights

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 12-13
Author(s):  
Julie Huang ◽  
Jamie Chin ◽  
Alexander Hindenburg ◽  
Lilia Davenport ◽  
Debra Willner
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Flutter ◽  
Conflicts Of Interest ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Primary Endpoints ◽  
Design And Methods ◽  
Anticoagulated Patients

Background: The clinical use of Direct oral anticoagulants (DOACs), as opposed to warfarin, has become more prevalent in patients with extremes in body weight. However, both the International Society on Thrombosis and Haemostasis' (ISTH) and anti-thrombotic therapy guidelines state that DOACs should be avoided in patients with a body mass index (BMI) &gt;40 kg/m2, weight &gt;120 kg, or weight &lt; 50 kg. The purpose of this study was to analyze the efficacy and safety of DOACs in extremes of weight compared to patients treated with warfarin. Warfarin may be a safer and more effective oral anticoagulant for patients in extremes of weight, due to the availability of dosing based on INR. DOAC standard dosing may either overdose/underdose in patients with low/high BMI respectively. Study Design and Methods: A retrospective, single-institution study evaluated patients with extreme weights receiving a DOAC or warfarin for either venous thromboembolism (VTE) or atrial fibrillation/atrial flutter between October 2016 and October 2020. Inclusion criteria consisted of patients admitted to NYU Langone Hospitals continued on a DOAC or warfarin for VTE or atrial fibrillation/atrial flutter with BMI &lt; 18 kg/m2 or BMI &gt; 30 kg/m2. Patients newly initiated on oral anticoagulation or received anticoagulation other than atrial fibrillation/atrial flutter or VTE were excluded. Primary endpoints include incidence of VTE or bleeding events in anticoagulated patients who meet extreme weight criteria. Disclosures No relevant conflicts of interest to declare.

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