scholarly journals Off-label-dosing of non-vitamin K-dependent oral antagonists in AF patients before and after stroke: results of the prospective multicenter Berlin Atrial Fibrillation Registry

2021 ◽  
Author(s):  
Serdar Tütüncü ◽  
Manuel Olma ◽  
Claudia Kunze ◽  
Joanna Dietzel ◽  
Johannes Schurig ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Hospital Discharge ◽  
Stroke Onset ◽  
Hospital Treatment ◽  
Clinical Trial Registration ◽  
Off Label ◽  
Before And After ◽  
Index Stroke ◽  
Label Dose ◽  
Post Hoc

Abstract Aims We aimed to analyze prevalence and predictors of NOAC off-label under-dosing in AF patients before and after the index stroke. Methods The post hoc analysis included 1080 patients of the investigator-initiated, multicenter prospective Berlin Atrial Fibrillation Registry, designed to analyze medical stroke prevention in AF patients after acute ischemic stroke. Results At stroke onset, an off-label daily dose was prescribed in 61 (25.5%) of 239 NOAC patients with known AF and CHA2DS2-VASc score ≥ 1, of which 52 (21.8%) patients were under-dosed. Under-dosing was associated with age ≥ 80 years in patients on rivaroxaban [OR 2.90, 95% CI 1.05–7.9, P = 0.04; n = 29] or apixaban [OR 3.24, 95% CI 1.04–10.1, P = 0.04; n = 22]. At hospital discharge after the index stroke, NOAC off-label dose on admission was continued in 30 (49.2%) of 61 patients. Overall, 79 (13.7%) of 708 patients prescribed a NOAC at hospital discharge received an off-label dose, of whom 75 (10.6%) patients were under-dosed. Rivaroxaban under-dosing at discharge was associated with age ≥ 80 years [OR 3.49, 95% CI 1.24–9.84, P = 0.02; n = 19]; apixaban under-dosing with body weight ≤ 60 kg [OR 0.06, 95% CI 0.01–0.47, P < 0.01; n = 56], CHA2DS2-VASc score [OR per point 1.47, 95% CI 1.08–2.00, P = 0.01], and HAS-BLED score [OR per point 1.91, 95% CI 1.28–2.84, P < 0.01]. Conclusion At stroke onset, off-label dosing was present in one out of four, and under-dosing in one out of five NOAC patients. Under-dosing of rivaroxaban or apixaban was related to old age. In-hospital treatment after stroke reduced off-label NOAC dosing, but one out of ten NOAC patients was under-dosed at discharge. Clinical trial registration NCT02306824.

scholarly journals Early versus late anticoagulation for ischaemic stroke associated with atrial fibrillation: multicentre cohort study

2018 ◽  
Vol 90 (3) ◽  
pp. 320-325 ◽  
Author(s):  
Duncan Wilson ◽  
Gareth Ambler ◽  
Gargi Banerjee ◽  
Clare Shakeshaft ◽  
Hannah Cohen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Ischaemic Stroke ◽  
Optimal Time ◽  
Composite Outcome ◽  
Clinical Trial Registration ◽  
Group 5 ◽  
Group 2 ◽  
Adjusted Logistic Regression ◽  
Post Hoc

Background and purposeThe optimal time to start oral anticoagulant (OAC) in patients with ischaemic stroke due to non-valvular atrial fibrillation (AF) is unknown. We reviewed OAC timing in relation to 90-day clinical outcomes as a post hoc analysis from a prospective multicentre observational study.MethodsWe included patients with data on time to initiation of OAC from CROMIS-2 (Clinical Relevence Of Microbleeds In Stroke-2), a prospective observational inception cohort study of 1490 patients with ischaemic stroke or transient ischaemic attack (TIA) and AF treated with OAC. The primary outcome was the composite outcome of TIA, stroke (ischaemic stroke or intracranial haemorrhage) or death within 90 days of the qualifying stroke or TIA. We performed adjusted logistic regression analyses to compare early (0–4 days) and later (≥5 days or never started) OAC initiation.ResultsWe included 1355 patients, mean age 76 (SD 10), 580 (43%) women. OAC was started early in 358 (26%) patients and later (or not at all) in 997 (74%) patients. The event rate within 90 days was 48/997 (5%) in the late-OAC group (2 intracranial haemorrhages, 18 ischaemic strokes or TIAs and 31 deaths (three deaths were as a result of new ischaemic strokes)) versus 7/358 (2%) in the early-OAC group (5 ischaemic strokes or TIAs and 2 deaths). In adjusted analyses, late OAC was not associated with the composite outcome (adjusted OR 1.17, 95% CI 0.48 to 2.84, p=0.736).ConclusionIn adjusted analyses, early OAC after acute ischaemic stroke or TIA associated with AF was not associated with a difference in the rate of the composite outcome of stroke, TIA or death at 90 days, compared with late OAC. However, despite adjustment for important baseline factors, patients selected for early OAC and late OAC might still have differed in important respects; evaluation of OAC timing in adequately powered randomised trials is required.Clinical trial registrationNCT02513316.

Effectiveness and Safety of Off-Label Dose-Reduced Direct Oral Anticoagulants in Atrial Fibrillation

2019 ◽  
Vol 132 (7) ◽  
pp. 847-855.e3 ◽  
Author(s):  
Ronen Arbel ◽  
Ruslan Sergienko ◽  
Ariel Hammerman ◽  
Sari Greenberg-Dotan ◽  
Erez Batat ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label ◽  
Label Dose

Abstract 13678: Validation of the Termination of Resuscitation Rules in Detroit

Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Adam D Chalek ◽  
Arqam Husain ◽  
Robert B Dunne
Keyword(s):  
Overall Survival ◽  
Cardiac Arrest ◽  
Hospital Discharge ◽  
Before And After ◽  
Traumatic Origin ◽  
Improved Performance ◽  
Patient Side ◽  
Post Hoc ◽  
Implementation Data ◽  
Hospital Cardiac Arrest

Introduction: 326,000 patients suffer from an out of hospital cardiac arrest (OHCA) each year. The Termination of Resuscitation (TOR) criteria, which recommends termination when the arrest is unwitnessed by EMS, no shocks are administered, and no ROSC occurs, guides physicians in determining the futility of continuing CPR and transporting patients to the hospital. We examined compliance with current BLS TOR rules as well as assessed an alternate set of rules, with the goal of retrospectively deriving improved TOR guidelines for OHCAs in Detroit. Methods: This is a retrospective study utilizing non-traumatic OHCA cases in Detroit from January 1, 2017 to December 31, 2019, which includes time before and after BLS TOR guidelines were officially implemented (June 1, 2018). Data is extracted from the Detroit Cardiac Arrest Registry (DCAR). Patients younger than 18 years of age and arrests of traumatic origin or those with no resuscitation attempted were excluded. Results: BLS TOR criteria was applied to the pre-TOR implementation data with resulting specificity of 79% (95% CI: 50.7-80.8) and PPV of 97.3% (95% CI: 95.5-98.6). Survival to hospital discharge when termination was recommended was projected at 2.9% (13/444). Overall transportation rate was 85% (559/656). Post-TOR implementation, specificity was 88.9% (95% CI: 78.6-99.1) and PPV was 99.1% (95% CI: 98.3-99.9). Survival to hospital discharge was 0.88% (4/453) with a 69% (451/650) overall transportation rate. Post-hoc addition of age or EMS time to patient side increased transportation rates to 81% (529/650) and 88% (571/650), respectively, and decreased false positive terminations to 0.84% (2/237) and 0% (0/148), respectively. Conclusion: Overall survival when TOR was recommended as well as futile transportation rates decreased since the implementation of the BLS TOR guidelines in Detroit. Addition of EMS time to patient side or patient age to the current TOR guidelines suggested improved performance. Although the additional criteria resulted in higher transportation rates, these factors may be useful for physicians to consider when deciding to transport patients who meet the current TOR criteria. However, further derivation and validation are needed to create optimal TOR guidelines.

scholarly journals Off-Label Underdosing or Overdosing of Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation: A Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Xiaojuan Wu ◽  
Linyan Hu ◽  
Jinjin Liu ◽  
Qiuping Gu
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Off Label ◽  
Label Dose

Background: Several studies have investigated the role of off-label non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). We aimed to compare the effectiveness and safety outcomes between off-label underdose or overdose vs. on-label dose of NOACs in AF patients.Methods: The PubMed database was systematically searched until August 2021. Observational cohorts were included if they compared the outcomes of off-label underdose or overdose with on-label dose of NOACs in AF patients. The risk ratios (RRs) and 95% confidence intervals (CIs) were pooled using a fixed-effects model (I2 ≤ 50%) or a random-effects model (I2 &gt; 50%).Results: A total of 15 observational studies were included. Compared with on-label dose of NOACs, off-label underdose of NOACs was associated with increased risks of stroke or systemic embolism (RR = 1.09, 95% CI 1.02–1.16), and all-cause death (RR = 1.29, 95% CI 1.10–1.52) but not ischemic stroke (RR = 1.34, 95% CI 0.76–2.36), myocardial infarction (RR = 1.08, 95% CI 0.92–1.28), major bleeding (RR = 0.97, 95% CI 0.89–1.05), intracranial hemorrhage (RR = 1.12, 95% CI 0.90–1.40), and gastrointestinal bleeding (RR = 0.96, 95% CI 0.85–1.07), whereas off-label overdose of NOACs was associated with increased risks of SSE (RR = 1.20, 95% CI 1.05–1.36), all-cause death (RR = 1.22, 95% CI 1.06–1.39), and major bleeding (RR = 1.33, 95% CI 1.16–1.52) but not gastrointestinal bleeding (RR = 1.18, 95% CI 0.99–1.42) and myocardial infarction (RR = 0.98, 95% CI 0.75–1.30).Conclusion: Compared with on-label dose of NOACs, off-label underdose was associated with increased risks of stroke or systemic embolism and all-cause death, whereas off-label overdose of NOACs was associated with increased risks of stroke or systemic embolism, all-cause death, and major bleeding.

scholarly journals Off-label Non-vitamin K Antagonist Oral Anticoagulants Does Not Decrease the Stroke Risk of Atrial Fibrillation Patients in East China

2021 ◽  
Author(s):  
Peng Zhou ◽  
Rongchen Liu ◽  
Yangjie Yu ◽  
Wei Chen ◽  
Yunzhi Ma ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Vitamin K Antagonist ◽  
East China ◽  
Once Daily ◽  
Off Label ◽  
Significant Difference ◽  
Label Dose

Abstract Background: For anticoagulation therapy of atrial fibrillation (AF) in east Asia, some off-label dose, so called “Asian Dose” of non-vitamin K antagonist oral anticoagulants (NOACs) was used concerning on the bleeding risks in these patients, such as low-dose rivaroxaban (10-15 mg once daily) or dabigatran (110-150 mg once daily). However, the efficacy of the off-label dose of NOACs remains controversial. Methods: We conducted a retrospective cohort study to compared the efficacy and safety among patients with AF in three groups: patients with the off-label dose of NOACs treatment (OFL group, dabigatran 110 mg once daily or rivaroxaban under 20 mg daily), patients with the standard dose of anti-coagulation therapy (SAG group, dabigatran 110 mg twice daily or rivaroxaban 20 mg once daily, or warfarin with international normalized ratio (INR) 2-3), and patients without non-coagulation treatment (NCG group) in east China. Results: A total of 296 patients were recruited in our study. Compared to patients in SAG group, patients in OFL group had higher risk in stroke and thromboembolism events (P=0.000). The risk of other events including major bleeding (P=0.597) was comparable in these two groups, while there was no significant difference in all-cause mortality, which were both dramatically lower than NAG group (0.52, P=0.000). Conclusions: Collectively, our results demonstrate that “Asian dose” of NOACs indeed can not bring much benefit for AF patients in east China.

Pattern of antithrombotic drugs in hospital treatment of atrial fibrillation

2018 ◽  
Vol 6 (1) ◽  
pp. 75-75
Author(s):  
A.V. Sokolov ◽  
I.G. Ryzhenkova ◽  
O.V. Reshetko
Keyword(s):  
Atrial Fibrillation ◽  
Hospital Treatment ◽  
Antithrombotic Drugs

Ventricular Rate During Atrial Fibrillation Before and After Slow-Pathway Ablation

Circulation ◽  
1996 ◽  
Vol 94 (5) ◽  
pp. 1023-1026 ◽  
Author(s):  
S. Adam Strickberger ◽  
Raul Weiss ◽  
Emile G. Daoud ◽  
Rajiva Goyal ◽  
Frank Bogun ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ventricular Rate ◽  
Slow Pathway ◽  
Slow Pathway Ablation ◽  
Before And After

scholarly journals Effect of mandibular complete dentures relining on occlusal force distribution using T-scan system

2021 ◽  
Vol 45 (1) ◽  
Author(s):  
Eman M. Ibraheem ◽  
Hisham S. ElGabry
Keyword(s):  
Trial Registration ◽  
Force Distribution ◽  
Complete Dentures ◽  
Clinical Trial Registration ◽  
Occlusal Force ◽  
Left Posterior ◽  
Before And After ◽  
Soft Denture Liner ◽  
Edentulous Patients ◽  
Posterior Area

Abstract Background This study aimed to evaluate the effect of mandibular complete dentures relining using soft relining material on the distribution of various occlusal forces using T-Scan system. Fifty completely edentulous patients having their conventional complete dentures earlier fabricated and utilized were selected for this study. Patients were controlled diabetics, characterized by having their residual alveolar ridges moderately developed and lined with firm mucoperiosteum. Mandibular complete dentures were relined with soft denture liner and T-Scan device was used for occlusal force distribution measurement prior to denture relining and three months thereafter the relinning procedure. Results Comparison between occlusal forces percentages before and after denture relining revealed that occlusal forces percentages was significantly lower after denture relining in anterior area, significantly higher after denture relining in right posterior area, where it was insignificantly higher after relining in left posterior area. Conclusions Our findings revealed that the use of soft denture liner for mandibular complete denture relining significantly improved the occlusal load distribution. Clinical trial registration Trial registration NCT, NCT04701970. Registered 23/11/2020—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04701970

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