On Oral Anticoagulant Therapy Research Articles

Description of self-care behaviours in patients with non-valvular atrial fibrillation on oral anticoagulant therapy: A scoping review.

The primary aim of this scoping review was to explore and categorise the medication-related self-care behaviours exhibited by patients with non-valvular atrial fibrillation (NVAF) who are on oral anticoagulant (OAC) therapy. A scoping review was performed, and the systematic search of the literature yielded an initial 887 records. After deduplication and screening, 61 studies were included in the analysis, ranging from 2003 to 2023. The studies represented a wide geographical distribution and diverse methodologies. The results identified 16 self-care behaviours: a higher focus of the included literature on self-care monitoring (60.65% of studies), followed by self-care management and self-care maintenance (each 16.39%). These behaviours ranged from regular blood testing to consulting healthcare providers and lifestyle changes. The results also highlighted the relationship between treatment satisfaction, self-efficacy, and adherence. Several studies emphasised the critical role of healthcare providers in influencing medication adherence. Furthermore, patient knowledge, quality of life, and psychological factors were identified as key elements affecting self-care behaviours. The review provides a comprehensive landscape of medication-related self-care behaviors among NVAF patients on OAC therapy. It underscores the predominance of self-care monitoring behaviours and the critical roles of healthcare providers, psychological factors, and patient knowledge in influencing these behaviours. The findings also highlight the necessity for an integrated, patient-centred approach to improving self-care and self-management in OAC treatment. Future research should focus on addressing the identified gaps, including the relative lack of studies on lifestyle modification, emotional well-being, and technology-assisted interventions. This review is part of a broader project and is documented at ClinicalTrials.gov (NCT05820854).

In old anticoagulated patients with mild traumatic brain injury, a 24-h observation period should not be recommended without evidence of a clear benefit: a retrospective study of delayed hemorrhagic versus iatrogenic complications.

Mild traumatic brain injury (mTBI) is a common cause of admission to the Emergency Department (ED). Many patients are elderly on oral anticoagulant therapy (OAT) at increased risk of immediate and delayed intracranial hemorrhage (ICH). To investigate the frequency of delayed ICH (DICH) in old patients with mTBI in OAT and the occurrence of complications related to the ED stay. In this single-center retrospective study, we recruited all patients in OAT aged 65 and over, admitted for mTBI to the ED of our Hospital in Florence from March 2019 to February 2021. Clinical variables were collected and cranial computed tomography (CT) scans reviewed. The primary outcome was the frequency of DICH occurring within 30days since the trauma after a first negative CT. Secondary outcomes included need of neurosurgical intervention and death for DICH, and hospital-related complications. Statistical analyses were conducted using IBM SPSS Statistics (version 22). Among 363 enrolled patients, there were 31 acute ICH (8.5%) at the first CT scan, while in the 316 negative included patients, 10 DICH (3.2%) were identified. Among the latter, no neurosurgical treatment, or death due to ICH occurred. Overall, 25 cases (6.9%) had iatrogenic complications during the 24-h observation period, often serious, such as respiratory failure after sedation due to restlessness, or COVID-19 infection. The low frequency of DICH and the occurrence of several iatrogenic complications suggest that the risk-benefit ratio of a 24-h ED observation is not advantageous in elderly with mTBI.

High On-Treatment Platelet Reactivity: Aspirin versus Clopidogrel

Background: Antithrombotic regimen in patients on oral anticoagulation (OAC) post-percutaneous coronary intervention (PCI) is challenging. At least, one antiplatelet agent in combination with OAC is recommended after PCI for 6–12 months. Clopidogrel is used most frequently in this setting. However, data comparing P2Y12 inhibition with clopidogrel versus cyclooxygenase inhibition by acetylsalicylic acid (ASA, aspirin) is missing. It is well known that the antiplatelet effects of ASA and clopidogrel are frequently impaired (high on-treatment platelet reactivity [HTPR]). In this pilot investigation, we compared the antiplatelet effects of clopidogrel versus ASA. Methods: In this retrospective single-center database analysis, we investigated platelet reactivity by light transmission aggregometry in patients under different antiplatelet regimes. Results were presented as maximum of aggregation (MoA). HTPR to ASA and to clopidogrel were assessed. Results: 755 patients were enrolled. 677 were on ASA, 521 were on clopidogrel, and 198 had OAC. Overall mean age was 73 ± 13.4 years, and 458 (60.7%) were male. HTPR to ASA occurred in 94/677 patients (13.9%), and mean arachidonic acid-induced MoA was 14.15 ± 19.04%. HTPR to clopidogrel occurred in 241/521 patients (46.3%), and mean adenosine diphosphate-induced MoA was 50.06 ± 20.42%. HTPR to clopidogrel was significantly more frequent than HTPR to ASA; single antiplatelet therapy (SAPT)-mono ASA: 27/199 (13.6%) versus mono clopidogrel: 6/18 (33.3%); p = 0.037; SAPT with OAC-OAC with ASA: 8/35 (22.9%) versus OAC with clopidogrel: 27/60 (45%); p = 0.046. Same difference in HTPR contingency could be shown in subgroups of dual antiplatelet therapy and ASA + clopidogrel + OAC therapy. Conclusion: Impaired pharmacodynamic response to clopidogrel was more frequent as HTPR to ASA. Hence, ASA should be tested in combination with OAC post-PCI.

Some good reasons to proceed with the occlusion of the auricle.

Atrial fibrillation (AF) is the most common arrhythmia. The most fearful complication of AF is represented by cardio-embolic stroke and 30% of ischaemic strokes are attributable to AF. The prevention of cardio-embolic risk is therefore based on oral anticoagulant therapy (OAT). Some categories of patients do not benefit from OAT. These are patients at increased bleeding risk and with varying degrees of contraindication to long-term anticoagulant therapy. On the opposite are those patients who develop an embolic event related to AF despite a well-conducted OAT. These types of patients benefit from an interventional approach, percutaneous closure of the left auricle (LAAO), aimed at eliminating what is the primary source of AF-related thrombo-embolism, precisely the left auricle. Percutaneous closure of the left auricle has proven to be an effective and safe procedure, significantly reducing the bleeding risks of patients who, after the procedure, will no longer have to take OAT. Furthermore, it has been shown to be effective in reducing cardio-embolic risk. Uncertainty still remains as to what is the optimal antithrombotic therapy after LAAO. In any case, LAAO represents a valid alternative to OAT for those patients in whom it is contraindicated or ineffective.

Performance of the ABC-bleeding risk score for assessing major bleeding risk in Chinese patients with atrial fibrillation on oral anticoagulation therapy: A real-world study.

To evaluate performance of the ABC (Age, Biomarkers, Clinical history)-bleeding risk score in estimating major bleeding risk in Chinese patients with atrial fibrillation (AF) on oral anticoagulation (OAC) therapy in real-world practice. Data were collected from the Chinese Atrial Fibrillation Registry study (CAFR). Patients were stratified into low-, medium-, and high-risk groups based on ABC-bleeding risk score with 1-year major bleeding risk (<1%, 1-2%, and > 2%) and modified HAS-BLED score (≤1, 2, and > 2 points). Cox proportional-hazards (Cox-PH) models were used to determine the association of major bleeding incidence with bleeding scores. Harrell's C-index of the two scores were compared. Net reclassification improvement (NRI) and integrated discrimination improvement (IDI) at 1 year were employed to evaluate the reclassification capacity. The calibration curve was plotted to compare the predicted major bleeding risk using ABC-bleeding risk score with the observed annualized event rate. The decision analysis curves (DCA) were performed to show the clinical utilization of two scores in identifying major bleeding events. The study included 2,892 AF patients on OAC therapy. After the follow-up of 3.0 years, 48 patients had major bleeding events; the incidence of a bleeding event in the low-, medium-, and high-risk groups according to ABC-bleeding risk score was 0.31% (reference group, HR = 1.00),0.51% (HR = 1.83, 95%CI: 0.91-3.69, P = 0.09), and 1.49% (HR = 4.92, 95%CI: 2.34-10.30, P < 0.001), respectively. Major bleeding incidence had an independent association with growth differentiation factor 15 (GDF-15) level (HR = 2.16, 95%CI: 1.27-3.68, P = 0.005) after adjusting components of the HAS-BLED score and cTnT-hs level. The ABC-bleeding score showed a Harrell's C-index of 0.67 (95%CI: 0.60-0.75) in estimating major bleeding risk, which was non-significant compared to the modified HAS-BLED score (0.67 vs. 0.63; P = 0.38). NRI and IDI also revealed comparable reclassification capacity of ABC-bleeding risk score compared with HAS-BLED score (14.6%, 95%CI: -10.2%, 39.4%, P = 0.25; 0.2%, 95%CI -0.1 to 0.9%, P = 0.64). Cross-tabulation of the two scores showed that the ABC-bleeding score outperformed the HAS-BLED score in identifying patients with a high risk of major bleeding. The calibration curve showed that the ABC-bleeding risk score overestimated the observed major bleeding risk. DCA did not show any difference in net benefit when using either of the scores. This study verified the value of the ABC-bleeding risk score in assessing major bleeding risk in Chinese patients with AF on OAC therapy in real-world practice. Despite the overestimation of major bleeding risk, ABC-bleeding score performed better in stratifying patients with a high risk than the modified HAS-BLED score. Combining the two scores could be a clinically practical strategy for precisely stratifying AF patients, especially those at a high risk of major bleeding, and further supporting the optimization of OAC treatment.

Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice

BackgroundSafety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking. MethodsConsecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded. ResultsA total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) (n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient. ConclusionsIn the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence.

Direct-acting oral anticoagulants use prior to COVID-19 diagnosis and associations with 30-day clinical outcomes

BackgroundIt is unclear if direct-acting oral anticoagulants (DOACs) use before hospitalization due to COVID-19 diagnosis would potentially impact the severity and clinical outcomes thereafter. We compared 30-day hospitalization/re-hospitalization and clinical outcomes between patients on chronic DOAC therapy and patients not on oral anticoagulation (OAC) therapy at time of COVID-19 diagnosis. MethodsWe used data from TriNetX, a global federated health research network. Patients aged ≥18 years who were treated with DOACs at time of COVID-19 diagnosis between 20 January 2020 and 28 February 2021 were included, and matched with patients not on OAC therapy from the same period. All patients were followed-up at 30-days after COVID-19 diagnosis. The primary outcomes were all-cause mortality, hospitalization/re-hospitalization, venous thromboembolism (VTE) and intracranial hemorrhage (ICH). Results738,423 patients were included. After propensity score matching (PSM), 26,006 patients remained in the study (13,003 on DOACs; 13,003 not on OAC). DOAC-treated patients (mean age 67.1 ± 15.4 years, 52.2% male) had higher relative risks (RRs) and lower 30-days event-free survival as compared to patients not on OAC for all-cause mortality (RR 1.27, 95% CI 1.12–1.44; Log-Rank test p = 0.010), hospitalization/re-hospitalization (RR 1.72, 95% CI 1.64–1.82; Log-Rank test p < 0.001) and VTE (RR 4.51, 95% CI 3.91–5.82; Log-Rank test p < 0.001), but not for ICH (RR 0.90, 95% CI 0.54–1.51; Log-Rank test p = 0.513). ConclusionIn COVID-19 patients, previous DOAC therapy at time of diagnosis was not associated with improved clinical outcomes or lower hospitalization/re-hospitalization rate compared to patients not taking OAC therapy.

Role of long-term continuous cardiac monitoring in oral anticoagulation management of patients with known atrial fibrillation

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic OnBehalf Reveal LINQ Registry Investigators Background Monitoring atrial fibrillation (AF) with an insertable cardiac monitor (ICM) provides objective data for clinicians to make decisions on oral anticoagulation (OAC) management, based on individual risk profiles. Whether ICM data is being used for that purpose has not been widely explored. Purpose To show the impact of AF burden measured by an ICM on OAC treatment initiation and discontinuation in patients with known AF. Methods Patients from the prospective, ongoing, multi-center Reveal LINQ Registry monitored for AF management, or pre- or post-ablation monitoring were eligible. Follow-up was scheduled every 6 months for up to 3 years. Patients were excluded if they had no AF data available within the last 6 months of follow-up (FU), or less than 6 months of FU and no change to their OAC treatment compared to baseline. AF burden was defined as the percentage of time in AF 6 months prior to last FU, excluding the first 3 months post-ablation for patients who had an ablation. Results The analysis included 225 patients (65 ± 10 years, 72% male, mean CHA2DS2-VASc score 2.1 ± 1.4) monitored with an ICM for 21.8 ± 7.9 months. At baseline, 164 (73%) were taking OAC therapy, 147 (65%) had a history of paroxysmal AF and 79 (35%) had persistent AF. Forty percent of patients had a history of atrial ablation prior to ICM insertion and 37% had ≥1 AF ablation procedure after ICM. Patients were grouped according to OAC status at baseline, CHA2DS2-VASc score and AF burden (Figure: bars show percentage of patients with a change in OAC status during monitoring). Patients at high risk of stroke and AF burden &amp;gt;0.5% were more likely to initiate OAC therapy, whereas patients with higher AF burden were less likely to discontinue OAC, regardless of their risk score. Among those with no AF burden detected during the last 6 months of follow-up and on OAC at baseline, approximately half discontinued OAC, whereas 1/3 of patients with high risk score had initiated OAC, despite having no AF detected. Conclusion Our results derived from real-world practice show that AF detected and quantified by an ICM influences OAC therapy management in patients with known AF. Many patients with a low CHA2DS2-VASc score and no AF or low AF burden have had OAC therapy discontinuation, whereas a high proportion of patients with high AF burden have initiated OAC, regardless of their risk score. Abstract Figure. OAC according to risk and AF burden

In-hospital Bleeding Outcomes of Oral Anticoagulant and Dual Antiplatelet Therapy During Percutaneous Coronary Intervention: An Analysis From the Japanese Nationwide Registry

The type of periprocedural antithrombotic regimen that is the safest and most effective in percutaneous coronary intervention (PCI) patients on oral anticoagulant (OAC) therapy has not been fully investigated. We aimed to retrospectively investigate the in-hospital bleeding outcomes of patients receiving OAC and antiplatelet therapies during PCI using Japanese nationwide multicenter registry data. A total of 26,938 patients who underwent PCI with OAC and antiplatelet therapies between 2016 and 2017 were included. We investigated in-hospital bleeding requiring blood transfusion, mortality, and stent thrombosis according to the antithrombotic regimens used at the time of PCI: OAC + single antiplatelet therapy (double therapy) and OAC + dual antiplatelet therapy (triple therapy). The antiplatelet agents included aspirin, clopidogrel, and prasugrel. The OAC agents included warfarin and direct OACs. Adjusting the dose of OAC or intermitting OAC before PCI was at each operator's discretion. In the study population [mean age (SD), 73.5 (9.5) years; women, 21.5%], the double therapy and triple therapy groups comprised 5546 (20.6%) and 21,392 (79.4%) patients, respectively. Bleeding requiring transfusion was not significantly different between the groups [adjusted odds ratio (aOR), 0.700; 95% confidence interval (CI), 0.420-1.160; P = 0.165] (triple therapy as a reference). Mortality was not significantly different (aOR, 1.370; 95% CI, 0.790-2.360; P = 0.258). Stent thrombosis was significantly different between the groups (aOR, 3.310; 95% CI, 1.040-10.500; P = 0.042) (triple therapy as a reference). In conclusion, for patients on OAC therapy who underwent PCI, periprocedural triple therapy may be safe with respect to in-hospital bleeding risks. However, further investigations are warranted to establish the safety and efficacy of periprocedural triple therapy.

Antithrombotic therapy for stroke prevention in patients with atrial fibrillation who survive an intracerebral haemorrhage: results of an EHRA survey.

The aim of this survey is to provide a snapshot of current practice regarding antithrombotic therapy (ATT) in patients with atrial fibrillation (AF) comorbid with intracerebral haemorrhage (ICH). An online survey was distributed to members of the European Heart Rhythm Association. A total of 163 clinicians responded, mostly cardiologists or electrophysiologists (87.7%), predominantly working in University hospitals (61.3%). Most respondents (47.2%) had seen one to five patients with AF comorbid with ICH in the last 12 months. Among patients sustaining an ICH on oral anticoagulation (OAC), 84.3% respondents would consider some form of ATT post-ICH, with 73.2% preferring to switch from a vitamin-K antagonist (VKA) to a non-VKA oral anticoagulant (NOAC) and 37.2% preferring to switch from one NOAC to another. Most (36.6%) would restart OAC >30 days post-ICH. Among patients considered unable to take OAC, left atrial appendage occlusion procedure was the therapy of choice in 73.3% respondents. When deciding on ATT, respondents considered patient's CHA2DS2-VASc score, ICH type, demographics, risk factors, and patient adherence. The main reason for not restarting or commencing ATT was concern about recurrent ICH (80.8%). National or international clinical guidelines would be advantageous to support decision-making (84.3%). Other helpful resources reported were multidisciplinary team involvement (46.9%) and patient education (82%). In summary, most survey respondents would prescribe OAC therapy for patients with AF who have sustained an ICH on OAC and would restart OAC >30 days post-ICH. The risk of recurrent ICH was the main reason for not prescribing any ATT post-ICH.

Comparison of hospital length of stay of acute ischemic stroke patients with non-valvular atrial fibrillation started on rivaroxaban or warfarin treatment during hospitalization

Objective To compare the hospital length of stay (LOS) between rivaroxaban and warfarin in hospitalized acute stroke patients with non-valvular atrial fibrillation (NVAF) in Japan. Methods This was a retrospective, observational study using a Japanese hospital claims database. Data of NVAF patients who were started on oral anticoagulant (OAC) treatment during hospitalization were extracted and LOS-OAC (period from the initiation of index OAC therapy to the end of hospitalization or censoring date) and medical costs were compared between rivaroxaban and warfarin treatments. To compare LOS-OAC, a time-to-event analysis was performed using the Kaplan–Meier method. The analysis period was from April 2012 to December 2015. Results This study included 773 rivaroxaban users and 1077 warfarin users. After the propensity score matching, 546 patients for each treatment constituted the matched cohorts. Although the rivaroxaban users had a similar LOS-OAC to warfarin users (median, 18 vs. 19 days, p = .657) in the matched cohorts, 3 days shorter LOS-OAC was observed in the rivaroxaban users (median, 17 vs. 20 days, p = .043) after IPTW adjustment. Subgroup analysis by the severity of stroke after IPTW adjustment demonstrated that rivaroxaban users had a shorter LOS-OAC than warfarin users among patients with mild (median, 10 vs. 14 days) and moderate stroke severity (22 vs. 27 days), but not among those with severe stroke severity (26 vs. 25 days). Limitations It is not possible to say that the only confounder was stroke severity and therefore other possible known and unknown confounders could not be ruled out. Conclusions The rivaroxaban users had a 3-day shorter LOS-OAC after IPTW-adjustment. Using rivaroxaban was associated with 4–5 days shorter LOS-OAC than using warfarin in patients with mild or moderate stroke, though treatment selection did not have a large impact in patients with severe stroke.

Vitamin K Concentration and Cognitive Status in Elderly Patients on Anticoagulant Therapy: A Pilot Study

Objectives Recent studies have suggested that vitamin K may exert significant effects on the central nervous system. The present study investigates the relationship between vitamin K plasmatic levels and cognitive functions in elderly patients on oral anticoagulant therapy (OAT). Design At the Thrombosis Centre of Haematology, “Sapienza” University of Rome, 85 patients on OAT, aged between 75 and 92, were randomly enrolled in the study. Patients were on OAT with vitamin K antagonists (VKAs). Vitamin K1 concentrations were determined using standardized High-Performance Liquid Chromatography (HPLC). Cognitive functions were assessed using the Milan Overall Dementia Assessment (MODA). Results MODA scores are positively correlated to vitamin K1 concentration. Patients with vitamin K1 below 0.100 μg/L and between 0.100 and 0.400 μg/L and between 0.100 and 0.400 μg/L and between 0.100 and 0.400 p < 0.001). Even long-term OAT (>10 years) does not affect MODA scores. Education seems to exert a greater role on the cognitive status in comparison with aging. Conclusions The study shows a positive association between vitamin K1 concentration and cognitive status in elderly patients (≥75 years) on OAT. The relationship between vitamin K1 concentration and MODA scores is described by a linear model. Cognitive status is not influenced by the duration of OAT but by the years of education.

P6536Implementation of a mass atrial fibrillation screening program in Canadian community practice

Abstract Background Atrial fibrillation is the most common arrhythmia seen in clinical practice, and is an important cause of stroke. In up to 10% of patients, stroke is the first clinical manifestation of undiagnosed atrial fibrillation (AF). Early detection of AF is therefore desirable, as it would provide an opportunity to initiate appropriate stroke prevention with anticoagulation. While European guidelines recommend screening for AF as part of routine care in patients with risk factors, the optimal modality has not yet been determined. Smartphone enabled single lead ECG devices have been shown to be highly accurate and could prove to be an effective point of care tool for uncovering AF in the community and may facilitate implementation of screening recommendations. Purpose We sought to describe the integration of a smartphone enabled single lead ECG device into the practice of selected Canadian community-based physicians and its impact on patient care. Methods Canadian community-based physicians were provided with a smartphone enabled single lead ECG device for a period of six months. Physicians were instructed to perform a single 30 second ECG recording in patients over the age of 65 who present for a regular follow-up visit. Patients with previous AF diagnosis were excluded. Outcomes related to screening, and stroke prevention-treatment initiation were prospectively ascertained and documented using a patient flow tracker. Results Among 612 physicians who were invited to participate in the program, 315 (51%) agreed to track and report the use of the device that was provided to them. During this program, 315 physicians screened a total of 15,538 patients. AF was detected 1103 patients (7.1%). The majority of patients with a positive screen underwent a subsequent 12-lead ECG confirmatory exam (79%). AF could not be confirmed in 277 patients (31.7% of patients undergoing 12-lead ECG). A total of 677 patients were initiated on oral anticoagulation (OAC), with 262 patients (24%) being initiated on OAC prior to ECG confirmation. Conclusion Undiagnosed AF is common in patients &gt;65 years of age in community practice. The results of this program indicate that single lead mobile ECG devices can be integrated into routine point of care use for Canadian physicians and, can be a valuable tool to detect previously undiagnosed AF. While this approach identified a large number of undiagnosed AF patients eligible for OAC therapy, undertreatment with OAC remains a concern. Acknowledgement/Funding Bristol-Myers Squibb/Pfizer Alliance

Hospitalization affects the anticoagulation patterns of patients with atrial fibrillation.

Scarce data are available on the effects of hospitalization on oral anticoagulation (OAC) patterns in patients with atrial fibrillation (AF). This study aimed to capture the evolving OAC patterns of patients with known non-valvular AF at high risk for stroke (CHA2DS2-Vasc score ≥ 2 for males and ≥ 3 for females) during hospitalization. A total of 561 eligible patients who were admitted to the cardiology ward of a tertiary hospital were studied. Pre- and post-hospitalization OAC patterns [vitamin-K antagonist (VKA), non-vitamin K oral anticoagulants (NOAC), no OAC], changes between these patterns (initiation, switch, discontinuation, no change) and the respective patient profiles and discharge diagnoses were assessed. During hospitalization, OAC administration increased from 73.1 to 86.6% of patients (p for trend < 0.001). NOAC use increased significantly (42.2-56.1%, p for trend < 0.001), whereas VKA use remained stable (30.8-30.5%). Of patients, 17.3% initiated OAC, 7.1% switched between OACs, 3.7% discontinued OAC treatment, while the rest underwent no change in anticoagulation status. Bleeding risk, use of concomitant antiplatelet therapy and incidence of primary dischargediagnosis of AF or ST-elevation myocardial infarction differed significantly between groups of initiation, switch, discontinuation and no change in OAC therapy. In conclusion, in patients with known AF at high risk for stroke, hospitalization was associated with an increase in OAC uptake, driven mainly by NOAC initiation. Three out of 10 patients initiated, switched or discontinued OAC treatment during hospitalization and this was associated with discrete epidemiologic parameters.

Causes and predictors of early readmission after percutaneous coronary intervention among patients discharged on oral anticoagulant therapy.

Patients discharged on oral anticoagulant (OAC) therapy after percutaneous coronary intervention (PCI) represent a complex population and are at higher risk of early readmission. The reasons and predictors of early readmission in this group have not been well characterized. We identified patients in an integrated health care system who underwent PCI between 2009 and 2014 and were readmitted within 30 days within this health care system. Of the 9,357 patients surviving to discharge after the index PCI, 692 were readmitted within 30 days (7.4%). At the time of readmission, 143 had been discharged from the index PCI hospitalization on OACs (96.5% on warfarin) and 549 had not been discharged on OACs, with readmission rates of 12.9% and 6.7%, respectively (p<0.01). The most common reason for readmission among all patients was chest pain syndromes (21.7% on OACs, 34.4% not on OACs). However, bleeding represented the next most frequent cause of readmission among patients on OACs (14.0% on OACs vs 6.0% not on OACs, p<0.01). Among patients on OAC therapy, peripheral arterial disease (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.07–2.57, p = 0.02) and nonelective PCI (OR 1.91, 95% CI 1.17–3.12, p<0.01) were found to be independent predictors of 30-day readmission. During rehospitalization, compared to patients not on OACs, patients on OACs suffered a higher unadjusted rate of mortality (6.3% vs 1.8%, p<0.01) and a longer length of stay (6.4 ± 7.1 days vs 4.9 ± 6.8 days, p = 0.02). In conclusion, patients discharged on OAC therapy after PCI are commonly readmitted, with bleeding representing a major reason. These readmissions are associated with high mortality and longer lengths of stay. Interventions targeted towards optimizing discharge planning for these complex patients are needed to potentially reduce readmissions.

Intracranial hemorrhage in anticoagulated patients with mild traumatic brain injury: significant differences between direct oral anticoagulants and vitamin K antagonists.

Prognosis after mild traumatic brain injury (MTBI) on oral anticoagulant therapy (OAT) is uncertain. We evaluated the rate of immediate and delayed traumatic intracranial hemorrhage (ICH) comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) and the safety of a clinical management protocol. In this single-center prospective observational study, we enrolled 220 patients on OAT with MTBI. After a first negative CT scan, asymptomatic patients underwent a close neurological observation; if neurologically stable, they were discharged without a second CT scan and followed up for 1month. Out of the 220 patients, 206 met the inclusion criteria. 23 of them (11.2%) had a positive first CT scan for ICH. Only 1 (0.5%, 95% CI 0.0-1.4%) died because of ICH; no one required neurosurgical intervention. The observed prevalence rate of immediate ICH resulted statistically higher in VKAs-treated patients compared to those treated with DOACs (15.7 vs. 4.7%, RR 3.34, 95% CI 1.18-9.46, P < 0.05). In the 1-month follow-up, 5 out of the 183 patients with a negative CT scan were lost. Out of the remaining 178 patients, only 3 showed a delayed ICH (1.7%, 95% CI 0.0-3.6%), 1of them died (0.6%, 95% CI 0.5-1.7%) and the others did not require neurosurgical intervention. DOACs resulted safer than VKAs also in the setting of MTBI. In our observation, the rate of delayed hemorrhage was relatively low. Patients presenting with a negative first CT scan and without neurological deterioration could be safely discharged after a short period of in-ward observation with a low rate of complications and without a second CT scan.

Clinical Significance of Hematuria in Atrial Fibrillation With Oral Anticoagulation Therapy.

Hematuria is a common and important complication in atrial fibrillation (AF) patients on oral anticoagulation therapy (OAT). This study evaluated the clinical significance of hematuria and its relationship with genitourinary disease in AF patients receiving OAT.Methods and Results:Among 20,456 consecutive AF patients who visited a tertiary hospital from January 2005 to April 2015, 5,833 had hematuria. Of these 5,833 patients, 3,798 were on OAT (OAT(+) group) and 2,035 were not (OAT(-) group). A total of 1,785 patients from each group were then matched on propensity score analysis. The prevalence of cancer and other diseases in the genitourinary tract was evaluated. While there was no difference in the prevalence of genitourinary stones or urinary tract infection, genitourinary cancer was significantly more common in the OAT(+) group than in the OAT(-) group (1.6% vs. 0.7%, P=0.011). Bladder cancer was the most common genitourinary malignancy, and it was significantly more common in the OAT(+) group (1.2% vs. 0.5%, P=0.019). Subjects on warfarin were more likely to have bladder cancers of lower pathologic grade (63.6% vs. 33.3%, P=0.124). OAT was associated with a higher prevalence and early detection of genitourinary cancer in AF patients with hematuria. Meticulous evaluation of the cause of hematuria is necessary in AF patients with hematuria receiving OAT.

An Evaluation of the Efficacy of Local Hemostatic Measures in Dental Patients Taking Oral Anticoagulants: A Critical Review of the Literature Over the Past Two Decades.

The increased risk of bleeding observed in patients on oral anticoagulant therapy (OAT) undergoing outpatient oral surgical procedures has been reported in the literature and remains a major concern in the care of these patients. This is still of great concern to dental surgeons that discontinuing OAT medication increases the risk of thromboembolism, while maintaining the therapeutic dose increases the risk of hemorrhage. Several local hemostatic measures have been used to control bleeding in patients on OAT. However, the effectiveness of these measures has not been thoroughly investigated. The aim of this study is to evaluate the efficacy of local hemostatic measures in patients taking oral anticoagulants. Various databases were searched using the key terms. Selection criteria included publications in English, Spanish, or Portuguese within the last 20 years. The titles and abstracts of papers were initially screened, and reports of 18 clinical trials were selected for a critical review and scored according to CONSORT 2010 guidelines. The data extracted from these trials represented 1821 patients receiving OAT, 4116 tooth extractions, and 144 cases of postoperative bleeding. In most studies, there were no differences in the effectiveness of various local hemostatic measures, and only tranexamic acid was proven effective as compared with a placebo group. The reported INR values varied widely among studies; the lowest INR value was 0.9 and the highest was 5.0. All local hemostatic methods showed low rates of bleeding; and when bleeding occurred, the use of these methods was essential for controlling postoperative bleeding. While local hemostatic measures appear to be effective in controlling postoperative bleeding, additional controlled randomized clinical trials are needed to assess the true effectiveness of these measures in patients taking OAT.

Prediction of Bleeding Risk in Patients on Extended Oral Anticoagulation for Venous Thromboembolism

▪Background: While tools exist to predict the risk of major bleeding in patients on oral anticoagulation therapy (OAT) for venous thromboembolism (VTE), these have focused on the higher risk period during the first 3 months of OAT therapy (risk of major bleeding 2.4% in first 3 months vs. 2% per year thereafter), and have not been developed or evaluated for bleeding risk after the first 3 months of therapy (extended OAT). It is widely considered that a bleeding risk tool that is able to identify patients with an annual rate of major bleeding over 3% is needed, as this is the cut-point at which the risk of continued anticoagulant therapy exceeds the benefit.Aims: We sought to evaluate if the rates of major bleeding were over 3% when four existing, previously published tools (RIETE,outpatient bleeding risk index (OBRI), ACCP and HAS-BLED) classified VTE patients during extended OAT as being high risk for major bleeding, and to assess if the differences in major bleeding risk between high risk and not high risk patients were statistically significantly different.Methods: The Bleeding Risk study was a multicentre, multinational prospective cohort study of patients on extended OAT for unprovoked VTE, or provoked VTE with prior VTE, designed to generate a new prediction tool for major bleeding. Patients were enrolled after at least 3 months of OAT. All major bleeding events during long term OAT were captured and adjudicated. We applied each of the 4 tools above to determine the risk for major bleeding according to patient scores. Not all variables in these tools were collected, including drug and alcohol history, and INR control.Results: 2514 patients enrolled at 12 sites have contributed over 7000 years of observation. The mean patient age was 60.2±14.7 years, 64% were male, 92% Caucasian, average BMI was 31.3, and 9% of patients were on antiplatelet agents. Patients were followed for a mean of 2.8 years (range, 0.1 to 6.8 years. 121 patients (4.8%) experienced at least one episode of major bleeding. The annual rate of bleeding was 1.7 per 100 patient years of observation.The proportion of patients classified as high risk of major bleeding by the RIETE (score of 3 or 4), OBRI (score of 3), ACCP (score ≥ 2) and HAS-BLED (score ≥ 3) scores were 12.3%, 13.3%, 28.0% and 23.1%, with major bleeding rates of 3.9%, 3.2%, 3.4% and 3.4% per year, respectively. The major bleeding rates of patients who were classified as not high risk of bleeding were 1.4%%, 1.5%, 1.1% and 1.2% per year, respectively. All differences were statistically significant with p values < 0.0001.Conclusion: Despite the potential to underestimate risk due to missing variables, all currently available prediction tools are able to identify patients with a 3% or higher risk of major bleeding per year. , The HAS-BLED and ACCP scores were able to identify the highest proportions of patients as high risk for major bleeding. DisclosuresWells:BMS/Pfizer: Research Funding; Bayer Healthcare: Other: Speaker Fees and Advisory Board; Janssen Pharmaceuticals: Consultancy; Itreas: Other: Served on a Writing Committee. Kovacs:Bayer: Honoraria, Research Funding; LEO Pharma: Honoraria; Daiichi Sankyo Pharma: Research Funding; Pfizer: Honoraria, Research Funding. Anderson:Bayer Healthcare: Research Funding. Rodger:Boehringer Ingelheim: Research Funding; Canadian Agency for Drugs and Technologies in Health: Consultancy.

Patients with antiphosholipid syndrome and thrombotic recurrences: A real world observation (the Piedmont cohort study).

Patients with antiphospholipid syndrome (APS) often have thrombotic recurrences, sometimes despite appropriate ongoing anticoagulant treatment. Identifying APS vascular patients at high risk for thrombotic recurrences is still an unsolved issue. To report the real-life experience of thrombotic recurrences in APS patients included in the Piedmont observational cohort study, and evaluate clinical and laboratory risk factors for thrombotic recurrences. A multi-centre observational study was performed by enrolling 177 patients with vascular APS (primary APS in 99 subjects (56%)); the median follow-up was five years (range 1-26 years). The observed thrombotic recurrence rate was about 7.5/100 patient years in the first five years after the first thrombotic event. While the first recurrence often occurred (45%) in patients who were not on oral anticoagulant therapy (OAT), the second recurrence mainly occurred despite ongoing OAT (80%). However, due to the real-life observational nature of this study, treatment was based on the treating physician's judgement, and no structured therapeutic protocol was applied. Moreover, compliance with OAT was not available. No differences in antiphospholipid antibodies (aPL) profile were observed between patients with or without thrombotic recurrences, but a high risk aPL profile (Miyakis type 1 and 2a) was present in 96% of our patients, 26% of whom had triple positivity. Diabetes (p < 0.01, OR 10), inherited thrombophilia (p < 0.0078, OR 4) and OAT withdrawal were independent risk factors for recurrences. With the limit of a real-life observational cohort study, the thrombotic recurrence rate in APS was as high as 7.5/100 patient years in the first five years after the first thrombotic event. OAT discontinuation, diabetes and inherited thrombophilia, when associated with a high-risk aPL profile, are risk factors for thrombotic recurrences.