Use Of Oral Anticoagulants In Patients Research Articles

Antithrombotic Therapy after Transcatheter Aortic Valve Replacement.

ABSTRACTTranscatheter aortic valve replacement (TAVR) is a treatment option for patients with asymptomatic severe aortic stenosis who are candidates for a bioprosthesis across the entire spectrum of risk. TAVR carries a risk for thrombotic and bleeding events, focusing on the importance of defining the optimal antithrombotic regimen. Patients undergoing TAVR are mostly elderly and have many comorbidities such as atrial fibrillation (AF) requiring oral anticoagulants (OACs) or coronary artery disease requiring antiplatelet agents. After TAVR among patients without baseline indications for OAC, recent data suggest dual-antiplatelet therapy is associated with an increased risk for bleeding events, particularly early postprocedure compared with single-antiplatelet therapy with aspirin. The risk of leaflet thrombosis in patients undergoing TAVR raised concern about the use of OAC in patients without an initial indication for anticoagulation therapy. Although it showed effectiveness in modulating thrombus formation at the valve level, the bleeding hazard has shown to be unacceptably high, and the net benefit of combining antiplatelet and OAC therapy is unproven. For patients with indications for the use of long-term OAC, such as those with AF, adding antiplatelet therapy increases bleeding events. A favorable effect of new OAC agents over Vitamin K antagonists is debatable. Overall, single-antiplatelet therapy and OAC appear to be reasonable strategies in patients without and with indications for concurrent anticoagulation, respectively. This article aims to review the available published studies and recommendations in the literature regarding the use of antithrombotic therapy post-TAVR.

Worldwide trends in oral anticoagulant use in patients with atrial fibrillation from 2010 to 2018: a systematic review and meta-analysis.

Non-vitamin K antagonist oral anticoagulants (NOACs) are effective and safe alternatives compared with vitamin K antagonists (VKAs) for thromboembolic prevention in atrial fibrillation (AF), while antiplatelets are no longer recommended. However, to which extent NOAC introduction and guideline updates have increased OAC use in AF, is unclear. Therefore, worldwide trends in real-life prescribing of OACs, NOACs, VKAs, and antiplatelet monotherapy in AF patients were investigated. Using PubMed and Embase, observational nationwide cohort studies on annual prevalent and/or incident OAC use in non-selected AF patients since 2010 were included. A meta-analysis of single proportions was performed. Twenty-one studies were included assessing prevalent and incident use among 9 758 637 and 197 483 OAC-eligible AF patients, respectively. Worldwide prevalence and incidence of OAC users increased from 0.42 [95% confidence interval (CI) 0.22-0.65] and 0.43 (95% CI 0.37-0.49) in 2010 to 0.78 (95% CI 0.77-0.78) and 0.75 (95% CI 0.74-0.76) in 2018, respectively. Prevalent and incident NOAC users increased globally from 0 in 2010 to 0.45 (95% CI 0.45-0.46) and 0.68 (95% CI 0.67-0.69) in 2018, respectively, whereas prevalent and incident VKA use decreased from 0.42 (95% CI 0.22-0.65) and 0.42 (95% CI 0.36-0.49) in 2010 to 0.32 (95% CI 0.32-0.32) and 0.06 (95% CI 0.06-0.07) in 2018, respectively. Prevalent antiplatelet monotherapy use decreased from 0.37 (95% CI 0.32-0.42) in 2010 to 0.09 (95% CI 0.09-0.10) in 2018. The proportion of OAC users worldwide almost doubled following NOAC introduction. As one-quarter of OAC-eligible AF subjects were not anticoagulated and 9% were only treated with antiplatelets in 2018, there is still room for improvement.

Warfarin Use Is Associated with Increased Mortality at One Year in Patients with Idiopathic Pulmonary Fibrosis.

Objectives We studied the safety and efficacy of warfarin compared to direct acting oral anticoagulant use in patients with IPF. Methods We conducted a retrospective cohort study of all patients with IPF who were prescribed warfarin or direct acting oral anticoagulants (DOACs) for cardiac or thromboembolic indications and followed at our institute for their care. Univariate tests and multivariable logistic regression analyses were used for assessing association of variables with outcomes. Results A total of 73 patients were included in the study with 28 and 45 patients in the warfarin and DOAC groups, respectively. Univariable analysis revealed a significant difference in mortality in one year between warfarin and DOAC groups (7/28 vs. 3/45, p value 0.027). Significantly more patients in the warfarin group suffered an exacerbation that required hospitalization within one year (9/28 vs. 5/45, p value 0.026). Multivariate logistic regression analysis showed that anticoagulation with warfarin was independently associated with mortality at one-year follow-up (OR: 77.4, 95% CI: 5.94–409.3, p value: 0.007). Conclusion In our study of patients with IPF requiring anticoagulants, we noted statistically significant higher mortality with warfarin anticoagulation when compared to DOAC use. Further larger prospective studies are needed to confirm these findings.

Abstract 14354: Optimal Anticoagulation Use in Patients Undergoing Transcatheter Mitral Valve Replacement a Quest for More Data

Background: Multiple studies have demonstrated an increased risk of valve thrombosis in patients with mitral valve prostheses. Data to guide decision-making in regards to the choice of anticoagulation agent and duration of the therapy is lacking. We present our single-center experience with oral anticoagulation use in patients undergoing transcatheter mitral valve replacement (TMVR). Methods: 32 patients underwent the TMVR procedure at our center from 1/1/2017 to 12/31/2020. Data points on baseline characteristics, STS-PROM, functional status (NYHA and KCCQ), baseline laboratory values, echocardiographic parameters (including LVEF, MV area, gradient, grading of MS, and MR was collected. We analyzed patterns of anticoagulation therapy including the type of agent, duration of therapy, and complications occurring related to anticoagulation use. Results: Our registry included 32 patients that underwent TMVR. 70.5 % were females, 96.8 % Caucasian with a mean NYHA class of 3.25. STS-PROM of 6.25 (5.56-9.43) and KCCQ score of 38.04 (SD 19.9). Out of 32 patients, 31 had retrievable data. Vitamin K antagonist (VKA) was used in 60 % (18), apixaban in 26.6 % (8), rivaroxaban in 16.6 % (3), and no anticoagulation was used in 0.03 % (1) of patients.74 % (22) of the patients were on anticoagulation at the time of TMVR for another indication. 33.3% (6) of patients on VKA suffered a complication such as gastrointestinal/genitourinary bleed, while 54.45% (6) of patients on DOAC reported similar complications. Conclusion: The choice of anticoagulant and optimal duration of anticoagulation in patients undergoing TMVR remains a gap in our evidence base. We present our single-center experience of anticoagulant use in this patient population. Further randomized studies are needed to address this knowledge gap.

Abstract 12176: Oral Anticoagulant Therapy Following Single-Lead ECG Screening Among Older Patients With Atrial Fibrillation: The VITAL-AF Trial

Introduction: A substantial proportion of patients with atrial fibrillation do not take oral anticoagulants (OAC). Point of care ECG testing at primary care visits may prompt reassessment of OAC eligibility in patients with AF. Methods: VITAL-AF (NCT035115057) was a cluster-randomized trial of AF screening using single-lead handheld electrocardiograms within 16 primary care practices affiliated with Massachusetts General Hospital. The goal of VITAL-AF was to screen for undiagnosed AF. For pragmatic reasons the trial included all individuals aged ≥ 65 years, including those with an established diagnosis of AF. We evaluated screening uptake among prevalent AF patients in the screening arm, OAC initiation among both screening and control patients with prevalent AF, and OAC initiation by screening result (adjusted for stroke/bleed risk factors compared to all patients not screened). OAC use was identified using electronic health record medication lists during the 1-year prior to and following a patient’s study index visit. Results: Prevalent AF was present in 2,250 patients (75% on OAC) in the screening arm and 2,343 patients (76% on OAC) in the control arm. 90% of patients in the screening arm were screened at least once during the study period (mean 2.4 times screened). 31.5% had a “Possible AF” and 17.2% had an “Unclassified” automated algorithm screening result during their first screening encounter (40.1% “Possible AF” and 27.4% “Unclassified” during any encounter). Overall, OAC initiation was similar among prevalent AF patients from the screening arm and control arm ( Table ). OAC initiation was higher among screened patients who had a “Possible AF” automated result (Adjusted Odds Ratio 1.14, 95% CI: 1.05-1.24). Conclusions: Point of care cardiac rhythm assessment was not associated with significant changes in the use of OAC in patients with a history of AF. However, screened patients not on OAC who had a positive single-lead ECG were more likely to initiate OAC.

Oral Anticoagulant Use in Patients with Morbid Obesity: A Systematic Review and Meta-Analysis

Obesity is associated with increased risks of atrial fibrillation (AF) and venous thromboembolism (VTE) for which anticoagulation is commonly used. However, data on the efficacy and safety of oral anticoagulants in patients with morbid obesity are limited. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) for AF or VTE in patients with morbid obesity. We included three randomized controlled trials (5 studies) and 18 observational studies in adult patients with a body weight ≥120 kg, body mass index ≥40 kg/m2, or classified as morbid obesity who received DOACs or VKAs for AF or VTE (N = 77,687). The primary efficacy outcome was stroke/systemic embolism or recurrent VTE, and the primary safety outcome was major bleeding. DOACs were associated with a pooled incidence rate of stroke/systemic embolism of 1.16 per 100 person-years, compared to 1.18 with VKAs. The incidence of recurrent VTE on DOACs was 3.83 per 100 person-years, compared to 6.81 on VKAs. In both VTE and AF populations, DOACs were associated with lower risks of major bleeding compared to VKAs. However, all observational studies had moderate to serious risks of bias. Patients with morbid obesity on DOACs had similar risks of stroke/systemic embolism, lower rates of recurrent VTE, and major bleeding events compared to those on VKAs. However, the certainty of evidence was low given that studies were mostly observational with high risk of confounding.

Clinical outcomes and the impact of prior oral anticoagulant use in patients with coronavirus disease 2019 admitted to hospitals in the UK - a multicentre observational study.

Coagulation dysfunction and thrombosis are major complications in patients with coronavirus disease 2019 (COVID-19). Patients on oral anticoagulants (OAC) prior to diagnosis of COVID-19 may therefore have better outcomes. In this multicentre observational study of 5 883 patients (≥18 years) admitted to 26 UK hospitals between 1 April 2020 and 31 July 2020, overall mortality was 29·2%. Incidences of thrombosis, major bleeding (MB) and multiorgan failure (MOF) were 5·4%, 1·7% and 3·3% respectively. The presence of thrombosis, MB, or MOF was associated with a 1·8, 4·5 or 5·9-fold increased risk of dying, respectively. Of the 5 883 patients studied, 83·6% (n = 4 920) were not on OAC and 16·4% (n = 963) were taking OAC at the time of admission. There was no difference in mortality between patients on OAC vs no OAC prior to admission when compared in an adjusted multivariate analysis [hazard ratio (HR) 1·05, 95% confidence interval (CI) 0·93-1·19; P = 0·15] or in an adjusted propensity score analysis (HR 0·92 95% CI 0·58-1·450; P = 0·18). In multivariate and adjusted propensity score analyses, the only significant association of no anticoagulation prior to diagnosis of COVID-19 was admission to the Intensive-Care Unit (ICU) (HR 1·98, 95% CI 1·37-2·85). Thrombosis, MB, and MOF were associated with higher mortality. Our results indicate that patients may have benefit from prior OAC use, especially reduced admission to ICU, without any increase in bleeding.

Antithrombotic Therapy After Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) is a treatment option for symptomatic patients with severe aortic stenosis who are candidates for a bioprosthesis across the entire spectrum of risk. However, TAVR carries a risk for thrombotic and bleeding events, underscoring the importance of defining the optimal adjuvant antithrombotic regimen. Antithrombotic considerations are convoluted by the fact that many patients undergoing TAVR are generally elderly and present with multiple comorbidities, including conditions that may require long-term oral anticoagulation (OAC) (eg, atrial fibrillation) and antiplatelet therapy (eg, coronary artery disease). After TAVR among patients without baseline indications for OAC, recent data suggest dual-antiplatelet therapy to be associated with an increased risk for bleeding events, particularly early postprocedure, compared with single-antiplatelet therapy with aspirin. Concerns surrounding the potential for thrombotic complications have raised the hypothesis of adjunctive use of OAC for patients with no baseline indications for anticoagulation. Although effective in modulating thrombus formation at the valve level, the bleeding hazard has shown to be unacceptably high, and the net benefit of combining antiplatelet and OAC therapy is unproven. For patients with indications for the use of long-term OAC, such as those with atrial fibrillation, the adjunctive use of antiplatelet therapy increases bleeding. Whether direct oral anticoagulant agents achieve better outcomes than vitamin K antagonists remains under investigation. Overall, single-antiplatelet therapy and OAC appear to be reasonable strategies in patients without and with indications for concurrent anticoagulation. The aim of the present review is to appraise the current published research and recommendations surrounding the management of antithrombotic therapy after TAVR, with perspectives on evolving paradigms and ongoing trials.

Abstract MP23: Neighborhood Disadvantage And Oral Anticoagulant Use In Patients With Atrial Fibrillation

Background: Atrial Fibrillation (AF) is the most common heart rhythm disorder in the US and is treated with anticoagulation to mediate patients’ increased risk of ischemic stroke and death. Direct-acting oral anticoagulants (DOACs) are associated with better patient outcomes than warfarin, but prior studies show disparities in DOAC prescription. AF patients with low socioeconomic status (SES) have an increased risk of AF incidence, adverse outcomes, and mortality. Despite SES disparities in AF outcomes and prescribed medications, the impact of neighborhood SES (ADI) on AF management is unclear. We hypothesized that in comparison to patients with high ADI (e.g. the most disadvantaged), those with low ADI will be more likely to initiate any oral anticoagulants (OACs) and will be more likely to initiate DOACs. Methods: We conducted a retrospective observational study using national data from the Veterans Health Administration (VA) of newly diagnosed AF patients. Our independent variable was ADI, a marker of SES incorporating income, education, employment etc. Our model assessed numerous baseline patient, provider, and system-level covariates. We grouped patients into ADI quintiles, with Q1 being the lowest ADI (e.g., the least disadvantaged) and Q5 being the highest ADI, and used Q5 as a reference value. We used mixed effects logistic regression models, with site as a random effect, to determine the adjusted odds of initiating any OACs and of initiating DOACs by ADI quintile. Results: In our final cohort including 111,666 patients, 10,9386 (98.0%) were male and 2280 (2.0%) were female. The overall mean age at diagnosis was 72.86 (SD 10.4). Patients had the following medical comorbidities: Congestive heart failure: 18212, (16.3%); Hypertension: 84944, (76.1%); Diabetes: 70673, (63.3%); Vascular Disease: 46599, (41.7%). The ADI quintiles included the following patients: Q1: 21570, (20.3%); Q2: 21032, (19.8%); Q3: 21439, (20.2%); Q4: 20974, (19.8%); Q5: 21215, (20.0%). There was no significant difference in the odds of initiating any OAC between ADI quintiles compared to Q5 (Q1: adjusted odds ratio [95% CI], 0.95 [ 0.9, 1.01]; p=0.11). Among patients initiating DOAC, there was a significant association between low ADI and higher odds of initiating DOAC (Q1: 1.39 [1.29, 1.50]); (Q2: 1.18 [1.10, 1.27]); (Q3: 1.13 [1.06, 1.20]); (Q4: 1.09 [1.02, 1.16]). Each ADI quintile had a significantly higher odds of initiating DOACs compared to the highest ADI quintile. Conclusions: Patients with lower ADI are significantly more likely to be prescribed DOACs compared to patients with the highest levels of ADI. We found no significant difference in initiation of any OAC between ADI quintiles, which may result from high Warfarin utilization in the VA compared to the general population. Our data suggests that differences in neighborhood deprivation contribute to disparities in the prescribing DOACs in the VA.

Off-label Use of Direct Oral Anticoagulants in Patients Receiving Surgical Mechanical and Bioprosthetic Heart Valves

This cohort study assesses direct oral anticoagulant use in patients with surgical prosthetic heart valves in the United States and evaluates differences in preoperative and postoperative profiles in patients discharged while receiving direct oral anticoagulant vs warfarin.

Long-term oral anticoagulation for atrial fibrillation in low and middle income countries

With increasing life-expectancy and changing demographics, non-valvular atrial fibrillation (AF) is currently the most common indication for long-term oral anticoagulation (OAC) in low and middle income countries (LMICs). Due to a decreasing trend in the prevalence of rheumatic heart disease (RHD), valve disease as a primary cause of AF now constitutes a small fraction of all people with AF. Moreover, emerging data also indicate that, patients with significant valve disease and AF may have a risk of stroke similar to, if not lower than, those with non-valvular AF. Previous trials of anticoagulation for AF excluded people from LMICs partly because valvular AF constituted a large proportion of those with AF, and it was thought to confer a prohibitively high risk of stroke. Trialists should therefore be less reluctant to include patients with AF from LMICs in general, and those with valve disease in particular, in future trials of anticoagulation. The quality of vitamin K antagonist based oral anticoagulation remains poor in LMICs to a large extent because of poor monitoring. The widespread use of the direct oral anticoagulants (DOAC) presents a practical approach to improve anticoagulation quality. Randomised trials of DOACs in valvular AF are particularlycriticalto bridge the knowledge gap in this area.Discussions regarding oral anticoagulation (OAC) use in low and middle income countries (LMICs) have historicallybeendominated by severallong-held beliefs. The first is that the quality of vitamin K antagonist (VKA) based anticoagulation is poor in these countries. The veracity of this assumption is supported by a large number of studies documenting both lower prescription of OACs, and a lower proportion of international normalised ratio (INR) values in the therapeutic range.1The second is that a large proportion of patients receiving OAC in LMICs have atrial fibrillation (AF) related to valvular heart disease, and rheumatic mitral stenosis in particular. This assumption, perhaps valid several decades ago, is no longer supported by the data. Finally, patients with valvular heart disease and AF (specifically those with moderate or severe valve lesions), are thought to be at prohibitively high thromboembolic risk. 2 However, recent evidence suggests that this risk may have been overestimated.34Nevertheless, the aforementioned assumptions continue to contribute to the underrepresentation of patients from LMICs in clinical trials of oral anticoagulation. Knowledge of the characteristics of contemporary patients in LMICs who are eligible for long-term OAC, estimates of their stroke risk, and a better understanding of the drivers of poor anticoagulation quality, may help guide research and clinical practice. In this review, we seek to provide an evidence-based perspective on OAC use in patients with AF living in LMICs and China.

Factors influencing oral anticoagulant use in patients newly diagnosed with atrial fibrillation.

We investigated factors that influenced oral anticoagulant (OAC) initiation and choice in Australian general practice patients newly diagnosed with AF. Using an Australian nationally representative general practice dataset, MedicineInsight, we identified patients newly diagnosed with AF between January 2009 and April 2019. Logistic regression analyses were used to examine factors associated with OAC initiation and choice. A total of 63212 patients with AF (53.7% males, mean age 72.4years) were identified. Nearly two-thirds of these patients (40854 [64.6%]) were initiated on an OAC, at a median time of 6days after the documented diagnosis date. The proportion of patients who were initiated an OAC increased from 44.8% in 2009 to 72.2% in 2019 (P<.001). High risk of stroke (CHA2 DS2 -VASc, adjusted odds ratio (AOR), 4.39 [95% CI, 3.99-4.83]), low risk of bleeding (ORBIT, AOR, 1.87 [95% CI, 1.72-2.03]), not having a recorded history of dementia (AOR, 1.81 [95% CI, 1.65-1.98]) and male sex (AOR, 1.29 [95% CI, 1.22-1.35]) were independently associated with OAC initiation. Direct-acting oral anticoagulant (DOAC) use increased from 11.9% in 2011 to 94.0% of all OAC initiations in April 2019 (P<.001). The proportion of newly diagnosed patients with AF initiated on OAC increased markedly following the introduction of the DOACs. Of those initiated, 9 in 10 were receiving a DOAC at the end of the study period. There is potential underuse in women and individuals with dementia.

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study

Abstract Aims Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention, are limited. We analysed the impact of LD and OAC treatment in determining stroke, major bleeding, all-cause death and secondary bleeding outcomes. Methods A retrospective observational population-based cohort study. The study cohort is derived from the administrative health databases of Lombardy region (&amp;gt;10 million inhabitants), Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. AF and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical (ATC) codes. Primary study outcomes were stroke, major bleeding and all-cause death. Results Among 393,507 AF patients, 16,168 (4.1%) had concomitant LD. LD AF patients were significantly less treated with OAC independent of associated clinical characteristics (OR: 0.96, 95% CI: 0.92–0.98). Concomitant LD was found associated with an increased risk in all the study outcomes (HR: 1.18, 95% CI: 1.11–1.25 for stroke; HR: 1.57, 95% CI: 1.47–1.66 for major bleeding; HR: 1.41, 95% CI: 1.39–1.44 for all-cause death. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70–0.92), major bleeding (HR: 0.86, 95% CI: 0.74–0.99) and all-cause death (HR: 0.85, 95% CI: 0.80–0.90), with similar results according to several clinically relevant subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375–0.472). Conclusions In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant benefit/risk ratio, even in high-risk patient subgroups. Funding Acknowledgement Type of funding source: None

Oral anticoagulant use in patients with atrial fibrillation and mitral valve repair

Patients with atrial fibrillation (AF) who have undergone mitral valve repair are at risk for thromboembolic strokes. Prior to 2019, only vitamin K antagonists were recommended for patients with AF who had undergone mitral valve repair despite the introduction of direct oral anticoagulants (DOAC) in 2010. To characterize the use of anticoagulants in patients with AF who underwent surgical mitral valve repair (sMVR) or transcatheter mitral valve repair (tMVR). We performed a retrospective cohort analysis of patients with AF undergoing sMVR or tMVR between 04/2014 and 12/2018 using Optum's de-identified Clinformatics® Data Mart Database. We identified anticoagulants prescribed within 90 days of discharge from hospitalization. Overall, 1997 patients with AF underwent valve repair: 1560 underwent sMVR, and 437 underwent tMVR. The mean CHA2DS2-VASc score among all patients was 4.1 (SD 1.9). The overall use of anticoagulation was unchanged between 2014 (72.2%) and 2018 (70.0%) (P = .49). Among patients who underwent sMVR or tMVR between April 2014 and December 2018, the use of VKA therapy decreased from 62.9% to 32.1% (P < .01 for trend) and the use of DOACs increased from 12.4% to 37.3% (P < .01 for trend). Among patients with AF who underwent sMVR or tMVR between 2014 and 2018, roughly 30% of patients were not treated with any anticoagulant within 90 days of discharge, despite an elevated stroke risk in the cohort. The rate of DOAC use increased steadily over the study period but did not significantly increase the rate of overall anticoagulant use in this high-risk cohort.

Efficacy and Safety of Oral Anticoagulants in Patients with Systolic Heart Failure in Sinus Rhythm: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Cohort Studies.

Introduction There is conflicting evidence on the risk–benefit ratio of oral anticoagulants (OAC) in heart failure (HF) patients without atrial fibrillation. We aimed to evaluate the efficacy and safety of OAC in HF patients in sinus rhythm. Methods A systematic literature search was conducted using PubMed and Embase. We included randomized controlled trials (RCT) and cohort studies, comparing OAC with antiplatelet or no treatment/placebo in patients with HF. Outcomes evaluated were stroke, myocardial infarction (MI), all-cause mortality, and major bleeding. Results Five RCTs and three cohort studies were included. OAC was associated with a reduced risk of ischemic stroke when compared with no treatment/placebo (odds ratio [OR] = 0.67, 95% confidence interval [CI]: [0.47, 0.94]) and antiplatelet therapy (OR = 0.55, 95% CI: [0.37, 0.81]). No significant reduction was found in MI, when OAC was compared with no treatment/placebo (OR = 0.82, 95% CI: [0.63, 1.07]) or antiplatelet therapy (OR = 1.04, 95% CI: [0.60, 1.81]). The all-cause mortality analysis showed no significant reduction when comparing OAC with no treatment/placebo (OR = 0.99, 95% CI: [0.87, 1.12]) or antiplatelet therapy (OR = 1.00, 95% CI: [0.86, 1.16]). The nonsignificant effect of OAC on all-cause mortality was supported by a meta-analysis of the three cohort studies (OR = 1.02, 95% CI: [0.75, 1.38]). Patients treated with OAC had a significantly higher risk of major bleeding than patients receiving antiplatelet therapy (OR = 2.16, 95% CI: [1.55, 3.00]) and a numerically higher risk when compared with no treatment/placebo (OR = 2.38, 95% CI: [0.87, 6.49]). Conclusion The present study does not support the routine use of OAC in patients with HF in sinus rhythm.

Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib)

Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population. Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017. Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA2DS2-VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis. The main outcome measures of the current analysis were rates of OAC use in the prior 12 months of cohort identification and factors associated with non-use. A total of 197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment. Of these, 179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old. Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis. Of these, 32,295 (33%) had no evidence of OAC use in the prior 12 months. Compared with patients with evidence of OAC use in the prior 12 months, patients without OAC use were more likely to be ≥80 years old, women, and have a history of anemia (51% vs 47%) and less likely to have diabetes (41% vs 44%), history of stroke or TIA (15% vs 19%), and history of heart failure (39% vs 48%). Despite a high risk of stroke, one-third of privately insured patients with AF and no obvious contraindications to an OAC were not treated with an OAC. There is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.

Nine-year trend of oral anticoagulant use in patients with embolic stroke due to nonvalvular atrial fibrillation.

BackgroundDirect oral anticoagulants (DOACs) are increasingly used as an alternative to warfarin in patients with nonvalvular atrial fibrillation (NVAF). However, whether there is sufficient prescription of oral anticoagulants (OACs) to decrease the incidence of embolic stroke remains unclear.Methods and ResultsWe conducted a retrospective observational study of patients hospitalized with ischemic stroke between January 1, 2010 and December 31, 2018. During the 8 years, the annual incidence ratio of embolic stroke to all ischemic strokes did not decrease over time (21‐33%) except for that in 2018. The proportion of OAC users did not also change over time (from 23% to 45% [overall 31%], P = .78). Among the OAC users, 19% patients were warfarin users, and 12% patients were DOAC users. In 73% of warfarin users, prothrombin time was subtherapeutic, whereas in 60% of DOAC users, the dose was adequately prescribed. OACs were prescribed more often in patients with high CHADS2 score than in those with low score (P = .01). The number of patients who had no medical history of a doctor visit before admission increased significantly in the recent period of 2015‐2018 (22% vs 8% in the previous period of 2010‐2014) (P = .01).ConclusionsThe incidence of embolic stroke patients without OACs did not decrease over time, and OACs in patients with NVAF have not been sufficient, even in DOAC era. In recent years, the incidence of undiagnosed AF has increased. To prevent embolic stroke, a correct AF diagnosis beforehand is important.

Association of Ischemic Stroke, Major Bleeding, and Other Adverse Events With Warfarin Use vs Non–vitamin K Antagonist Oral Anticoagulant Use in Patients With Atrial Fibrillation With a History of Intracranial Hemorrhage

Current guidelines recommend the use of non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in patients with atrial fibrillation (AF). Data regarding warfarin sodium use compared with NOAC use in patients with AF with a history of intracranial hemorrhage (ICH) are limited. To compare the clinical outcomes of warfarin use and NOAC use in patients with AF with a history of ICH using a nationwide cohort with AF. A nationwide cohort study from January 1, 2012, to December 31, 2016, was performed using data from the Taiwan National Health Insurance Research Database. The dates of analysis were July 1 to September 1, 2019. The study population comprised patients with AF with a history of ICH and a CHA2DS2-VASc score (congestive heart failure, hypertension, age ≥75 years [doubled], diabetes, prior stroke/transient ischemic attack/thromboembolism [doubled], vascular disease [prior myocardial infarction, peripheral artery disease], age 65-74 years, sex category [female]) of at least 1 for men or at least 2 for women who had received warfarin or NOACs. The clinical outcomes were examined using Cox proportional hazards regression analyses among the study population before and after propensity score matching. Oral anticoagulation with warfarin or NOACs. The clinical outcomes measured were all-cause mortality, ischemic stroke, ICH, major bleeding, and adverse events. The study cohort included 4540 patients (mean [SD] age, 76.0 [10.5] years; 2653 men [58.4%]), with 1047 patients receiving warfarin (mean [SD] age, 75.1 [11.4] years; 571 men [54.5%]) and 3493 patients receiving NOACs (mean [SD] age, 76.3 [10.2] years; 2082 men [59.6%]). Compared with warfarin use, NOAC use was associated with statistically significantly lower risk of all-cause mortality (adjusted hazard ratio [aHR], 0.517; 95% CI, 0.457-0.585), ICH (aHR, 0.556; 95% CI, 0.389-0.796), and major bleeding (aHR, 0.645; 95% CI, 0.525-0.793), whereas the rate of ischemic stroke was similar in the 2 groups (aHR, 0.879; 95% CI, 0.678-1.141). These results were generally consistent after propensity score matching among 973 patients in each group. Among patients with AF with prior ICH, NOAC use was associated with lower rates of ICH and major bleeding compared with warfarin use, whereas the rate of ischemic stroke was similar in the 2 groups. Among patients with AF with prior ICH, NOACs could be the preferred choice for stroke prevention.

Endovascular Treatment for Acute Ischemic Stroke in Patients on Oral Anticoagulants

Background and Purpose- The use of oral anticoagulants (OAC) is considered a contra-indication for intravenous thrombolytics as acute treatment of ischemic stroke. However, little is known about the risks and benefits of endovascular treatment in patients on prior OAC. We aim to compare outcomes after endovascular treatment between patients with and without prior use of OAC. Methods- Data of patients with acute ischemic stroke caused by an intracranial anterior circulation occlusion, included in the nationwide, prospective, MR CLEAN Registry between March 2014 and November 2017, were analyzed. Outcomes of interest included symptomatic intracranial hemorrhage and functional outcome at 90 days (modified Rankin Scale score). Outcomes between groups were compared with (ordinal) logistic regression analyses, adjusted for prognostic factors. Results- Three thousand one hundred sixty-two patients were included in this study, of whom 502 (16%) used OAC. There was no significant difference in the occurrence of symptomatic intracranial hemorrhage between patients with and without prior OACs (5% versus 6%; adjusted odds ratio, 0.63 [95% CI, 0.38-1.06]). Patients on OACs had worse functional outcomes than patients without OACs (common odds ratio, 0.57 [95% CI, 0.47-0.66]). However, this observed difference in functional outcome disappeared after adjustment for prognostic factors (adjusted common odds ratio, 0.91 [95% CI, 0.74-1.13]). Conclusions- Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use. Therefore, prior OAC use should not be a contra-indication for endovascular treatment.

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study.

Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention are limited. A retrospective observational population-based cohort study on the administrative health databases of Lombardy region Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. Atrial fibrillation and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical codes. Primary study outcomes were stroke, major bleeding, and all-cause death. Among 393 507 AF patients, 16 168 (4.1%) had concomitant LD. Liver disease AF patients were significantly less treated with OAC. Concomitant LD was associated with an increased risk in all the study outcomes [hazard ratio (HR): 1.18, 95% confidence interval (CI): 1.11-1.25 for stroke; HR: 1.57, 95% CI: 1.47-1.66 for major bleeding; HR: 1.41, 95% CI: 1.39-1.44 for all-cause death]. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70-0.92), major bleeding (HR: 0.86, 95% CI: 0.74-0.99), and all-cause death (HR: 0.77, 95% CI: 0.73-0.80), with similar results according to subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375-0.472). In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant favourablebenefit/risk ratio, even in high-risk patient subgroups.