Abstract 19108: Anticoagulation Treatment in High-Risk Medicare Advantage Patients with Non-Valvular Atrial Fibrillation

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Amanda S Bruno ◽  
Jeffrey N Trocio ◽  
Daniel Wiederkehr ◽  
Younos Abdulsattar ◽  
Joette Gdovin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Treatment Options ◽  
Medicare Advantage ◽  
Risk Levels ◽  
High Risk Patients ◽  
Index Stroke ◽  
Risk Patients

OBJECTIVE: Examine anticoagulation (AC) treatment in Medicare Advantage Prescription Drug (MAPD) plan members diagnosed with non-valvular atrial fibrillation (NVAF) and at high risk for stroke. METHODS: A retrospective analysis of claims data from a large US health plan was conducted. Patients with NVAF were identified between 1/1/2011 and 11/30/2013. Index date was based on NVAF diagnosis and patients were required to have ≥18 months of continuous enrollment: 6 months pre-index and 12 months post-index. Pre-index stroke risk was calculated using the CHADS 2 . Patients classified as high risk (CHADS 2 score ≥2) were included in the analysis. Post-index AC treatment options were warfarin and novel oral anticoagulants (NOACs), dabigatran, apixaban, rivaroxaban. The proportion of high-risk patients with time in therapeutic range (TTR)≥60% was calculated among those receiving warfarin with ≥2 INR values within a 3-month period. Adherence among high-risk patients receiving a NOAC or warfarin without available INR values was calculated using the proportion of days covered (PDC)≥80%. Risk for major bleeding was also calculated using the HASBLED score. Descriptive statistics were used to summarize AC treatment. FINDINGS: Of 93,864 patients with NVAF, 70,646 were identified as high risk for stroke. Among them, 36,601 (51.8%) were treated with an AC while 34,045 (48.1%) did not receive any AC treatment during post-index. Of those treated with an AC, 30,802 (84.2%) were treated with warfarin and 5,799 (15.8%) were treated with a NOAC. TTR was calculated for 7,034 (22.8%) of those receiving warfarin, of which 3,215 (45.7%) had a TTR≥60%. PDC≥80% was observed for 13,758 (57.9%) of the remaining warfarin users and 3,353 (58.7%) of NOAC users. A total of 64,191 (90.8%) patients had a HASBLED score ≥3. CONCLUSIONS: A large proportion of NVAF patients at high risk for stroke are untreated or potentially undertreated_as evidenced by the low TTR values and low adherence estimates observed here. These patients’ high risk levels for stroke and major bleeding necessitate optimal prophylactic treatment with AC and careful management. Further research with providers may identify potential causes for non-treatment and undertreatment with AC in high risk NVAF patients.

Long-term outcomes of Japan-specific dosage of rivaroxaban in high-risk patients with non-valvular atrial fibrillation: analysis from the XAPASS

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Ikeda ◽  
S Ogawa ◽  
T Kitazono ◽  
J Nakagawara ◽  
K Minematsu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Major Bleeding ◽  
Factor Xa ◽  
Incidence Rates ◽  
Funding Source ◽  
High Risk Patients ◽  
Reduced Dose ◽  
Risk Patients

Abstract Background XAPASS is a real-world, prospective, single-arm, observational study conducted as a post-marketing surveillance mandated by the health authority in Japan. Nowadays, direct oral anticoagulant therapy using factor Xa or thrombin inhibitor has been the standard of care for patients with non-valvular atrial fibrillation (NVAF) to prevent ischemic stroke. However, the clinical impact of reduced dosage (approved dose of 15 or 10 mg once daily in Japan is relatively reduced compared to global dosage) factor Xa inhibitor rivaroxaban in high-risk patients remains unclear. Purpose The present sub-analysis of XAPASS was carried out to assess long-term safety and effectiveness of reduced-dose rivaroxaban in high-risk NVAF patients for bleeding and thromboembolism. Methods All patients with NVAF who were newly started on rivaroxaban were eligible for surveillance. The principal safety outcome was a composite of major and non-major bleeding events, and the primary effectiveness outcome was a composite of ischaemic stroke, haemorrhagic stroke, non-central nervous system systemic embolism (non-CNS SE), and myocardial infarction (MI). In this present sub-analysis, high-risk patients were defined as those who had two of the following three risk factors: elderly (≥75 years old), low body weight (≤50 kg), and renal impairment (CrCl <50 mL/min). Results In total, 11,308 patients were enrolled between April 2012 and June 2014 from 1,419 hospitals, and overall data were analysed from 10,664 patients from whom data were collected. Among them, 3,694 patients matched the criteria for the high-risk patients defined in this sub-analysis, and 6,970 patients did not match the criteria (non-high-risk patients). The mean treatment duration was 791±673 days in the high-risk patients and 944±709 days in the non-high-risk patients. Mean patient age was 80.9±5.5 years and 69.0±9.0 years at baseline, respectively. Mean CHADS2 score was 2.8 and 1.8, and CHA2DS2-VASc score was 4.4 and 2.9, respectively. The rates of CHADS2 component comorbidities were lower in the non-high-risk patients except for diabetes mellitus. The incidence rates of any bleeding, major bleeding, and the primary effectiveness outcomes were 4.8, 1.6, and 2.1%/patient-year in the high-risk patients. The incidence rates of these clinical events in the non-high-risk patients were 3.3, 0.9, and 1.0%/patient-year, respectively. Conclusions Incidence rates of long-term bleeding and thromboembolism were higher in the high-risk patients than in the non-high-risk patients. However, the rates of these outcomes using the Japan-specific reduced dose were not so high. Furthermore, the balance between safety and effectiveness outcomes was within an acceptable range. The present study provides useful information for physicians to stratify high-risk patients using the reduced dose in daily clinical practice. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer Yakuhin Ltd.

scholarly journals Cardiovascular outcomes, bleeding risk, and achieved blood pressure in patients on long-term anticoagulation with the thrombin antagonist dabigatran or warfarin: data from the RE-LY trial

2020 ◽  
Vol 41 (30) ◽  
pp. 2848-2859 ◽  
Author(s):  
Michael Böhm ◽  
Martina Brueckmann ◽  
John W Eikelboom ◽  
Michael Ezekowitz ◽  
Mandy Fräßdorf ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
High Risk ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Bleeding Events ◽  
High Risk Patients ◽  
Increased Risk ◽  
Risk Patients

Abstract Aims A J-shaped association of cardiovascular events to achieved systolic (SBP) and diastolic (DBP) blood pressure was shown in high-risk patients. This association on oral anticoagulation is unknown. This analysis from RELY assessed the risks of death, stroke or systemic emboli, and bleeding according to mean achieved SBP and DBP in atrial fibrillation on oral anticoagulation. Methods and results RE-LY patients were followed for 2 years and recruited between 22 December 2005 until 15 December 2007. 18.113 patients were randomized in 951 centres in 54 countries and 18,107 patients with complete blood pressure (BP) data were analysed with a median follow-up of 2.0 years and a complete follow-up in 99.9%. The association between achieved mean SBP and DBP on all-cause death, stroke and systemic embolic events (SSE), major, and any bleeding were explored. On treatment, SBP >140 mmHg and <120 mmHg was associated with all-cause death compared with SBP 120–130 mmHg (reference). For SSE, risk was unchanged at SBP <110 mmHg but increased at 140–160 mmHg (adjusted hazard ratio (HR) 1.81; 1.40–2.33) and SBP ≥160 mmHg (HR 3.35; 2.09–5.36). Major bleeding events were also increased at <110 mmHg and at 110 to <120 mmHg. Interestingly, there was no increased risk of major bleeding at SBP >130 mmHg. Similar patterns were observed for DBP with an increased risk at <70 mmHg (HR 1.55; 1.35–1.78) and >90 mmHg (HR 1.88; 1.43–2.46) for all-cause death compared to 70 to <80 mmHg (reference). Risk for any bleeding was increased at low DBP <70 mmHg (HR 1.46; 1.37–1.56) at DBP 80 to <90 mmHg (HR 1.13; 1.06–1.31) without increased risk at higher achieved DBP. Dabigatran 150 mg twice daily showed an advantage in all patients for all-cause death and SSE and there was an advantage for 110 mg dabigatran twice daily for major bleeding and any bleeding irrespective of SBP or DBP achieved. Similar results were obtained for baseline BP, time-updated BP, and BP as time-varying covariate. Conclusion Low achieved SBP associates with increased risk of death, SSE, and bleeding in patients with atrial fibrillation on oral anticoagulation. Major bleeding events did not occur at higher BP. Low BP might identify high-risk patients not only for death but also for high bleeding risks. Clinical trial registration  ClinicalTrials.gov—Identifier: NCT00262600.

P4767VTE-BLEED score predicts major bleeding in patients with atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F A Klok ◽  
K G Chu ◽  
L Valerio ◽  
S J Van Der Wall ◽  
S Barco ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
High Risk ◽  
Dose Reduction ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Composite Outcome ◽  
Systemic Embolism ◽  
High Risk Patients ◽  
Risk Patients

Abstract Background Bleeding risk scores in atrial fibrillation (AF) are used to identify risk factors for bleeding but not to determine anticoagulant therapy since high bleeding risk strongly correlates to high risk of stroke. VTE-BLEED is a simple bleeding risk score (Klok FA Eur Respir J 2016) that predicts major bleeding (MB) in patients with venous thromboembolism, but has never been evaluated in AF. Aims To evaluate VTE-BLEED in AF and whether dabigatran dose reduction in VTE-BLEED high-risk patients would result in a lower incidence of MB and the composite endpoint of MB plus stroke/systemic embolism. Methods Assessment of VTE-BLEED in 18040 patients of the RE-LY trial (Connolly SJ NEJM 2009) that compared dabigatran (both 150mg BID and 110mg BID) to warfarin. The score was calibrated to fit the AF population. Hazard ratios (HR) were obtained for the VTE-BLEED high-risk patients randomized to dabigatran. The risk ratios for MB and the composite outcome of MB plus stroke/systemic embolism between dabigatran 150mg and 110mg were calculated for the VTE-BLEED high-risk group. Results The adapted VTE-BLEED score classified 4060 patients (22.5%) as high-risk. A high score indeed predicted MB in patients treated with dabigatran 150mg BID or 110mg BID, for HRs of 2.48 (95% CI 1.96–3.13) and 2.61 (95% CI 2.04–3.33), respectively. In VTE-BLEED high-risk patients, the risk ratio between the two dabigatran doses was 0.53 (95% CI 0.35–0.78) for MB and 0.55 (95% CI 0.38–0.79) for the composite outcome, both in favor of dabigatran 110mg BID (Figure 1). Compared to the current European label of dabigatran, application of VTE-BLEED to determine dabigatran dosing would result in a different dose for 21% of patients. Figure 1 Conclusions VTE-BLEED was validated for AF. Our data suggest that dabigatran dose reduction in VTE-BLEED bleed high-risk patients -in addition to targeting individual modifiable risk factors for bleeding- may lower the risk of MB and improve patient outcome. This finding could have important clinical implications but should be confirmed in future studies.

scholarly journals Potential drug-drug interactions between oral anticoagulants for high-risk patients with atrial fibrillation in Latvia

Cor et Vasa ◽  
2019 ◽  
Vol 61 (3) ◽  
pp. e266-e271
Author(s):  
Ketija Apsite ◽  
Katrina Pukite ◽  
Andris Tupahins ◽  
Natalija Nikrus ◽  
Baiba Lurina ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Drug Interactions ◽  
Oral Anticoagulants ◽  
Potential Drug ◽  
High Risk Patients ◽  
Risk Patients

scholarly journals The effects of a preoperative multidisciplinary conference on outcomes for high-risk patients with challenging surgical treatment options: a retrospective study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Masayoshi Koike ◽  
Mie Yoshimura ◽  
Yasushi Mio ◽  
Shoichi Uezono
Keyword(s):  
Patient Safety ◽  
Retrospective Study ◽  
High Risk ◽  
Treatment Plan ◽  
Treatment Options ◽  
High Risk Patients ◽  
Appropriate Treatment ◽  
Risk Patients ◽  
Treatment Plans ◽  
Multidisciplinary Conference

Abstract Background Surgical options for patients vary with age and comorbidities, advances in medical technology and patients’ wishes. This complexity can make it difficult for surgeons to determine appropriate treatment plans independently. At our institution, final decisions regarding treatment for patients are made at multidisciplinary meetings, termed High-Risk Conferences, led by the Patient Safety Committee. Methods In this retrospective study, we assessed the reasons for convening High-Risk Conferences, the final decisions made and treatment outcomes using conference records and patient medical records for conferences conducted at our institution from April 2010 to March 2018. Results A total of 410 High-Risk Conferences were conducted for 406 patients during the study period. The department with the most conferences was cardiovascular surgery (24%), and the reasons for convening conferences included the presence of severe comorbidities (51%), highly difficult surgeries (41%) and nonmedical/personal issues (8%). Treatment changes were made for 49 patients (12%), including surgical modifications for 20 patients and surgery cancellation for 29. The most common surgical modification was procedure reduction (16 patients); 4 deaths were reported. Follow-up was available for 21 patients for whom surgery was cancelled, with 11 deaths reported. Conclusions Given that some change to the treatment plan was made for 12% of the patients discussed at the High-Risk Conferences, we conclude that participants of these conferences did not always agree with the original surgical plan and that the multidisciplinary decision-making process of the conferences served to allow for modifications. Many of the modifications involved reductions in procedures to reflect a more conservative approach, which might have decreased perioperative mortality and the incidence of complications as well as unnecessary surgeries. High-risk patients have complex issues, and it is difficult to verify statistically whether outcomes are associated with changes in course of treatment. Nevertheless, these conferences might be useful from a patient safety perspective and minimize the potential for legal disputes.

Right Atrial Thrombosis and Pulmonary Embolism: A Narrative Review

2020 ◽  
Vol 46 (08) ◽  
pp. 895-907
Author(s):  
Nina D. Anfinogenova ◽  
Oksana Y. Vasiltseva ◽  
Alexander V. Vrublevsky ◽  
Irina N. Vorozhtsova ◽  
Sergey V. Popov ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Embolism ◽  
High Risk ◽  
Transesophageal Echocardiography ◽  
Three Dimensional ◽  
Right Atrial ◽  
Treatment Protocols ◽  
High Risk Patients ◽  
Risk Patients ◽  
The Right

AbstractPrompt diagnosis of pulmonary embolism (PE) remains challenging, which often results in a delayed or inappropriate treatment of this life-threatening condition. Mobile thrombus in the right cardiac chambers is a neglected cause of PE. It poses an immediate risk to life and is associated with an unfavorable outcome and high mortality. Thrombus residing in the right atrial appendage (RAA) is an underestimated cause of PE, especially in patients with atrial fibrillation. This article reviews achievements and challenges of detection and management of the right atrial thrombus with emphasis on RAA thrombus. The capabilities of transthoracic and transesophageal echocardiography and advantages of three-dimensional and two-dimensional echocardiography are reviewed. Strengths of cardiac magnetic resonance imaging (CMR), computed tomography, and cardiac ventriculography are summarized. We suggest that a targeted search for RAA thrombus is necessary in high-risk patients with PE and atrial fibrillation using transesophageal echocardiography and/or CMR when available independently on the duration of the disease. High-risk patients may also benefit from transthoracic echocardiography with right parasternal approach. The examination of high-risk patients should involve compression ultrasonography of lower extremity veins along with the above-mentioned technologies. Algorithms for RAA thrombus risk assessment and protocols aimed at identification of patients with RAA thrombosis, who will potentially benefit from treatment, are warranted. The development of treatment protocols specific for the diverse populations of patients with right cardiac thrombosis is important.

Abstract 14782: Sex Comparisons in Anticoagulation Treatment for Atrial Fibrillation in a Large Rural Healthcare System

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Macaela N Rudeck ◽  
Catherine P Benziger
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Atrial Flutter ◽  
Electronic Medical Record System ◽  
Record System ◽  
High Risk Patients ◽  
Occlusion Device ◽  
Increased Risk ◽  
Medical Record System ◽  
Risk Patients

Introduction: Atrial fibrillation (AF) and flutter lead to increased risk of thromboembolism (TE). The CHA 2 DS 2 -VASc score is used to determine the risk of TE. Objective: We aim to evaluate the anticoagulation use across CHA 2 DS 2 -VASc scores calculated using a validated automatic calculator. Methods: An AF registry was created for patients with AF or atrial flutter who had seen a primary care or cardiology provider within the past 2 years (5/28/2018-5/28/2020). An automatic CHA 2 DS 2 -VASc calculator was integrated into the electronic medical record system at Essentia Health on 10/1/2019. High-risk of TE was defined as a score of ≥3 for females and a score of ≥2 for males. AF registry included demographics, anticoagulation prescription, CHA 2 DS 2 -VASc and ATRIA bleed score, contraindications, and presence of left atrial appendage (LAA) occlusion device. Results: A total of 10992 patients with AF or atrial flutter were included in the registry (74.8 ±11.8 years, 41.7% female). A total of 6703 (61.0%) had a CHA 2 DS 2 -VASc score calculated (mean score 3.9 ± 1.5). Mean ATRIA bleed score was 3.0 ± 2.0. Within these patients, 90.7% of males and 93.0% of females were at high-risk of TE. Of these high-risk patients, anticoagulation use was 82.7% for females and 83.5% for males and increased with increasing score (p<0.01 for males, p<0.01 for females) (Figure 1). Overall, 36.9% were prescribed NOAC, 47.0% warfarin, and 0.8% heparin. There was no sex difference in the prescription of NOAC (37.7% male vs. 35.9% female, p=0.1). Fewer than 1% had WATCHMAN LAA device (0.3% male vs. 0.4% female, p=0.5). Conclusion: Four out of 5 patients at increased risk of TE are prescribed an anticoagulant. Interventions to improve anticoagulation use in high-risk patients are needed. Figure 1. Anticoagulation prescription use in atrial fibrillation patients by CHA 2 DS 2 -VASc score and sex between 5/28/2018-5/28/2020 at Essentia Health (N=6703).

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