scholarly journals Adherence Trajectories of Extended Direct-Acting Oral Anticoagulants and Risk of Recurrent Venous Thromboembolism and Major Bleeding: A Retrospective Cohort Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4059-4059
Author(s):  
Hye-Rim Kang ◽  
Bobby L Jones ◽  
Wei-Hsuan Lo-Ciganic ◽  
Christina E DeRemer ◽  
Eric A Dietrich ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Research Program ◽  
Research Funding ◽  
Reference Group ◽  
Oral Anticoagulants ◽  
Extended Treatment ◽  
Recurrent Vte ◽  
Group 2 ◽  
Group 1 ◽  
Program Research

Abstract Introduction: The optimal duration of extended oral anticoagulant treatment for patients with venous thromboembolism (VTE) beyond the initial 3 to 6 months of the treatment remains undetermined. Group-based trajectory modeling (GBTM) is a data-driven method that can categorize patients with similar longitudinal adherence patterns over time into distinct subgroups. This study identified distinct patient subgroups with similar adherence trajectories of extended treatment of direct-acting oral anticoagulants (DOACs), and then examined the association between adherence trajectories and the risk of recurrent VTE and major bleeding among patients with VTE. Methods: We identified patients ≥18 years with a diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE) from inpatient claims using 2013-2019 Truven Commercial and Medicare Supplemental database. Patients were included if they initiated anticoagulants within 30 days of their first VTE diagnosis, completed 6 months of therapy-defined as ≥83% proportion days covered (PDC) with oral anticoagulants during the initial 6-month treatment period, and had extended treatment with any DOACs or no extended therapy. Based on the monthly PDC as the DOAC adherence measure, we used GBTM to identify DOAC adherence trajectories during 6 months of the extended treatment. The final trajectory model was chosen by assessing the Bayesian information criteria, Nagin's criteria, and having at least 10% of patients in each trajectory group for improving clinical utility. We compared recurrent VTE and major bleeding among adherence trajectory subgroups. Patients were followed up from the initiation of the extended treatment until the occurrence of the study outcomes, discontinuation of DOACs, switching to warfarin, end of study period, or end of enrollment, whichever occurred first. Cox proportional hazard modeling with inverse probability treatment weighting (IPTW) was used to obtain hazard ratios (HR) and 95% confidence intervals (95% CI). Results: The study cohort (mean age=58.7 years and 51.1% males) consisted of 10,960 patients with extended treatment of DOACs (4,294 apixaban, 6,409 rivaroxaban, 238 dabigatran, and 19 edoxaban users) with a mean treatment duration of 7.7 months and 5,133 patients with no extended treatment following completion of an initial 6 months of anticoagulant treatment. The final GBTM models identified four distinct adherence trajectories for extended therapy including (1) patients with consistent adherence (group 1, 40.7%), (2) patients with gradually declining adherence (group 2, 14.3%), (3) patients with rapidly declining adherence (group 3, 13.1%), and (4) patients with no extended treatment (reference group, 31.9%) (Figure 1). The incidence rates of recurrent VTE were 18.6, 46.9, 84.1, and 160.7 per 10,000 person-years, and those of major bleeding were 61.0, 125.1, 168.3, and 48.7 per 10,000 person-years in group 1, group 2, group 3, and the reference group, respectively. After IPTW, demographics and clinical characteristics (e.g., HAS-BLED bleeding risk score, provoked VTE) were comparable across the four trajectory groups with <0.1 of the standardized mean difference for each pairwise comparison. Compared to the reference group, group 1 (HR=0.09, 95% CI=0.05-0.17) and group 2 (HR=0.16, 95% CI=0.04-0.58) had decreased risk of recurrent VTE without increasing risk of major bleeding (HR=1.26, 95% CI=0.76-2.10 in group 1, HR=2.28, 95% CI=0.96-5.36 in group 2). There was no difference in the risk of recurrent VTE (HR=0.32, 95% CI=0.09-1.16) in group 3 but they had an increased risk of major bleeding (HR=2.69, 95% CI=1.00-7.23). The findings were consistent across different types of DOACs, suggesting a class effect of DOACs as extended therapy. Conclusions: We identified 4 distinct trajectories of DOAC adherence during the 6 months of extended therapy among patients who completed 6 months of initial treatment. Compared to no extended treatment, persistent use of DOACs during extended treatment was associated with a lower risk of recurrent VTE without increasing major bleeding risk, whereas a rapid decline in adherence was associated with an increased risk of major bleeding with no difference in the risk of recurrence. Our findings provide evidence on the benefits of continuing and being adherent to extended anticoagulant treatment in patients with VTE without increasing the risk of major bleeding. Figure 1 Figure 1. Disclosures Kang: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Jones: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Lo-Ciganic: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding; MERCK: Research Funding. DeRemer: BMS advisory board attendee: Honoraria; Portola Pharmaceuticals: Current equity holder in publicly-traded company; BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Dietrich: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Huang: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Murphy: North American Thrombosis Foundation: Honoraria. Park: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding.

scholarly journals Comparative Effectiveness and Safety of Extended Anticoagulant Therapy Among Medicare Beneficiaries with Venous Thromboembolism

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 178-178
Author(s):  
Haesuk Park ◽  
Hye-Rim Kang ◽  
Pei-Lin Huang ◽  
Wei-Hsuan Lo-Ciganic ◽  
Eric A Dietrich ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Research Program ◽  
Initial Treatment ◽  
Research Funding ◽  
Oral Anticoagulants ◽  
Medicare Beneficiaries ◽  
Bleeding Events ◽  
Extended Treatment ◽  
Recurrent Vte ◽  
Program Research

Abstract Introduction: Approximately 30% of patients with venous thromboembolism (VTE) experience a recurrence within 10 years of the initial event with their recurrence risk peaking during the first 6-12 months. Two large randomized clinical trials AMPLIFY-EXT and PADIS-PE reported that extended treatment with apixaban and warfarin beyond 6 months of initial treatment reduced recurrent VTE without increasing the rate of major bleeding compared to placebo, respectively. Little is known about real-world effectiveness and safety of extended oral anticoagulation beyond 6 months of initial treatment for Medicare beneficiaries with VTE, despite the fact that VTE disproportionately affects the elderly. We assessed the effectiveness and safety of extended use of apixaban and warfarin beyond 6 months of initial treatment for prevention of recurrent VTE and adverse major bleeding events among Medicare beneficiaries with newly diagnosed VTE. Methods: A retrospective cohort study using 2014-2018 Medicare data (5% samples in 2014-2016 and 15% samples of Medicare beneficiaries in 2017-2018) was conducted for patients aged ≥18 years with a diagnosis of deep vein thrombosis or pulmonary embolism ascertained from inpatient claims. Patients were included if they initiated anticoagulants within 30 days of their first VTE diagnosis, completed 6 months of therapy defined as ≥83% proportion days covered with oral anticoagulants during the initial 6-month period, and received extended treatment with either apixaban or warfarin or no extended therapy. We compared the risks of recurrent VTE and major bleeding between apixaban, warfarin, and no treatment groups. To adjust for differences in baseline characteristics and clinical factors (e.g., HAS-BLED score, active cancer, and provoked VTE) between groups, we used the stabilized inverse probability treatment weighting (IPTW) method. Follow-up continued until the occurrence of the first event, switch to the comparator, disenrollment, death, or end of the study period. Multivariable Cox proportional hazards modeling with IPTW was used to obtain adjusted hazard ratios (aHR) and 95% confidence intervals (95%CI). Results: The study cohort (mean age=74 ±12 years, 40% male, 76% White) consisted of 2,315 users of extended apixaban treatment (83% with 5 mg twice a day and 17% with 2.5 mg twice a day; mean duration=6.2 months), 2,757 users of extended warfarin treatment (mean duration=8.2 months), and 2,328 patients with no extended treatment following completion of an initial 6 months of anticoagulant treatment. The incidence rates of recurrent VTE were 0.42, 1.73, and 1.72 per 100 person-years, and those of major bleeding were 2.28, 3.62, and 1.43 per 100 person-years in the apixaban, warfarin, and no treatment groups, respectively (Table 1). Compared to no extended treatment, the use of apixaban was associated with an 80% decreased risk of recurrent VTE (aHR=0.19, 95%CI=0.06-0.55) without increasing the risk of major bleeding (aHR=1.19, 95%CI=0.65-2.19); the use of warfarin did not lower the risk of recurrent VTE (aHR=0.75, 95%CI=0.42-1.37) but increased the risk of major bleeding (aHR=1.92, 95%CI=1.13-3.25). Compared to the use of warfarin, the use of apixaban was associated with a decreased risk of recurrent VTE (aHR=0.26, 95% CI=0.09-0.76) and no difference in major bleeding risk (aHR=0.61, 95%CI=0.36-1.06). These findings remained consistent in subgroup (e.g., patients with provoked vs. unprovoked VTE, patients with active cancer vs. those without, and patients with chronic kidney diseases vs. those without) and sensitivity analyses (e.g., ≥92% proportion days covered with oral anticoagulants during the initial 6-month period). Conclusions: Compared to no extended therapy, extended anticoagulation with apixaban was associated with a reduced risk of recurrent VTE without increasing the risk of major bleeding, whereas warfarin did not lower risk of recurrent VTE but increased the risk of major bleeding among Medicare beneficiaries with VTE. In the head-to-head comparison, the use of apixaban was more effective than warfarin in preventing recurrent VTE, without increasing the risk of major bleeding events. Our findings suggest that apixaban is an effective and safer option for extended treatment of VTE when compared to warfarin or no treatment among Medicare beneficiaries with VTE. Figure 1 Figure 1. Disclosures Park: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Kang: BMS/Pfizer Alliance American Thrombosis InvestigatorInitiated Research Program: Research Funding. Huang: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Lo-Ciganic: MERCK: Research Funding; BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Dietrich: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding. Murphy: North American Thrombosis Foundation: Honoraria. DeRemer: BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program: Research Funding; Portola Pharmaceuticals: Current equity holder in publicly-traded company; BMS advisory board attendee: Honoraria.

scholarly journals Impacts of hemoglobin levels and platelet counts on clinical outcomes in patients with atrial fibrillation: oral anticoagulant use for patients with anemia and/or thrombocytopenia

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Oral Anticoagulants ◽  
High Risk Population ◽  
Group 3 ◽  
Composite Risk ◽  
Group 2 ◽  
Group 1

Abstract Background Hemoglobin (Hgb) levels and platelet (PLT) counts have beeen associated with adverse clinical outcomes in some patients with cardiovascular conditions. We aimed to assess the risks of clinical events among patients with atrial fibrillation (AF) in relation to Hgb levels and PLT counts. Second, we investigated clinical outcomes on warfarin or non-vitamin K antagonist oral anticoagulants (NOACs) compared to no oral anticoagulant use (non-OAC), in different Hgb and PLT strata. Methods We used medical data from a multi-center healthcare system in Taiwan which included 37,074 AF patients. Patients were categorized into 3 groups based on their Hgb levels and PLT counts: Group 1 (Hgb>10g/dL and PLT>100K/uL; n=29,147), Group 2 (Hgb<10g/dL or PLT<100K/uL; n=7,078) and Group 3 (Hgb<10g/dL and PLT<100K/uL; n=849). Patients in each category were further stratified as 3 groups according to their stroke prevention strategies; that is, non-OAC, warfarin or NOACs. Results A higher Hgb level and/or PLT count was associated with a higher risk of ischemic stroke/systemic embolism (IS/SE), but lower risks of intracranial hemorrhage (ICH) and major bleeding. The composite risks of IS/SE, ICH and major bleeding were higher in Group 3 or Group 2, compared to Group 1 (6.75%/yr versus 6.41%/yr versus 4.13%/yr). Compared to non-OACs, the use of warfarin was not associated with a lower composite risk of IS/SE, ICH and major bleeding in the 3 groups. NOACs were associated with a lower composite risk in Group 1 (aHR 0.68, 95% CI 0.60–0.76) and Group 2 (aHR 0.73, 95% CI 0.53–0.99), but was non-significant in Group 3 (aHR 0.73, 95% CI 0.17–3.07) (Figure). The net clinical benefits were consistently positive in different weight models, in favor of NOAC use, in Group 2 and its subgroups with either anemia or thrombocytopenia. Conclusions AF patients with anemia and/or thrombocytopenia were a high-risk population. Compared to no OAC use, NOACs were associated with significantly better clinical outcomes for patients with advanced anemia (Hgb<10g/dL) or thrombocytopenia (PLT<100K/uL), but not for those with both conditions. Harms or benefits of NOACs should be carefully evaluated and balanced in this population. FUNDunding Acknowledgement Type of funding sources: None.

Abstract 12901: Novel Oral Anticoagulants Are Associated With Decreased Recurrence of Venous Thromboembolism in Patients With Cancer: An Updated Meta-Analysis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sunil Upadhaya ◽  
Seetharamprasad Madala ◽  
Sunil Badami
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Novel Oral Anticoagulants ◽  
P Value ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Recurrent Vte

Introduction: Patients with cancer are at high risk for recurrent thromboembolic phenomenon. Use of novel oral anticoagulants (NOAC) for treatment of venous thromboembolism (VTE) in such patients is controversial. We conducted this updated meta-analysis to evaluate the pooled efficacy and safety of NOAC in patients with cancer. Methods: We did systematic search of PubMed and Cochrane library databases for randomized controlled trials comparing NOAC with low molecular weight heparin (LMWH) for VTE treatment in cancer patients till April 2020. The efficacy outcomes were recurrent VTE and all-cause mortality rates, and the primary safety outcome was incidence of major bleeding rate. Results: Four randomized controlled studies comparing NOAC with LMWH (1446 patients in NOAC group and 1448 patients in LMWH group) were included in our study. Use of NOAC lead to significant reduction in recurrent VTE rate (odds ratio (OR): 0.55 [0.36-0.84], I 2 = 45 %, p value = 0.006) (Figure 1). However, we did not find any significant difference in rate of major bleeding (OR: 1.30 [0.76-2.23], I 2 = 35%, p value = 0.34) (Figure 2) and all-cause mortality (OR: 1 [0.80 - 1.26], I 2 = 33%, p value = 0.98). Conclusions: This updated meta-analysis showed comparatively lower pooled recurrent VTE rate in patient being treated with NOAC, whereas similar rates of major bleeding and all-cause death. NOAC are more efficacious and has similar safety profile compared with LMWH.

scholarly journals Efficacy of Chemotherapy or Chemo-Anti-PD-1 Combination after Unsatisfactory Response of Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: A Retrospective Series from Lysa Centers

Blood ◽  
2017 ◽  
Vol 130 (Suppl_1) ◽  
pp. 652-652
Author(s):  
Cédric Rossi ◽  
Julia Gilhodes ◽  
Marie Maerevoet ◽  
Charles Herbaux ◽  
Pauline Brice ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hodgkin Lymphoma ◽  
Research Funding ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Complete Response ◽  
High Rate ◽  
High Dose ◽  
Group 2 ◽  
Group 1

Abstract Introduction: Hodgkin lymphoma (HL) pts who relapse after high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV) therapy have a poor outcome. For these relapsed and refractory (R/R) HL pts, anti-PD-1 therapy gives a high rate of objective responses. However, the rate of complete response (CR) remains modest and in the updated results of anti-PD-1 therapy clinical trials, about 50% of pts are still without progressive disease after one year of treatment. As anti-PD-1 therapy modifies the anticancer immune response, we hypothesize that anti-PD-1 therapy may increase sensitivity to chemotherapy (CT) given after anti-PD-1 therapy (sequential strategy) or in combination with anti-PD-1 therapy after an unsatisfactory response to immunotherapy (concomitant strategy). We retrospectively analyzed these two clinical situations in 30 R/R HL pts from LYSA centers treated with anti-PD-1 therapy. Methods: We included R/R HL pts from 14 LYSA centers who received anti-PD-1 therapy in the context of clinical trials (N=4) or an authorization for temporary use (ATU) from the French medical drug agency (N=26). Before the anti-PD-1 therapy, pts had received a median of six (range, 2-14) lines of therapy, 69% had HDT+ASCT, 14% had allograft and 93% had been treated with BV. We considered two groups of pts: i. 19 pts (63%) in whom the anti-PD-1 therapy was stopped at the introduction of CT (Group 1); ii. 11 pts (37%) with an unsatisfactory response to anti-PD-1 therapy in whom a combination of CT with immunotherapy was initiated to optimize the response (Group 2). The quality of the response after the introduction of CT was evaluated retrospectively by each treating physicians according to Cheson 2007 or 2014 criteria. We also determined whether new CT treatments after and in combination with anti-PD-1 therapy led to unexpected toxicities and whether new treatment schedules made pts eligible for allograft. Results: At the start of anti-PD-1, the median age of pts was 37 years old (range, 20-75), 24% had Ann Arbor III/IV stages, 34% had B symptoms and 21% had a performance status (PS) of 2-3. Patients received a median of 10 infusions (range, 2-52) of anti-PD-1 therapy with nivolumab (N=26, 87%) or pembrolizumab (N=4, 13%). The best responses achieved during anti-PD-1 therapy were a complete response (CR) for 5 patients, a partial response (PR) for 17 pts, stable disease (SD) for 2 pts and progression for 6 pts. In group 1, 17 pts were in progression, one pt in PR, and another pt in SD at the end of anti-PD-1 therapy alone. In group 1, after anti-PD-1 therapy, the pts were treated with vinblastine (N=3), gemcitabine (N=2) or bendamustine alone (N=3) or in combination with BV (N=4), GVD (N=1), ICE (N=1), DHAP (N=1), escalated BEACOPP (N=1), vinorelbine (N=1), vepeside (N=1) and caelyx (N=1). In group 2, before the combination, the response status was progression for 7 pts and PR for 4 pts. In group 2, to optimize the response to anti-PD-1, pts received vinblastine (N=7), gemcitabine (N=2) and BV (N=2). In the 28 evaluable pts, 11/18 (61%) in group 1 and 9/10 (90%) in group 2 showed an improved response after chemotherapy alone or combination with anti-PD-1 therapy respectively. In group 1, there were 6 CR (32%), 5 PR (26%), 1 SD (5%) and 6 PD (32%) (Figure 1B). In group 2, there were 5 CR (45%), 5 PR (45%) and 1 SD (10%) (Figure 1A). Of note, among the ten pts treated with vinblastine, 4 were in CR, 3 in RP, 1 in SD and 2 in progression. No unexpected toxicity was observed during the CT. Four pts had an allograft after the sequential CT (N=3) and concomitant CT strategy (N=1). Three pts were in CR 274, 279 and 480 days after the allograft and the fourth has not yet been evaluated. Allografts are now scheduled for 6 pts. With a median follow-up of 9.1 months (95%CI, 6.1-14) following the initiation of chemotherapy (alone or combined) the median PFS and OS were 8.4 and 14.6 months, respectively. Conclusions: Our retrospective study showed that pts with an unsatisfactory response or PD with anti-PD-1 therapy had a new objective response with CT alone (61%) or CT in combination with anti-PD-1 therapy (90%). This response could make some pts eligible for allograft. Prospective clinical trials are needed to confirm the synergistic effect of CT with anti-PD-1 therapy and to determine which CT provides the best results in combination with these checkpoint inhibitors. Figure 1 Figure 1. Disclosures Ysebaert: Janssen: Consultancy, Research Funding, Speakers Bureau. Ghesquières: Celgene and Mundipharma: Consultancy, Honoraria; Roche: Research Funding.

Analysis of therapy effectiveness of deep vein thrombosis of lower limbs with warfarin and rivaroxaban in the long-term period

2020 ◽  
Author(s):  
А.А. Полянцев ◽  
Д.В. Фролов ◽  
Д.В. Линченко ◽  
Ю.В. Щелокова ◽  
Т.А. Литвинова ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Oral Anticoagulants ◽  
Lower Limbs ◽  
Prophylactic Regimen ◽  
Therapy Regimen ◽  
Vein Thrombosis ◽  
Group 2 ◽  
Deep Vein ◽  
Group 1

Введение. Влияние стандартной и альтернативных схем антикоагулянтной терапии на степень и скорость реканализации глубоких вен привлекает внимание современных исследователей. Цель исследования: сравнение эффективности терапии тромбоза глубоких вен (ТГВ) нижних конечностей варфарином и ривароксабаном в отдаленном периоде. Материалы и методы. В исследование включено 94 пациента с ТГВ нижних конечностей, которые были разделены на 2 группы в зависимости от назначенной схемы лечения. Средний возраст 50 пациентов группы 1 составил 44,0 12,6 лет, 44 больных группы 2 39,5 11,7 лет. Пациентам группы 1 был назначен варфарин, группы 2 ривароксабан в течение 6 мес после выписки. Конечная точка наблюдения 4 года. Результаты. Прием антикоагулянта ранее установленного срока прекратили 18 (36) пациентов из группы 1 и 2 (4,5) пациента из группы 2. Режим эластической компрессии в обеих группах пациенты соблюдали нерегулярно. Рецидив венозных тромбоэмболических осложнений в группе 1 отмечен в 11 (22) случаях, в группе 2 у 7 (15,9) пациентов. Отрицательная динамика ультразвукового обследования складывалась у пациентов обеих групп: у 16 пациентов группы 1 и у 9,1 группы 2 появились признаки поражения ранее неизмененных вен или окклюзия ранее проходимой вены после перенесенного тромбоза без клиники острого венозного тромбоза в анамнезе. Трофические расстройства отмечены у одного пациента группы 2 и у 1/3 пациентов группы 1 к четвертому году наблюдения. Значимые отличия между группами были получены по таким параметрам, как приверженность к лечению и степень тяжести венозной недостаточности, оцениваемая клинически, в пользу ривароксабана. Заключение. Неудовлетворительные результаты лечения при использовании стандартной схемы терапии ТГВ требуют назначения препаратов из группы новых оральных антикоагулянтов с возможным внедрением схемы профилактического приема. Introduction. Effect of standard and alternative anticoagulant therapy regimens on the degree and rapidity of deep vein recanalization attracts the attention of modern researchers. Aim: to compare the treatment effectiveness of deep vein thrombosis (DVT) of lower limbs with warfarin and rivaroxaban in the long-term period. Materials and methods. The study included 94 patients with DVT of lower limbs they were divided into 2 groups depending on the prescribed treatment regimen. The average age of 50 patients of group 1 was 44.0 12.6 years, 44 patients of group 2 39.5 11.7 years. Warfarin was prescribed to patients of group 1, rivaroxaban to patients of group 2 treatment was prescribed for 6 months after discharge. The endpoint of observation was 4 years. Results. 18 (36) patients from group 1 and 2 (4.5) patients from group 2 stopped taking the anticoagulant earlier than target date. Elastic compression treatment patients in both groups kept irregularly. Recurrence of venous thromboembolic complications in group 1 was noted in 11 (22) cases, in group 2 in 7 (15.9) patients. The negative ultrasound dynamics was observed in patients of both groups: 16 of patients in group 1 and 9.1 in group 2 had lesion signs of previously unchanged veins or occlusion of a previously passable vein after thrombosis without clinic of acute venous thrombosis. Trophic disorders were identified in 1 patient in group 2 and in 1/3 of patients in group 1 by the 4th year of observation. Significant differences between the groups were obtained in favor of rivaroxaban according to such parameters as adherence to treatment and the severity of venous insufficiency. Conclusion. Unsatisfactory results of DVT treatment with standard therapy regimen require the administration of new oral anticoagulants with the possible introduction of prophylactic regimen.

Abstract 15073: Best Anticoagulation Strategy for Stroke Prophylaxis in Atrial Fibrillation Patients With Amyloidosis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sanghamitra Mohanty ◽  
CHINTAN G TRIVEDI ◽  
Joseph Gallinghouse ◽  
Domenico G Della Rocca ◽  
Carola Gianni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Bleeding Complications ◽  
Considerable Proportion ◽  
Medical Procedure ◽  
Bleeding Events ◽  
Full Dose ◽  
Half Dose ◽  
Group 2 ◽  
Group 1

Background: A considerable proportion of elderly patients are known to have coexistent atrial fibrillation (AF) and amyloidosis. Both conditions increase stroke risk. Objective: We evaluated the best anticoagulation strategy in a series of AF patients with amyloidosis. Methods: Consecutive AF patients with coexistent amyloidosis undergoing catheter ablation at our center were included in the analysis. Based on the stroke-prophylaxis approach they were divided into 2 groups; group 1: left atrial appendage occlusion (LAAO) with Watchman and group 2: oral anticoagulation. Following LAAO, all patients remained on full dose non-vitamin K oral anticoagulants (NOAC) for 45 days. Transesophageal echocardiogram (TEE) was performed at 45 days to assess completeness of closure. If the occlusion was complete, patients were kept on aspirin, 81 mg/day for long-term. In case of leak or dense ‘smoke’ in the left atrium (LA) or enlarged LA, they were prescribed half-dose NOAC. NOACs included dabigatran, apixaban, endoxaban and rivaroxaban. Group 2 patients remained on full-dose NOAC during the whole study period (1 year). All patients were prospectively followed up for 1 year. Results: A total of 87 patients were included in the analysis; group 1: 56 and group 2: 31 . CHA 2 DS 2 -VASc score was comparable between the groups (gr. 1: 3.7±1.6 and gr. 2: 3.2±1.7, p=0.18). The most commonly used NOACs were apixaban (45, 51.7%) and rivaroxaban (34, 39%). After the 45-day TEE, 34 patients from group 1 remained on baby-aspirin and 22 on half-dose NOAC. Of the 22, 12 patients had leaks <5 mm, 6 had large LA (mean diameter 5.2±1.4 cm) and 4 patients had dense LA smoke. At 1-year follow-up, 3 stroke and 1 transient ischemic attack were reported in group 1 on baby-aspirin (4/34, 11.8%). No stroke or bleeding complications occurred in the 22 patients on half-dose NOAC. In group 2 patients on full-dose OAC, a total of 5 (5/31, 16.1%) bleeding events (1 subdural hematoma and 4 GI bleedings) were recorded. Additionally, a stroke was reported that happened during brief discontinuation of OAC for another medical procedure. Conclusion: In our series of patients with coexistent AF and amyloidosis, half-dose NOAC following LAA occlusion procedure was observed to be the safest stroke-prophylaxis strategy.

scholarly journals Direct Oral Anticoagulants for the Treatment of Acute Venous Thromboembolism Associated with Cancer: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 120 (07) ◽  
pp. 1128-1136 ◽  
Author(s):  
Michela Giustozzi ◽  
Giancarlo Agnelli ◽  
Jorge del Toro-Cervera ◽  
Frederikus A. Klok ◽  
Rachel P. Rosovsky ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Recurrent Vte ◽  
Acute Venous Thromboembolism

Abstract Background International guidelines have endorsed the use of edoxaban or rivaroxaban as an alternative to low-molecular-weight heparin (LMWH) for the treatment of acute venous thromboembolism (VTE) in cancer patients. Recently, a large randomized controlled trial of apixaban versus dalteparin in patients with cancer was completed. We performed an updated meta-analysis to assess the efficacy and safety of direct oral anticoagulants (DOACs) versus LMWH in patients with cancer-associated VTE. Methods MEDLINE, EMBASE, and CENTRAL (Cochrane Controlled Trials Registry) were systematically searched up to March 30, 2020 for randomized controlled trials comparing DOACs versus LMWH for the treatment of VTE in patients with cancer. The two coprimary outcomes were recurrent VTE and major bleeding at 6 months. Data were pooled by the Mantel–Haenszel method and compared by relative risk ratios (RRs) and 95% confidence intervals (CIs). Results Four randomized controlled studies (2,894 patients) comparing apixaban, edoxaban, or rivaroxaban with dalteparin were included in the meta-analysis. Recurrent VTE occurred in 75 of 1,446 patients (5.2%) treated with oral factor Xa inhibitors and in 119 of 1,448 patients (8.2%) treated with LMWH (RR 0.62; 95% CI 0.43–0.91; I 2, 30%). Major bleeding occurred in 62 (4.3%) and 48 (3.3%) patients receiving oral factor Xa inhibitors or LMWH, respectively (RR 1.31; 95% CI 0.83–2.08; I 2, 23%). Conclusion In patients with cancer-associated VTE, oral factor Xa inhibitors reduced the risk of recurrent VTE without a significantly higher likelihood of major bleeding at 6 months compared with LMWH.

Cyclophosphamide-induced disturbance of gonadotropin secretion manifesting testicular damage

1992 ◽  
Vol 126 (2) ◽  
pp. 143-148 ◽  
Author(s):  
Jantine JG Hoorweg-Nijman ◽  
Henriette A Delemarre-van de Waal ◽  
Frans C de Waal ◽  
Henk Behrendt
Keyword(s):  
Reference Group ◽  
Semen Analysis ◽  
Cytotoxic Drugs ◽  
Gonadal Function ◽  
Testicular Damage ◽  
Gonadotropin Secretion ◽  
Group 2 ◽  
Normal Men ◽  
Almost All ◽  
Group 1

Gonadal function was evaluated in 23 men (aged 14.8–28.8 years) treated in childhood with cytotoxic drugs for a solid tumour. Group 1 (N = 14) had been treated with non-alkylating drugs only, while group 2 (N=9) received the alkylating drug cyclophosphamide in addition (range 3.8–19.5 g/m2). Median age at the start of treatment was 4.6 years (range 0.6–16.1) in group 1 and 13.9 years (range 3.7–16.9) in group 2. Data of the patients were compared with a reference group consisting of 14 normal men. Almost all patients of both groups showed normal development of puberty; 13 of the 14 men in group 1 showed normal hormonal values. In group 2, basal LH and FSH as well as the LH and FSH responses to GnRH showed higher levels compared to those of a reference group (p<0.001). Correlation analysis showed an evident correlation between the total dose of received cyclophosphamide and the basal FSH level (r=0.78; p=0.002), the FSH response to GnRH (r=0.73; p=0.002) and the LH response to GnRH (r=0.67; p=0.002). There was no correlation between the hormonal parameters and the doses of the other cytotoxic drugs. Semen analysis showed azoospermia in four boys of group 2 and in none of group 1. Two patients in group 2 had an elevated FSH response to GnRH while their semen analysis was normal. Conclusions: (1) There is a dose-response relationship between the basal FSH. the LH and FSH responses to GnRH and the dose of cyclophosphamide. In all cyclophosphamide-treated patients the FSH response to GnRH increased. (2) Increased gonadotropin secretion can be found while semen analysis is normal; an increased FSH response to GnRH can be the first manifestation of testicular damage. (3) Evaluation of gonadotropins, both basal and stimulated LH and FSH values, is an easy and useful method for following up gonadal function in cyclophosphamide-treated men, especially for detecting early and subtle testicular damage.

scholarly journals Cardiometabolic Risk Factor in Obese and Normal Weight Individuals in Community Dwelling Men

2020 ◽  
Vol 17 (23) ◽  
pp. 8925
Author(s):  
Hyunsoo Kim ◽  
Kijeong Kim ◽  
Sohee Shin
Keyword(s):  
Waist Circumference ◽  
Cardiometabolic Risk ◽  
Reference Group ◽  
Normal Weight ◽  
Community Dwelling ◽  
Cross Sectional ◽  
High Blood Glucose ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

The aim of this study was to investigate the cardiometabolic risk factors (CRFs) in community dwelling men based on a combination of body mass index (BMI) and waist circumference (WC). This cross-sectional study was based on 867 males between the ages of 20 and 71 years. Subjects were categorized into 4 groups by BMI and WC (Group 1, BMI < 25 kg/m2 and WC < 90 cm; Group 2, BMI < 25 kg/m2 and WC > 90 cm; Group 3, BMI > 25 kg/m2 and WC < 90 cm; and Group 4 BMI > 25 kg/m2 and WC > 90 cm). The proportion of subjects with a normal weight with high WC was 3.2%. Among normal weight men with the high range of WC, significantly high Odds ratios (ORs) and 95% CI were found for hypertriglyceridemia (3.8, 1.8–8.2) and high blood glucose (3.2, 1.5–6.9). The probability that the general obesity group (Group 3) had one CRF was around twice that of the reference group (Group 1) (1.9 to 2.1 times), but Group 2 had probability more than 4 times higher (4.3 to 4.6 times). In community dwelling adult men, normal weight with high waist circumference was associated with the highest cardiometabolic risk. In conclusion, follow-up screening of those with high WC may be necessary to detect and prevent cardiometabolic diseases, particularly for men with a normal weight.

P4766Edoxaban Treatment in routiNe clinical prActice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe): 1-year follow-up according to body mass index

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Weiss ◽  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Weight ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Normal Weight ◽  
Routine Practice ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), and available routine care data have so far broadly confirmed the safety of different NOACs in routine practice. However, such data for edoxaban are scarce, especially in extremely low and high body weight (BW). These extreme BWs may affect the bioavailability, distribution, and half-life of NOACs and, consequently, outcomes of treatment. Methods We analysed outcomes in normal-weight (BMI 18.5–25) vs overweight (BMI 25–30) and obese (BMI >30) patients enrolled into the ETNA-AF-Europe observational study (NCT02944019) collecting information on patients treated with edoxaban in 825 sites in 10 European countries. This snapshot analysis set includes data of 7,672 patients (56.3% of all enrolled patients) which have completed their 1-year follow-up visit (mean follow-up: 343.5 days). Results Median patient age was 74 years for all patients, 76 years for patients with a BMI 18.5–25 (group 1), 75 years for patients with BMI 25–30 (group 2), and 72 for patients with a BMI >30 (group 3). CrCl was 64 mL/min for patients with a BMI 18.5–25, 68 mL/min for patients with BMI 25–30, and 72 mL/min for patients with a BMI >30. The CHA2DS2-VASc (mean 3.1±1.38) and HAS-BLED (mean 2.5±1.10) score did not differ significantly between groups. As expected, diabetes and hypertension were significantly less prevalent in leaner patients and - accordingly - inversely correlated to age. There was no correlation between body weight and life-threatening bleeding (group 1: 0.28%; group 2: 0.40%; group 3: 0.14%). Also, stroke rates (group 1: 0.74%; group 2: 0.81%; group 3: 0.76%) did not differ between groups. Conclusion BMI, within the range here assessed, does not affect 1-year outcomes in European AF patients treated with edoxaban. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany

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