scholarly journals Effectiveness and Safety of Apixaban vs. Warfarin in Venous Thromboembolism Patients with Obesity and Morbid Obesity

2021 ◽  
Vol 10 (2) ◽  
pp. 200
Author(s):  
Alexander Cohen ◽  
Janvi Sah ◽  
Theodore Lee ◽  
Lisa Rosenblatt ◽  
Patrick Hlavacek ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Lower Risk ◽  
Interaction Analysis ◽  
Patient Characteristics ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Diagnosis Codes ◽  
Obesity Status ◽  
Cox Proportional Hazard Models ◽  
Recurrent Vte

This study integrated 5 United States healthcare claims databases to evaluate the risk of recurrent venous thromboembolism (VTE) and major bleeding (MB) among VTE patients who initiated apixaban vs. warfarin, stratified by obesity. Obese and morbidly obese patients were identified based on diagnosis codes. Stabilized inverse probability treatment weighting (IPTW) was conducted to balance observed patient characteristics between treatment cohorts. An interaction analysis was conducted to evaluate treatment effects of apixaban vs. warfarin according to obesity status. Cox proportional hazard models were used to evaluate the risk of recurrent VTE and MB among IPTW weighted obese and morbidly obese patients. A total of 112,024 non-obese patients and 43,095 obese patients were identified, of whom 19,751 were morbidly obese. When stratified by obesity status post-IPTW, no significant interactions were observed for effects of apixaban vs. warfarin on recurrent VTE or MB (interaction p > 0.10). Among IPTW obese and morbidly obese patients, apixaban was associated with a significantly lower risk of recurrent VTE (obese: 0.73 [0.64–0.84]; morbidly obese: 0.65 [0.53–0.80]) and MB (obese: 0.73 [0.62–0.85]; morbidly obese: 0.68 [0.54–0.86]) as compared with warfarin. In this large sample of obese and morbidly obese VTE patients, apixaban had a significantly lower risk of recurrent VTE and MB vs. warfarin.

scholarly journals Effectiveness and Safety of Apixaban Vs Warfarin Among Venous Thromboembolism Patients Using Five US Databases: A Subgroup Analysis of Obesity

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 1-1
Author(s):  
Alexander T Cohen ◽  
Janvi Sah ◽  
Theodore Lee ◽  
Gail Wygant ◽  
Lisa Rosenblatt ◽  
...  
Keyword(s):  
Lower Risk ◽  
Research Funding ◽  
Interaction Analysis ◽  
Statistical Significance ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Patient Characteristics ◽  
Obese Patients ◽  
Increased Risk ◽  
Recurrent Vte

Background: Obesity is associated with an increased risk of VTE. Although four direct oral anticoagulants (DOACs) have been approved for the treatment of VTE, limited real-world evidence is available on their effectiveness and safety in obese patients. This study pooled 5 US healthcare claims databases to evaluate the risk of recurrent VTE, major bleeding (MB), and clinically relevant non-major (CRNM) bleeding among VTE patients initiating apixaban or warfarin stratified by obesity. Methods: A pooled retrospective study of adult VTE patients who initiated apixaban or warfarin from 01MAR2014-31DEC2018 was conducted using CMS Medicare and four other claims databases. Patients were followed to the earliest of: index therapy discontinuation, switch to another oral anticoagulant, initiation of a new parenteral anticoagulant, health plan disenrollment, death, study end, or a maximum of 6 months. Stabilized inverse probability treatment weighting (IPTW) was conducted to balance patient characteristics between the treatment cohorts within each database. After pooling post-IPTW cohorts from the five databases, subgroup interaction analysis was conducted to evaluate whether treatment effects were consistent across patients with and without obesity. Obesity was identified based on diagnosis codes that indicated obesity or codes that indicated a body mass index of at least 30. Cox proportional hazard models were used to evaluate the risk of recurrent VTE, MB, and CRNM bleeding. The statistical significance (P<0.10) of the interaction between treatment and obesity was evaluated. Results: After applying eligibility criteria, 60,786 VTE patients were selected into the apixaban treatment cohort, and 94,333 were selected into the warfarin treatment cohort. Apixaban patients were younger (65 vs 67 years) and had a lower mean CCI (2.1 vs. 2.3) compared to warfarin patients. After IPTW, all patient characteristics were balanced. In the post-IPTW population, apixaban was associated with a significantly lower risk of recurrent VTE, MB, and CRNM bleeding compared to warfarin during the follow-up (p<0.001 [Figure]). When stratified by obesity, for each treatment cohort, obese patients were younger (64-65 vs. 68 years), more likely to be diagnosed with PE (51.2%-53.0% vs. 39.9%-40.5%), experienced a higher proportion of provoked VTE events (63.3-63.9% vs. 53.3-53.7%), had higher mean CCI (2.6-2.7 vs. 2.0) and were more likely to have comorbidities such as hypertension (80.2%-80.3% vs. 64.7%-64.8%), hyperlipidemia (57.1%-57.8% vs. 44.6%-44.7%), and diabetes (41.9%-43.9% vs. 24.4-26.7%) compared to non-obese patients. Comparison of apixaban with warfarin when stratifying by obesity showed consistently lower risk of recurrent VTE, MB, and CRNM bleeding associated with apixaban across obese and non-obese patients and these subgroup findings were consistent with those of the overall population. No significant interactions were observed for treatment and obesity on recurrent VTE, MB, or CRNM bleeding (Figure). Conclusion: In the VTE patients initiating apixaban or warfarin, obese patients showed differences in patient characteristics as compared to non-obese patients. Across subgroups of patients with and without obesity, apixaban patients had a lower risk of recurrent VTE, MB, and CRNM bleeding compared to warfarin patients, which was consistent with the overall population results. These findings may be useful in informing treatment decisions for this high-risk subgroup of VTE patients. Disclosures Cohen: Pfizer, Inc.: Research Funding; Bristol-Myers Squibb Company: Research Funding. Sah:Bristol-Myers Squibb Company: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company; Pfizer, Inc.: Other: I am a paid employee of STATinMED Research which is a paid consultant to Pfizer, Inc.. Lee:Pfizer, Inc.: Current Employment. Wygant:Bristol-Myers Squibb Company: Current Employment. Rosenblatt:Bristol-Myers Squibb Company: Current Employment. Hlavacek:Pfizer, Inc.: Current Employment. Emir:Pfizer, Inc.: Current Employment. Keshishian:Pfizer, Inc.: Other: I am a paid employee of STATinMED Research which is a paid consultant to Pfizer, Inc.; Bristol-Myers Squibb Company: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company.. Delinger:Bristol-Myers Squibb Company: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company.; Pfizer, Inc.: Other: I am a paid employee of STATinMED Research which is a paid consultant to Pfizer, Inc.. Luo:Pfizer, Inc.: Current Employment.

scholarly journals Effectiveness and Safety of Apixaban versus Warfarin in Venous Thromboembolism Patients with Chronic Kidney Disease

2021 ◽  
Author(s):  
Alexander T. Cohen ◽  
Janvi Sah ◽  
Amol D. Dhamane ◽  
Theodore Lee ◽  
Lisa Rosenblatt ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Venous Thromboembolism ◽  
Kidney Disease ◽  
Lower Risk ◽  
Treatment Effects ◽  
Interaction Analysis ◽  
Oral Anticoagulants ◽  
Cohort Analysis ◽  
Ckd Stage ◽  
Recurrent Vte

AbstractThere has been limited evidence reported about the outcomes of oral anticoagulants among patients with venous thromboembolism (VTE) and chronic kidney disease (CKD), especially those with stage V/end-stage renal disease (ESRD). This retrospective cohort analysis of five U.S. claims databases evaluated the risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB) for apixaban versus warfarin among VTE patients diagnosed with CKD, including ESRD. Inverse probability treatment weighting (IPTW) was used to balance patient characteristics between treatment cohorts. Hazard ratios (HRs) were calculated for recurrent VTE, MB, and CRNMB among patients with CKD who experienced an index VTE. An interaction analysis was conducted to evaluate treatment effects across different stages of CKD. A total of 29,790 VTE patients with CKD were selected for analyses, of whom 10,669 (35.8%) initiated apixaban and 19,121 (64.2%) initiated warfarin. Among IPTW-balanced patient cohorts, the apixaban group had significantly lower risk of recurrent VTE (HR: 0.78; 95% confidence interval [CI]: 0.66–0.92), MB (HR: 0.76; 95% CI: 0.65–0.88), and CRNMB (HR: 0.86; 95% CI: 0.80–0.93) than the warfarin group. When stratified by CKD stage (stage I/II: 8.2%; stage III: 49.4%; stage IV: 12.8%; stage V/ESRD: 12.0%; stage unspecified: 17.6%), no significant interaction was observed for effects of apixaban versus warfarin on recurrent VTE or MB. In summary, apixaban was associated with a significantly lower risk of recurrent VTE and MB than warfarin among VTE patients with CKD. CKD stages did not have significant impact on treatment effects for recurrent VTE and MB.

scholarly journals Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 326-326 ◽  
Author(s):  
Alexander T Cohen ◽  
Allison Keshishian ◽  
Theodore Lee ◽  
Gail Wygant ◽  
Lisa Rosenblatt ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Lower Risk ◽  
Select Committee ◽  
Advisory Committees ◽  
Recurrent Vte ◽  
High Risk Cancer ◽  
Similar Risk ◽  
Active Cancer

BACKGROUND: Venous thromboembolism (VTE) is the second leading cause of death in cancer patients. The treatment of cancer-associated VTE carries a significantly greater risk of major bleeding (MB) and recurrent VTE compared to that in non-cancer patients. CHEST Guidelines suggest the use of low molecular weight heparin (LMWH) over a vitamin K antagonist (VKA) in patients diagnosed with VTE and cancer. The last decade has seen an emergence of non-VKA anticoagulants (NOACs) for the treatment of VTE. Despite completed and ongoing clinical trials, there is a lack of real-world evidence comparing the effectiveness and safety of LWMH with VKAs and NOACs among VTE patients with active cancer. Therefore, this study evaluates the risk of MB, clinically relevant non-MB (CRNMB), and recurrent VTE (fatal or non-fatal) among VTE patients with active cancer prescribed apixaban, LMWH, or warfarin in routine clinical practice. METHODS: Four US commercial insurance claims databases were used to identify VTE patients with active cancer (defined as cancer diagnosis or cancer treatment [chemotherapy, radiation and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30-days following the first VTE event (01SEP2014-31MAR2018). Patients who used LMWH as bridging therapy for warfarin (≤14 days before or after warfarin initiation) were classified as warfarin users. Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Additional analysis using all available follow-up was also conducted. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. Cox proportional hazard models were used to evaluate the risk of MB, CRNMB, and recurrent VTE. RESULTS: After applying all eligibility criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. The mean follow-up was 105, 88, and 113 days for apixaban, LMWH, and warfarin, respectively. Among the weighted VTE cancer population, 51% of the patients had metastatic cancer and 77% of patients received cancer treatment. Further, 15% of patients had very high-risk cancer (brain, stomach, or pancreas), and 40% patients had high-risk cancer (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma). Apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients also had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH (Figure). When the entire available follow-up period (mean follow-up was 137, 106, and 166 days for apixaban, LMWH, and warfarin, respectively) was used, the trends were similar to the 6-month analysis for apixaban vs. LMWH and warfarin vs. LMWH. However, apixaban patients were associated with a lower risk of both MB and recurrent VTE compared to warfarin patients. CONCLUSION: VTE patients with active cancer initiating apixaban had significantly lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH patients. Apixaban patients also had a lower risk of recurrent VTE compared to warfarin patients. These results may be helpful for clinicians in evaluating different anticoagulation treatments for VTE patients with active cancer. Further studies are needed to evaluate these outcomes between different anticoagulation treatment options. Figure Disclosures Cohen: Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; ACI Clinical: Consultancy; Navigant: Consultancy; McKinsey: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy; Aspen: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boston Scientific: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; GLG: Consultancy; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.

Factors Predictive of Venous Thromboembolism in Bariatric Surgery

2011 ◽  
Vol 77 (10) ◽  
pp. 1403-1406 ◽  
Author(s):  
Hossein Masoomi ◽  
Brian Buchberg ◽  
Kevin M. Reavis ◽  
Steven D. Mills ◽  
Michael Stamos ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Gastric Bypass ◽  
Venous Thromboembolism ◽  
Surgical Techniques ◽  
Significant Risk ◽  
Patient Characteristics ◽  
Morbidly Obese ◽  
Open Gastric Bypass ◽  
Open Operation ◽  
Surgical Options

Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in bariatric surgery. The aim of this study was to evaluate the effect of patient characteristics, payer type, comorbidities, and surgical techniques on development of VTE in bariatric surgery. Using the National Inpatient Sample (NIS) database from 2006 to 2008, clinical data of 304,515 morbidly obese patients who underwent bariatric surgery were examined. Multiple regression analysis was performed to identify factors predictive of VTE. The overall rate of in-hospital VTE was 0.17 per cent, with the highest rate of VTE observed in open gastric bypass (0.45%). The VTE rate was significantly lower in laparoscopic compared with open gastric bypass (0.13% vs 0.45%, respectively, P < 0.01) and in nongastric bypass compared with gastric bypass procedures (0.06% vs 0.21%, respectively, P < 0.01). Alcohol abuse [odds ratio (OR): 8.7], open operation (OR: 2.5), gastric bypass procedures (OR: 2.4), renal failure (OR: 2.3), congestive heart failure (OR: 2.0), male gender (OR: 1.5), and chronic lung disease (OR: 1.4) were associated with a higher rate of VTE. This study identified several significant risk factors for development of VTE in bariatric surgery. To minimize the risk of VTE, surgeons may consider these factors in selection of appropriate prophylaxis and bariatric surgical options.

scholarly journals Efficacy and Safety of Direct Oral Factor Xa Inhibitors in 795 Morbidly Obese Patients

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 423-423 ◽  
Author(s):  
Margarita Kushnir ◽  
Yun Choi ◽  
Ruth Eisenberg ◽  
Devika Rao ◽  
Seda Tolu ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Research Funding ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Prescription Date ◽  
Recurrent Vte

Abstract Background: Studies of acute venous thromboembolism (VTE) and non-valvular atrial fibrillation (AF) have shown comparable therapeutic efficacy and similar or lower bleeding risk for direct oral anticoagulants (DOACs) compared to warfarin. Because the representation of morbidly obese patients (BMI ≥40 kg/m2) in pivotal clinical trials has been minimal, efficacy and safety of DOACs in this population are unclear. Our goal was to investigate whether direct oral factor Xa inhibitors, apixaban and rivaroxaban, are as effective and safe as warfarin in morbidly obese (BMI ≥40) patients. Methods: Using our institutional database, we identified all adult patients at Montefiore Medical Center with BMI ≥40 who were started on anticoagulation with apixaban, rivaroxaban or warfarin, for either AF or VTE, between March 1, 2013 and March 1, 2017. We reviewed charts to obtain detailed information on patient demographics and to document clinical outcomes of recurrent VTE, ischemic stroke (CVA) and bleeding from the first prescription date to the earliest of a thrombotic event, discontinuation of medication, death, or June 30, 2017. VTE and CVA episodes were confirmed by imaging (compression sonography, CT scans, ventilation/perfusion scans, MRIs). Bleeding events were classified according to criteria from the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Analyses were stratified by anticoagulation indication. Chi-squared tests or Fisher's exact tests were used to assess statistical significance of the differences in VTE, CVA and bleeding rates between anticoagulant cohorts. Differences in times from first prescription date to VTE, CVA and bleeding were analyzed with Kaplan-Meier curves, Log-rank tests, and Cox proportional hazards models. Data were adjusted for age, CHA2DS2-VASc, and Charlson scores. Subgroup analyses were performed for patients with BMI ≥50 kg/m2. Results: Data on 795 patients were collected. In 366 patients with a history of VTE, the rates of recurrent VTE were low and comparable among the apixaban, rivaroxaban and warfarin cohorts [1/47 (2.1%), 3/152 (2%), and 2/167 (1.2%), respectively, p=0.74]. In the subgroup of individuals with BMI ≥50 kg/m2 (n=92), none of the 40 DOAC patients had recurrent VTE. The rates of clinically relevant bleeding, including major bleeding, among VTE patients, were comparable between the three cohorts. Among the 429 patients with AF, stroke rates were also low and similar among anticoagulant cohorts [1/103 (1%) for apixaban, 4/174 (2.3%) for rivaroxaban, and 2/152 (1.3%) for warfarin, p=0.71]. CVAs were similarly rare in patients with BMI ≥50 (1/19 patients on apixaban, 0/37 on rivaroxaban and 1/44 patients on warfarin). In the AF sample, there was no statistically significant difference in the rate of bleeding, including major bleeding, among the 3 cohorts. In an analysis with combined DOAC cohort (apixaban + rivaroxaban vs. warfarin), the recurrent VTE and stroke rates were still low and comparable. There were more major bleeding events in AF patients on warfarin than the combined DOAC cohort (7.9% vs. 2.9%, p=0.02), a finding that became non-significant when adjusted for age, CHA2DS2-VASc, and Charlson scores (p=0.06). The rates of bleeding, including major bleeding, were comparable among the three anticoagulants in both VTE and AF patients with BMI ≥50. Conclusions: Our study is the largest study examining morbidly obese patients on DOACS and provides further evidence of comparable efficacy and safety of the direct oral anti-Xa inhibitors, compared to warfarin, in morbidly obese patients with AF and VTE. Disclosures Kushnir: Janssen: Research Funding. Billett:Bayer: Consultancy; Janssen: Research Funding.

The Morbidly Obese Surgical Patient

2020 ◽  
Author(s):  
Michael A. Schweitzer ◽  
Gregory Grimberg
Keyword(s):  
Weight Loss ◽  
Obstructive Sleep Apnea ◽  
Venous Thromboembolism ◽  
Sleep Apnea ◽  
Children And Adolescents ◽  
Respiratory Insufficiency ◽  
Gastric Surgery ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Obstructive Sleep

Over the past few decades, the incidence of obesity has been steadily rising in the United States. The Centers for Disease Control and Prevention estimates greater than 40% of the US adult population is obese. Rising obesity rates are also increasing among children and adolescents as well, with nearly one in five children and adolescents considered obese. As a result, surgeons today face the challenge of caring for an increasing number of morbidly obese patients, and this trend is expected to worsen over time. This review covers preoperative evaluation, obesity-related comorbidities, respiratory insufficiency, anesthesia in patients with respiratory insufficiency, intraoperative management, postoperative management, complications of gastric surgery for obesity, diabetes mellitus, wound care, and other obesity-related diseases. Figures show impaired pulmonary function in the morbidly obese improved significantly after weight loss induced by bariatric surgery, significant improvement in mean pulmonary arterial pressure in 18 patients, 3 to 9 months after gastric surgery-induced weight loss of 42% ± 19% of excess weight, and a chronic venous stasis ulcer present for several years in a morbidly obese patient. The tables list evaluation and treatment of obstructive sleep apnea, and indications for extended postoperative chemoprophylaxis for venous thromboembolism in morbidly obese patients. This review contains 3 highly rendered figures, 2 tables, and 46 references Keywords: morbid obesity, obesity, metabolic surgery, venous thromboembolism chemoprophylaxis, Obstructive Sleep Apnea

Abstract 14569: Direct Oral Anticoagulants in the Treatment of Acute Venous Thromboembolism in Obese Patients: A Systematic Review With Meta-analysis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Vicky Mai ◽  
Emmanuelle Marceau-Ferron ◽  
Laurent BERTOLETTI ◽  
Yves Lacasse ◽  
Sebastien Bonnet ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Data Extraction ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Random Effect ◽  
Random Effect Model ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Efficacy And Safety

Background: Obesity is a real burden and its prevalence is constantly increasing. High body weight is a risk factor for developing venous thromboembolism (VTE). Direct oral anticoagulants’ (DOAC) pharmacokinetics and pharmacodynamics are affected by obesity. Their efficacy and safety in obese (BMI ≥30kg/m 2 ) and morbidly obese (BMI ≥40kg/m 2 ) patients are still unclear in the treatment of VTE. Objectives: To compare the efficacy and safety of DOAC with vitamin K antagonist (VKA)/low molecular weight heparin (LMWH) in the acute treatment of VTE in obese and morbidly obese patients. The primary efficacy outcome was VTE recurrences. The safety outcomes were major bleeding (MB) and clinically relevant non-MB (CRNMB). All-cause mortality was also assessed. Hypothesis: We hypothesized that DOAC would present the same efficacy and safety for the treatment of acute VTE in obese and morbidly obese patients compared to VKA/LMWH. Methods: A systematic literature search (MEDLINE, EMBASE, CENTRAL, Web of Science) was conducted from inception to April 15 th 2020, identifying trials studying DOAC in the treatment of acute VTE in obese patients. Studies were included if one of the outcomes was reported. Two independent reviewers performed the study selection, data extraction, risk of bias assessment and strength of body evidence evaluation using the GRADE methodology. Analyses were conducted using the Mantel-Haenszel method based on a random-effect model. Relative risks (RR) were estimated for the effect measure with 95% confidence intervals. Results: From 1240 citations screened, we included 21 studies (58,590 patients). VTE recurrences was similar with DOAC compared to VKA/LMWH in obese patients (risk ratio (RR): 1.03; 95%CI 0.93-1.15; p=0.55) and morbidly obese patients (RR 1.06; 95CI 0.94-1.19; p=0.35). DOAC was associated with a reduction in MB in obese patients (RR 0.57; 95%CI 0.34-0.94; p=0.03) and morbidly obese patients (RR 0.71; 95%CI 0.50-1.00; p=0.05) compared to VKA/LMWH. In obese patients, no difference was observed in CRNMB with DOAC compared to VKA/LMWH. Conclusion: DOAC is as effective in reducing VTE and is associated with less MB compared to VKA/LMWH in obese and morbidly obese patients.

Efficacy and safety of direct oral anticoagulant in morbidly obese patients with atrial fibrillation: systematic review and meta-analysis

2021 ◽  
Author(s):  
Sittinun Thangjui ◽  
Jakrin Kewcharoen ◽  
Ratdanai Yodsuwan ◽  
Angkawipa Trongtorsak ◽  
Harshith Thyagaturu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Lower Risk ◽  
Meta Analysis ◽  
Bleeding Risk ◽  
Normal Weight ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Direct Oral Anticoagulant ◽  
Efficacy And Safety

Abstract Aims  We conducted a systematic review and meta-analysis on three outcomes. We assessed the efficacy and safety of direct oral anticoagulants (DOAC) compared to vitamin K antagonists (VKA) in morbidly obese patients with atrial fibrillation (AF). We compared the efficacy and safety of DOAC in obese patients and non-obese patients with AF. Finally, we updated the current knowledge of outcomes of AF patients with obesity compared with normal-weight patients regardless of anticoagulation type. Methods and results  Using PubMed and Embase, we searched for literature published from inception to August 2020 for studies conducted in morbidly obese patients with AF who used DOACs and/or VKA for stroke or systemic embolism (stroke/SE) prevention that report efficacy and/or safety data. GRADE assessment was performed to determine the quality of the meta-analysis results. Direct oral anticoagulant was not statistically different from VKA in reducing stroke/SE with relative risk (RR) of 0.85 [95% confidence interval (CI): 0.56–1.29; very low certainty evidence]. Major bleeding risk was lower in the DOAC groups with RR of 0.62 (95% CI: 0.48–0.80; low certainty evidence). Obese patients with AF who used DOACs had lower risk of stroke/SE and similar major bleeding risk compared to non-obese patients with RR of 0.77 (95% CI: 0.70–0.84; low certainty evidence) and 1.02 (95% CI: 0.94–1.09; low certainty evidence), respectively. Obese patients with AF who used any type of anticoagulant had lower risk of stroke/SE compared to normal-weight patients with RR of 0.62 (95% CI: 0.57–0.69; low certainty evidence). Conclusion  The use of DOACs in morbidly obese patients may be reasonable if needed, and more dedicated studies are needed to make a more robust recommendation.

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