scholarly journals Thromboprophylactic Efficacy and Safety of Anticoagulants After Arthroscopic Knee Surgery: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 25 ◽  
pp. 107602961988140
Author(s):  
Yang Yu ◽  
Shitao Lu ◽  
Jinpeng Sun ◽  
Wei Zhou ◽  
Hongjian Liu
Keyword(s):  
Major Bleeding ◽  
Bleeding Event ◽  
Control Group ◽  
Controlled Trials ◽  
Number Needed To Treat ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Increased Risk ◽  
Significant Difference

To examine the efficacy and safety of anticoagulants after knee arthroscopy (KA), PubMed, EMBASE, databases of Cochrane Central Register of Controlled Trials, and Chinese National Knowledge Infrastructure were searched up to August 2019 for randomized controlled trials (RCT). Seven RCTs including 4097 patients were demonstrated eligible according to the inclusion and exclusion criteria. The efficacy and safety of thromboprophylaxis were assessed and expressed using relative risk (RR) and 95% confidence intervals (95% CIs). The analysis of pooled data showed that anticoagulants group exhibited significant lower overall incidence of symptomatic and asymptomatic venous thromboembolism (VTE; RR = 0.35, 95% CIs: 0.22-0.55, P < .00001), significant higher incidence of all bleeding events (RR = 1.42, 95% CIs: 1.08-1.86, P = .01) compared to control group. However, no significant difference was found in terms of incidence of symptomatic VTE (RR = 0.43, 95% CIs: 0.15-1.21, P = .11) and incidence of major bleeding events (RR = 1.87, 95% CIs: 0.40-8.67, P = .42). The pooled number needed to treat to prevent one symptomatic or asymptomatic VTE was 26, while the pooled number needed to harm to cause one major bleeding event was 869. These results show that anticoagulants can effectively reduce the overall risk of VTE after KA; however, the increased risk of bleeding should be fully considered. Further studies are required to address the risk–benefit calculus and cost-effectiveness of anticoagulants after KA.

scholarly journals Rivaroxaban for cancer-associated venous thromboembolism

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110121
Author(s):  
Bo Liang ◽  
Yi Liang ◽  
Li-Zhi Zhao ◽  
Yu-Xiu Zhao ◽  
Ning Gu
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
China National Knowledge Infrastructure ◽  
Bleeding Events ◽  
Significant Difference ◽  
Major Bleeding Events

All cancers can increase the risk of developing venous thromboembolism (VTE), and anticoagulants should be considered as an optimal treatment for patients suffering from cancer-associated VTE. However, there is still a debate about whether the new oral anticoagulant, rivaroxaban, can bring better efficacy and safety outcomes globally. Thus, this systematic review and meta-analysis was conducted to evaluate the efficacy and safety of rivaroxaban. We searched PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and China National Knowledge Infrastructure for relevant published papers before 1 September 2019, with no language restrictions. The primary outcomes are defined as the recurrence of VTE. The secondary outcomes are defined as clinically relevant non-major bleeding, adverse major bleeding events, and all-cause of death. The data were analyzed by Stata with risk ratio (RR) and 95% confidence interval (CI). Four trials encompassing 1996 patients were included. Rivaroxaban reduced recurrent VTE with no significant difference (RR = 0.68, 95% CI = 0.43–1.07). Similarly, there were no significant differences in adverse major bleeding events (RR = 0.86, 95% CI = 0.37–2.00), clinically relevant non-major bleeding (RR = 1.24, 95% CI = 0.73–2.12) and all-cause mortality (RR = 0.76, 95% CI = 0.40–1.44). In a selected study population of cancer patients with VTE, rivaroxaban is as good as other anticoagulants. Further, carefully designed randomized controlled trials should be performed to confirm these results.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals The safety of morphine use in acute coronary syndrome: a meta-analysis

Heart Asia ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. e011142 ◽  
Author(s):  
Rugheed Ghadban ◽  
Tariq Enezate ◽  
Joshua Payne ◽  
Haytham Allaham ◽  
Ahmad Halawa ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Major Bleeding ◽  
Pain Control ◽  
Controlled Trial ◽  
Cochrane Central Register ◽  
Minor Bleeding ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Significant Difference ◽  
All Cause Mortality

BackgroundMorphine is widely used for pain control in patients with acute coronary syndrome (ACS). Several studies have questioned the safety of morphine in this setting with a concern of interaction with and reduced efficacy of antiplatelet agents.ObjectiveThis study aims to systematically review the safety of morphine use in ACS.MethodsMEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were queried from inception through April 2018. Studies comparing morphine to nonmorphine use in ACS were included. Study endpoints included: in-hospital myocardial infarction (MI), all-cause mortality, stroke, major bleeding, minor bleeding and dyspnoea.ResultsA total of 64 323 patients with ACS were included from eight studies, seven of which were observational studies and one was a randomised controlled trial. The use of morphine was associated with increased risk of in-hospital recurrent MI (OR 1.30, 95% CI 1.18 to 1.43, p < 0.00001). There was, however, no significant difference in terms of all-cause mortality (OR 0.87, 95% CI 0.62 to 1.22, p = 0.44), stroke (OR 0.81, 95% CI 0.39 to 1.66, p = 0.57), major bleeding (OR 0.49, 95% CI 0.24 to 1.00, p = 0.05), minor bleeding (OR 0.98, 95% CI 0.41 to 2.34, p = 0.97), or dyspnoea (OR 0.55, 95% CI 0.16 to 1.83, p = 0.33).ConclusionThe use of morphine for pain control in ACS was associated with an increased risk of in-hospital recurrent MI. Randomised clinical trials are needed to further investigate the safety of morphine in ACS.

A phase I feasability study of concurrent fondaparinux (F) with carboplatin (Crb) and paclitaxel (P) for metastatic non-small cell lung cancer (NSCLC): An analysis of coagulation/angiogenic biomarker (CABM) kinetics.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19143-e19143
Author(s):  
David James Mooney ◽  
Debi Miley ◽  
Mary Jerome ◽  
Stefan C. Grant ◽  
Francisco Robert
Keyword(s):  
Major Bleeding ◽  
Metastatic Cancer ◽  
Bleeding Event ◽  
Stage Iv ◽  
Endothelial Damage ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Thrombotic Risk ◽  
Increased Risk ◽  
Angiogenic Biomarkers

e19143 Background: There is an association between risk of thrombosis and metastatic cancer. Chemotherapy (C) also independently increases thrombotic risk. This increased risk is multifactorial, including endothelial damage and release of angiogenic cytokines. We hypothesized that adding anticoagulation to C may decrease thrombotic risk and also, potentially, have anti-tumor effect. Methods: The primary aim of this study was to determine the tolerability and safety (bleeding events) of the combination of F with 21-day cycle chemotherapy (Crb AUC 6 + P 200 mg/m2) in two cohorts of untreated patients (pts) with stage IV NSCLC. The secondary objectives were to determine incidence of venous thrombosis (VT), changes in CABM parameters during treatment, and clinical efficacy endpoints. Two cohorts of pts received F from cycles 2-4 with Crb+P. Cohort A received 2.5 mg F daily from cycle 2-4. Cohort B received 7.5 mg of F on day 1, 2 of cycle 2-4 and 2.5 mg F on day 3-21. Results: Clinical data from 19 evaluable pts are as follows: median age 55 years, 63% male, and 32% adenocarcinoma. There was no major bleeding event (BE) in either cohort, and 5 pts had a minor BE. There was no VT. Median time to progression was 5 months (3.8-6.2 months), and overall survival was 10 months (4.3-15.6 months). Baseline values of sensitive markers of activated coagulation (D-Dimer, Thrombin Anti-Thrombin Complex) were above the normal range in most patients. These biomarkers tended to increase during the first cycle (without F); whereas the same markers decreased during the second cycle (with F). A reduction of the angiogenic biomarkers during therapy was observed with VEGF, TGF-β1, and Angiopoietin-1. Conclusions: Concurrent treatment with F and chemotherapy for metastatic NSCLC is feasible with no major bleeding and little minor bleeding. During chemotherapy, coagulant and angiogenic biomarkers tended to increase, perhaps suggesting an increase in thrombogenic state. When F was added, these markers trended downward, suggesting that the proangiogenic state associated with cancer may be significantly altered by anticoagulation. Clinical trial information: NCT00476216.

scholarly journals Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome or Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Yuttana Wonngsalap ◽  
Supakorn Ungsriwong ◽  
Wanalee Kumtepm ◽  
Surasak Saokaew ◽  
Vichai Senthong ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Observational Studies ◽  
Low Dose ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Percutaneous Coronary

Abstract Purpose To assess the efficacy and safety of prasugrel at low doses compared to clopidogrel by looking at the occurrence of major adverse cardiac events (MACE) and major bleeding in patients with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). Methods We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for eligible randomized controlled trials (RCTs) and observational studies assessing efficacy and safety of low-dose prasugrel versus clopidogrel in patients with ACS or undergoing PCI up to May 22, 2020. We did a meta-analysis using a random-effects model to estimate relative risks (RRs). The primary efficacy and safety endpoints were MACE and major bleeding, respectively. Results Six RCTs (n = 6,131) and six observational studies (n = 31,426) were included. There was no MACE reduction in patients receiving low-dose prasugrel compared with those receiving clopidogrel (RR 1.02, 95%CI 0.91 to 1.14), but there was an increased risk of major bleeding (RR 1.35, 95%CI 1.10 to 1.67). Conclusions Low-dose prasugrel yields no increase in efficacy when compared with clopidogrel, but it does expose patients to an increased risk of bleeding. Most studies considered here were conducted in Japan. Studies conducted with non-Asian patients may find that low-dose prasugrel offers a more favorable efficacy and risk profile. Considering the results of this analysis we believe low-dose prasugrel should be prescribed with extreme caution as it may result in bleeding events without any additional benefit over clopidogrel.

scholarly journals Electroacupuncture for Gastrointestinal Function Recovery after Gynecological Surgery: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-16
Author(s):  
Xiang Gao ◽  
Yuzhuo Zhang ◽  
Yizhe Zhang ◽  
YuTzu Ku ◽  
Yi Guo
Keyword(s):  
Large Scale ◽  
Ph Value ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Gastrointestinal Function ◽  
Cochrane Central Register ◽  
Gynecological Surgery ◽  
Function Recovery ◽  
Significant Difference

Background. Evidence for the efficacy and safety of electroacupuncture (EA) on gastrointestinal function recovery after gynecological surgery is unclear. Objective. This meta-analysis aimed to evaluate the effects of EA on recovery of postoperative gastrointestinal function for patients receiving gynecological surgery. Data sources: PubMed, Cochrane Central Register of Controlled Trials (CINAHL), Embase, China National Knowledge Infrastructure (CNKI), Weipu (CQVIP), and Wanfang databases were systematically searched from the inception dates to May 30, 2020, for relevant randomized controlled trials (RCTs). Study selection: RCTs that evaluated EA for postoperative gastrointestinal function directly related to gynecological surgery in adults aged 18 years or over. Data extraction and synthesis: paired reviewer independently extracted the data and assessed study quality. Standardized mean differences (SMD) were calculated as the effect measure from a random effects model. Main outcomes and measures: time to first flatus (TFF), time to bowel sounds recovery (TBS), and time to first defecation (TFD) were recorded as primary outcomes; postoperative nausea and vomiting (PONV), motilin (MTL), gastrin (GAS), pH value of gastric mucosa (pHi), gastric mucosal partial pressure of carbon dioxide (PgCO2), vasoactive intestinal peptide (VIP), and adverse event were reported as secondary outcomes. Results. We included eighteen RCTs (1117 participants). Our findings suggested that compared to the control group (CG), electroacupuncture group (EG) showed significant effects on TFF (SMD = −0.98, 95% CI: [−1.28, −0.68], P < 0.00001 , I2 = 69%), TBS (SMD = −0.98, 95% CI: [−1.84, −0.12], P = 0.03 , I2 = 92%), and TFD (SMD = −1.23, 95% CI: [−1.59, −0.88], P < 0.0001 , I2 = 0%). Moreover, the incidence of PONV at postoperative 6 h (OR = 0.42, 95% CI: [0.27, 0.64], P < 0.0001 , I2 = 0%) and 24 h (OR = 0.46, 95% CI: [0.32, 0.68], P < 0.0001 , I2 = 0%) was lower in the EG than that in the CG, whereas no significant difference in ratio of PONV at postoperative 48 h (OR = 0.55, 95% CI: [0.20, 1.51], P = 0.25 , I2 = 0%) was detected between the two groups. Meanwhile, there was a significant effect in favor of EA on the level of MTL at postoperative 6 h (SMD = −0.93, 95% CI: [−1.36, −0.61], P < 0.0001 , I2 = 21%), while no significant effect was observed at postoperative 24 h (SMD = −0.43, 95% CI: [−0.89, 0.02], P = 0.06 , I2 = 69%) in the EG when compared to the CG. Additionally, a large significant effect on decreasing PgCO2 was found in the EG in comparison to the CG, but no significant effect in favor of EA on GAS, VIP, or pHi was observed. It was reported that there was one participant with pain at the needling sites and bruising, and three participants withdrew because they were not intolerant to EA. Conclusions. EA could be a promising strategy for the prevention and treatment of gastrointestinal dysfunction after gynecological surgery, including shortening TFF and TFD, TBS, regulating MTL, and decreasing the ratio of PONV within postoperative 24h. The effects on MTL and PONV varied with different intervention points, and EA used at 30 min prior to surgery might be recommended. However, the evidence quality ranged from low to very low, and large-scale and high-quality RCTs were warranted.

Abstract 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Matthew R Weir ◽  
Lloyd Haskell ◽  
Jeffrey S Berger ◽  
Veronica Ashton ◽  
François Laliberté ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Data Availability ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Claims Database ◽  
Increased Risk

Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.

Does Thromboprophylaxis Reduce Mortality in Medical Patients? A Systematic Review and Meta-Analysis of Randomized Cntrolled Tials.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 905-905
Author(s):  
Francesco Dentali ◽  
Monica Gianni ◽  
Wendy Lim ◽  
James D. Douketis
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Good Evidence ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Medical Patients ◽  
Central Register ◽  
Increased Risk ◽  
Patients At Risk

Abstract Background: Despite good evidence that anticoagulants are effective in preventing venous thromboembolism in medical patients at risk for this disease, only one-third of such patients are receiving thromboprophylaxis. Underutilization of thromboprophylaxis in medical patients may be due to lack of evidence that thromboprophylaxis reduces mortality, concerns about anticoagulant-related bleeding, and questions about the clinical significance of surrogate (venographic) outcomes to assess efficacy in these trials. We performed a meta-analysis of randomized, placebo-controlled trials of anticoagulant thromboprophylaxis in medical patients to assess effects on mortality and bleeding. Methods: The MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases were searched until June 2005. Studies were included that were randomized, placebo-controlled trials investigated a prophylactic dose of unfractionated heparin, low-molecular-weight heparin, or fondaparinux in medical patients. Meta-analysis was done to obtain pooled estimates of the effects of anticoagulant thromboprophylaxis on mortality and clinically important (major) bleeding. The effect of treatment on venous thromboembolism was not pooled because of across-study difference in methods used to diagnose this, and use of asymptomatic (venographic) outcomes in some studies. Results: There were 8 studies of 20,631 patients in the assessment of mortality and 4 studies of 5,428 patients in the assessment of major bleeding. Death occurred in 536 of 10,321 (5.2%) patients who received thromboprophylaxis, and in 608 of 10,510 (5.8%) who received placebo. Thromboprophylaxis was associated with 10% decreased risk for all-cause mortality, although this effect was not quite statistically significant (odds ratio [OR] = 0.90; 95% confidence interval [CI]: 0.81, 1.01). Major bleeding occurred in 22 of 2,726 (0.8%) patients who received thromboprophylaxis, and in 11 of 2,702 (0.4%) patients who received placebo. Thromboprophylaxis was associated with 2-fold increased risk for major bleeding, although this effect was not quite statistically significant (OR = 2.04; 95% CI: 0.98, 4.23). Conclusion: In medical patients who are at increased risk for venous thromboembolism, anticoagulant thromboprophylaxis appears to confer a small reduction in mortality; this benefit should be balanced against an increased risk for major bleeding.

Patient outcomes using the European label for dabigatran

2014 ◽  
Vol 111 (05) ◽  
pp. 933-942 ◽  
Author(s):  
Andreas Clemens ◽  
Herbert Noack ◽  
Jorge Ferreira ◽  
Stuart J. Connolly ◽  
Salim Yusuf ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Haemorrhagic Stroke ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Increased Risk ◽  
Life Threatening ◽  
Net Clinical Benefit ◽  
European Society Of Cardiology ◽  
Post Hoc ◽  
The Eu

SummaryIn the RE-LY trial dabigatran 150 mg twice daily (D150) showed significantly fewer strokes, and 110 mg (D110) significantly fewer major bleeding events (MBE) compared to well-controlled warfarin in patients with atrial fibrillation (AF). The European (EU) label currently recommends the use of D150 in AF patients who are aged < 80 years without an increased risk for bleeding (e.g. HAS-BLED score <3) and not on concomitant verapamil. In other patients, D110 is recommended. In this post-hoc analysis of the RE-LY dataset, we simulated how dabigatran (n=6,004) would compare to well-controlled warfarin (n=6,022) used according to the EU label. “EU label simulated dabigatran treatment” was associated with significant reductions in stroke and systemic embolism (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.60–0.91), haemorrhagic stroke (HR 0.22; 95%CI 0.11–0.44), death (HR 0.86; 95%CI 0.75–0.98), and vascular death (HR 0.80; 95%CI 0.68–0.95) compared to warfarin. Dabigatran was also associated with less major bleeding (HR 0.85; 95%CI 0.73–0.98), life-threatening bleeding (HR 0.72; 95%CI 0.58–0.91), intracranial haemorrhage (HR 0.28; 95%CI 0.17–0.45), and “any bleeds” (HR 0.86; 95%CI 0.81–0.92), but not gastrointestinal major bleeding (HR 1.23; 95%CI 0.96–1.59). The net clinical benefit was significantly better for dabigatran compared to warfarin. In conclusion, this post-hoc simulation of dabigatran usage based on RE-LY trial dataset indicates that “EU label simulated dabigatran treatment” may be associated with superior efficacy and safety compared to warfarin, and are in support of the EU label and the 2012 European Society of Cardiology AF guideline recommendations. Thus, adherence to European label/guideline use results in a clinically relevant benefit for dabigatran over warfarin, for both efficacy and safety.Note: The editorial process for this paper was fully handled by Prof Christian Weber, Editor in Chief.

scholarly journals Efficacy and Safety of Direct Oral Factor Xa Inhibitors in Patients after Bariatric Surgery

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2439-2439 ◽  
Author(s):  
Margarita Kushnir ◽  
Radhika Gali ◽  
Mariam Alexander ◽  
Henny Heisler H. Billett
Keyword(s):  
Bariatric Surgery ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Significant Difference ◽  
Recurrent Vte ◽  
Post Bariatric Surgery

Background: Over 200,000 people underwent weight loss surgery in the United States in 2017. The absorption of numerous drugs has been shown to be altered in patients after bariatric procedures, as gastrointestinal absorptive surface, food volume, and gastric pH all affect bioavailability. Dosing of warfarin, which is commonly used for the treatment of venous thromboembolism (VTE), often needs to be adjusted, based on INR, after bariatric surgery. Since direct oral anticoagulants (DOACs), which are rapidly replacing warfarin as standard anticoagulant therapy, are not monitored, there is concern regarding their efficacy and safety in patients who have had bariatric surgery, particularly rivaroxaban, which is absorbed primarily in the stomach and must be taken with food at therapeutic doses. One study found that 9 out of 9 apixaban patients (but only 2 of 7 rivaroxaban patients) had levels that fell within the expected range after bariatric surgery. Effects of bariatric surgery on DOACs may be further complicated by baseline obesity and subsequent weight loss of the patients. The goal of our current study is to determine whether DOACs are safe and effective in preventing recurrent VTE in patients who have undergone bariatric surgery. Methods: Using our institutional database, we identified all adult patients (age ≥18 years) with a history of bariatric surgery (gastric banding, sleeve gastrectomy, and Roux-en-Y gastric bypass) who were started on anticoagulation with apixaban or rivaroxaban for VTE, between July 1, 2013 and June 30, 2018. We performed retrospective chart review to obtain information on patient demographics, BMI and type of bariatric surgery. We documented clinical outcomes of recurrent VTE and bleeding from the first prescription date to the earliest of a thrombotic event, discontinuation of medication, death, or the end of study period, June 30, 2018. VTE events were confirmed by a review of imaging studies (compression ultrasonography, ventilation/perfusions scans, and CT scans). Bleeding events were included if they met criteria for clinically relevant non-major bleeding and/or major bleeding according to the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Safety outcomes included major bleeding (MB) and clinically relevant non-major bleeding (CRNMB). We also compared VTE recurrence and bleeding rates between the post-bariatric surgery patients and patients with BMI >40 from our prior study. Chi- squared tests were used to assess statistical significance of the differences in recurrent VTE and bleeding rates between anticoagulant cohorts. Results: Data on 102 patients were collected: 42 patients on apixaban and 60 patients on rivaroxaban. Our population was predominantly female (82.4%) with a mean age of 48.5 years and a median BMI of 35.7 at initiation of anticoagulation. Gastric bypass was the most common bariatric procedure (51%), followed by sleeve gastrectomy (37.3%), and gastric banding (11.8%). There were no recurrent VTE events in the apixaban cohort with a median follow-up duration of 137 days. Among patients on rivaroxaban, with a median follow-up of 232 days, there was one recurrent VTE (1.7%) in a patient with a BMI of 54 at the time of event. When we compared VTE recurrence rates of our combined DOAC cohort (apixaban + rivaroxaban) between our general morbidly obese population, from a prior study at our institution, and post-bariatric surgery patients, there was no statistically significant difference (2.0% vs. 1.0%, respectively, p=0.5). In bariatric surgery patients, one CRNMB event was recorded in apixaban group (2.4%) while 4 major bleeding events occurred on rivaroxaban (6.7%), p=0.3. There was no significant difference in the rate of composite MB and CRNMB between the general obesity and bariatric surgery patients (8.0% vs. 4.9%, respectively, p=0.3). Conclusions: In a review of post-bariatric surgery patients on anticoagulation for VTE, we found low rates of recurrent VTE for patients on DOACs. Although we had a relatively small sample size, the incidence of VTE recurrence was not higher in this cohort than was found in our previously published study of general obesity population. Prospective studies are needed to further investigate the efficacy and safety of direct oral anticoagulants in patients after bariatric surgery. Table. Disclosures Kushnir: Janssen Pharmaceuticals: Research Funding. Billett:Janssen: Research Funding.

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