Oral anticoagulation versus antiplatelet or placebo for stroke prevention in patients with heart failure and sinus rhythm: Systematic review and meta-analysis of randomized controlled trials

2019 ◽  
Vol 14 (9) ◽  
pp. 856-861 ◽  
Author(s):  
George Ntaios ◽  
Konstantinos Vemmos ◽  
Gregory YH Lip

Background Previous meta-analyses of randomized controlled trials of oral anticoagulation in patients with heart failure and sinus rhythm reported reduced stroke risk and increased bleeding risk compared to antiplatelets or placebo. However, the effect estimates may be subject to imprecision, as all included trials were prematurely terminated; stroke was not the primary outcome and overall results were primarily driven by a single trial. Recently, new trial data became available. Aim To provide more accurate estimates of the effect of oral anticoagulation on stroke risk in heart failure patients with sinus rhythm by systematic review and meta-analysis of available randomized controlled trials including recently published evidence. Methods We searched PubMed and Scopus for full-text articles of randomized controlled trials of oral anticoagulation versus antiplatelet or placebo in heart failure patients with sinus rhythm published between inception and 28 August 2018. The outcomes assessed were any stroke, major bleeding, and death. Results In five trials (9490 patients; 21,067 patient-years), oral anticoagulation-treated patients had lower stroke risk (odds ratio (OR) 0.60, 95%CI: 0.46–0.78, absolute-risk-reduction: 1.3%, number-needed-to-treat: 77), higher major bleeding risk (OR: 1.92, 95%CI: 1.51–2.45, absolute-risk-increase: 2.0%, number-needed-to-harm: 50), and no significant difference in death rates (OR: 0.90, 95%CI: 0.73–1.11) compared to antiplatelets or placebo. Conclusions In the largest meta-analysis to date, oral anticoagulation is associated with a considerable reduction of stroke risk, which is offset by a significant increase in major bleeding risk. For every 1000 patients treated with oral anticoagulation rather than antiplatelet or no antithrombotic treatment for 2.21 years, 13 strokes are prevented but 20 additional major hemorrhages occur, without significant difference in death rates.

Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S297
Author(s):  
Ahmad Al-Abdouh ◽  
Mohammad As Sayaideh ◽  
Ahmad Jabri ◽  
Waiel Abusnina ◽  
Mahmoud Barbarawi ◽  
...  

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e383-e392
Author(s):  
Marie H. Nygaard ◽  
Anne-Mette Hvas ◽  
Erik L. Grove

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


2020 ◽  
Author(s):  
Caiyun Zheng ◽  
Hengfen Dai ◽  
Chun Lin ◽  
Yan Zhang ◽  
Hong Zhang ◽  
...  

BACKGROUND An increasing number of patients have received prophylactic or therapeutic oral anticoagulants (OACs) for thromboembolic complications of diseases. The use of OACs is associated with both clinical benefits and risks. Considering the challenges imposed by this class of drugs, as well as the enormous progress made in portable device technology, it is possible that technology-based interventions may improve clinical benefits for patients and optimize anticoagulation management. OBJECTIVE This study was designed to comprehensively evaluate the role of technology-based interventions in the management of OACs. METHODS We searched 6 databases—PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, Scopus, and PsycINFO—to retrieve relevant studies published as of November 1, 2019, to evaluate the effect of technology-based interventions on oral anticoagulation management. RevMan (version 5.3; Cochrane) software was used to evaluate and analyze clinical outcomes. The methodological quality of studies was assessed by the Cochrane risk of bias tool. RESULTS A total of 15 randomized controlled trials (RCTs) were selected for analysis. They reported data for 2218 patients (1110 patients in the intervention groups and 1108 patients in the control groups). A meta-analysis was performed on the effectiveness and safety data reported in the RCTs. Technology-based interventions significantly improved the effectiveness of oral anticoagulation management (mean difference [MD]=6.07; 95% CI 0.84-11.30; I<sup>2</sup>=72%; <i>P</i>=.02). The safety of oral anticoagulation management was also improved, but the results were not statistically significant. Bleeding events were reduced (major bleeding events MD=1.02; 95% CI 0.78-1.32; I<sup>2</sup>=0%; <i>P</i>=.90; minor bleeding events MD=1.06, 95% CI 0.77-1.44; I<sup>2</sup>=41%; <i>P</i>=.73) and thromboembolism events were reduced (MD=0.71; 95% CI 0.49-1.01; I<sup>2</sup>=0%; <i>P</i>=.06). In general, patients were more satisfied with technology-based interventions, which could also improve their knowledge of anticoagulation management, improve their quality of life, and reduce mortality and hospitalization events. CONCLUSIONS Using technology to manage OACs can improve the effectiveness and safety of oral anticoagulation management, result in higher patient satisfaction, and allow greater understanding of anticoagulation.


2021 ◽  
Vol 8 ◽  
Author(s):  
Wen-Jiao Zhang ◽  
Xuan Qiao ◽  
Wen-Fen Guo ◽  
Xi-Ying Liang ◽  
Yan Li ◽  
...  

Background and Objective: The optimum duration of dual antiplatelet therapy (DAPT) remains uncertain in patients with acute coronary syndrome treated with new generation stents. This meta-analysis was performed to investigate ischemia and bleeding outcomes with different DAPT strategies.Methods: PubMed, Embase, Cochrane and Web of science from inception to May 27, 2020, were systematically searched. Randomized controlled trials were included to compare short-term (6 months or less) with standard (12 months) DAPT in patients with acute coronary syndrome treated with new generation stents. The primary endpoints were myocardial infarction, definite or probable stent thrombosis and major bleeding. The secondary endpoints included all-cause death, cardiovascular death, stroke, target vessel revascularization and net adverse clinical events. Random effect model and fixed effect model were used to calculate the odds ratio (OR) and 95% confidence interval (CI) of each endpoint.Results: Four randomized controlled trials and seven subgroup analyses of larger randomized controlled trials, including a total of 21,344 patients with acute coronary syndrome, met our inclusion criteria. The shorter DAPT was associated with significantly lower major bleeding compared with the standard DAPT (OR 0.71, 95% CI 0.56–0.90, P = 0.005, I2 = 25%), while without increasing the risk of myocardial infarction (OR 1.18, 0.88–1.58, P = 0.28, I2 = 20%), definite or probable stent thrombosis (OR 1.60, 0.98–2.59, P = 0.06, I2 = 0%). No significantly difference was observed in the risk of all-cause death (OR 0.96, 0.72–1.27, P = 0.76, I2 = 2%), cardiovascular death (OR 0.91, 0.62–1.33, P = 0.62, I2 = 0%), stroke (OR 0.84, 0.54–1.30, P = 0.43, I2 = 0%), target vessel revascularization (OR 1.14, 0.84–1.55, P = 0.41, I2 = 8%), and net adverse clinical events (OR 0.93, 0.80–1.07, P = 0.3, I2 = 18%) between the two groups.Conclusions: In patients with acute coronary syndrome treated with new generation stents, the shorter DAPT leads to a marked reduction in the risk of major bleeding compared with the standard DAPT. This benefit is achieved without increasing the risk of mortality or ischemic outcomes. The study protocol was registered in PROSPERO (CRD42020189871).


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