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Efficacy and safety of triple versus dual antithrombotic therapy in atrial fibrillation and ischemic heart disease: a systematic review and meta-analysis.

ABSTRACT: The optimal antithrombotic regimen for patients with atrial fibrillation and ischemic heart disease remains unclear. Therefore, we aimed to compare the efficacy and safety of triple therapy (TT [an anticoagulant and 2 antiplatelet drugs]) with dual therapy (DAPT [2 antiplatelet drugs] or DT [an anticoagulant and a single antiplatelet drug]) in patients with atrial fibrillation and ischemic heart disease. We systematically searched the Cochrane Library, PubMed and Embase databases for all relevant studies up to August 2017. The overall risk estimates were calculated using the random-effects model. A total of 17 observational studies were included. Regarding the efficacy outcomes, no differences were observed between the triple therapy and the dual therapy for all-cause death, cardiovascular death, or thrombotic complications (i.e., acute coronary syndrome, stent thrombosis, thromboembolism/stroke, and major adverse cardiac and cerebrovascular events). Regarding the safety outcomes, compared with DAPT, TT was associated with increased risks of major bleeding (a relative risk of 1.96 [1.40-2.74]), minor bleeding (1.69 [1.06-2.71]) and overall bleeding (1.80 [1.23-2.64]). Compared wtih DT, TT was associated with a greater risk of major bleeding (1.65 [1.23-2.21]), but rates of minor bleeding (0.99 [0.56-1.77]) and overall bleeding (1.14 [0.76-1.71]) were similar. Overall, TT confers an increased hazard of major bleeding with no thromboembolic protection compared with dual therapy in patients with atrial fibrillation and ischemic heart disease.

SUBMITTER: Zhu W

PROVIDER: S-EPMC5655270 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Efficacy and safety of triple <i>versus</i> dual antithrombotic therapy in atrial fibrillation and ischemic heart disease: a systematic review and meta-analysis.

Zhu Wengen W Guo Linjuan L Liu Fadi F Wan Rong R Shen Yang Y Lip Gregory Y H GYH Hong Kui K

Oncotarget 20170914 46

The optimal antithrombotic regimen for patients with atrial fibrillation and ischemic heart disease remains unclear. Therefore, we aimed to compare the efficacy and safety of triple therapy (TT [an anticoagulant and 2 antiplatelet drugs]) with dual therapy (DAPT [2 antiplatelet drugs] or DT [an anticoagulant and a single antiplatelet drug]) in patients with atrial fibrillation and ischemic heart disease. We systematically searched the Cochrane Library, PubMed and Embase databases for all relevan ...[more]

PMID: 29113375

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Project description:ObjectiveCreating an appropriate antithrombotic therapy for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) remains a dilemma. Several clinical trials compared the use of a dual antithrombotic therapy (DAT) regimen with a direct oral anticoagulants including (apixaban, dabigatran, edoxaban or rivaroxaban) and a P2Y12 inhibitor versus a triple antithrombotic therapy (TAT) that includes a vitamin K antagonist plus aspirin and a P2Y12 inhibitor in patients with AF who have undergone PCI. However, there are no head-to-head trials comparing the DAT regimens to each other. We aimed to compare the efficacy and safety of DAT regimens using a network meta-analysis (NMA) approach.DesignA systematic review and NMA of randomised clinical trials.MethodsWe conducted a systematic literature review to identify relevant randomised clinical trials and performed a Bayesian NMA for International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding, all-cause mortality, stroke, myocardial infarction (MI) and stent thrombosis outcomes. We used NetMetaXL V.1.6.1 and WinBUGS V.1.4.3 for the NMA and estimated the probability of ranking the treatments based on the surface under the cumulative ranking curve.ResultsThe comparison between DAT regimens showed no significant difference in the safety or efficacy outcomes. Apixaban regimen was ranked first as the preferred therapy in terms of ISTH major or CRNM bleeding and stroke, with a probability of 52% and 54%, respectively. Rivaroxaban regimen was the preferred therapy in terms of MI and stent thrombosis, with a probability of 34% and 27%, respectively. Dabigatran regimen was ranked first in terms of all-cause mortality, with a probability of 28%.ConclusionThe DAT regimens are as safe and effective as TAT regimens. However, ranking probabilities for the best option in the selected outcomes can be used to guide the selection among these agents based on different patients' conditions.

Project description:BackgroundThe RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI.HypothesisThe reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males.MethodsThe primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint.ResultsA total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively).ConclusionsConsistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.

Project description:BackgroundThe optimal antithrombotic therapy for atrial fibrillation (AF) patients undergoing coronary stenting is unknown. The present meta-analysis sought to investigate the efficacy and safety of triple therapy (TT; warfarin, clopidogrel and aspirin) vs dual antiplatelet therapy (DAPT; clopidogrel plus aspirin) in those patients.MethodsPubMed and Cochrane Library were searched for studies enrolling AF patients undergoing coronary stenting on TT and DAPT up to September 2016, and fourteen studies were included. Efficacy outcomes included ischemic stroke, stent thrombosis, major adverse cardiovascular event (MACE), all-cause mortality and myocardial infarction (MI); safety outcome was major bleeding. We conducted meta-analysis and used odds ratio (OR) with 95% confidence intervals (CI) to compare TT and DAPT. Meta-regression, sensitivity and subgroup analysis were taken to investigate the source of heterogeneity in the outcome of major bleeding.Results14 eligible observational studies with 11,697 subjects were identified. Compared with DAPT, TT had decreased the risk of ischemic stroke [OR = 0.74, 95% CI (0.59, 0.93), P = 0.009] and stent thrombosis [OR = 0.40, 95% CI (0.18, 0.93), P = 0.033]. While, there was an increased risk of major bleeding [OR = 1.55, 95% CI (1.16, 2.09), P = 0.004] associated with TT. The risk of MACE, all-cause mortality and MI had no significant statistical difference between TT and DAPT. Furthermore, the results of univariate and multivariate meta-regression analysis implicated that there were no obvious correlations between certain baseline characteristics (age, gender, race, hypertension, study design) and risk of major bleeding. Also of major bleeding, the findings of sensitivity analysis were generally robust, and a prespecified subgroup analysis of race demonstrated that the source of heterogeneity might attribute to Asian studies mostly.ConclusionsTT reduced the risk of ischemic stroke and stent thrombosis with an acceptable major bleeding risk compared with DAPT, and TT was considered as a valid alternative in AF patients undergoing coronary stenting. Further prospective randomized trials are needed to ensure the reliability of these data and find the optimal therapeutic strategy in this setting of patients.

Project description:BackgroundAntithrombotic therapy for patients with atrial fibrillation undergoing percutaneous coronary intervention is facing major treatment problems in clinical practice.MethodsWe firstly conducted a Bayesian network meta-analysis to study the safety and efficacy of different antithrombotic regimens. Only randomized controlled trials from PubMed, Web of Science, Cochrane Central Register of Controlled Trials, Embase, and China National Knowledge Infrastructure were included in our study. The Bayesian random-effects model was used in this study. The primary safety and efficacy outcomes were major bleeding according to the criteria of Thrombolysis In Myocardial Infarction (TIMI) and trial-defined major adverse cardiovascular events, respectively. The secondary safety outcomes were combined TIMI major and minor bleeding, trial-defined primary bleeding events, and intracranial hemorrhage. The secondary efficacy outcomes were all-cause or cardiovascular mortality, myocardial infarction, stroke, stent thrombosis, and hospitalization.ResultsTotal of 11,532 patients from the five randomized controlled trials were analyzed, of whom 8,426 were male. Compared with vitamin K antagonist (VKA) plus P2Y12 inhibitor, the odds ratios (95% credible intervals) for TIMI major bleeding were 1.70 (0.77-3.80) for VKA plus dual antiplatelet therapy (DAPT), 1.20 (0.30-4.60) for rivaroxaban plus P2Y12 inhibitor, 1.00 (0.25-3.90) for rivaroxaban plus DAPT, 0.76 (0.21-2.80) for dabigatran plus P2Y12 inhibitor, 0.71 (0.25-2.10) for apixaban plus P2Y12 inhibitor, 1.40 (0.52-3.80) for apixaban plus DAPT, and 1.00 (0.27-4.00) for edoxaban plus P2Y12 inhibitor. For trial-defined major adverse cardiovascular events, compared with VKA plus P2Y12 inhibitor, the odds ratios (95% credible intervals) were 1.10 (0.61-2.00) for VKA plus DAPT, 1.20 (0.45-3.70) for rivaroxaban plus P2Y12 inhibitor, 1.10 (0.38-3.20) for rivaroxaban plus DAPT, 1.10 (0.43-3.10) for dabigatran plus P2Y12 inhibitor, 1.00 (0.47-2.20) for apixaban plus P2Y12 inhibitor, 0.99 (0.46-2.20) for apixaban plus DAPT, and 1.20 (0.43-3.40) for edoxaban plus P2Y12 inhibitor. Apixaban plus P2Y12 inhibitor was the highest-ranking of safety outcomes and VKA plus P2Y12 inhibitor was the highest-ranking of efficacy outcomes other than trial-defined major adverse cardiovascular events.ConclusionApixaban plus P2Y12 inhibitor seems to be linked with fewer bleeding complications while retaining antithrombotic efficacy. Moreover, for most efficacy indicators, the ranking of VKA plus P2Y12 inhibitor is still very high.Systematic review registration[www.crd.york.ac.uk/prospero/], identifier [CRD42020149894].

Project description:We examined a large community-based sample of patients with atrial fibrillation (AF) and valvular heart disease (VHD) (excluding prosthetic valves) with a goal to compare outcomes among patients with AF, with and without VHD, taking warfarin, dabigatran, and rivaroxaban. We identified Medicare beneficiaries enrolled in Medicare Part D benefit plan from 2011 to 2013 with newly diagnosed AF (18 137 patients with VHD [dabigatran, 1979; rivaroxaban, 2027; warfarin, 14 131] and 85 596 patients without VHD [dabigatran, 13 522; rivaroxaban, 14 257; warfarin, 57 817]). Primary outcomes of all-cause mortality, ischemic strokes, major bleeding, and myocardial infarction were compared across the 3 anticoagulants using 3-way propensity-matched samples. After propensity matching, a total of 5871 patients with VHD and 40 221 patients without VHD and AF were studied. Both dabigatran and rivaroxaban were associated with significantly lower risk of death in patients with VHD with AF (dabigatran versus warfarin: hazard ratio, 0.71; 95% confidence interval, 0.52-0.98; P=0.038; rivaroxaban versus warfarin: hazard ratio, 0.68; 95% confidence interval, 0.49-0.95; P=0.022). Nongastrointestinal bleeding was significantly reduced with dabigatran and rivaroxaban versus warfarin in those with VHD (dabigatran versus warfarin: hazard ratio, 0.17; 95% confidence interval, 0.06-0.49; P=0.001; rivaroxaban versus warfarin: hazard ratio, 0.37; 95% confidence interval, 0.17-0.84; P=0.017). Ischemic stroke and gastrointestinal bleeding rates did not differ between rivaroxaban, dabigatran, and warfarin in patients with VHD. The effects of the 3 anticoagulants on outcomes were comparable in patients with and without VHD and with AF. In this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new-onset AF between 2011 and 2013, novel oral non-vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism.

Dataset Information

Efficacy and safety of triple versus dual antithrombotic therapy in atrial fibrillation and ischemic heart disease: a systematic review and meta-analysis.

Publications

Efficacy and safety of triple <i>versus</i> dual antithrombotic therapy in atrial fibrillation and ischemic heart disease: a systematic review and meta-analysis.

Similar Datasets

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