Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial

Vranckx, Pascal; Lewalter, Thorsten; Valgimigli, Marco; Tijssen, Jan G.P.; Reimitz, Paul-Egbert; Eckardt, Lars; Lanz, Hans; Zierhut, Wolfgang; Smolnik, Rüdiger; Goette, Andreas

doi:10.1016/j.ahj.2017.10.009

Cited by 86 publications

(46 citation statements)

References 24 publications

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“…A total of 59 Citations were identified using Medline, EMBASE, SCOPUS, Web of Science, and Cochrane databases. A total of four RCTs were selected to be included in the evaluation . Based on the title and abstracts, 46 studies were excluded.…”

Section: Resultsmentioning

confidence: 99%

“…The results showed that the antithrombotic regimen with apixaban had caused no significant differences in ischemic events but resulted in less bleeding and fewer hospitalizations when compared to a regimen including VKA, aspirin, or both . ENTRUST AF PCI (randomized, multicenter, open‐label trial) was performed to determine the safety of edoxaban plus P2Y12 inhibitor in patients with AF who had PCI and results showed that edoxaban‐based regimen was noninferior to VKA regimen for bleeding, without having significant differences in ischemic events …”

Section: Discussionmentioning

confidence: 99%

“…24 ENTRUST AF PCI (randomized, multicenter, open-label trial) was performed to determine the safety of edoxaban plus P2Y12 inhibitor in patients with AF who had PCI and results showed that edoxaban-based regimen was noninferior to VKA regimen for bleeding, without having significant differences in ischemic events. 25 There is a delicate balance between the risk of bleeding and the risk of ischemia in patients with AF who develop ACS or undergo PCI. For these patients, an optimal regimen needs to be defined, with the primary considerations being double vs triple therapy and DOAC vs VKA.…”

Section: Discussionmentioning

confidence: 99%

“…A total of four RCTs were selected to be included in the evaluation. [22][23][24][25] Based on the title and abstracts, 46 studies were excluded. The rest of the publications were studied in detail, and four studies met the inclusion criteria mentioned above.…”

Section: Study Selectionmentioning

confidence: 99%

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Safety and efficacy of direct oral anticoagulants compared to Vitamin K antagonists postpercutaneous coronary interventions in patients with atrial fibrillation: A systematic review and meta‐analysis

Agasthi

Lee

Pujari

et al. 2020

Journal of Arrhythmia

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Background Atrial fibrillation (AF) and coronary artery disease (CAD) are commonly associated. Cotreatment with multiple antithrombotic agents can increase the risk of bleeding. We sought to evaluate patient‐centered outcomes in patients with AF on double therapy with direct oral anticoagulants (DOACs) compared to patients with standard triple therapy, [a vitamin K antagonist (VKA) plus dual antiplatelet therapy]. Methods We performed a literature search of randomized controlled trials (RCTs) reporting outcomes of patients receiving double therapy with DOACs compared to triple therapy with VKAs in patients with AF undergoing percutaneous coronary intervention (PCI). Patient‐centered outcomes were the International Society of Thrombosis and Hemostasis (ISTH) major or clinically relevant nonmajor bleeding (CRNB), all‐cause mortality, major adverse cardiovascular events (MACE), stent thrombosis, myocardial infarction, and stroke. Results Four RCTs (9602 patients) met our inclusion criteria. Compared to VKAs, DOACs were associated with significantly lower ISTH major bleeding/ CRNB (RR: 0.75, 95% CI: 0.67‐0.82, P < .00001, I2 = 11%). There were no statistically significant differences in the efficacy outcomes, including myocardial infarction (RR: 0.99, 95% CI :0.79‐1.25, P = .96), stent thrombosis (RR: 0.97, 95% CI: 0.6‐1.55, P = .89), ischemic stroke (RR: 0.76, 95% CI: 0.5‐1.15, P = .19), all‐cause mortality (RR: 1.06, 95% CI: 0.85‐1.31, P = .61), and MACE (RR: 1.06, 95% CI: 0.91‐1.22, P = .97). Conclusion Compared with triple therapy with VKAS, double therapy with DOACs is associated with a reduced risk of bleeding and is as effective in patients with AF undergoing PCI.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

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Safety and efficacy of direct oral anticoagulants compared to Vitamin K antagonists postpercutaneous coronary interventions in patients with atrial fibrillation: A systematic review and meta‐analysis

Agasthi

Lee

Pujari

et al. 2020

Journal of Arrhythmia

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“…Finally, further analysis is required in the future to incorporate the results of the ongoing trial using edoxaban in AF and concomitant CAD (ENTRUST-AF-PCINCT02866175). 29 In comparison with TATT, DATT showed no difference in the outcomes of mortality, nonfatal MI, and stroke. DATT also demonstrated a lower incidence of major bleeding.…”

Section: Discussionmentioning

confidence: 94%

Meta-Analysis Comparing Double Versus Triple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Disease

Ravi

Pulipati

Vij

et al. 2020

The American Journal of Cardiology

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Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

et al. 2019

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The antithrombotic treatment of patients with atrial fibrillation (AF) and coronary artery disease, in particular with acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), poses a significant treatment dilemma in clinical practice.OBJECTIVE To study the safety and efficacy of different antithrombotic regimens using a network meta-analysis of randomized controlled trials in this population.DATA SOURCES PubMed, EMBASE, EBSCO, and Cochrane databases were searched to identify randomized controlled trials comparing antithrombotic regimens.STUDY SELECTION Four randomized studies were included (n = 10 026; WOEST, PIONEER AF-PCI, RE-DUAL PCI, and AUGUSTUS). DATA EXTRACTION AND SYNTHESISThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this systematic review and network meta-analysis between 4 regimens using a Bayesian random-effects model. A pre hoc statistical analysis plan was written, and the review protocol was registered at PROSPERO. Data were analyzed between November 2018 and February 2019. MAIN OUTCOMES AND MEASURESThe primary safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding; secondary safety outcomes were combined TIMI major and minor bleeding, trial-defined primary bleeding events, intracranial hemorrhage, and hospitalization. The primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE); secondary efficacy outcomes were individual components of MACE. RESULTSThe overall prevalence of ACS varied from 28% to 61%. The mean age ranged from 70 to 72 years; 20% to 29% of the trial population were women; and most patients were at high risk for thromboembolic and bleeding events. Compared with a regimen of vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT; P2Y 12 inhibitor plus aspirin), the odds ratios (ORs) for TIMI major bleeding were 0.58 (95% CI, 0.31-1.08) for VKA plus P2Y 12 inhibitor, 0.49 (95% CI, 0.30-0.82) for non-VKA oral anticoagulant (NOAC) plus P2Y 12 inhibitor, and 0.70 (95% CI, 0.38-1.23) for NOAC plus DAPT. Compared with VKA plus DAPT, the ORs for MACE were 0.96 (95% CI, 0.60-1.46) for VKA plus P2Y 12 inhibitor, 1.02 (95% CI, 0.71-1.47) for NOAC plus P2Y 12 inhibitor, and 0.94 (95% CI, 0.60-1.45) for NOAC plus DAPT. CONCLUSIONS AND RELEVANCEA regimen of NOACs plus P2Y 12 inhibitor was associated with less bleeding compared with VKAs plus DAPT. Strategies omitting aspirin caused less bleeding, including intracranial bleeding, without significant difference in MACE, compared with strategies including aspirin. Our results support the use of NOAC plus P2Y 12 inhibitor as the preferred regimen post-percutaneous coronary intervention for these high-risk patients with AF. A regimen of VKA plus DAPT should generally be avoided.

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Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial

Cited by 86 publications

References 24 publications

Safety and efficacy of direct oral anticoagulants compared to Vitamin K antagonists postpercutaneous coronary interventions in patients with atrial fibrillation: A systematic review and meta‐analysis

Safety and efficacy of direct oral anticoagulants compared to Vitamin K antagonists postpercutaneous coronary interventions in patients with atrial fibrillation: A systematic review and meta‐analysis

Meta-Analysis Comparing Double Versus Triple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Disease

Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

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