Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial

Vranckx, Pascal; Valgimigli, Marco; Eckardt, Lars; Tijssen, Jan G.P.; Lewalter, Thorsten; Gargiulo, Giuseppe; Batushkin, V.; Campo, Gianluca; Lysak, Z.V.; Vakaliuk, І. P.; Milewski, Krzysztof; Laeis, Petra; Reimitz, Paul-Egbert; Smolnik, Rüdiger; Zierhut, Wolfgang; Goette, Andreas

doi:10.1016/s0140-6736(19)31872-0

Cited by 488 publications

(472 citation statements)

References 27 publications

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“…The recently published AUGUSTUS trial (apixaban), that also included medically managed ACS patients, also supports the safety advantage of dual pathway therapy over triple therapy . The ENTRUST‐PCI AF trial (edoxaban) furtherly reinforced the safety and anti‐ischemic efficacy of dual pathway regimens of dual pathway over triple therapy, with no significant difference in ischemic events between the two groups …”

Section: Discussionmentioning

confidence: 88%

“…12 The ENTRUST-PCI AF trial (edoxaban) furtherly reinforced the safety and anti-ischemic efficacy of dual pathway regimens of dual pathway over triple therapy, with no significant difference in ischemic events between the two groups. 18 Interventional cardiologists at our center no longer appear to be avoiding DES in AF patients when anticoagulation is indicated. 24,25 Avoidance of restenosis with the use of DES may also help reduce the risk of bleeding complications by avoiding repeat procedures in a typically fragile AF population.…”

Section: Resultsmentioning

confidence: 93%

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Time‐trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF‐STENT Registry

Boivin‐Proulx

Deneault‐Marchand

Matteau

et al. 2019

Clinical Cardiology

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Background The management of atrial fibrillation and flutter (AF) patients undergoing percutaneous coronary intervention (PCI) has undergone a rapid recent evolution. In 2016, the Canadian Cardiovascular Society (CCS) published expert recommendations to help guide clinicians in balancing bleeding and thrombotic risks in these patients. Hypothesis Antithrombotic regimen prescriptions for AF patients undergoing PCI evolved after the publication of the 2016 CCS AF guidelines. Methods A prospective cohort of AF patients undergoing PCI with placement of a coronary stent from a single tertiary academic center was analyzed for the recommended antithrombotic regimen at discharge. Prescribing behavior was compared between three time periods (Cohort A [2010‐2011]; Cohort B [2014‐2015]; Cohort C [2017]) using the χ2 test. In addition, antithrombotic management in Cohorts B and C were compared to guideline‐recommended therapy. Results A total of 459 patients with AF undergoing PCI were identified. Clinical and procedural characteristics were similar between cohorts, with the exception of an increase in drug‐eluting stent (DES) use over time (P < .01). Overall, the rate of oral anticoagulation (OAC) increased over time (P < .01), associated with an increase in nonvitamin K OAC prescription (P < .01) and a concomitant decrease in vitamin K antagonist prescription (P < .01). Despite this, the overall rate of anticoagulation remains below what would be predicted with perfect guideline compliance (75% vs 94%, P < .01). Conclusion There has been a dramatic shift in clinical practice for AF patients requiring PCI, with increases in prescription of OAC even in the context of an increase in the use of DES. However, room for further practice optimization still exists.

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Section: Discussionmentioning

confidence: 88%

Section: Resultsmentioning

confidence: 93%

Time‐trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF‐STENT Registry

Boivin‐Proulx

Deneault‐Marchand

Matteau

et al. 2019

Clinical Cardiology

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“…Four recent open‐label, randomized, controlled clinical trials investigated the use of DOACs in patients with AF with a recent ACS and/or undergoing a PCI see Table . The PIONEER AF‐PCI (an open‐label, randomized, controlled, multicenter study exploring 2 treatment strategies of rivaroxaban and dose‐adjusted oral VKA treatment strategy in subjects with AF undergoing PCI) was an exploratory study comparing bleeding rates across 3 strategies (low‐dose rivaroxaban [2.5 mg twice daily] plus DAPT vs. rivaroxaban 15 mg once daily, or 10 mg once daily in patients with a creatinine clearance of <50 mL/min, plus clopidogrel [dual antithrombotic therapy with DOAC or TT with DOAC] vs. TT with VKA plus DAPT) in patients with AF after a PCI with stent placement.…”

Section: Overview Of Published Datamentioning

confidence: 99%

“…In the Safety and Efficacy of an Edoxaban‐Based Antithrombotic Regimen in Patients With AF Following Successful PCI With Stent Placement (the ENTRUST‐AF PCI) trial, AF patients undergoing PCI for stable coronary artery disease or ACS were randomized to dual antithrombotic therapy with a DOAC (edoxaban [60 mg once daily or 30 mg once daily where dose reduction criteria were fulfilled] with a P2Y 12 inhibitor for 12 months) or TT with VKA plus P2Y 12 inhibitor and aspirin (100 mg once daily for 1‐12 months). The primary end point was defined as the composite of major or CRNM bleeding defined by the ISTH.…”

Section: Overview Of Published Datamentioning

confidence: 99%

“…The Danish nationwide registry-based study, for example, reported that among patients with AF and MI and/ or PCI, those taking a DOAC plus DAPT had a significantly lower risk of bleeding than patients taking a VKA plus DAPT, with no significant differences in all-cause mortality, ischemic stroke, or MI between the 2 treatment regimens. 18 The study was limited by lack of significant pa- Four recent open-label, randomized, controlled clinical trials investigated the use of DOACs in patients with AF with a recent ACS and/or undergoing a PCI [19][20][21][22] see Table 1. The PIONEER AF-PCI (an open-label, randomized, controlled, multicenter study exploring 2 treatment strategies of rivaroxaban and dose-adjusted oral VKA treatment strategy in subjects with AF undergoing PCI) 19 was an exploratory study comparing bleeding rates across 3 strategies (low-dose rivaroxaban Both the PIONEER AF-PCI and RE-DUAL PCI trial clearly showed that dual therapy including the respective DOAC plus a P2Y 12 inhibitor (mostly clopidogrel) was associated with significantly less major bleeding in comparison to TT with VKA plus dual antiplatelet therapy.…”

Section: Overview Of Published Datamentioning

confidence: 99%

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Triple therapy in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention/stenting

Kozieł

Potpara

Lip

2020

Research and Practice in Thrombosis and Haemostasis

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Patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) are at high risk of stroke, recurrent coronary ischemic events, and cardiovascular mortality. The composition of antithrombotic therapy including an oral anticoagulant and antiplatelet drug(s) should be tailored according to the individual patient’s risk profile, to reduce the bleeding risk and maintain antithrombotic effect. There is no single antithrombotic treatment regimen that would fit to all patients with AF and ACS. However, available data promote the use of full‐dose direct oral anticoagulants (DOACs) (dabigatran 150 mg twice daily or apixaban 5 mg twice daily) or rivaroxaban 15 mg once daily in patients with AF and ACS or percutaneous coronary intervention (PCI). For many patients, a DOAC plus P2Y12 inhibitor early after ACS and/or PCI would be optimal, whereas a longer course of triple therapy should be used in patients at high thrombotic risk.

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Optimal Antithrombotic Regimens for Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

et al. 2020

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IMPORTANCE Antithrombotic treatment in patients with atrial fibrillation (AF) and percutaneous coronary intervention (PCI) presents a balancing act with regard to bleeding and ischemic risks.OBJECTIVES To evaluate the safety and efficacy of 4 antithrombotic regimens by conducting an up-to-date network meta-analysis and to identify the optimal treatment for patients with AF undergoing PCI. DATA SOURCES Online computerized database (MEDLINE).STUDY SELECTION Five randomized studies were included (N = 11 542; WOEST, PIONEER AF-PCI, RE-DUAL PCI, AUGUSTUS, ENTRUST-AF PCI). DATA EXTRACTION AND SYNTHESISThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used in this network meta-analysis, in which bayesian random-effects models were applied. The data were analyzed from September 9 to 29, 2019. MAIN OUTCOMES AND MEASURESThe primary safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding and the primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE). RESULTSThe total number of participants included in the study was 11 532. The mean age of the participants ranged from 70 to 72 years, 69% to 83% were male, 20% to 26% were female, and the participants were predominantly white (>90%). Compared with vitamin K antagonists (VKA) plus dual antiplatelet therapy (DAPT) (reference), the odds ratios (ORs) (95% credible intervals) for TIMI major bleeding were 0.57 (0.31-1.00) for VKA plus P2Y 12 inhibitor, 0.69 (0.40-1.16) for non-VKA oral anticoagulant (NOAC) plus DAPT, and 0.52 (0.35-0.79) for NOAC plus P2Y 12 inhibitor. For MACE, using VKA plus DAPT as reference, the ORs (95% credible intervals) were 0.97 (0.64-1.42) for VKA plus P2Y 12 inhibitor, 0.95 (0.64-1.39) for NOAC plus DAPT, and 1.03 (0.77-1.38) for NOAC plus P2Y 12 inhibitor. CONCLUSIONS AND RELEVANCEThe findings of this study suggest that an antithrombotic regimen of VKA plus DAPT should generally be avoided, because regimens in which aspirin is discontinued may lead to lower bleeding risk and no difference in antithrombotic effectiveness. The use of a NOAC plus a P2Y 12 inhibitor without aspirin may be the most favorable treatment option and the preferred antithrombotic regimen for most patients with AF undergoing PCI.

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Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial

Cited by 488 publications

References 27 publications

Time‐trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF‐STENT Registry

Time‐trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF‐STENT Registry

Triple therapy in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention/stenting

Optimal Antithrombotic Regimens for Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

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