Dataset Information

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.

ABSTRACT:

Aims?

To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS).

Methods and results?

In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n?=?388, VKA n?=?389) vs. CCS (edoxaban n?=?363, VKA?=?366). Participants received edoxaban 60?mg once-daily plus a P2Y12 inhibitor for 12?months, or VKA combined with a P2Y12 inhibitor and aspirin 100?mg (for 1-12?months). The primary bleeding endpoint at 12?months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59-1.02, P?=?0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68-1.31, P?=?0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70-1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47-1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int?=?0.5573).

Conclusions?

In patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation.

SUBMITTER: Vranckx P

PROVIDER: S-EPMC7767635 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.

Vranckx Pascal P Valgimigli Marco M Eckardt Lars L Lewalter Thorsten T Unikas Ramunas R Marin Francisco F Schiele François F Laeis Petra P Reimitz Paul-Egbert PE Smolnik Rüdiger R Zierhut Wolfgang W Tijssen Jan J Goette Andreas A

European heart journal 20201201 47

<h4>Aims</h4>To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS).<h4>Methods and results</h4>In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (e ...[more]

PMID: 32860041

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Project description:BackgroundIn patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), selecting an antithrombotic regimen requires balancing risks of ischemic cardiac events, stroke, and bleeding.MethodsWe studied 467 patients with AF undergoing PCI in the time period from December 2015 to July 2018 identified via a chart audit by 47 Canadian cardiologists in the CONNECT AF+PCI (the Coordinated National Network to Engage Interventional Cardiologists in the Antithrombotic Treatment of Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) study, to determine patterns of initial antithrombotic therapy selection.ResultsThe median (25th, 75th percentile) CHADS2 score was 2 (1, 3), and PCI was performed in the setting of acute coronary syndrome in 62.1%. Triple antithrombotic therapy (TAT) was the initial treatment in 62.7%, dual-pathway therapy in 25.7%, and dual antiplatelet therapy in 11.6%, with a temporal increase in use of dual-pathway therapy during the course of the study; median intended TAT duration was 1 (1, 3) month. Compared with patients selected for TAT, patients selected for dual-pathway therapy were less likely to have prior myocardial infarction (35.8% vs 25.8%, P = 0.045) and prior PCI (33.8% vs 23.3%, P = 0.03), and they received shorter total length of stents (38 [23, 56] vs 30 [20, 46] mm, P = 0.03). Patients selected for dual-pathway therapy had a higher prevalence of prior stroke/transient ischemic attack (13.0% vs 23.3%, P = 0.01). There was no difference in prevalence of anemia (21.5% vs 25.8%, P = 0.30). Use of dual-pathway therapy was similar among patients with acute coronary syndrome and those with stable disease (24.1% vs 28.2%, P = 0.32).ConclusionsApproximately one-quarter of AF patients undergoing PCI are treated with dual-pathway therapy in Canadian practice, with its use increasing during the studied period. Patients selected for dual-pathway therapy have less-complex coronary disease history and intervention.

Project description:BACKGROUND AND OBJECTIVE:In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy? METHODS:The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor. RESULTS:Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy). CONCLUSIONS:Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS. GOV UNIQUE IDENTIFIER:NCT02164864.

Project description:BackgroundAlthough triple antithrombotic therapy (TAT) is recommended in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), guidelines allow an option of dual antithrombotic therapy (DAT). This study assesses the everyday practice of 10 cardiology departments in antithrombotic therapy in AF patients undergoing PCI and its agreement with current guidelines.MethodsThis analysis included medical data of AF patients enrolled in the prospective, observational registry (The POLish Atrial Fibrillation-POL-AF) that underwent PCI [elective or due to acute coronary syndrome (ACS)].ResultsOf the 3,999 consecutive subjects included, a final analysis was performed on 359 patients that underwent PCI: 148 with urgent PCI due to ACSand 211 patients with elective PCI. Eighty patients in the ACS-group and 120 patients in the elective-PCI group were treated with TAT, although guidelines also allowed DAT. Of 316 patients treated with oral anticoagulants as a part of combination therapy, 275 were on non-vitamin K antagonist oral anticoagulant (NOAC). Reduced doses of NOAC were used in 74 patients treated with rivaroxaban, 60 patients with dabigatran, and 54 patients with apixaban. The proportion of patients treated with reduced NOAC doses adequately to the guidelines was 29%, 100%, and 33% for rivaroxaban, dabigatran, and apixaban, respectively. Inappropriate low doses of NOACs were used in 71% of subjects on rivaroxaban and 67% on apixaban.ConclusionsIn patients with AF undergoing PCI, NOACs are definitely preferred over vitamin-K antagonists (VKAs) in TAT/DAT, and an aggressive antithrombotic strategy with TAT is frequently chosen even if DAT is permissible by the guidelines. Label adherence of using reduced NOAC dose during combination therapy is not satisfactory for apixaban and rivaroxaban and probably results from too cautious an approach to the known indications for reduced therapy. The study is registered in the database Clinical Trials-NCT04419012.

Dataset Information

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.

Aims?

Methods and results?

Conclusions?

Publications

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.

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