Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm S

Lip, Gregory Y.H.; Windecker, Stephan; Huber, Kurt; Kirchhof, Paulus; Marı́n, Francisco; Berg, Jürrien M. ten; Hæusler, Karl Georg; Boriani, Giuseppe; Capodanno, Davide; Gilard, Martine; Zeymer, Uwe; Lane, Deirdre A.; Storey, Robert F.; Bueno, Héctor; Collet, Jean‐Philippe; Fauchier, Laurent; Halvorsen, Sigrun; Lettino, Maddalena; Morais, João; Mueller, Christian; Potpara, Tatjana; Rasmussen, Lars Hvilsted; Rubboli, Andrea; Tamargo, Juan; Valgimigli, Marco; Zamorano, José Luís

doi:10.1093/eurheartj/ehu298

Cited by 487 publications

(200 citation statements)

References 136 publications

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“…The definition of valvular AF has evolved to include rheumatic mitral stenosis and mechanical valve, bioprosthetic heart valve, and mitral valve repair, according to the American College of Cardiology/American Heart Association/Heart Rhythm Society 2014 guidelines26; or mechanical heart valves and hemodynamically significant valve disease, severe enough to warrant surgical or percutaneous intervention, according to a recent consensus from the European Heart Rhythm Association 27. The randomized controlled trials of NOACs2, 3, 4, 5 excluded patients with severe mitral stenosis (ARISTOTLE, ENGAGE‐AF [Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation], RE‐LY, ROCKET‐AF), prosthetic or mechanical valves (excluded in all 4 pivotal trials), and hemodynamically significant valve disease (ROCKET‐AF and RE‐LY trial).…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Briasoulis

Inampudi

Akintoye

et al. 2018

JAHA

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BackgroundWe 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.Methods and ResultsWe 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.ConclusionsIn 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.

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Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Briasoulis

Inampudi

Akintoye

et al. 2018

JAHA

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“…Though oral anticoagulants are more effective than antiplatelet agents in preventing stroke/SEE in patients with AF, it is thought that the latter may be more protective in reducing vascular events in patients with CAD or at high risk of acute coronary events 4, 5. The choice of optimal antithrombotic management to prevent both thromboembolic and acute ischemic events in patients with AF and coexisting CAD is challenging given that combination therapy of anticoagulant and ‐antiplatelet agents is associated with an increased risk of bleeding and its efficacy is not clear 6, 7, 8, 9, 10. Here, we report on the effects of single antiplatelet therapy (SAPT) on the comparison of edoxaban with warfarin in patients with non‐valvular AF.…”

Section: Introductionmentioning

confidence: 99%

Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF‐TIMI48 Trial

Ruff

Giugliano

et al. 2016

JAHA

100

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BackgroundWe studied the concomitant use of single antiplatelet therapy (SAPT) on the efficacy and safety of the anti‐Xa agent edoxaban in patients with atrial fibrillation (AF).Methods and Results ENGAGE AF‐TIMI 48 was a randomized trial that compared 2 dose regimens of edoxaban with warfarin. We studied both the approved high‐dose edoxaban regimen (HDER; 60 mg daily reduced by one half in patients with anticipated increased drug exposure), as well as a lower‐dose edoxaban regimen (LDER; 30 mg daily, also reduced by one half in patients with anticipated increased drug regimen). SAPT (aspirin in 92.5%) was administered at the discretion of the treating physician. Cox proportional hazard regressions stratified by SAPT at 3 months with treatment as a covariate were performed. The 4912 patients who received SAPT were more frequently male, with histories of coronary artery disease and diabetes, and had higher CHADS 2Vasc and HAS BLED scores than did the 14 977 patients not receiving SAPT. When compared to patients not receiving SAPT, those receiving SAPT had a higher incidence of major bleeding; (adjusted hazard ratio [HR adj]=1.46; 95% CI, 1.27–1.67, P<0.001). SAPT did not alter the relative efficacy of edoxaban compared to warfarin in preventing stroke or systemic embolic events (SEEs): edoxaban versus warfarin without SAPT, hazard ratio (HR adj for HDER)=0.94; (95% CI: 0.77–1.15) with SAPT, HR adj=0.70 (95% CI: 0.50–0.98), P interaction (P int)=0.14. (HR adj for LDER versus warfarin without SAPT=1.19 (95% CI 0.99–1.43) With SAPT, 1.03 (95% CI, 0.76–1.39) P int=0.42. Major bleeding was lower with edoxaban than warfarin both without SAPT, HR adj for HDER=0.80 (95% CI, 0.68–0.95), and with SAPT, HR adj=0.82 (95% CI, 0.65–1.03; P int=0.91). For LDER without SAPT (HR adj=0.56 [95% CI 0.46–0.67]) and with SAPT (HR adj=0.51 [95% CI 0.39–0.66]).ConclusionsPatients with AF who were selected by their physicians to receive SAPT in addition to an anticoagulant had a similar risk of stroke/SEE and higher rates of bleeding than those not receiving SAPT. Edoxaban exhibited similar relative efficacy and reduced bleeding compared to warfarin, with or without concomitant SAPT.Clinical Trial Registration URL: http://www.clinicaltrials.gov/. Unique identifier: NCT00781391.

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“…In the latest European Society of Cardiology consensus statement,25 dual antithrombotic therapy is recommended over triple antithrombotic therapy in AF patients with low stroke risk, high bleeding risk, stable CAD, and PCI; is an option in most other situations; but is not suggested as an early treatment option in patients with low bleeding risk and an ACS. However, prospective clinical data with any new dual antithrombotic therapy or triple antithrombotic therapy regimen with dabigatran etexilate or other NOACs in nonvalvular AF patients undergoing PCI would be helpful 41…”

Section: Discussionmentioning

confidence: 99%

“…Discontinuation of clopidogrel or ticagrelor or switching to aspirin (≤100 mg once daily) after 12 months of treatment will also be at the discretion of the investigator, allowing investigators to discontinue antiplatelet therapy as suggested by a European consensus 25. The use of prasugrel is not allowed based on a study showing that prasugrel was associated with a 4‐fold increase in major bleeding when used in the setting of triple antithrombotic therapy in patients with evidence of clopidogrel resistance 31…”

Section: Methodsmentioning

confidence: 99%

“…However, evidence supporting this recommendation is limited (class IIb, level of evidence B). The European Society of Cardiology, along with various other groups, released a joint consensus statement that also recommends dual antithrombotic therapy as an option in many patient groups, based on bleeding and thrombotic risk 25. However, these recommendations are complex, derived from a single small trial,19 and therefore relatively weak.…”

Section: Introductionmentioning

confidence: 99%

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Design and Rationale of the RE‐DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting

Cannon

Gropper

Bhatt

et al. 2016

Clinical Cardiology

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Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest‐sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. The RE‐DUAL PCI trial (NCT 02164864) is a phase 3b, a strategy of prospective, randomized, open‐label, blinded‐endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibtor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a P2Y12 inhibtor (either clopidogrel or ticagrelor, and low‐dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular AF patients who have undergone percutaneous coronary intervention with stenting. The primary endpoint is time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding event. Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize ∼ 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population.

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Cited by 487 publications

References 136 publications

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF‐TIMI48 Trial

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