Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial

Dewilde, Willem; Oirbans, Tom; Verheugt, Freek W.A.; Kelder, Johannes C.; Smet, Bart J. G. L. de; Herrman, Jean‐Paul R.; Adriaenssens, Tom; Vrolix, Mathias; Heestermans, Antonius A.C.M.; Vis, Marije M.; Tijsen, Jan G. P.; Hof, Arnoud W van ’t; Berg, Jurriën Ten

doi:10.1016/s0140-6736(12)62177-1

Cited by 1,561 publications

(1,120 citation statements)

References 38 publications

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“…In this trial, 573 patients who were receiving anticoagulation with VKAs (mostly for AF) and needed PCI were randomized to standard triple antithrombotic therapy (anticoagulant, clopidogrel, and aspirin) vs dual antithrombotic therapy (anticoagulant and clopidogrel). The study showed that dual antithrombotic therapy significantly reduced the risk of bleeding and was also associated with a lower risk of death or thrombotic events than was triple antithrombotic therapy 19. Data from registries support the WOEST findings 19, 20.…”

Section: Introductionmentioning

confidence: 63%

“…As such, RE‐DUAL PCI will be a large follow‐up study to test a WOEST19‐like strategy in an adequately powered manner. With dabigatran, the risk of MI was not statistically higher than with warfarin in RE‐LY, whereas all thrombotic events (MI, stroke/embolism, revascularization, unstable angina, or cardiac death) were statistically significantly lower with dabigatran 150 mg 37.…”

Section: Discussionmentioning

confidence: 99%

“…The study showed that dual antithrombotic therapy significantly reduced the risk of bleeding and was also associated with a lower risk of death or thrombotic events than was triple antithrombotic therapy 19. Data from registries support the WOEST findings 19, 20. More recently, the findings from the open‐label ISAR‐TRIPLE trial,21 which involved 614 patients with an indication for OAC who were undergoing drug‐eluting stent (DES) implantation, support a limited duration (6 weeks vs 6 months) of triple antithrombotic therapy 22…”

Section: Introductionmentioning

confidence: 99%

“…The other major development in this field came from the randomized What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary Stenting (WOEST) study 19. In this trial, 573 patients who were receiving anticoagulation with VKAs (mostly for AF) and needed PCI were randomized to standard triple antithrombotic therapy (anticoagulant, clopidogrel, and aspirin) vs dual antithrombotic therapy (anticoagulant and clopidogrel).…”

Section: Introductionmentioning

confidence: 99%

“…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. Consequently, a single, 3‐stage algorithm, applicable to a broad range of patients with coronary artery disease (CAD), has been proposed 26…”

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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Section: Introductionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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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Medical Management After Coronary Stent Implantation

Brilakis

Patel

Banerjee

2013

JAMA

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Atrial Fibrillation

Ko,

Chung,

Evans

et al. 2024

JAMA

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ImportanceIn the US, approximately 10.55 million adults have atrial fibrillation (AF). AF is associated with significantly increased risk of stroke, heart failure, myocardial infarction, dementia, chronic kidney disease, and mortality.ObservationsSymptoms of AF include palpitations, dyspnea, chest pain, presyncope, exertional intolerance, and fatigue, although approximately 10% to 40% of people with AF are asymptomatic. AF can be detected incidentally during clinical encounters, with wearable devices, or through interrogation of cardiac implanted electronic devices. In patients presenting with ischemic stroke without diagnosed AF, an implantable loop recorder (ie, subcutaneous telemetry device) can evaluate patients for intermittent AF. The 2023 American College of Cardiology (ACC)/American Heart Association (AHA)/American College of Clinical Pharmacy (ACCP)/Heart Rhythm Society (HRS) Guideline writing group proposed 4 stages of AF evolution: stage 1, at risk, defined as patients with AF-associated risk factors (eg, obesity, hypertension); stage 2, pre-AF, signs of atrial pathology on electrocardiogram or imaging without AF; stage 3, the presence of paroxysmal (recurrent AF episodes lasting ≤7 days) or persistent (continuous AF episode lasting &gt;7 days) AF subtypes; and stage 4, permanent AF. Lifestyle and risk factor modification, including weight loss and exercise, to prevent AF onset, recurrence, and complications are recommended for all stages. In patients with estimated risk of stroke and thromboembolic events of 2% or greater per year, anticoagulation with a vitamin K antagonist or direct oral anticoagulant reduces stroke risk by 60% to 80% compared with placebo. In most patients, a direct oral anticoagulant, such as apixaban, rivaroxaban, or edoxaban, is recommended over warfarin because of lower bleeding risks. Compared with anticoagulation, aspirin is associated with poorer efficacy and is not recommended for stroke prevention. Early rhythm control with antiarrhythmic drugs or catheter ablation to restore and maintain sinus rhythm is recommended by the 2023 ACC/AHA/ACCP/HRS Guideline for some patients with AF. Catheter ablation is first-line therapy in patients with symptomatic paroxysmal AF to improve symptoms and slow progression to persistent AF. Catheter ablation is also recommended for patients with AF who have heart failure with reduced ejection fraction (HFrEF) to improve quality of life, left ventricular systolic function, and cardiovascular outcomes, such as rates of mortality and heart failure hospitalization.Conclusions and RelevanceAF is associated with increased rates of stroke, heart failure, and mortality. Lifestyle and risk factor modification are recommended to prevent AF onset, recurrence, and complications, and oral anticoagulants are recommended for those with an estimated risk of stroke or thromboembolic events of 2% or greater per year. Early rhythm control using antiarrhythmic drugs or catheter ablation is recommended in select patients with AF experiencing symptomatic paroxysmal AF or HFrEF.

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Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial

Cited by 1,561 publications

References 38 publications

Medical Management After Coronary Stent Implantation

Atrial Fibrillation

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