Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study

Yang, Hyeon Jong; Bouma, Berto J.; Dimopoulos, Konstantinos; Khairy, Paul; Ladouceur, Magalie; Niwa, Koichiro; Greutmann, Matthias; Schwerzmann, Markus; Egbe, Alexander C.; Scognamiglio, Giancarlo; Budts, Werner; Veldtman, Gruschen; Opotowsky, Alexander R.; Broberg, Craig S.; Gumbienė, Lina; Meijboom, Folkert J.; Rutz, Tobias; Post, Marco C.; Moe, Tabitha G.; Lipczyńska, Magdalena; Tsai, Shane; Chakrabarti, S.; Tobler, Daniel; Davidson, William R.; Morissens, Marielle; Dijk, A. van; Buber, Jonathan; Bouchardy, Judith; Skoglund, Kristofer; Christersson, Christina; Kronvall, Thomas; Konings, T.C.; Alonso‐Gonzalez, Rafael; Mizuno, Atsushi; Webb, Gary D.; Laukytė, Monika; Sieswerda, Gertjan T.; Shafer, Keri M.; Aboulhosn, Jamil; Mulder, Barbara J.M.

doi:10.1016/j.ijcard.2019.06.014

Cited by 71 publications

(54 citation statements)

References 33 publications

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“…Yang et al [ 28 ] reported on the results of the NOTE registry, the first international multicenter cohort study assessing the safety and efficacy of NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) in ACHD patients. A quarter of patients (28%, n = 150) were previously on Vitamin K Antagonist (VKA) therapy and served as historic controls.…”

Section: Resultsmentioning

confidence: 99%

Non-Vitamin K Oral Anticoagulants in Adults with Congenital Heart Disease: A Systematic Review

Stalikas

Doundoulakis

Karagiannidis

et al. 2020

JCM

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Adults with congenital heart disease (ACHD) experience more thromboembolic complications than the general population. We systematically searched and critically appraised all studies on the safety and efficacy of non-vitamin-K oral anticoagulants (NOACs) in adult patients with various forms of congenital heart disease. PubMed and the Cochrane Central Register of Controlled Trials (CENTRAL) were used, with duplicate extraction of data and risk of bias assessment. The Newcastle-Ottawa quality assessment scale was used to assess study quality. Three studies fulfilled the inclusion criteria and were analyzed. The total number of participants was 766, with a total follow-up of 923 patient-years. The majority of patients (77%) received a NOAC for atrial arrhythmias, while the remainder were prescribed NOACs for secondary (19%) or primary (4%) thromboprophylaxis. The annual rate of thromboembolic and major bleeding events was low: 0.98% (95% CI: 0.51–1.86) and 1.74% (95% CI: 0.86–3.49) respectively. In Fontan patients, the annual rate of thromboembolic and major bleeding events was 3.13% (95% CI: 1.18–8.03) and 3.17% (95% CI: 0.15–41.39) respectively. NOACs appear safe and effective in ACHD without mechanical prostheses. Additional studies are, however, needed to confirm their efficacy in complex ACHD, especially those with a Fontan-type circulation.

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Section: Resultsmentioning

confidence: 99%

Non-Vitamin K Oral Anticoagulants in Adults with Congenital Heart Disease: A Systematic Review

Stalikas

Doundoulakis

Karagiannidis

et al. 2020

JCM

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“… 33 34 The independent endpoint adjudication of PROTECT-AR will allow for comprehensive, quality details on the endpoints of interest, in compliance with predefined standards. In a similar fashion to the NOTE (NOACs for thromboembolic prevention in patients with CHD) study, 10 PROTECT-AR exploits an existing pool of phenotypically characterised patients with ACHD, nested into active, local ACHD-all-comers registries, from which ongoing apixaban users are to be selected. Such use of already available resources is expected to offer several advantages compared with other studies: First, it will reduce time and recruitment costs.…”

Section: Discussionmentioning

confidence: 99%

“…Yet even after a decade on the market, most data generated by studies on ACHD patients with AA focused on NOACs in general, rather than apixaban per se. [7][8][9][10] To address this gap in knowledge, we designed the PReventiOn of ThromboEmbolism in Adults with Congenital HearΤ disease and Atrial aRrhythmias (PROTECT-AR) trial. The trial aims to evaluate the safety and efficacy of apixaban use for thromboembolism prevention, in routine, 'real-world' practice regarding ACHD patients with AA.…”

Section: Introductionmentioning

confidence: 99%

Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study

et al. 2020

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IntroductionThe risk for stroke in adults with congenital heart disease (ACHD) is increased, especially in the setting of commonly ensuing atrial arrhythmias (AA), namely atrial fibrillation, atrial flutter or intra-atrial re-entrant tachycardia. Data are limited regarding treatment with non-vitamin K oral anticoagulants in long-term studies involving patients with ACHD and AA.Methods and analysisPReventiOn of ThromboEmbolism in Adults with Congenital HearΤ disease and Atrial aRrhythmias is a prospective, multicenter, single-arm, non-interventional cohort study designed to investigate the safety and efficacy of apixaban for the prevention of thromboembolism in ACHD with AA in a ‘real-world’ setting. Eligible patients will be evaluated by the means of available registries and clinical counter. The study aims to accumulate approximately 500 patient-years of exposure to apixaban as part of routine care. Enrolment will take place at four ACHD centres in Greece. The first patient was enrolled in July 2019. The primary efficacy endpoint is a composite of stroke, systemic or pulmonary embolism and intracardiac thrombosis. The primary safety endpoint is major bleeding, according to the International Society on Thrombosis and Haemostasis bleeding criteria.Ethics and disseminationThe study protocol has been approved by the institutional review board/independent ethics committee at each site prior to study commencement. All patients will provide written informed consent. Results will be disseminated at scientific meetings and published in peer-reviewed journals.Trial registration numberNCT03854149; Pre-results.

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“…Our national registry (CONCOR) and international networks such as the ISACHD and the EuroGUCH facilitate worldwide collaborative ACHD research and education. Several international initiatives have been undertaken to improve efficacy, such as the NOTE Registry, a global study assessing the efficacy and safety of non-vitamin K oral antagonists in preventing thromboembolic complications in ACHD and the ROPAC study, describing the outcome of pregnancy in cardiac patients, including ACHD [ 38 , 39 ]. Much of this research is integrated in the 2020 European Cardiac Society guideline on adult CHD.…”

Section: Clinical Researchmentioning

confidence: 99%

New developments in adult congenital heart disease

et al. 2020

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Congenital heart disease (CHD) affects 0.8% of live births and over the past decades technical improvements and large-scale repair has led to increased survival into adulthood of over 95% of the newborn. A new group of patients, those who survived their congenital heart defect, has emerged but late complications including heart failure, pulmonary hypertension (PH), arrhythmias, aneurysms and endocarditis appeared numerous, with a huge impact on mortality and morbidity. However, innovations over the past years have changed the landscape of adult CHD dramatically. In the diagnostic process important improvements have been made in the use of MRI, biomarkers, e-health concepts and 3D visualisation of anatomy. Care is now concentrated in specialised centres, with a continuous emphasis on education and the introduction of weekly multidisciplinary consultations on diagnosis and intervention. Surgery

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Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study

Cited by 71 publications

References 33 publications

Non-Vitamin K Oral Anticoagulants in Adults with Congenital Heart Disease: A Systematic Review

Non-Vitamin K Oral Anticoagulants in Adults with Congenital Heart Disease: A Systematic Review

Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study

New developments in adult congenital heart disease

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