Non-vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: are they safe

被引:25
作者
Yang, Hayang [1 ]
Veldtman, Gruschen R. [2 ]
Bouma, Berto J. [3 ]
Budts, Werner [4 ]
Niwa, Koichiro [5 ]
Meijboom, Folkert [6 ]
Scognamiglio, Giancarlo [7 ]
Egbe, Alexander Chima [8 ]
Schwerzmann, Markus [9 ]
Broberg, Craig [10 ]
Morissens, Marielle [11 ]
Buber, Jonathan [12 ]
Tsai, Shane [13 ]
Polyzois, Ioannis [14 ,15 ]
Post, Martijn C. [16 ]
Greutmann, Matthias [17 ]
Van Dijk, Arie [18 ]
Mulder, Barbara J. M. [19 ]
Aboulhosn, Jamil [20 ]
机构
[1] AMC, Dept Cardiol, Amsterdam, Netherlands
[2] Cincinnati Childrens Hosp Med Ctr, Adolescent & Adult Congenital Heart Dis Program, Cincinnati, OH 45229 USA
[3] Univ Amsterdam, Acad Med Ctr, Cardiol, Amsterdam, Netherlands
[4] Univ Hosp Gasthuisberg, Dept Cardiol, Leuven, Belgium
[5] St Lukes Int Hosp, Dept Cardiol, Tokyo, Japan
[6] Univ Med Ctr Utrecht, Cardiol, Utrecht, Netherlands
[7] Univ Naples 2, Monaldi Hosp, Cardiol, Naples, Italy
[8] Mayo Clin, Div Cardiovasc Dis, Dept Med, Rochester, NY USA
[9] Univ Hosp Inselspital, Adult Congenital Heart Diseae Program, Bern, Switzerland
[10] Oregon Hlth & Sci Univ, Knight Cardiovasc Inst, Portland, OR 97201 USA
[11] CHU Brugmann, Dept Cardiol, Brussels, Belgium
[12] Sheba Med Ctr, Heart Ctr, Ramat Gan, Israel
[13] Univ Nebraska Med Ctr, Dept Cardiol, Omaha, NE USA
[14] Royal Brompton Hosp, Adult Congenital Heart Ctr, London, England
[15] Royal Brompton Hosp, Ctr Pulm Hypertens, London, England
[16] St Antonius Hosp, Dept Cardiol, Nieuwegein, Netherlands
[17] Univ Hosp Zurich, Cardiol, Zurich, Switzerland
[18] Univ Nijmegen, Med Ctr, Cardiol, Nijmegen, Netherlands
[19] Acad Med Ctr, Cardiol, Amsterdam, Netherlands
[20] UCLA, Cardiol, Los Angeles, CA USA
关键词
EMBOLIC COMPLICATIONS; ARRHYTHMIAS; ASPIRIN; THERAPY;
D O I
10.1136/openhrt-2018-000985
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background In Fontan patients with atrial arrhythmias (AA), non-vitamin K antagonist oral anticoagulants(NOACs) have a class III recommendation according to the Pediatric & Congenital Electrophysiology Society (PACES)/Heart Rhythm Society (HRS) guideline in 2014, due to lack of data on outcomes as opposed to evidence of harm. To address this gap in data, we investigated the safety and efficacy of NOACs in adults with a Fontan circulation in a worldwide study. Methods This is an international multicentre prospective cohort study, using data from the NOTE (non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding. Results From April 2014 onward, 74 patients (mean age 32 +/- 10 years (range 18-68), 54% male) with a Fontan circulation using NOACs were included. During a median follow-up of 1.2 (IQR 0.8-2.0) years, three thromboembolic events (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) and three major bleedings (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) occurred in five atriopulmonary Fontan and one total cavopulmonary connection Fontan patients with AA. Fifteen patients experienced minor bleeding episodes (15.8 per 100 patient-years (95% CI 9.1 to 25.2)). In patients (n= 37) using vitamin K antagonists (VKAs) prior to the initiation of NOAC, annual incidence of historical thromboembolic events and major bleeding were 2.4% (95% CI 0.4% to 7.4%) (n = 2) and 1.2% (95% CI 0.7% to 5.1%) (n = 1), respectively. Conclusions In this review of the largest Fontan cohort using NOACs with prospective follow-up, NOACs appear to be well tolerated and their efficacy and safety during shortterm follow-up seem comparable to VKAs. Longer term data are required to confirm these promising short-term results.
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