Editorial comment
Thromboembolic events in patients with atrial fibrillation under anticoagulation
Acidentes tromboembólicos em doentes com fibrilhação auricular sob anticoagulação
Daniel Bonhorst
Instituto Português do Ritmo Cardíaco, Porto Salvo, Portugal
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(A) Family with multiple variants in <span class="elsevierStyleItalic">TNNT2</span> (c.325C>T, p.His109Tyr) and <span class="elsevierStyleItalic">TCAP</span> (c.313G>C, p.Glu105Gln), in which the phenotype is only expressed in cases of double heterozygosity, and the presence of just one variant is not associated with the expression of DCM; (B and C) families with non-segregating <span class="elsevierStyleItalic">TNNT2</span> variant (c.325C>T, p.His109Tyr) and <span class="elsevierStyleItalic">LMNA</span> variant (c.460G>A, p.Glu154Lys), respectively. Square: male; circle: female; black symbol: dilated cardiomyopathy; gray symbol: probable cardiac pathology; crossed symbol: deceased family member; arrow: proband; +/− symbols: presence/absence of the variant; numbers inside the symbols: age (years); ?: unavailability for clinical/genetic assessment; CABG: coronary artery bypass grafting; CE: cardiac evaluation; HT: heart transplantation; LBBB: left bundle branch block; LVD: left ventricular dysfunction; LVF: left ventricular function; RBBB: right bundle branch block; SD: sudden death; y: years.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Alexandra Sousa, Paulo Canedo, Olga Azevedo, Luís Lopes, Teresa Pinho, Márcia Baixia, Francisco Rocha-Gonçalves, Lino Gonçalves, José Silva Cardoso, José Carlos Machado, Elisabete Martins" "autores" => array:12 [ 0 => array:2 [ "nombre" => "Alexandra" "apellidos" => "Sousa" ] 1 => array:2 [ "nombre" => "Paulo" "apellidos" => "Canedo" ] 2 => array:2 [ "nombre" => "Olga" "apellidos" => "Azevedo" ] 3 => array:2 [ "nombre" => "Luís" "apellidos" => "Lopes" ] 4 => array:2 [ "nombre" => "Teresa" "apellidos" => "Pinho" ] 5 => array:2 [ "nombre" => "Márcia" "apellidos" => "Baixia" ] 6 => array:2 [ "nombre" => "Francisco" "apellidos" => "Rocha-Gonçalves" ] 7 => array:2 [ "nombre" => "Lino" "apellidos" => "Gonçalves" ] 8 => array:2 [ "nombre" => "José Silva" "apellidos" => "Cardoso" ] 9 => array:2 [ "nombre" => "José Carlos" "apellidos" => "Machado" ] 10 => array:2 [ "nombre" => "Elisabete" "apellidos" => "Martins" ] 11 => array:1 [ "colaborador" => "on behalf of FATIMA investigators" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S0870255118302269" "doi" => "10.1016/j.repc.2018.10.010" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255118302269?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204919300595?idApp=UINPBA00004E" "url" => "/21742049/0000003800000002/v1_201904100624/S2174204919300595/v1_201904100624/en/main.assets" ] "itemAnterior" => array:20 [ "pii" => "S2174204919300510" "issn" => "21742049" "doi" => "10.1016/j.repce.2018.06.007" "estado" => "S300" "fechaPublicacion" => "2019-02-01" "aid" => "1276" "copyright" => "Sociedade Portuguesa de Cardiologia" "documento" => "article" "crossmark" => 1 "licencia" => "http://creativecommons.org/licenses/by-nc-nd/4.0/" "subdocumento" => "fla" "cita" => "Rev Port Cardiol. 2019;38:117-24" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:2 [ "total" => 610 "formatos" => array:3 [ "EPUB" => 74 "HTML" => 349 "PDF" => 187 ] ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original Article</span>" "titulo" => "Ischemic stroke in patients previously anticoagulated for non-valvular atrial fibrillation: Why does it happen?" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "pt" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "117" "paginaFinal" => "124" ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Acidente vascular cerebral isquémico em doentes previamente anticoagulados por fibrilhação auricular não valvular: por que acontece?" ] ] "contieneResumen" => array:2 [ "en" => true "pt" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1404 "Ancho" => 2547 "Tamanyo" => 151584 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Possible mechanisms for stroke occurrence in patients chronically anticoagulated with NOACs compared to VKAs. NOACs: novel oral anticoagulants; VKAs: vitamin K antagonists.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Luís Fernandes, João Sargento-Freitas, James Milner, Alexandra Silva, Ana Novo, Tatiana Gonçalves, Ana Vera Marinho, Guilherme Mariano Pego, Luís Cunha, Natália António" "autores" => array:10 [ 0 => array:2 [ "nombre" => "Luís" "apellidos" => "Fernandes" ] 1 => array:2 [ "nombre" => "João" "apellidos" => "Sargento-Freitas" ] 2 => array:2 [ "nombre" => "James" "apellidos" => "Milner" ] 3 => array:2 [ "nombre" => "Alexandra" "apellidos" => "Silva" ] 4 => array:2 [ "nombre" => "Ana" "apellidos" => "Novo" ] 5 => array:2 [ "nombre" => "Tatiana" "apellidos" => "Gonçalves" ] 6 => array:2 [ "nombre" => "Ana Vera" "apellidos" => "Marinho" ] 7 => array:2 [ "nombre" => "Guilherme Mariano" "apellidos" => "Pego" ] 8 => array:2 [ "nombre" => "Luís" "apellidos" => "Cunha" ] 9 => array:2 [ "nombre" => "Natália" "apellidos" => "António" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "pt" => array:9 [ "pii" => "S0870255118300155" "doi" => "10.1016/j.repc.2018.06.004" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "pt" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255118300155?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204919300510?idApp=UINPBA00004E" "url" => "/21742049/0000003800000002/v1_201904100624/S2174204919300510/v1_201904100624/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial comment</span>" "titulo" => "Thromboembolic events in patients with atrial fibrillation under anticoagulation" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "125" "paginaFinal" => "127" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Daniel Bonhorst" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Daniel" "apellidos" => "Bonhorst" "email" => array:1 [ 0 => "danielbonhorst@iprc.pt" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Instituto Português do Ritmo Cardíaco, Porto Salvo, Portugal" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Acidentes tromboembólicos em doentes com fibrilhação auricular sob anticoagulação" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The article by Fernandes et al. published in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> addresses an important subject, particularly in view of the introduction of the new oral anticoagulants (NOACs): the occurrence of thromboembolic events in patients with atrial fibrillation (AF) under oral anticoagulation therapy.</p><p id="par0010" class="elsevierStylePara elsevierViewall">It is known that patients medicated with vitamin K antagonists (VKAs) may still be at thromboembolic risk due to periods in which their international normalized ratio (INR) is outside the therapeutic range.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a> This may be due to various factors, including poor treatment adherence, inadequate clinical control of dosing, and drug-drug or drug-food interactions. The main measure for the appropriacy of VKA therapy is time in therapeutic range (TTR), the percentage of time in which the patient's INR is within the established limits.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Less well known is the occurrence of thromboembolic complications in patients medicated with NOACs. These may be due to the short duration of their therapeutic effect, which means that missing even one dose can be critical.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The factors underlying the occurrence of stroke in patients with AF despite anticoagulant therapy may be patient-related, such as missing one or more doses or discontinuing treatment altogether. The physician, lacking the means to monitor treatment adherence, may be unaware of these events. In other cases, the fault may be clinical, such as dosing errors or inappropriate discontinuation, or inadequate knowledge of the risks of bleeding complications; it may also be due to suspending medication for too long before surgery or other interventions.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Drug-drug or drug-food interactions may lead to thromboembolism if they reduce the drug's anticoagulant effect. This is an important problem with VKAs but not with NOACs, for which interactions with other drugs or foods are rare or non-existent.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">3</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The limitations of VKA therapy have long been known, including their narrow therapeutic window, drug-drug and drug-food interactions, and need for frequent laboratory testing. Maintaining therapeutic levels of these drugs is thus a challenge and failure can have deleterious consequences, notably the occurrence of thromboembolic events.</p><p id="par0035" class="elsevierStylePara elsevierViewall">An important aspect of prevention of thromboembolic events is to ensure that patients prescribed an anticoagulant are aware that they will need to continue the treatment indefinitely. However, persistence with VKAs is low; 21-50% of patients discontinue their medication by one year after inception.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">4</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Most cases of stroke under VKA therapy are attributed to periods in which the patient's INR is below the therapeutic window (<2). The most frequently used measure of quality of anticoagulation is TTR, which is subject to various factors, some patient-related and others clinical.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Using the AFFIRM trial population,<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">5</span></a> Apostolakis et al.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">6</span></a> developed a score based on the clinical and demographic characteristics of patients with AF to assess the likelihood of poor INR control in VKA therapy. Using linear regression analysis, the authors identified female gender, age <60 years, ethnic minority status, smoking, more than two comorbidities, and medication with amiodarone as predictors of low TTR. In this score, which the authors designated as SAMe-TT<span class="elsevierStyleInf">2</span>R<span class="elsevierStyleInf">2</span> (sex, age, medical history; treatment, tobacco, race), ethnic minority status and smoking score two points, while age <60 years, more than two comorbidities, female gender and amiodarone for rhythm control score one point. The score was tested in derivation and internal validation cohorts and the derived model was validated externally in a real-world population of AF patients. The authors concluded that, using a mean TTR cut-off of 0.65, a score of 0 or 1 predicted good INR control and scores ≥2 predicted poor control. This score may be useful before beginning VKA treatment by identifying patients in whom poor INR control is more likely, information that may be useful in identifying patients who will need more frequent follow-up and appropriate counseling.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Problems of adherence should be reduced with NOACs, with the convenience of fixed doses without need for INR monitoring, less interactions with other drugs, and lower bleeding risk. However, real-world experience shows that this is not always the case; the high price of the drugs, together with concerns about bleeding complications, lead some patients or their physicians to discontinue NOACs or to replace them with less effective remedies in high-risk situations.</p><p id="par0055" class="elsevierStylePara elsevierViewall">At the same time, the fact that patients under NOACs do not need to be seen regularly to monitor INR leads to lower levels of clinical surveillance and thereby reduces the physician's ability to assess whether patients are adhering to their prescribed treatment.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">7</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">Tests to measure serum levels of NOACs can be performed in only a few specialized centers and, given the short half-life of these drugs, the information on adherence that they provide is limited to a short period before the test.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">8</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Clinical trials on patients with AF under NOACs suggest that, each year, 1.0-2.0% may experience stroke, which causes major problems since effective anticoagulation is a contraindication for the standard approach of thrombolytic therapy in cases of stroke.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">Assessment of adherence to NOAC therapy has shown varying results.<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10,11</span></a> In the few prospective studies carried out, levels of adherence have generally been high (70-98%). Factors associated with poor adherence include educational level, employment status, social isolation and cognitive problems. However, these results may have been influenced by selection bias and by the close clinical surveillance to which these patients are subjected, which may not reflect clinical practice.</p><p id="par0075" class="elsevierStylePara elsevierViewall">Observational studies and small series, which are closer to real-world populations, reveal more variable adherence levels (57-96%), due in part to differences in definitions of adherence and in ways of determining it. Many of these studies were unable to identify factors determining adherence, or produced sharply differing results.</p><p id="par0080" class="elsevierStylePara elsevierViewall">It is now considered that assessment of patients taking NOACs should take into consideration not only adherence (the percentage of doses of a drug taken as prescribed) but also persistence (the duration of treatment from initiation to discontinuation).<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">12</span></a> However, data on which to base a rigorous assessment are lacking, since few studies have been performed using objective measures such as electronic monitoring devices to count pills taken.</p><p id="par0085" class="elsevierStylePara elsevierViewall">There have also been few studies comparing adherence to NOACs with adherence to VKAs and the results are conflicting; several have shown no significant differences between the two.<a class="elsevierStyleCrossRefs" href="#bib0105"><span class="elsevierStyleSup">7,10,11,13</span></a> There are some data suggesting lower rates of discontinuation with NOACs compared to VKAs, although it is unclear whether adherence in these cases corresponds to correct intake of the medication.</p><p id="par0090" class="elsevierStylePara elsevierViewall">In a study by Beyer-Westendorf<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">14</span></a> of 7265 patients with AF, persistence in a follow-up of at least 180 days was better with rivaroxaban and dabigatran than with a VKA, and in a follow-up of at least 360 days was better with rivaroxaban than with dabigatran.</p><p id="par0095" class="elsevierStylePara elsevierViewall">The study by Fernandes et al.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> comes to three main conclusions, not all of them in agreement with the literature:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0100" class="elsevierStylePara elsevierViewall">Among patients with ischemic stroke despite chronic oral anticoagulation, poor treatment adherence is more frequent in patients taking NOACs than in those taking VKAs;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0105" class="elsevierStylePara elsevierViewall">The majority of patients taking VKAs had a subtherapeutic INR at admission;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0110" class="elsevierStylePara elsevierViewall">In most patients suffering a cardioembolic stroke despite taking a NOAC, the event was associated with subtherapeutic dosage or poor treatment adherence.</p></li></ul></p><p id="par0115" class="elsevierStylePara elsevierViewall">One of the study's limitations is that it is observational, being based on patients with non-valvular AF admitted to a neurology department with a diagnosis of ischemic stroke. The authors acknowledge other limitations, including the small sample size, the subjectivity inevitable with the use of questionnaires and the acute clinical status of patients following stroke, which often prevents the patient from collaborating.</p><p id="par0120" class="elsevierStylePara elsevierViewall">The most unexpected result was the high level of non-adherence in patients taking NOACs (almost 40%), significantly higher than in those taking VKAs, which suggests serious failings in physicians’ counseling of patients taking these new drugs.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0125" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Bonhorst D. Acidentes tromboembólicos em doentes com fibrilhação auricular sob anticoagulação. Rev Port Cardiol. 2019;38:125–127.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:14 [ 0 => array:3 [ "identificador" => "bib0075" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Acidente vascular cerebral isquémico em doentes previamente anticoagulados por fibrilhação auricular não valvular: porque acontece?" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "L. Fernandes" 1 => "J. Sargento-Freitas" 2 => "J. Milner" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.repc.2018.06.004" "Revista" => array:6 [ "tituloSerie" => "Rev Port Cardiol." 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 6 | 5 | 11 |
| 2024 October | 53 | 32 | 85 |
| 2024 September | 39 | 24 | 63 |
| 2024 August | 33 | 21 | 54 |
| 2024 July | 27 | 33 | 60 |
| 2024 June | 27 | 19 | 46 |
| 2024 May | 26 | 20 | 46 |
| 2024 April | 26 | 32 | 58 |
| 2024 March | 43 | 20 | 63 |
| 2024 February | 31 | 24 | 55 |
| 2024 January | 33 | 29 | 62 |
| 2023 December | 23 | 24 | 47 |
| 2023 November | 35 | 28 | 63 |
| 2023 October | 20 | 12 | 32 |
| 2023 September | 19 | 26 | 45 |
| 2023 August | 27 | 18 | 45 |
| 2023 July | 26 | 11 | 37 |
| 2023 June | 22 | 11 | 33 |
| 2023 May | 35 | 30 | 65 |
| 2023 April | 34 | 9 | 43 |
| 2023 March | 40 | 19 | 59 |
| 2023 February | 31 | 22 | 53 |
| 2023 January | 19 | 17 | 36 |
| 2022 December | 46 | 21 | 67 |
| 2022 November | 43 | 20 | 63 |
| 2022 October | 49 | 27 | 76 |
| 2022 September | 26 | 32 | 58 |
| 2022 August | 25 | 24 | 49 |
| 2022 July | 34 | 41 | 75 |
| 2022 June | 25 | 27 | 52 |
| 2022 May | 22 | 34 | 56 |
| 2022 April | 26 | 28 | 54 |
| 2022 March | 29 | 40 | 69 |
| 2022 February | 35 | 40 | 75 |
| 2022 January | 34 | 32 | 66 |
| 2021 December | 32 | 23 | 55 |
| 2021 November | 29 | 43 | 72 |
| 2021 October | 43 | 57 | 100 |
| 2021 September | 29 | 27 | 56 |
| 2021 August | 21 | 29 | 50 |
| 2021 July | 15 | 22 | 37 |
| 2021 June | 32 | 19 | 51 |
| 2021 May | 35 | 37 | 72 |
| 2021 April | 44 | 46 | 90 |
| 2021 March | 51 | 23 | 74 |
| 2021 February | 38 | 13 | 51 |
| 2021 January | 34 | 24 | 58 |
| 2020 December | 43 | 22 | 65 |
| 2020 November | 29 | 10 | 39 |
| 2020 October | 51 | 17 | 68 |
| 2020 September | 30 | 11 | 41 |
| 2020 August | 34 | 14 | 48 |
| 2020 July | 19 | 10 | 29 |
| 2020 June | 22 | 24 | 46 |
| 2020 May | 29 | 15 | 44 |
| 2020 April | 23 | 13 | 36 |
| 2020 March | 22 | 14 | 36 |
| 2020 February | 74 | 22 | 96 |
| 2020 January | 20 | 13 | 33 |
| 2019 December | 27 | 13 | 40 |
| 2019 November | 15 | 11 | 26 |
| 2019 October | 12 | 6 | 18 |
| 2019 September | 66 | 10 | 76 |
| 2019 August | 19 | 11 | 30 |
| 2019 July | 30 | 10 | 40 |
| 2019 June | 26 | 29 | 55 |
| 2019 May | 30 | 17 | 47 |
| 2019 April | 39 | 22 | 61 |
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