Scientific letter
Importance of appropriate clinical management of direct oral anticoagulants
Importancia del empleo adecuado de los anticoagulantes orales directos
Juan Antonio Millón Caño
, Noelia Vilalta Setó, José Mateo Arranz, Juan Carlos Souto Andrés
Corresponding author
Unidad de Hemostasia y Trombosis, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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They offer certain advantages over AVK agents, such as more stable plasma levels, fewer drug and food interactions, and a lower incidence of intracranial bleeding. They also present certain drawbacks when compared to AVK drugs, such as greater accumulation in renal failure, increased incidence of gastrointestinal bleeding, shorter experience in its use and a potential risk of lower adherence as it does not require frequent checks to monitor its effect.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> Still, numerous clinical trials have demonstrated the efficacy and safety of the DOACs.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">2</span></a> In addition, data are beginning to be available on “real life” complications associated with DOACs in some countries, obtained from national registers.<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">3,4</span></a> However, there is a lack of data on these drugs’ efficacy and safety in our country.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the Haemostasis and Thrombosis Unit of the Hospital de Sant Pau a total of 223 patients under treatment with dabigatran (137) and rivaroxaban (86) received follow-up visits from January 2011 to April 2014. The indications of anticoagulant therapy included prevention of embolic events by non-valvular atrial fibrillation, and the treatment and prevention of recurrent venous thromboembolism.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The incidence of serious complications observed was significantly higher compared to those reported in clinical trials. Bleeding complications were classified according to the <span class="elsevierStyleItalic">Bleeding Academy Research Council</span> (BARC) scale and bleeding of grade 3–5 was classified as severe.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">5</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">During follow-up, the incidence of serious bleeding complications was 2.1 per 100 patients/year with dabigatran and 11.2 per 100 patients/year with rivaroxaban. As for thrombotic complications, an incidence of 4.1 cases was observed in 100 patients/year with dabigatran and 2.8 per 100 patients/year with rivaroxaban (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">The following problems were detected in half of all hemorrhagic and thrombotic complications: inadequate dose (5), poor adhesion (2), inadequate monitoring of the patient (3) or DOACs withdrawal too many days before an invasive procedure, according to clinical guidelines (1).</p><p id="par0030" class="elsevierStylePara elsevierViewall">Within its whole health area, the Haemostasis and Thrombosis Unit of the Hospital de Sant Pau controls only 26% of dabigatran patients and 21.9% rivaroxaban patients. It is not known whether the remaining patients are receiving an appropriate follow-up. This results in a selection bias in the sample, as patients who did not receive follow-up by the unit were referred to the same after having suffered a serious thrombotic or hemorrhagic event, while those who did not suffer it and who did not receive follow-up by this unit were not included in their observational data (they were not visited in the unit). Therefore, these retrospective observational data probably overstate the actual proportion of serious complications with DOACs.</p><p id="par0035" class="elsevierStylePara elsevierViewall">1.5% of patients with dabigatran and 14% of patients with rivaroxaban initiated anticoagulant treatment with inadequate doses. 6% of patients had to reduce the dose or withdraw DOACs due to a glomerular filtration rate deterioration during follow-up.</p><p id="par0040" class="elsevierStylePara elsevierViewall">A quarter of all ischemic complications had to do with poor adherence to treatment, with unjustified dose omissions by the patient in the days prior to the complication. In another quarter of these ischemic complications there was a withdrawal of DOACs too many days before an invasive procedure, according to clinical guidelines or unjustified withdrawal by medical personnel.</p><p id="par0045" class="elsevierStylePara elsevierViewall">In conclusion, in the sample described, half of the serious complications were related to factors which were independent to the pharmacological effect of DOACs: poor adhesion, poor clinical monitoring, inadequate dose adjustment as per renal function and unjustified drug withdrawal or too many days (according to clinical guidelines) before an invasive procedure. DOACs prescription should be made according to the dosage schedule of the Summary of Product Characteristics (SmPC), the patient needs to be trained and appropriate clinical follow-up through periodic assessments of renal function and blood counts has to be implemented, and if DOACs withdrawal is indicated in order to perform an invasive procedure, this should be done according to clinical guidelines.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">6</span></a> These measures should be undertaken by units that have experience with antithrombotic treatments. As it happens with AVK, poor administration, lack of patient training and improper monitoring carry increased bleeding and thrombotic risks, otherwise avoidable.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Please cite this article as: Millón Caño JA, Vilalta Setó N, Mateo Arranz J, Souto Andrés JC. Importancia del empleo adecuado de los anticoagulantes orales directos. Med Clin (Barc). 2016;146:41–42.</p>" ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="4" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Clinical trials</th><th class="td" title="table-head " colspan="5" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Studies in “real life”</th></tr><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">RE-LY<span class="elsevierStyleSup">®</span> (Dabigatran)</th><th class="td" title="table-head " align="left" valign="top" scope="col">ROCKET-AF (Rivaroxaban) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col">ARISTOTLE (Apixaban) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="2" align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Dabigatran (Denmark)</th><th class="td" title="table-head " align="left" valign="top" scope="col">Rivaroxaban (USA) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Our experience</th></tr><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">150<span class="elsevierStyleHsp" style=""></span>mg/12<span class="elsevierStyleHsp" style=""></span>h \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">110<span class="elsevierStyleHsp" style=""></span>mg/12<span class="elsevierStyleHsp" style=""></span>h \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">150<span class="elsevierStyleHsp" style=""></span>mg/12<span class="elsevierStyleHsp" style=""></span>h \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">110<span class="elsevierStyleHsp" style=""></span>mg/12<span class="elsevierStyleHsp" style=""></span>h \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Dabigatran \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Rivaroxaban \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No. patients in the study \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6076 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6015 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7131 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">9120 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2239 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2739 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3654 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">137 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">86 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Stroke/systemic embolism<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1.11 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1.53 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1.27 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.8 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Severe bleeding<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.11 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.71 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.13 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">11.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total complications<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4.22 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4.24 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">5.7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">5.9 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">5.8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.9 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6.2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">14 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1053356.png" ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Percentage incidence rate in patients/year.</p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Comparison between DOACs complications observed.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:6 [ 0 => array:3 [ "identificador" => "bib0035" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Antithrombotic therapy for stroke prevention in non-valvular atrial fibrillation" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "M.J. 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