New oral anticoagulants in patients with atrial fibrillation in a urban health centre

Rodríguez Pérez, Leoncio; Capilla Lozano, Fabiola; Gallego Fuentes, Rogelio; Buitrago, Francisco
doi:10.1016/j.medcle.2015.06.010
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Atrial fibrillation &#40;AF&#41; is the most common chronic cardiac arrhythmia and a major problem of disability and death related to cerebral stroke&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a> Its prevalence increases with age&#44; affecting 9&#37; of those over 80 years old&#46; Anticoagulation with warfarin and acenocoumarol reduces the risk of ischaemic stroke and systemic embolism&#44; and has been for decades been the only oral anticoagulant therapy available&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The emergence of new oral anticoagulants &#40;NOAC&#41; as a direct thrombin inhibitor &#40;dabigatran&#41; and direct factor Xa inhibitor &#40;rivaroxaban and apixaban&#41; has provided an alternative oral anticoagulant therapy&#46; NOACs have demonstrated non-inferiority to warfarin in preventing stroke and systemic embolism&#44; with a decreased risk of brain haemorrhage&#44; but an increased risk of gastrointestinal bleeding&#44; especially in patients &#8805;75 years old&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">3&#44;4</span></a> They have benefits &#40;simplified dosing&#44; less medication interaction&#44; no monitoring required&#41; and disadvantages &#40;they do not have antidotes&#44; are not dialysable&#44; limited experience of use and lack of knowledge regarding their long-term safety&#41;&#46; Hence their use has been widely discussed by regulatory agencies&#44; including the Spanish Agency for Medicines and Health Products &#40;AEMPS&#41;&#44; which has published a report on general criteria and recommendations for the use of NOACs in the prevention of stroke and systemic embolism in patients with non-valvular AF&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">With this background&#44; this study was designed with the purpose of exploring the criteria and scores on thromboembolic risk scales in patients admitted into our hospital who are undergoing treatment with NOACs since their commercialisation has been authorised&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The La Paz health centre &#40;Badajoz&#41; treats a population of 26&#44;980 inhabitants &#40;53&#46;6&#37; women&#41;&#44; predominantly middle class&#46; On April 30&#44; 2015&#44; there was a total of 415 patients undergoing oral anticoagulant therapy&#44; 39 of them &#40;9&#46;4&#37;&#41; with NOACs&#46; Thromboembolic risk was calculated with the CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a> scale&#44; recommended by the European Society of Cardiology&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">7</span></a> The data analysis used the SPSS<span class="elsevierStyleSup">&#174;</span> 22&#46;0 software&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Of the total of 39 patients included &#40;20 women&#44; 19 men&#41;&#44; 17 took rivaroxaban &#40;43&#46;6&#37; of the sample&#41;&#44; 14 apixaban &#40;35&#46;9&#37;&#41; and 8 dabigatran &#40;20&#46;5&#37;&#41;&#46; The mean age was 77&#46;9 &#40;80&#46;3 for women and 75&#46;5 men&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;135&#41; and the mean score on the CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc for the total sample was 4&#46;03 points &#40;4&#46;6 females and 3&#46;4 males&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleMonospace">&#60;</span><span class="elsevierStyleHsp" style=""></span>0&#46;05&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">26 of 39 patients &#40;12 females and 14 males&#41; were directly prescribed an NOAC&#44; that is&#44; 66&#46;7&#37; of patients started their treatment with one of the new anticoagulants&#46; The mean age was 76&#46;3 &#40;79&#46;8 for women compared with 73&#46;4 men&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;127&#41; and the mean score on the CHA2DS2-VASc was 3&#46;8 &#40;4&#46;2 females and 3&#46;4 males&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;083&#41;&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The average age of the 13 patients &#40;8 females&#47;5 males&#41; who had previously taken acenocumarol was 81&#46;1 &#40;81&#46;0 for female and 81&#46;2 for males&#41;&#44; with a CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc score of 4&#46;5 points &#40;5&#46;1 female and 3&#46;4 male&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;070&#41;&#46; 23&#37; of these patients who had previously taken acenocumarol and subsequently received an NOAC &#40;3 patients&#41; had an adequate INR control time and had not reported any significant bleeding&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">There were no significant differences between the CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc score of those who had been previously undergoing treatment with acenocoumarol and those who started directly with an NOAC &#40;4&#46;5 compared with 3&#46;8&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;127&#41;&#44; nor between their mean ages &#40;81&#46;1 compared with 76&#46;3&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;112&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In four of the 39 patients &#40;10&#46;3&#37;&#41;&#44; the scheduled dosing of NOACs was considered inadequate according to the patient and accepted guidelines&#46; And two patients &#40;5&#46;1&#37;&#41; being treated with NOACs &#40;apixaban&#41; also took acetylsalicylic acid&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">In summary&#44; the results of our study show that a high percentage of patients &#40;66&#46;7&#37;&#41; receive an NOAC prescription as their first oral anticoagulant therapy&#44; without any of AEMPS&#8217; recommendations that justify not having started anticoagulant therapy with a vitamin K antagonist being present in their clinical history&#46; The results also found that NOACs and rivaroxaban in particular show a higher CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc score for women&#44; which could be a reflection not only of the extra point that the table gives females&#44; but perhaps of a different behaviour depending on the sex of the patient&#46; Finally&#44; the results show a significant percentage of dosage &#40;10&#46;3&#37;&#41; and prescription &#40;5&#46;1&#37;&#41; errors&#44; which could increase the risk of bleeding&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">This study has limitations inherent to the small sample size available and its specific scope&#46; But the data encourage further research&#44; indicating that the prescription of NOACs is not conditioned only by evidence levels achieved so far&#44; so should be closely monitored in these patients&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest&#46;</p></span></span>"
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                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Dabigatran &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>8&#41;&nbsp;\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">Totals&nbsp;\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"><span class="elsevierStyleItalic">Mean age &#40;SD&#41; years</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">75&#46;2 &#40;9&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">80&#46;9 &#40;7&#46;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">78&#46;5 &#40;13&#46;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">77&#46;9 &#40;9&#46;9&#41;&nbsp;\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"><span class="elsevierStyleHsp" style=""></span>Female&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">78&#46;0 &#40;7&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">79&#46;5 &#40;10&#46;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">80&#46;3 &#40;7&#46;3&#41;&nbsp;\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"><span class="elsevierStyleHsp" style=""></span>Male&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">71&#46;1 &#40;12&#46;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">78&#46;3 &#40;9&#46;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">77&#46;5 &#40;17&#46;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">75&#46;5 &#40;11&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="5" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">CHA</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">DS</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">-VASc score</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;4 &#40;1&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;9 &#40;1&#46;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;5 &#40;1&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;03 &#40;1&#46;5&#41;&nbsp;\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"><span class="elsevierStyleHsp" style=""></span>Female&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">5&#46;1 &#40;1&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;5 &#40;1&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;5 &#40;1&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;6 &#40;1&#46;5&#41;&nbsp;\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"><span class="elsevierStyleHsp" style=""></span>Male&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;3 &#40;1&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;5 &#40;0&#46;9&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;5 &#40;1&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;4 &#40;1&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">CHA<span class="elsevierStyleInf">2</span>DS<span class="elsevierStyleInf">2</span>-VASc scales scores by type of anticoagulant and sex&#46;</p>"
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