Editorial
National Consensus on the Diagnosis, Risk Stratification and Treatment of Patients with Pulmonary Embolism: An Update
Actualización del Consenso nacional sobre el diagnóstico, estratificación de riesgo y tratamiento de los pacientes con tromboembolia de pulmón
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These anticoagulants have all been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Spanish Agency of Medicines and Medical Devices (AEMPS) for the treatment of deep vein thrombosis (DVT) and PE, and for the prevention of recurrent DVT and PE in adults. In this editorial, we will analyze the design and the results of the pivotal clinical trials, and update our recommendations on anticoagulant treatment for PE.</p><p id="par0015" class="elsevierStylePara elsevierViewall">In a pooled analysis of 2 clinical trials which evaluated rivaroxaban in the acute and long-term treatment (e.g. during the first 3, 6 or 12 months) of DVT and PE (58%), the efficacy of rivaroxaban was found to be similar to that of standard treatment (parenteral anticoagulation overlap therapy followed by vitamin K antagonists) (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.66–1.19), with a 50% reduction in major bleeding (HR: 0.54; 95% CI: 0.37–0.79).<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> Rivaroxaban is administered orally (previous parenteral anticoagulation is not required) at doses of 15<span class="elsevierStyleHsp" style=""></span>mg twice a day for 3 weeks, followed by 20<span class="elsevierStyleHsp" style=""></span>mg once a day.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The AMPLIFY trial evaluated the efficacy and safety of apixaban in the treatment of 5395 patients with DVT or PE (34%) in the first 6 months after a thrombotic event.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> The efficacy of apixaban was similar to that of standard treatment (relative risk [RR]: 0.84; 95% CI: 0.60–1.18) with a statistically significant reduction in major bleeding (RR: 0.31; 95% CI: 0.17–0.55) and clinically relevant non-major bleeding (RR: 0.48; 95% CI: 0.38–0.60). Apixaban is administered orally (previous parenteral anticoagulation is not required) at doses of 10<span class="elsevierStyleHsp" style=""></span>mg twice a day for the first 7 days, followed by 5<span class="elsevierStyleHsp" style=""></span>mg twice a day. For extended treatment (e.g., beyond the first 3–6 months), a dose of 2.5<span class="elsevierStyleHsp" style=""></span>mg twice a day is recommended.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Clinical trials RECOVER and RECOVER II, which included 5107 patients with DVT and/or PE (31%) who were treated with low-molecular-weight heparin or unfractionated heparin during the first 5–11 days, compared the efficacy and safety of dabigatran 150<span class="elsevierStyleHsp" style=""></span>mg twice a day with warfarin for 6 months.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> The results of these studies demonstrated non-inferiority for recurrent thrombotic events (HR: 1.09; 95% CI: 0.76–1.57) and for major bleeding (HR: 0.73; 95% CI: 0.48–1.11), and a significant reduction of 30% for all bleeds (HR: 0.70; 95% CI: 0.61–0.79).</p><p id="par0030" class="elsevierStylePara elsevierViewall">The Hokusai-VTE randomized clinical trial, which included 4921 patients with DVT and 3319 with PE who had received heparin for a median period of 7 days, compared the efficacy and safety of edoxaban 60<span class="elsevierStyleHsp" style=""></span>mg/day (30<span class="elsevierStyleHsp" style=""></span>mg in patients with creatinine clearance 30–50<span class="elsevierStyleHsp" style=""></span>ml, weight ≤60<span class="elsevierStyleHsp" style=""></span>kg, or concomitant use of potent P-glycoprotein inhibitors) with warfarin for 3–12 months.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> Edoxaban was not inferior to warfarin for the primary efficacy outcome (incidence of fatal or non-fatal recurrent thrombotic event) (HR: 0.89; 95% CI: 0.70–1.13). The incidence of major or clinically relevant non-major bleeding was significant lower in the group which received edoxaban (HR: 0.81; 95% CI: 0.71–0.94).</p><p id="par0035" class="elsevierStylePara elsevierViewall">No studies have been designed to directly compare direct oral anticoagulants with agents of the same class:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">−</span><p id="par0040" class="elsevierStylePara elsevierViewall">For acute and long-term treatment (e.g., first 3–6 months) of non-cancer patients with PE, we suggest the use of rivaroxaban or apixaban over vitamin K antagonists.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">−</span><p id="par0045" class="elsevierStylePara elsevierViewall">For long-term treatment (e.g., first 3–6 months) of non-cancer patients with PE who have received an initial period of at least 5 days of parenteral anticoagulation, we suggest the use of dabigatran or edoxaban over vitamin K antagonists</p></li></ul></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0050" class="elsevierStylePara elsevierViewall">Fernando Uresandi has received funding from Bayer HealthCare Pharmaceuticals for giving talks at educational events and/or scientific consultancy and/or research.</p><p id="par0055" class="elsevierStylePara elsevierViewall">David Jiménez has received funding for giving talks at educational events and/or scientific consultancy and/or research from Bayer HealthCare Pharmaceuticals; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb Company; Daiichi Sankyo, Inc; Leo Pharma; Pfizer; ROVI and Sanofi-Aventis.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of interests" ] 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: Uresandi F, Jiménez D. Actualización del Consenso nacional sobre el diagnóstico, estratificación de riesgo y tratamiento de los pacientes con tromboembolia de pulmón. Arch Bronconeumol. 2016;52:61–62.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "National Consensus on Diagnosis, Risk Stratification and Treatment of Patients With Pulmonary Thromboembolism; Spanish Society of Pneumology and Thoracic Surgery (SEPAR); Society Española Internal Medicine (SEMI); Spanish Society of Thrombosis and Haemostasis (SETH); Spanish Society of Cardiology (ESC); Spanish Society of Medicine Accident and Emergency (SEMES); Spanish Society of Angiology and Surgery Vascular (SEACV). National Consensus on the Diagnosis, Risk Stratification and Treatment of Patients with Pulmonary Embolism. Spanish Society of Pneumology and Thoracic Surgery (SEPAR). Society Española Internal Medicine (SEMI). Spanish Society of Thrombosis and Haemostasis (SETH). Spanish Society of Cardiology (ESC). Spanish Society of Medicine Accident and Emergency (SEMES). Spanish Society of Angiology and Surgery Vascular (SEACV)" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "F. Uresandi" 1 => "M. Monreal" 2 => "F. García-Bragado" 3 => "P. Domenech" 4 => "R. Lecumberri" 5 => "P. Escribano" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.arbres.2013.07.008" "Revista" => array:6 [ "tituloSerie" => "Arch Bronconeumol" "fecha" => "2013" "volumen" => "49" "paginaInicial" => "534" "paginaFinal" => "547" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24041726" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0035" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "M.H. Prins" 1 => "A.W. Lensing" 2 => "R. Bauersachs" 3 => "B. van Bellen" 4 => "H. Bounameaux" 5 => "T.A. 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Mismetti" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1161/CIRCULATIONAHA.113.004450" "Revista" => array:6 [ "tituloSerie" => "Circulation" "fecha" => "2014" "volumen" => "129" "paginaInicial" => "764" "paginaFinal" => "772" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24344086" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "H.R. Büller" 1 => "H. Décousus" 2 => "M.A. Grosso" 3 => "M. Mercuri" 4 => "S. Middeldorp" 5 => "M.H. Prins" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1056/NEJMoa1306638" "Revista" => array:6 [ "tituloSerie" => "N Engl J Med" "fecha" => "2013" "volumen" => "369" "paginaInicial" => "1406" "paginaFinal" => "1415" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23991658" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/15792129/0000005200000002/v1_201601300120/S157921291500436X/v1_201601300120/en/main.assets" "Apartado" => array:4 [ "identificador" => "46447" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Editorial" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/15792129/0000005200000002/v1_201601300120/S157921291500436X/v1_201601300120/en/main.pdf?idApp=UINPBA00003Z&text.app=https://archbronconeumol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S157921291500436X?idApp=UINPBA00003Z" ]
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| 2024 October | 44 | 15 | 59 |
| 2024 September | 32 | 15 | 47 |
| 2024 August | 54 | 29 | 83 |
| 2024 July | 49 | 21 | 70 |
| 2024 June | 57 | 29 | 86 |
| 2024 May | 67 | 25 | 92 |
| 2024 April | 30 | 23 | 53 |
| 2024 March | 42 | 19 | 61 |
| 2024 February | 32 | 20 | 52 |
| 2023 March | 7 | 3 | 10 |
| 2023 February | 22 | 16 | 38 |
| 2023 January | 14 | 22 | 36 |
| 2022 December | 30 | 38 | 68 |
| 2022 November | 25 | 16 | 41 |
| 2022 October | 31 | 22 | 53 |
| 2022 September | 19 | 17 | 36 |
| 2022 August | 63 | 37 | 100 |
| 2022 July | 65 | 42 | 107 |
| 2022 June | 56 | 35 | 91 |
| 2022 May | 60 | 36 | 96 |
| 2022 April | 25 | 33 | 58 |
| 2022 March | 34 | 47 | 81 |
| 2022 February | 39 | 46 | 85 |
| 2022 January | 37 | 30 | 67 |
| 2021 December | 26 | 34 | 60 |
| 2021 November | 35 | 36 | 71 |
| 2021 October | 36 | 44 | 80 |
| 2021 September | 29 | 49 | 78 |
| 2021 August | 30 | 28 | 58 |
| 2021 July | 21 | 25 | 46 |
| 2021 June | 28 | 40 | 68 |
| 2021 May | 30 | 38 | 68 |
| 2021 April | 51 | 77 | 128 |
| 2021 March | 40 | 18 | 58 |
| 2021 February | 17 | 25 | 42 |
| 2021 January | 20 | 24 | 44 |
| 2020 December | 24 | 26 | 50 |
| 2020 November | 18 | 17 | 35 |
| 2020 October | 17 | 18 | 35 |
| 2020 September | 18 | 16 | 34 |
| 2020 August | 24 | 15 | 39 |
| 2020 July | 34 | 23 | 57 |
| 2020 June | 19 | 3 | 22 |
| 2020 May | 39 | 15 | 54 |
| 2020 April | 30 | 16 | 46 |
| 2020 March | 29 | 11 | 40 |
| 2020 February | 36 | 15 | 51 |
| 2020 January | 27 | 18 | 45 |
| 2019 December | 32 | 11 | 43 |
| 2019 November | 23 | 16 | 39 |
| 2019 October | 11 | 9 | 20 |
| 2019 September | 20 | 11 | 31 |
| 2019 August | 20 | 22 | 42 |
| 2019 July | 22 | 14 | 36 |
| 2019 June | 18 | 20 | 38 |
| 2019 May | 50 | 35 | 85 |
| 2019 April | 51 | 46 | 97 |
| 2019 March | 30 | 27 | 57 |
| 2019 February | 30 | 22 | 52 |
| 2019 January | 22 | 13 | 35 |
| 2018 December | 30 | 13 | 43 |
| 2018 November | 54 | 24 | 78 |
| 2018 October | 63 | 34 | 97 |
| 2018 September | 24 | 16 | 40 |
| 2018 May | 12 | 0 | 12 |
| 2018 April | 25 | 5 | 30 |
| 2018 March | 26 | 3 | 29 |
| 2018 February | 21 | 8 | 29 |
| 2018 January | 25 | 5 | 30 |
| 2017 December | 26 | 5 | 31 |
| 2017 November | 21 | 5 | 26 |
| 2017 October | 16 | 6 | 22 |
| 2017 September | 22 | 9 | 31 |
| 2017 August | 18 | 11 | 29 |
| 2017 July | 19 | 17 | 36 |
| 2017 June | 27 | 11 | 38 |
| 2017 May | 34 | 9 | 43 |
| 2017 April | 33 | 9 | 42 |
| 2017 March | 12 | 4 | 16 |
| 2017 February | 15 | 5 | 20 |
| 2017 January | 15 | 4 | 19 |
| 2016 December | 17 | 14 | 31 |
| 2016 November | 20 | 14 | 34 |
| 2016 October | 28 | 28 | 56 |
| 2016 September | 29 | 14 | 43 |
| 2016 August | 33 | 8 | 41 |
| 2016 July | 21 | 8 | 29 |
Show all
