{"id":74895,"date":"2020-04-15T08:37:19","date_gmt":"2020-04-15T13:37:19","guid":{"rendered":"https:\/\/pulmonx.com\/liberate-estudio-clinico\/"},"modified":"2021-05-03T14:42:54","modified_gmt":"2021-05-03T19:42:54","slug":"liberate-estudio-clinico","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/es\/liberate-estudio-clinico\/","title":{"rendered":"LIBERATE Estudio cl\u00ednico"},"content":{"rendered":"\n
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\n \"LIBERATE--Estudio-Clinico\" \n <\/div>\n \n \n <\/div>\n\n
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\u201cLos beneficios son comparables a los observados con la CRVP (cirug\u00eda de reducci\u00f3n del volumen pulmonar), pero con una disminuci\u00f3n de la morbilidad despu\u00e9s del procedimiento.\u201d1<\/sup><\/a><\/p>\n

\u00a0<\/p>\n<\/blockquote> <\/div>\n<\/div>\n\n

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\n \n Descargar resumen de ensayos <\/a>\n <\/div>\n <\/div>\n\n <\/div>\n
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Publicado en The American Journal of Respiratory and Critical Care Medicine1<\/a><\/sup><\/h1>\n

Ensayo controlado aleatorizado, multinacional y multic\u00e9ntrico de v\u00e1lvulas endobronquiales Zephyr\u00ae<\/sup> en pacientes con enfisema heterog\u00e9neo y poca o ninguna ventilaci\u00f3n colateral.<\/p>\n

M\u00e9todos y criterios de valoraci\u00f3n<\/h3>\n
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  • Primer ensayo multic\u00e9ntrico que eval\u00faa la efectividad y seguridad de las v\u00e1lvulas endobronquiales Zephyr en pacientes con poca o ninguna ventilaci\u00f3n colateral (VC) durante un per\u00edodo m\u00e1ximo de 12 meses<\/li>\n
  • 190 pacientes con distensi\u00f3n (VR medio inicial, 225% pred.; VEF1<\/sub>, 27% pred.; DLCO, 34% pred.) aleatorizados 2:1 (128 v\u00e1lvula Zephyr: 62 TR)<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n
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    Dise\u00f1o del ensayo<\/h2> <\/div>\n<\/div>\n\n
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    \n \"LIBERATE \n <\/div>\n \n \n <\/div>\n\n
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    Resultados en poblaci\u00f3n por IDT<\/h2> <\/div>\n<\/div>\n
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    An\u00e1lisis de pacientes que respondieron al tratamiento y alcanzaron el criterio de valoraci\u00f3n principal<\/h4>\n

    Porcentaje de pacientes con un cambio en el VEF1<\/sub> \u226515%<\/h5> <\/div>\n<\/div>\n\n
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class=\"tb_text_wrap\">\n <h3>Criterios de valoraci\u00f3n secundarios<\/h3> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_2 tb_ojvn222\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_akwx224 first\">\n <!-- module text -->\n<div class=\"module module-text tb_vi93559 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Cambio en el Cuestionario respiratorio St.George<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_5lz7540 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>LIBERATE Study Page - Spanish: LIBERATE - SGRQ - Line | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script 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data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Cambio en la DR6<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_vll9203 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>LIBERATE Study Page - Spanish: LIBERATE - 6MWD - Line | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"spanish-liberate-6mwd-line\",\r\n\t\t\t\t{\r\n \t\t\"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": \"category\",\r\n\t\t\t\t\t\"autoMarginOffset\": 0,\r\n\t\t\t\t\t\"autoMargins\": false,\r\n\t\t\t\t\t\"marginBottom\": 32,\r\n\t\t\t\t\t\"marginLeft\": 60,\r\n\t\t\t\t\t\"marginTop\": 65,\r\n\t\t\t\t\t\"sequencedAnimation\": false,\r\n\t\t\t\t\t\"startDuration\": 2,\r\n\t\t\t\t\t\"startEffect\": \"easeOutSine\",\r\n\t\t\t\t\t\"accessibleTitle\": \"cambioenladr6\",\r\n\t\t\t\t\t\"backgroundAlpha\": 0.8,\r\n\t\t\t\t\t\"fontFamily\": \"Arial\",\r\n\t\t\t\t\t\"fontSize\": 14,\r\n\t\t\t\t\t\"pathToImages\": \"http:\/\/cdn.amcharts.com\/lib\/3\/images\/\",\r\n\t\t\t\t\t\"percentPrecision\": 1,\r\n\t\t\t\t\t\"precision\": 1,\r\n\t\t\t\t\t\"theme\": \"light\",\r\n\t\t\t\t\t\"categoryAxis\": {\r\n\t\t\t\t\t\t\"classNameField\": \"\",\r\n\t\t\t\t\t\t\"gridPosition\": 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\"triangleUp\",\r\n\t\t\t\t\t\t\t\"dashLength\": 3,\r\n\t\t\t\t\t\t\t\"id\": \"Between Group Difference\",\r\n\t\t\t\t\t\t\t\"lineColor\": \"#FF5C39\",\r\n\t\t\t\t\t\t\t\"lineThickness\": 3,\r\n\t\t\t\t\t\t\t\"markerType\": \"triangleUp\",\r\n\t\t\t\t\t\t\t\"showBalloon\": false,\r\n\t\t\t\t\t\t\t\"title\": \"Diferencia entre grupos\",\r\n\t\t\t\t\t\t\t\"valueField\": \"Between Group Difference\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t],\r\n\t\t\t\t\t\"guides\": [],\r\n\t\t\t\t\t\"valueAxes\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"axisFrequency\": 2,\r\n\t\t\t\t\t\t\t\"id\": \"ValueAxis-1\",\r\n\t\t\t\t\t\t\t\"maximum\": 50,\r\n\t\t\t\t\t\t\t\"minimum\": -50,\r\n\t\t\t\t\t\t\t\"minMaxMultiplier\": 6,\r\n\t\t\t\t\t\t\t\"unit\": \"\",\r\n\t\t\t\t\t\t\t\"autoGridCount\": false,\r\n\t\t\t\t\t\t\t\"gridCount\": 11,\r\n\t\t\t\t\t\t\t\"minVerticalGap\": 39,\r\n\t\t\t\t\t\t\t\"title\": \"Metros (m)\",\r\n\t\t\t\t\t\t\t\"titleFontSize\": 14\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t],\r\n\t\t\t\t\t\"allLabels\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"id\": \"Label-1\",\r\n\t\t\t\t\t\t\t\"text\": \"p<0,001\",\r\n\t\t\t\t\t\t\t\"x\": \"67%\",\r\n\t\t\t\t\t\t\t\"y\": \"21%\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t],\r\n\t\t\t\t\t\"balloon\": {\r\n\t\t\t\t\t\t\"borderThickness\": 1\r\n\t\t\t\t\t},\r\n\t\t\t\t\t\"legend\": {\r\n\t\t\t\t\t\t\"enabled\": true,\r\n\t\t\t\t\t\t\"switchable\": false,\r\n\t\t\t\t\t\t\"tabIndex\": 8,\r\n\t\t\t\t\t\t\"valueAlign\": \"left\"\r\n\t\t\t\t\t},\r\n\t\t\t\t\t\"titles\": [],\r\n\t\t\t\t\t\"dataProvider\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"Valor inicial de referencia\",\r\n\t\t\t\t\t\t\t\"EBV\": \"0\",\r\n\t\t\t\t\t\t\t\"Control\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"0\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"0\",\r\n\t\t\t\t\t\t\t\"Control High\": \"0\",\r\n\t\t\t\t\t\t\t\"Control low\": \"0\",\r\n\t\t\t\t\t\t\t\"Control open\": \"0\",\r\n\t\t\t\t\t\t\t\"Control close\": \"0\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"0\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"45 d\u00edas\",\r\n\t\t\t\t\t\t\t\"EBV\": \"13\",\r\n\t\t\t\t\t\t\t\"Control\": \"-4\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"19\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"8\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"19\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"8\",\r\n\t\t\t\t\t\t\t\"Control High\": \"2\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-11\",\r\n\t\t\t\t\t\t\t\"Control open\": \"2\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-11\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"17\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"6 meses\",\r\n\t\t\t\t\t\t\t\"EBV\": \"8\",\r\n\t\t\t\t\t\t\t\"Control\": \"-15\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"15\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"1\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"15\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"1\",\r\n\t\t\t\t\t\t\t\"Control High\": \"-4\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-25\",\r\n\t\t\t\t\t\t\t\"Control open\": \"-4\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-25\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"21.5\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"12 meses\",\r\n\t\t\t\t\t\t\t\"EBV\": \"11\",\r\n\t\t\t\t\t\t\t\"Control\": \"-27\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"19\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"4\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"19\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"4\",\r\n\t\t\t\t\t\t\t\"Control High\": \"-16\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-38\",\r\n\t\t\t\t\t\t\t\"Control open\": \"-16\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-38\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"38\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"spanish-liberate-6mwd-line\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_znrq202 last\">\n <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_kgi885\">\n <div data-lazy=\"1\" class=\"module_column sub_column col-full tb_gf5k87 first\">\n <!-- module text -->\n<div class=\"module module-text tb_2smb156 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h3>Seguridad: al menos el 3% de los pacientes de cada grupo sufri\u00f3 acontecimientos adversos pulmonares graves (AAG).<\/h3> <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div class=\"module module-text tb_9jun652 hide-tablet hide-mobile\" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n \n<table id=\"tablepress-13\" class=\"tablepress tablepress-id-13 study tbody-has-connected-cells\" aria-describedby=\"tablepress-13-description\">\n<tbody class=\"row-striping\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td colspan=\"2\" class=\"column-2\">Per\u00edodo del tratamiento<br \/>\n(0\u201345 d\u00edas)<\/td><td colspan=\"2\" class=\"column-4\">Per\u00edodo del tratamiento<br \/>\n(46 d\u00edas\u20131 a\u00f1o)<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">EBV (n=128)<\/td><td class=\"column-3\">TR (n=62)<\/td><td class=\"column-4\">EBV (n=122)<\/td><td class=\"column-5\">TR (n=62)<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Fallecimiento<\/td><td class=\"column-2\">3.1%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">0.8%<\/td><td class=\"column-5\">1.6%<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Neumot\u00f3rax<\/td><td class=\"column-2\">26.6%*<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">6.6%<\/td><td class=\"column-5\">0%<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Exacerbaci\u00f3n de la EPOC<\/td><td class=\"column-2\">7.8%<\/td><td class=\"column-3\">4.8%<\/td><td class=\"column-4\">23.0%<\/td><td class=\"column-5\">30.6%<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Neumon\u00eda<\/td><td class=\"column-2\">0.8%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">5.7%<\/td><td class=\"column-5\">8.1%<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">Insuficiencia respiratoria<\/td><td class=\"column-2\">1.6%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">0.8%<\/td><td class=\"column-5\">3.2%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span id=\"tablepress-13-description\" class=\"tablepress-table-description tablepress-table-description-id-13\">*Diferencia estad\u00edsticamente significativa con respecto al TR<\/span>\n<!-- #tablepress-13 from cache --> <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div class=\"module module-image tb_13b1442 image-center tf_mw hide-desktop hide-tablet_landscape\" data-lazy=\"1\">\n <div class=\"image-wrap tf_rel tf_mw\">\n <img decoding=\"async\" width=\"1664\" height=\"812\" src=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-table.png\" class=\"wp-post-image wp-image-75376\" title=\"LIBERATE-table\" alt=\"LIBERATE-table\" srcset=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-table.png 1664w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-table-300x146.png 300w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-table-1024x500.png 1024w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-table-768x375.png 768w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-table-1536x750.png 1536w\" sizes=\"(max-width: 1664px) 100vw, 1664px\" \/> \n <\/div>\n <!-- \/image-wrap -->\n \n <\/div>\n<!-- \/module image --><!-- module text -->\n<div class=\"module module-text tb_7lx993 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <ul>\n<li class=\"p1\">Aumento de la tasa de AAG con el tratamiento con v\u00e1lvulas Zephyr en comparaci\u00f3n con el tratamiento de referencia a corto plazo (primeros 45 d\u00edas despu\u00e9s del procedimiento)<\/li>\n<li class=\"p1\">Disminuci\u00f3n de la tasa de AAG a largo plazo (de 46 d\u00edas a 12 meses) con el tratamiento con v\u00e1lvulas Zephyr en comparaci\u00f3n con el tratamiento de referencia<\/li>\n<li class=\"p1\">5 de los 8 pacientes que experimentaron un neumot\u00f3rax en el per\u00edodo a largo plazo se hab\u00edan sometido recientemente a una broncoscopia secundaria para la sustituci\u00f3n o retirada de alguna v\u00e1lvula<\/li>\n<\/ul> <\/div>\n<\/div>\n<!-- \/module text --><!-- module divider -->\n<div class=\"module tf_mw module-divider tb_gb3g584 solid \" style=\"border-width: 1px;border-color: #3095b4;margin-top: 10px;margin-bottom: 40px;\" data-lazy=\"1\">\n <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div class=\"module module-text tb_u6r8619 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h2 class=\"p1\">Conclusi\u00f3n<\/h2>\n<p class=\"p1\">El tratamiento con v\u00e1lvulas endobronquiales Zephyr<sup><span class=\"s1\">\u00ae<\/span><\/sup> en pacientes cuidadosamente seleccionados con poca o ninguna ventilaci\u00f3n colateral en el l\u00f3bulo objetivo proporcion\u00f3 beneficios cl\u00ednica y estad\u00edsticamente significativos en la funci\u00f3n pulmonar, la tolerancia al ejercicio, la disnea y la calidad de vida por encima del est\u00e1ndar actual del tratamiento m\u00e9dico durante al menos 12 meses.<\/p>\n<p>Entre las complicaciones del tratamiento con la v\u00e1lvula endobronquial Zephyr, se pueden incluir, entre otras, neumot\u00f3rax, empeoramiento de la sintomatolog\u00eda de EPOC, hemoptisis, neumon\u00eda, disnea y, con escasa incidencia, fallecimiento.<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<!--\/themify_builder_content-->","protected":false},"excerpt":{"rendered":"<p>Ensayo controlado aleatorizado, multinacional y multic\u00e9ntrico de v\u00e1lvulas endobronquiales Zephyr\u00ae en pacientes con enfisema heterog\u00e9neo y poca o ninguna ventilaci\u00f3n colateral.<\/p>\n","protected":false},"author":2,"featured_media":75345,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[51],"tags":[],"class_list":["post-74895","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-evidencia-clinica","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>LIBERATE Estudio cl\u00ednico - Pulmonx<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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