{"id":7006,"date":"2019-03-01T15:06:53","date_gmt":"2019-03-01T20:06:53","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=7006"},"modified":"2019-03-01T15:06:53","modified_gmt":"2019-03-01T20:06:53","slug":"nationwide-comparison-of-oral-anticoagulants-in-nonvalvular-atrial-fibrillation-patients-of-low-body-weight","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=7006","title":{"rendered":"Nationwide Comparison of Oral Anticoagulants in Nonvalvular Atrial Fibrillation Patients of Low Body Weight"},"content":{"rendered":"

The first nationwide comparison of the effectiveness and safety of warfarin and direct oral anticoagulants (DOACs) in a large atrial fibrillation (AF) cohort with data on low body weight (LBW) was conducted. \u00a0The findings, published in JACC<\/em><\/a>, showed that DOACs are associated with a reduced risk of ischemic stroke, intracranial hemorrhage, hospitalization for gastrointestinal or major bleeds, all-cause death or the composite outcome in patients with LBW (<60kg). \u00a0A consistent trend was observed in patients with extremely LBW (<50kg), with the exception of hospitalization for gastrointestinal bleeding.<\/p>\n

\u00a0OACs are the most fundamental therapy for patients with AF because it prevents ischemic stroke and reduces mortality. \u00a0Warfarin has been used for decades as the only available OAC, but not used as much due to a narrow therapeutic range, frequent monitoring, and concerns about bleeding complications. \u00a0In comparison, the introduction of direct OACs has been proven to be convenient, safe and effective alternatives to warfarin.\u00a0 The effects of OACs are closely related to plasma concentrations which are affected by body distribution volume; therefore, extremely low body weight may influence the efficacy and safety of OACs.\u00a0 LBW is relatively common in Asian populations, and individuals frequently present with comorbidities such as old age, frailty and renal impairment which may increase the risk of thromboembolic and bleeding events. \u00a0 However, no data is available for patients weighing <60kg or <50kg based on a large AF cohort that analyzed four DOACs.\u00a0 Additionally, it’s unclear whether overall effectiveness and safety of DOACs are consistent in patients with LBW and nonvalvular AF.<\/p>\n

\"\"[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]“Although the criterion of body weight looks simple,\u00a0additional characteristics of patients with AF (age,\u00a0renal function, and concomitant medications) have to\u00a0be taken into account for candidates to be eligible for\u00a0dose reduction of DOACs. Although the current study\u00a0is reassuring that DOACs can be used in AF patients\u00a0with low to very low body weight, we must take into\u00a0account that the study results originate from a region\u00a0where low body weight is common. Because of this\u00a0characteristic, the results do not necessarily apply for\u00a0such patients in the Western world.”-\u00a0 Dr. Freek W.A. Verheugt, M.D.<\/strong>[\/perfectpullquote]<\/p>\n

This retrospective cohort study was conducted in South Korea, using data from the Korean National Health Insurance Services (NHIS) database from January 2014 to December 2016. \u00a0The trial enrolled 21,589 adult nonvalvular AF participants with body weight <60kg treated with either warfarin (n=7,576) or DOACs (n=14,013).\u00a0 The study population was supplemented by stratified analysis according to the doses, regular and reduced, label adherence of DOAC dosing, and types of DOACs; Rivaroxaban, Dabigatran, Apixaban, Edoxaban. \u00a0The study outcome included six clinical outcomes to determine effectiveness and safety of warfarin and DOACs: ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, all-cause death, and the composite outcome.\u00a0 Trial results showcased that in comparison with warfarin use, DOACs were associated with lower risks of ischemic stroke (hazard ratio [HR]: 0.591; 95% con\ufb01dence interval [CI]: 0.510 to 0.686), major bleeding (HR: 0.705; 95% CI 0.601 to 0.825), a greater reduction in intracranial hemorrhage (HR: 0.554; 95% CI: 0.429 to 0.713), and a lower risk of all-cause death (HR: 0.705; 95% CI: 0.630 to 0.789). DOAC use showed improved net clinical bene\ufb01t compared with warfarin (HR for the composite outcome: 0.660; 95% CI: 0.606 to 0.717), and this was consistent in patients who weighed <50 kg (HR for the composite outcome: 0.665; 95% CI: 0.581 to 0.762).<\/p>\n

\u00a0In this study where an LBW Asian population was the prime focus, the investigators established that DOACs showed better effectiveness and safety as compared to warfarin. \u00a0The results remained consistent in patients with extremely LBW.\u00a0 Additionally, regular doses of DOACs showed comparable results to reduced doses of DOACs. \u00a0As per discussion, study limitations do exist.\u00a0 First, the quality of warfarin treatment represented as time in the therapeutic range (TTR) was not evaluated.\u00a0 The Korean NHIS claims the database and health checkup database did not include individual data on the International Normalized Ratio (INR) of prothrombin time.\u00a0 Poor TTR control in Asian patients treated with warfarin has been consistently observed in previous studies.\u00a0 Secondly, the study was based on the database of the entire Korean population; therefore ethnic uniformity of cohort studies should be considered when these results are interpreted.\u00a0 Thirdly, patients with a history of intracranial hemorrhage, ischemic stroke or GI bleed were excluded from the study.\u00a0 And lastly, although both study groups achieved well-balanced cohorts, the possibility of confounding variables from unmeasured factors still exists. Commenting on the study results and its generalizability, Dr. Freek W.A. Verheugt,\u00a0 from the department of cardiology, Heartcenter, Amsterdam, the Netherlands stated, “In conclusion, as previously stated, dosing with\u00a0oral anticoagulation is crucial, not only with warfarin,\u00a0in which INR is used for analysis, but also with\u00a0DOACs. Most dose reduction schemes are simple\u00a0(dabigatran and rivaroxaban), but some are more\u00a0complex (edoxaban) or very complex (apixaban).\u00a0Although the criterion of body weight looks simple,\u00a0additional characteristics of patients with AF (age,\u00a0renal function, and concomitant medications) have to\u00a0be taken into account for candidates to be eligible for\u00a0dose reduction of DOACs. Although the current study\u00a0is reassuring that DOACs can be used in AF patients\u00a0with low to very low body weight, we must take into
\naccount that the study results originate from a region\u00a0where low body weight is common. Because of this\u00a0characteristic, the results do not necessarily apply for\u00a0such patients in the Western world.”<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The first nationwide comparison of the effectiveness and safety of warfarin and direct oral anticoagulants (DOACs) in a large atrial fibrillation (AF) cohort with data on low body weight (LBW) was conducted. \u00a0The findings, published in JACC, showed that DOACs are associated with a reduced risk of ischemic stroke, intracranial hemorrhage, hospitalization for gastrointestinal or […]<\/p>\n","protected":false},"author":1406,"featured_media":7016,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[170,8],"tags":[47],"ppma_author":[1053],"class_list":{"0":"post-7006","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-atrial-fibrillation","8":"category-news","9":"tag-featured","10":"author-swathi"},"authors":[{"term_id":1053,"user_id":1406,"is_guest":0,"slug":"swathi","display_name":"Swathi Venkatesan, M.D.","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/11e79f05e73c03ac9344c4c025ae2edc4191de98de0ca52acf2c075d8ff80879?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/7006","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/1406"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7006"}],"version-history":[{"count":12,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/7006\/revisions"}],"predecessor-version":[{"id":7021,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/7006\/revisions\/7021"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/7016"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7006"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7006"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7006"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=7006"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}