Patients with atrial fibrillation (AF) are at elevated risk of cardioembolic stroke, and they are therefore traditionally treated with anticoagulation to ameliorate this risk. However, anticoagulation poses a considerable challenge for patients with elevated bleeding risk; in these patients, left atrial appendage closure (LAAC) devices have been used to decrease the risk of thrombus formation and decrease the necessity for anticoagulation therapy. \u00a0The short-term outcomes of the PRAGUE-17<\/a> study, which compared LAAC devices with novel oral anticoagulants (NOACs), were published in 2019. At this short-term time point (with a median timepoint of 19.9 months), LAAC devices were demonstrated to be noninferior to NOACs in preventing AF-related cardiovascular, neurologic, and bleeding events. However, the long-term outcomes have yet to be determined. In a breaking presentation at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) Conference today, Dr. Pavel Osmancik<\/a> (Charles University and University Hospital, Prague) and his team presented the results of the PRAGUE-17 trial.<\/p>\n The PRAGUE-17 study (NCT02426944<\/a>) was an investigator-initiated, multicenter randomized non-inferiority trial, conducted at 10 centers across the Czech Republic. Patients were treated with either a LAAC device or a NOAC. All recruited patients were required to have non-valvular atrial fibrillation and at least ONE of the following features: history of bleeding requiring hospitalization or intervention, history of cardioembolic event on anticoagulation, or CHADS-VASC<\/a> score >3 and HAS-BLED<\/a> score >2. Some relevant exclusion criteria included other non-AF indications for anticoagulation, presence of LA thrombus (if in LAAC group), pericardial effusion >1cm, recent bleeding or stroke (<30 days), recent ACS (<90 days), or creatinine clearance <30mL\/min.<\/p>\n A total of 402 patients were randomized, 201 in each group. Rivaroxaban, Apixaban, or Dabigatran could be used as the NOAC, with a preference given for apixaban. Either Amulet or Watchman devices could be utilized in the LAAC arm. \u00a0In the LAAC group, the default anticoagulation strategy was to receive 3 months of DAPT, followed by a TEE and de-escalation to aspirin if negative for thrombus. In high bleeding risk patients, the period of DAPT could be shortened to 6 weeks.<\/p>\n The primary outcome (analyzed in a modified intention-to-treat analysis) was a composite of stroke or TIA, systemic embolism, clinically relevant bleeding, CV death, or peri-procedural\/device complication. Secondary analyses included analysis of each individual outcome of the composite in the primary outcome. Patients were followed for a median of 3.5 years. LAAC was noninferior for the primary outcome (8.6 vs 11.9 events per 100 patient-years, p<0.001 for noninferiority). LAAC was similarly noninferior for the secondary analyses of CV death and stroke\/TIA. Non-procedural bleeding was significantly lower in the LAAC group 3.4 vs 5.9 events per 100 patient-years, p=0.038).<\/p>\n When discussing the implications of the study and his next steps with the Cardiology Now News team, Dr. Osmancik stated: \u201cThe question we had is whether left atrial appendage closure devices still have a role in the market and in stroke prevention\u2026and the long-term outcomes are much more important than the short-term outcomes, because only over the long-term can you see if there is any benefit to the patient. We would like to continue to follow-up [even longer]\u2026.for another 1-2 years. Our goal is to reduce stroke rate, and I think the combination of appendage closure and NOACs would be a great trial for the future as well.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":" Key Points: In the PRAGUE-17 study, patients with non-valvular atrial fibrillation were treated with either oral anticoagulants or left atrial appendage closure devices and followed over a median of 3.5 years of follow-up. The primary endpoint was a composite of stroke or TIA, systemic embolism, clinically relevant bleeding, CV death, or peri-procedural\/device complication. Treatment with […]<\/p>\n","protected":false},"author":35656,"featured_media":5711,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"aside","meta":{"footnotes":""},"categories":[829,1],"tags":[47,185],"ppma_author":[1063],"class_list":{"0":"post-27525","1":"post","2":"type-post","3":"status-publish","4":"format-aside","5":"has-post-thumbnail","7":"category-tct-2021","8":"category-uncategorized","9":"tag-featured","10":"tag-news","11":"post_format-post-format-aside","12":"author-wallyomar"},"authors":[{"term_id":1063,"user_id":35656,"is_guest":0,"slug":"wallyomar","display_name":"WallyOmar","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/a6f105232fa7a2d967ba5e1e19104eeb3b45b6d9e588caf37850c2d596fbcae1?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\/27525","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\/35656"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27525"}],"version-history":[{"count":2,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/27525\/revisions"}],"predecessor-version":[{"id":27540,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/27525\/revisions\/27540"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/5711"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27525"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27525"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27525"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=27525"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"](\"https:\/\/cardiologynownews.org\/wp-content\/uploads\/2021\/11\/Osmancik-393x500.png\")
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