<div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1438515871" paraeid="{a7214dc5-ea02-4917-8e5e-486a598c4208}{244}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">Left atrial appendage closure (LAAC) is noninferior to<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">blood thinner medications</span><span> </span><span class="NormalTextRun SCXW33838876 BCX0">in patients with atrial fibrillation</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>(</span><span class="NormalTextRun SCXW33838876 BCX0">AF</span><span class="NormalTextRun SCXW33838876 BCX0">)<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">who qualify to receive anticoagulant therapy, results from the CHAMPION-</span><span class="NormalTextRun SCXW33838876 BCX0">AF</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>trial show.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2079484102" paraeid="{520133ea-b522-494d-a076-5e0a18003ae6}{34}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">These data were presented on Saturday by<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">co-principal investigators (PIs)<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">Saibal Kar, MD, of Los Robles Medical Center, California,<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">and<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW33838876 BCX0">Shepal</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>K. Doshi, MD, of Cedars Sinai Smidt Heart Institute, California, on behalf of the CHAMPION-</span><span class="NormalTextRun SCXW33838876 BCX0">AF</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>investigators during a late-breaking clinical trials session at the American College of Cardiology (ACC) Scientific Sessions in New Orleans.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="718911766" paraeid="{9ea9545a-e475-4099-a4e6-25f381f8ad65}{175}"><span class="NormalTextRun SCXW33838876 BCX0">“Our data suggest that the left atrial appendage closure device used in this trial is a potential and reasonable alternative to medication—even among patients who are suitable for long-term blood thinners—and may be discussed as part of a shared decision-making process,” said Dr. Kar in a corresponding ACC press release.</span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1019122842" paraeid="{40f3347a-a9ed-458c-8c4a-350e1b0557d8}{69}"><span class="NormalTextRun SCXW33838876 BCX0">Results were simultaneously published in a manuscript online in the<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">New England Journal of Medicine</span><span class="NormalTextRun SCXW33838876 BCX0">.</span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2032793626" paraeid="{10fc17bc-c5eb-494a-bf23-feb26f403e17}{76}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">Non-vitamin K oral anticoagulants (NOACs) are used in patients with<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">AF</span><span class="NormalTextRun SCXW33838876 BCX0">, but this treatment method is limiting for patients who cannot be on blood thinners long-term. LAAC was proposed to take the place of blood thinners in patients with<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">AF</span><span class="NormalTextRun SCXW33838876 BCX0">.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="799185280" paraeid="{ed63a447-ba4f-45d6-b74e-ee4d0227a5e8}{141}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">Investigators in the<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">prospective, international, randomized<span> </span></span></span><a class="Hyperlink SCXW33838876 BCX0" href="https://clinicaltrials.gov/study/NCT04394546" target="_blank" rel="noreferrer noopener"><span data-contrast="none" xml:lang="EN-US" lang="EN-US" class="TextRun Underlined SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0" data-ccp-charstyle="Hyperlink">CHAMPION-</span><span class="NormalTextRun SCXW33838876 BCX0" data-ccp-charstyle="Hyperlink">AF</span></span></a><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span> </span><span class="NormalTextRun SCXW33838876 BCX0">(</span><span class="NormalTextRun SCXW33838876 BCX0">WATCHMAN</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>FLX versus NOAC for Embolic Protection in the Management of Patients with Non-Valvular<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">Atrial Fi</span><span class="NormalTextRun SCXW33838876 BCX0">b</span><span class="NormalTextRun SCXW33838876 BCX0">rillation)<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">trial examined the use of the<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">WA</span><span class="NormalTextRun SCXW33838876 BCX0">TCHMAN</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>F</span><span class="NormalTextRun SCXW33838876 BCX0">LX<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">(Boston Scientific)<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">device for LAAC in patients with<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">AF</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>who were simultaneously suitable for blood thinner medications. They<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">so</span><span class="NormalTextRun SCXW33838876 BCX0">ug</span><span class="NormalTextRun SCXW33838876 BCX0">ht</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>t</span><span class="NormalTextRun SCXW33838876 BCX0">o<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">de</span><span class="NormalTextRun SCXW33838876 BCX0">termine</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>i</span><span class="NormalTextRun SCXW33838876 BCX0">f LAAC would be a sound<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">op</span><span class="NormalTextRun SCXW33838876 BCX0">tion</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>f</span><span class="NormalTextRun SCXW33838876 BCX0">or this patient population.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="612528883" paraeid="{09329391-503d-4330-9682-4b505a42bd8c}{16}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">Patients were randomized to undergo LAAC with the<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">WATCHMAN</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>FLX device or receive NOACs.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1784205640" paraeid="{63eab5cc-7b02-449a-b781-081c445d0721}{105}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">At 3-years follow-up, the primary composite<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">efficacy<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">endpoint was cardiac death,<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">stroke</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>or systemic embolism. This was tested for noninferiority with a margin of 4.8 percentage points.</span><span> </span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="405887336" paraeid="{4f56b52e-ca68-46f2-9300-2e036f0c480b}{20}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">The primary s</span><span class="NormalTextRun SCXW33838876 BCX0">af</span><span class="NormalTextRun SCXW33838876 BCX0">ety endpoint for superiority was<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW33838876 BCX0">non</span><span class="NormalTextRun SCXW33838876 BCX0">-procedural<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">ISTH<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">major and modified<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">ISTH<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW33838876 BCX0">clinically-relevant</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>non-major</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>bleeding.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1661573738" paraeid="{c8fe7c62-84ea-4483-8ed4-8645de90e7ff}{130}"><span class="NormalTextRun SCXW33838876 BCX0">A total of 3,000 patients (mean age=71.7 years, 31.9% women) were randomized (n=1,499 in the device group; n=1,501 in the anticoagulation group).<span> </span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="212595248" paraeid="{577942b2-47fc-49fb-a8c7-6761c5ba32c6}{21}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">At 3-years follow-up, 81 patients in the device group and 65 patients in the anticoagulation group experienced the primary endpoint (</span><span class="NormalTextRun SCXW33838876 BCX0">95% confidence interval [CI]: -0.81 to 2.6; p<0.001 for noninferiority).<span> </span></span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="525774160" paraeid="{080952ea-1f24-426b-bbff-58dffca2dabb}{183}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">In the device group, 154 patients experienced non-procedure-related bleeding, and this number was 260 in the anticoagulation group (hazard ratio [HR]=0.55, 95% CI=0.45-0.67, p<0.001 for superiority)</span><span class="NormalTextRun SCXW33838876 BCX0">.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1795656688" paraeid="{93d6419a-743d-485b-8e73-ea834f81b533}{153}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">No between-group differences were found when comparing the number of deaths, systemic<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">embolism</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>or hemorrhagic strokes, but patients in the LAAC group had slightly more ischemic strokes. The investigators will continue to investigate all outcomes through 5-</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW33838876 BCX0">years</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>follow-up.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1590249457" paraeid="{a554f209-514b-4dda-af57-4dd62a518b60}{26}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">Overall, patients who received device-based LAAC had similar rates of a composite of death from cardiovascular causes,<span> </span></span><span class="NormalTextRun SCXW33838876 BCX0">stroke</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>or systemic embolism at 3-years follow-up compared with patients who received NOAC therapy.</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>The study met both the noninferiority and superiority endpoints at 3-</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW33838876 BCX0">years</span><span class="NormalTextRun SCXW33838876 BCX0"><span> </span>follow-up.</span></span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1204446236" paraeid="{5c997647-1bf2-40da-b610-2052e703c180}{188}"><strong><span class="NormalTextRun SCXW33838876 BCX0">This study was funded by Boston Scientific Corporation.</span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1010932483" paraeid="{10fc17bc-c5eb-494a-bf23-feb26f403e17}{31}"><strong><span class="NormalTextRun SCXW33838876 BCX0">Source:</span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="448060309" paraeid="{6b9c50aa-7cc9-4f92-9be9-b688a0f4d6f6}{195}"><span class="NormalTextRun SCXW33838876 BCX0">Doshi SK, Kar S, Nair DG, et al. Left atrial appendage closure or anticoagulation for atrial fibrillation.<span> </span></span><em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW33838876 BCX0"><span class="NormalTextRun SCXW33838876 BCX0">N</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW33838876 BCX0"> Engl</span><span class="NormalTextRun SCXW33838876 BCX0"> J Med</span></span></em><span class="NormalTextRun SCXW33838876 BCX0">. 2026 March 28 (Article in Press).</span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW33838876 BCX0"> <p class="Paragraph SCXW33838876 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2051533850" paraeid="{10fc17bc-c5eb-494a-bf23-feb26f403e17}{68}"><strong><span class="NormalTextRun SCXW33838876 BCX0">Image Credit: Screenshot by Bailey G. Salimes, CRTonline.org</span><span class="EOP Selected SCXW33838876 BCX0" data-ccp-props="{}"> </span></strong></p> </div>