{"id":33140,"date":"2012-11-20T14:33:25","date_gmt":"2012-11-20T19:33:25","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&#038;p=33140"},"modified":"2012-11-20T14:33:25","modified_gmt":"2012-11-20T19:33:25","slug":"pfo-occluder-devices-dont-get-no-respect","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/11\/20\/pfo-occluder-devices-dont-get-no-respect\/","title":{"rendered":"PFO Occluder Devices Don\u2019t Get No RESPECT"},"content":{"rendered":"<p>In the\u00a0<a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00465270\">RESPECT<\/a>\u00a0(Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial, 980 patients were\u00a0randomly assigned to (1) PFO closure with the AMPLATZER PFO occluder device (St. Jude Medical, which sponsored the trial) or (2) medical therapy. The trial\u2019s primary endpoint was a composite of recurrence of nonfatal stroke, fatal ischemic stroke, or early (within 45 days after randomization) all-cause mortality.<\/p>\n<p>Patients\u00a0assigned to\u00a0received the AMPLATZER device\u00a0had a 46.6% relative reduction in event risk compared\u00a0with those\u00a0assigned to medical management (9 vs. 16 events).\u00a0 <em><a href=\"http:\/\/www.tctmd.com\/show.aspx?id=115251\">However,\u00a0in the intent-to-treat (ITT) analysis, this difference did not reach statistical significance (p = 0.157).<\/a><\/em><\/p>\n<p><strong><em>Does\u00a0what\u00a0followed call to mind a straight man, a song and dance, or a comedy routine? <\/em><\/strong><\/p>\n<p>The statistician noted a differential length of follow-up in the two arms, which was attributed to \u201clate trial fatigue\u201d: More of the\u00a0patients in the medical group than in the device group left the study early (90 vs. 48) \u2014\u00a0some because they wanted to\u00a0get an off-label device outside the study \u2014\u00a0resulting in more years of observation in the device group for events to occur (1,375 vs. 1,184 patient-years; <em>P<\/em>=0.009). \u00a0As a result, the ITT raw-count analysis was deemed invalid and a prespecified Kaplan Meier (i.e., time to event) analysis was performed, which showed a strong trend\u00a0toward benefit (P value, 0.08\u20130.09).\u00a0 Not statistically significant. . .but close.\u00a0<\/p>\n<p>The investigators next performed an analysis that excluded events\u00a0that occurred in the device arm before a closure procedure was attempted.\u00a0The resulting per protocol analysis (which eliminated 3 of the 9 strokes in the device arm) showed a 63% reduction in the primary endpoint with the device as compared with\u00a0medical therapy (<em>P<\/em>=0.032).<\/p>\n<p><strong><em>The punch line:<\/em><\/strong> The RESPECT investigators concluded that their study&#8221; provides evidence of benefit in stroke risk reduction from closure with the AMPLATZER PFO Occluder\u00a0over medical management alone.&#8221;<\/p>\n<p><strong><em>Rodney Dangerfield was famous for claiming, \u201cI don&#8217;t get no respect.\u201d\u00a0 After all the slicing and dicing of these data, should the PFO Occluder device get any respect?\u00a0 <\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>David Hillis invokes Rodney Dangerfield in considering the findings of a recent trial of a PFO closure device.<\/p>\n","protected":false},"author":190,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[1338,561,1571,615,395],"class_list":["post-33140","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-amplatzer-cardiac-plug","tag-pfo-closure","tag-respect-trial","tag-statistics","tag-tct"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/33140","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/190"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=33140"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/33140\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=33140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=33140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=33140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}