{"id":15214,"date":"2012-01-09T13:29:09","date_gmt":"2012-01-09T18:29:09","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&#038;p=15214"},"modified":"2012-01-09T14:23:53","modified_gmt":"2012-01-09T19:23:53","slug":"do-drug-eluting-stents-reduce-death-the-devil-the-details-and-the-missing-swedes","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/01\/09\/do-drug-eluting-stents-reduce-death-the-devil-the-details-and-the-missing-swedes\/","title":{"rendered":"Do Drug-Eluting Stents Reduce Death? The Devil, the Details, and the Missing Swedes"},"content":{"rendered":"<p>In a <a href=\"http:\/\/www.nejm.org\/doi\/pdf\/10.1056\/NEJMoa0809902\">2009 NEJM article<\/a>, the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) study group published 1 to 5 (mean, 2.7) year follow-up data for almost 48,000 registry patients who received a bare metal (BMS) or drug-eluting coronary stent (DES) between 2003 and 2006, concluding that the two are associated with a similar long-term incidence of death.<\/p>\n<p>Now <a href=\"http:\/\/eurheartj.oxfordjournals.org\/content\/early\/2012\/01\/06\/eurheartj.ehr479.full\">the same group reports in the <em>European Heart Journal\u00a0<\/em>that DES reduce the incidence of death when compared to BMS<\/a>.\u00a0 Examining follow-up data from 94,384 consecutive stent implantations recorded in SCAAR from 2006 to 2010, they report that older generation DES (i.e., the same ones reported in the 2009 study) were associated with a significantly lower mortality (adjusted HR, 0.72; 95% CI, 0.64\u20130.81) when compared with BMS; furthermore, the risk of death in those receiving a newer DES was even lower than those receiving an older DES (adjusted HR, 0.77; 95% CI, 0.63\u20130.95).<\/p>\n<p>Although the authors of the recent analysis warn that their results \u201cneed to be interpreted with caution\u201d (because it is an observational study), they argue that the larger sample size of the more recent study may have provided \u201cmore statistical power to detect differences in low-frequency events, such as death.\u201d<\/p>\n<p><strong><em>Wait just a moment\u2026.the devil is in the <\/em><\/strong><em><\/em><strong><em>details of the study.<\/em><\/strong>\u00a0\u00a0Of the 29,753 DES patients whose data comprise the recent study, follow-up information was available at 1 and 2 years in relatively few &#8212; \u00a0much fewer, in fact, than in the 2009 study.<\/p>\n<p>&nbsp;<\/p>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\" width=\"122\"><\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">No patients enrolled<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">No. at risk<br \/>\nat 1 yr<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">No. at risk<br \/>\nat 2 yrs<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" valign=\"top\" width=\"257\"><strong>2009 study<\/strong><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"122\">\u00a0BMS<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">28,286<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">26,843<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">19,429<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"122\">\u00a0DES<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">19,681<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">12,691<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">12,691<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"122\"><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" valign=\"top\" width=\"257\"><strong>Recent study<\/strong><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<td valign=\"top\" width=\"135\"><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"122\">BMS<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">64,631<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">31,329<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">21,813<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"122\">Older DES<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">19,202<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">6857<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">4679<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"122\">Newer DES<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">10,551<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">1636<\/p>\n<\/td>\n<td valign=\"top\" width=\"135\">\n<p align=\"center\">346<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<div>\n<p>&nbsp;<\/p>\n<p>One might legitimately inquire, <em><strong>\u201cWhere are the missing Swedes?\u201d<\/strong><\/em> Of the 29,753 DES subjects whose data are reported in the recent study, 2-year follow-up data were available in only 5,025 (17%).\u00a0 Even more striking, of the 10,551 DES patients, 2-year follow-up data were available in only 346 (3%!!). \u00a0I\u2019d expect more to be alive and available for follow-up if DES actually reduces death.<\/p>\n<p><strong><em>Now which is correct, the 2009 study or the more recent study?\u00a0 Is mortality truly lower with DES when compared to BMS?\u00a0 <\/em><\/strong><\/p>\n<p>&nbsp;<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In a 2009 NEJM article, the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) study group published 1 to 5 (mean, 2.7) year follow-up data for almost 48,000 registry patients who received a bare metal (BMS) or drug-eluting coronary stent (DES) between 2003 and 2006, concluding that the two are associated with a similar long-term incidence [&hellip;]<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-15214","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15214","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\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=15214"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15214\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=15214"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=15214"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=15214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}