{"id":4944,"date":"2018-09-08T12:40:24","date_gmt":"2018-09-08T17:40:24","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=4944"},"modified":"2018-09-08T12:47:47","modified_gmt":"2018-09-08T17:47:47","slug":"biodegradable-polymer-sirolimus-eluting-stent-proven-non-inferior-to-durable-polymer-everolimus-eluting-stent","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=4944","title":{"rendered":"Biodegradable Polymer Sirolimus- Eluting Stent Proven Non-Inferior to Durable-Polymer, Everolimus-Eluting Stent"},"content":{"rendered":"

Results of the BIOSCIENCE study that were presented at the ESC Annual Congress by Dr. Thomas Pilgrim, University Clinic for Cardiology, Bern, Switzerland<\/a>, show that the 5-year risk of target lesion failure among patients undergoing percutaneous coronary intervention (PCI) is similar after implantation of the ultrathin-strut, biodegradable-polymer sirolimus-eluting stents as compared with thin-strut, durable-polymer, everolimus-eluting stents. However, higher incidence of all-cause and non-cardiovascular mortality in patients treated with the biodegradable polymer sirolimus-eluting-stents as compared with the durable-polymer stents eluting everolimus warrant careful scrutiny in ongoing clinical trials. The announcement of the results of this trial at the ESC was accompanied by a publication in the Lancet<\/a>.<\/em><\/p>\n

This independent, investigator-initiated, multi-center, randomized, controlled non-inferiority study was conducted in order to compare the 5-year outcomes of safety and efficacy of the sirolimus-eluting stent with a biodegradable polymer (Orsiro) versus an everolimus-eluting stent with a durable polymer (Xience Prime). In a population of 2119 patients with chronic stable coronary artery disease or acute coronary syndromes recruited between February 2012 and May 2013, BIOSCIENCE aimed to compare these products with a primary endpoint of Target Lesion Failure (TLF), defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI) and clinically driven Target Lesion Revascularization (TLR) at 1 year. Intention to treat was the primary analysis performed. In the trial, the time to the first event for each outcome, numbers of patients and Kaplan-Meier estimates of cumulative incidence were reported.<\/p>\n

\"\"[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]\u201cI think the Orsiro stent has the potential to be as established as other newer generation drug-eluting stents. We will see if there is a difference in large meta-analyses of randomized controlled trials, but as for now, I think it will be as good as the newer generation drug-eluting stents.\u201d-\u00a0Dr. Thomas Pilgrim, M.D.<\/strong>[\/perfectpullquote]<\/p>\n

Pilgrim and his colleagues reported that 95% of all patients were able to complete 5 years of follow-up. Target lesion failure occurred in 20.2% and 18.8 % of those treated with biodegradable-polymer sirolimus-eluting stents and durable-polymer everolimus-eluting stents respectively. (RR 1.07; 95% CI, 0.88\u20131.31; p = 0.487). However, all-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14.1% vs. 10.3%; RR, 1.36; 95% CI, 1.06\u20131.75; p = 0.017), driven by a difference in noncardiovascular deaths (mainly due to cancer). The investigators reported no difference between groups in the cumulative incidence of definite stent thrombosis at 5 years (1.6% in both groups; 1.02, 0.51\u20132.05; p = 0.950).<\/p>\n

The results were encouraging as the primary endpoint results from the 12-month follow-up demonstrated that Orsiro met its study objective of non-inferiority versus Xience Prime and the 5-year risk of target lesion failure did not differ between patients undergoing percutaneous coronary intervention after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. While the higher risk of all-cause mortality in Orsiro warrants careful observation in patients, its safety and efficacy in relation to ST-segment elevation myocardial infarction (STEMI) is currently under evaluation in the BIOSTEMI trial. Expressing his optimism regarding the future of Orsiro, Dr. Thomas Pilgrim remarks<\/a>, \u201cI think the Orsiro stent has the potential to be as established as other newer generation drug-eluting stents. We will see if there is a difference in large meta-analyses of randomized controlled trials, but as for now, I think it will be as good as the newer generation drug-eluting stents.\u201d<\/p>\n

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Results of the BIOSCIENCE study that were presented at the ESC Annual Congress by Dr. Thomas Pilgrim, University Clinic for Cardiology, Bern, Switzerland, show that the 5-year risk of target lesion failure among patients undergoing percutaneous coronary intervention (PCI) is similar after implantation of the ultrathin-strut, biodegradable-polymer sirolimus-eluting stents as compared with thin-strut, durable-polymer, everolimus-eluting […]<\/p>\n","protected":false},"author":8,"featured_media":4947,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[184,29,19,8],"tags":[47],"ppma_author":[1033],"class_list":{"0":"post-4944","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical-trials","8":"category-conferences","9":"category-interventional-cardiology","10":"category-news","11":"tag-featured","12":"author-sudarshana-datta"},"authors":[{"term_id":1033,"user_id":8,"is_guest":0,"slug":"sudarshana-datta","display_name":"Sudarshana Datta, M.D.","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/b79d07e34756cd9e4c6fe8c77835538219f3ec30c82a6bf8f218760a5f29c84a?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\/4944","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\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4944"}],"version-history":[{"count":4,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/4944\/revisions"}],"predecessor-version":[{"id":4967,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/4944\/revisions\/4967"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/4947"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4944"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4944"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4944"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=4944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}