{"id":5904,"date":"2011-01-11T15:23:42","date_gmt":"2011-01-11T20:23:42","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=5904"},"modified":"2011-07-19T17:44:14","modified_gmt":"2011-07-19T21:44:14","slug":"absorbable-stent-approved-now-you-see-it-now-you-dont","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/01\/11\/absorbable-stent-approved-now-you-see-it-now-you-dont\/","title":{"rendered":"Absorbable Stent Approved: Now You See It, Now You Don’t"},"content":{"rendered":"

Have questions about the new stent<\/a> that just received CE Mark approval in Europe? Here’s a reality checklist.<\/p>\n

1. What\u2019s it called?<\/em><\/strong> The bioresorbable vascular scaffold (BVS) from Abbott Laboratories is named ABSORB (clever, huh?).<\/em><\/p>\n

2. What are its advantages over a drug-eluting stent (DES)?<\/em><\/strong> Don\u2019t know yet.\u00a0 It may eliminate the need for long-term intensive antiplatelet therapy (speculative)<\/em>. Abbott says that the vessel treated with a BVS may \u201cultimately move, flex and pulsate similar to an untreated vessel\u201d and calls this potential \u201cvascular restoration therapy.\u201d (In my opinion, this is a stretch\u2026pun intended.)<\/em><\/p>\n

3. What\u2019s the composition?<\/em><\/strong> Everolimus is adhered to a bioabsorbable scaffold of polylactide, which is a biocompatible material commonly used in resorbable sutures.<\/p>\n

4. How long does it take to absorb?<\/em><\/strong> The device dissolves within 2 years.<\/p>\n

5. When will it be available in the U.S?<\/em><\/strong> Not in the near future. It\u2019s not been studied in the U.S. Although available for clinical studies in Europe soon, it won\u2019t be fully commercially available even there until late 2012.<\/p>\n

6. Lots of data on its efficacy and safety?<\/em><\/strong> Surprisingly not. Thus far, the only safety and efficacy data come from a prospective, non-randomized (open label), 2-phase study that enrolled 131 patients from six European countries, Australia, and New Zealand. \u00a0In the study, major adverse cardiac events (MACE) and treated site thrombosis rates were evaluated at 30 days as well as at 6, 9, 12, and 24 months.<\/p>\n

7. What do we know?<\/em><\/strong><\/p>\n