DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): Rationale and study design of a randomized multicenter trial in a Dutch all-comers population

作者：Tandjung Kenneth; Basalus Mounir W Z; Sen Hanim; Jessurun Gillian A J; Danse Peter W; Stoel Martin; Linssen Gerard C M; Derks Anita; van Loenhout Ton T; Nienhuis Mark B; Hautvast Raymond W M; von Birgelen Clemens^*

来源：American Heart Journal, 2012, 163(4): 557-562.

DOI：10.1016/j.ahj.2012.02.001

Background Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity. %26lt;br%26gt;Methods DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1: 1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up. %26lt;br%26gt;Summary DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES. (Am Heart J 2012; 163:557-62.)

• 出版日期2012-4