Angiographic outcomes of Orsiro biodegradable polymer sirolimus-eluting stents and Resolute Integrity durable polymer zotarolimus-eluting stents: results of the ORIENT trial

作者：Kang Si Hyuck; Chung Woo Young; Lee Joo Myung; Park Jin Joo; Yoon Chang Hwan; Suh Jung Won; Cho Young Seok; Doh Joon Hyung; Cho Jin Man; Bae Jang Whan; Youn Tae Jin; Chae In Ho

来源：Eurointervention, 2017, 12(13): 1623-1631.

DOI：10.4244/EIJ-D16-00179

• biodegradable polymer
• coronary artery disease
• drug-eluting stents
• percutaneous coronary intervation

Aims: We performed a randomised controlled open-label non-inferiority trial to compare angiographic outcomes between the ultra-thin strut, biodegradable hybrid polymer Orsiro sirolimus-eluting stent (0-SES) and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES).
Methods and results: A total of 372 patients planned to undergo percutaneous coronary revascularisation were randomly assigned 2:1 to treatment with 0-SES or R-ZES (250 and 122 patients, respectively). 0-SES was non-inferior to R-ZES for the primary endpoint, in-stent late lumen loss at nine months (median 0.06 mm [interquartile range,-0.09 to 0.24 mm] versus 0.12 mm [-0.07 to 0.32 mm]; p for non-inferiority <0.001; p for superiority=0.205). Percent diameter stenosis was significantly lower in the 0-SES group than in the R-ZES group (15.0 [10.0 to 20.0] versus 20.0 [13.3 to 26.0]; p=0.002). Target lesion failure occurred in 2.4% and 3.3% of the 0-SES and R-ZES groups, respectively (p=0.621). Subgroup analyses showed consistently similar outcomes between the two groups in terms of the primary endpoint, except for the diabetic subgroup.
Conclusions: 0-SES was non-inferiorto R-ZES in terms of in-stent late loss at nine months. Angiographic restenosis and clinical adverse events were low in both groups. This study confirms the good safety and efficacy profiles of both contemporary coronary stents.

• 出版日期2017-1