Trial shows Orsiro is non-inferior to Resolute Integrity


According to data presented at EuroPCR (17–20 May, Paris, France), a hybrid sirolimus-eluting stent (Orsiro, Biotronik) is non-inferior to a zotarolimus-eluting (Resolute Intergrity, Medtronic). The multicentre, randomised, controlled all-comers ORIENT trial enrolled 372 patients who received either Orsiro or Resolute Integrity in treatment of a wide variety of coronary heart disease. The primary endpoin was in-stent late lumen loss at nine months, an angiographic endpoint.

According to a press release, Orsiro demonstrated significant non-inferiority for the primary end point—at nine months the trial’s Orsiro arm had an average late lumen loss of 0.10 ± 0.35, while patients in the Resolute Integrity arm had a late lumen loss of 0.16 ± 0.39 (P for non-inferiority≤0.001). The press release reports that the trial furthermore highlighted Orsiro’s excellent safety profile, with no stent thrombosis observed.

Tae-Jin Youn (Seoul National University Bundang Hospital, South Korea), the principal investigator of the ORIENT trial, comments: “In this trial, Orsiro conclusively demonstrated non-inferiority to the competitor drug-eluting stent in terms of in-stent late lumen loss.”

Also at EuroPCR 2016, 24-month results from multicentre, randomised, controlled non-inferiority BIOSCIENCE trial were presented. These data, from a subanalysis of 407 patients with ST-segment elevation myocardial infarction (STEMI), indicate that Orsiro might be associated with better clinical outcomes than an everolimus-eluting stent (Xience Prime/Xpedition, Abbott Vascular) for STEMI. At two years, BIOSCIENCE’s primary endpoint of target lesion failure occurred in 5.4% of STEMI patients treated with Orsiro compared with 10.8% of those treated with Xience Prime/Xpedition.