Data on Biotronik's Orsiro Hybrid DES Presented at EuroPCR

May 31, 2016—Biotronik announced results establishing the noninferiority of its Orsiro hybrid drug-eluting stent (DES) compared to the Resolute Integrity DES (Medtronic plc), which were presented at the EuroPCR 2016 conference held May 17–20 in Paris, France.

According to Biotronik, the multicenter, randomized controlled, all-comers ORIENT trial enrolled 372 patients who received either Orsiro or Resolute Integrity for the treatment of a wide variety of coronary heart disease. The ORIENT trial’s primary endpoint was in-stent late lumen loss at 9 months, which was an angiographic endpoint.

At 9 months, Orsiro demonstrated significant noninferiority compared to Resolute Integrity for the primary endpoint of average late lumen loss (10 ± 0.35 mm vs 0.16 ± 0.39 mm; P noninferiority ≤ .001). Additionally, the trial supported Orsiro’s safety profile with no observed stent thrombosis.

In the company’s announcement, the trial’s Principal Investigator Tae-Jin Youn, MD, commented, “Orsiro’s refined design, including a biodegradable polymer and ultrathin struts, improve patient safety and angiographic outcomes. In this trial, Orsiro conclusively demonstrated noninferiority to the competitor DES in terms of in-stent late lumen loss.” Dr. Youn is with Seoul National University Bundang Hospital in Seongnam, South Korea.

Also at EuroPCR 2016, positive 24-month results were presented for ST-segment elevation myocardial infarction (STEMI) patients studied in a subanalysis of 407 STEMI patients in the multicenter, randomized controlled, noninferiority BIOSCIENCE trial. BIOSCIENCE is an investigator-initiated study evaluating the safety and efficacy of the bioabsorbable-polymer Orsiro DES in comparison to the durable-polymer Xience Prime/Xpedition DES (Abbott Vascular). At 2 years, BIOSCIENCE’s primary endpoint of target lesion failure occurred in 5.4% of STEMI patients treated with Orsiro compared with 10.8% of patients treated with Xience Prime/Xpedition, reported Biotronik.