News | Stents Drug Eluting | June 03, 2016

ORIENT Trial Results on Orsiro Hybrid Drug-Eluting Stent Presented at EuroPCR 2016

Data establish Orsiro's non-inferiority to Resolute Integrity Stent; STEMI subgroup from BIOSCIENCE trial has 50 Percent lower target lesion failure rate versus Xience

Biotronik, ORIENT trial results, EuroPCR 2016, Orsiro DES, hybrid drug-eluting stent

June 3, 2016 — Biotronik announced results establishing non-inferiority of the Orsiro hybrid drug-eluting stent (DES) to the Resolute Integrity DES were presented during a Hotline Session at EuroPCR 2016. The multicenter, randomized, 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.

“Orsiro’s refined design, including a biodegradable polymer and ultrathin struts, improve patient safety and angiographic outcomes,” commented ORIENT trial principal investigator Tae-Jin Youn, M.D., Seoul National University Bundang Hospital, South Korea. “In this trial, Orsiro conclusively demonstrated non-inferiority to the competitor DES in terms of in-stent late lumen loss.”

The ORIENT trial’s primary endpoint was in-stent late lumen loss (LLL) at nine months, an angiographic endpoint. Orsiro demonstrated significant non-inferiority for the primary end point — at nine months the trial’s Orsiro arm had an average LLL of 0.10 ± 0.35, while patients in the Resolute Integrity arm had an LLL of 0.16 ± 0.39 (P for non-inferiority=<0.001). The trial furthermore highlighted Orsiro’s excellent safety profile, with no stent thrombosis observed.

At EuroPCR 2016, positive 24 months results for ST-segment elevation myocardial infarction (STEMI) patients were also presented as part of the official program and during a scientific symposium on Orsiro. STEMI is a potentially fatal type of heart attack caused by a prolonged obstruction of blood supply in the heart. Every year nearly 250,000 people experience STEMI heart attacks. A subanalysis of 407 STEMI patients was included in the multicenter, randomized, controlled non-inferiority BIOSCIENCE trial. Results from the trial have been published in The Lancet and EuroIntervention; these had already revealed that Orsiro might be associated with better clinical outcomes than Xience Prime/Xpedition for this indication.

At two years, BIOSCIENCE’s primary endpoint of target lesion failure (TLF) occurred in 5.4 percent of STEMI patients treated with Orsiro compared with 10.8 percent of those treated with Xience Prime/Xpedition. BIOSCIENCE is the largest investigator-initiated study to date evaluating the safety and efficacy of Orsiro, a bioabsorbable polymer DES, in comparison to the durable polymer Xience Prime/Xpedition DES.

The Orsiro Hybrid Drug-Eluting Stent (DES), launched in 2011, combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating is layered on top of the high performance PRO-Kinetic Energy stent platform, renowned for its advanced ultrathin-strut stent design and outstanding deliverability.

For more information:

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Overlay Init