News | Stents Drug Eluting | March 07, 2016

Orsiro Demonstrates Benefit over Xience in Heart Attack Subgroup

Lower rate of target lesion failure with Orsiro for ST-segment elevation myocardial infarction patients in randomized controlled BIOSCIENCE trial

Biotronik, BIOSCIENCE trial, Orsiro hybrid DES, drug-eluting stent, STEMI heart attack patients

March 7, 2016 — Biotronik announced publication of results from the BIOSCIENCE trial in the journal EuroIntervention. The study’s authors suggest the Orsiro hybrid drug-eluting stent (DES) may have an advantage over Xience Prime/Xpedition in treating ST-segment elevation myocardial infarction (STEMI) patients. 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 included in the BIOSCIENCE trial revealed that Orsiro might be associated with better clinical outcomes than Xience Prime/Xpedition for this indication. At one year, BIOSCIENCE’s primary endpoint of target lesion failure (TLF) occurred in seven (3.3 percent) STEMI patients treated with Orsiro compared with 17 (8.7 percent) patients 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. Results from the multi-center, randomized, controlled non-inferiority trial were first published in The Lancet.

“During the BIOSCIENCE trial, Orsiro was associated with a significantly reduced risk of the primary endpoint of TLF for STEMI patients,” commented lead author Thomas Pilgrim, M.D., University Clinic for Cardiology, Bern, Switzerland. “We hypothesize this is due to Orsiro’s bioabsorbable polymer, which might provide favorable results on arterial healing after implantation. The effect of an enhanced healing response may be more pronounced in the inflammatory milieu of STEMI. As we currently have only limited data available on the clinical performance of newer generation DES in STEMI patients, we will soon attempt to extend these results in a dedicated randomized trial known as BIOSTEMI.”

The Orsiro Hybrid 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 system is layered on top of the high performance PRO-Kinetic Energy stent platform.

Read the February 2019 article FDA Clears Biotronik Orsiro Stent That Outperforms Xience

For more information: www.biotronik.com

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo