News | Stents | October 04, 2018

Orsiro Stent Performs in Two Comparison Studies Presented at TCT 2018

New study data fnds durable polymer and polymer-free stents provide no benefit in target vessel failure over the ultrathin Orsiro DES in all-comers randomized studies

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent. #TCT2018

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent.

October 4, 2018 – Investigators unveiled clinical data from the independent BIONYX and SORT OUT IX all-comers trials which respectively compared durable polymer Resolute Onyx and polymer-free BioFreedom to bioresorbable polymer Orsiro.[1,2] The data was presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in September.

In both studies, patients who were treated with the durable or polymer free stents showed no additional benefit at 12 months in target vessel or lesion failure and its components of cardiac death, myocardial infarction and target lesion/vessel revascularization. 

The BIONYX study included 2,488 all-comer patients and assessed the safety and efficacy of the Medtronic Resolute Onyx durable polymer drug eluting stent (DES) compared to the ultrathin strut bioresorbable polymer Orsiro DES. The primary endpoint of target vessel failure at one year showed no statistically significant difference in outcomes for Resolute Onyx (n=1,243) at 4.5% compared to 4.7% (p=0.77) with Orsiro (n=1,245).[1] Stent thrombosis was also exceptionally low for both devices1.

“The results of this head-to-head comparison of the ultrathin strut sirolimus-eluting Orsiro stent with a novel zotarolimus-eluting stent confirm the excellent results of the Orsiro stent, seen in several previous head-to-head comparisons with newer-generation DES,” commented Prof. Clemens von Birgelen, Thoraxcentrum Twente, Enschede, the Netherlands. “At one-year follow-up, we found an excellent and similar safety and efficacy for both stents in all-comers. As our study does not have the statistical power to assess rare events, the stent thrombosis data are hypothesis-generating only and could be the result of a play of chance.”

The SORT OUT IX trial included 3,151 all-comer patients randomized to receive either the thick strut stainless steel BioFreedom polymer-free DES or the ultrathin strut bioresorbable polymer Orsiro DES. The trial was also presented in the same late-breaking session and again showed excellent results for the ultrathin device. The primary endpoint of target lesion failure at one year showed low rates for Orsiro 4% compared to the BioFreedom 5.3% (p for non-inferiority=0.01) and a similar low rate of definite/probable stent thrombosis for both devices: Orsiro 1.1% compared to BioFreedom 1% (p=0.73).

More insights into the SORT-OUT IX study — Polymer-Free BioFreedom Stent as Safe as Orsiro, but Not as Effective

 

Orsiro: Lower Event Rates Drive Lower In-Hospital Costs

Also presented at TCT were the results of a Health Economic evaluation of the Orsiro stent in comparison to Xience, based on the statistically significant improved outcomes for Orsiro in the BIOFLOW-V FDA pivotal trial.[3]

An assessment of the clinical and cost impact in the USA was performed resulting in an estimated net reduction in medical cost of $125 per patient when using Orsiro compared to Xience, with $115 accrued during the initial admission. 

Find links to TCT 2018 Late-breaking Cardiovascular Clinical Trials and Videos
 

For more information: www.biotronik.com

 

References:

1. von Birgelen C, BIONYX: A Randomized Trial Evaluating a Thin Composite Wire Strut Durable Polymer-Based DES Compared with an Ultra-Thin Strut Bioresorbable Polymer-Based DES in an All-Comers Patient Population, Presented at TCT, San Diego USA, September 2018.

2. Okkels Jensen L, SORT OUT IX: A Randomized Trial Comparing a Polymer-Free Coronary Drug-Eluting Stent With an Ultra-Thin Strut Bioresorbable Polymer-Based Drug-Eluting Stent in an All-Comers Patient Population, Presented at TCT, San Diego USA, September 2018.

3. Mattke S, et al. Health Economic Evaluation of an Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable Polymer Everolimus-Eluting Stent. Presented at TCT, September 2018, San Diego USA.

Related Content

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
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init