TCT 2016: Orsiro drug-eluting stent proves non-inferiority to resolute integrity and synergy stents
Results of Late Breaking All-Comers BIO-RESORT Trial Simultaneously Published in The Lancet
WASHINGTON, DC, US and BUELACH, Switzerland – BIOTRONIK announced results establishing the Orsiro1 hybrid drug-eluting stent (DES) as non-inferior to competing Resolute Integrity DES, with outcomes similar to Synergy DES. The investigator-initiated, multicenter, three-arm, randomized BIO-RESORT trial assessed 3,514 subjects in an all-comers population with coronary artery disease. With release of this data, Orsiro has now proven non-inferiority to all three major coronary DES competitors. Full results of the BIO-RESORT trial were simultaneously published in The Lancet.2
BIO-RESORT randomly assigned patients to treatment with the ultra-thin strut sirolimus-eluting Orsiro (n=1169), the very thin strut everolimus-eluting Synergy (n=1172), or the zotarolimus-eluting Resolute Integrity (n =1173). Its primary endpoint was target vessel failure (TVF) at one year: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. In the three stent groups, the primary endpoint result was 4.7%, 4.7%, and 5.4%, respectively, demonstrating both Orsiro’s and Synergy’s non-inferiority to Resolute Integrity (p non-inferiority <0.0001). Furthermore, a very low rate of stent thrombosis occurred in all three study arms, only 0.3%.
BIO-RESORT’s all-comers population included a significantly high proportion of almost 70 percent of acutely diseased patients, including diabetics and heart attack patients. “The rate of patients with ST-elevation myocardial infarction (STEMI) was extremely high, at over 30 percent,” explained BIO-RESORT lead investigator Dr. Clemens von Birgelen, Thoraxcentrum Twente and University of Twente, Enschede, the Netherlands. “The rate of complex lesions treated was also high. The challenging population in this trial can therefore be said to truly reflect routine clinical practice.”
“This positive outcome is in line with the results of two previous randomized trials in all-comers that compared Orsiro versus Xience3 and Nobori4, respectively,” commented Dr. von Birgelen. “BIO-RESORT demonstrates the continued value of high-quality randomized DES trials in true all-comers, reflecting real world clinical practice. The long-term results will also be of great interest.”
“The results of BIO-RESORT are in line with long-term data from the large SCAAR registry (Orsiro: n=6969)5, which confirms Orsiro’s outstanding performance for restenosis,” stated Dr. Alexander Uhl, Vice President Marketing, BIOTRONIK Vascular Intervention. “Orsiro has now proven non-inferior to all major competitors across a variety of indications, giving physicians confidence to use our highly deliverable DES for the treatment of coronary artery disease in diverse clinical settings. Orsiro has already benefited over half a million patients, and clinical evidence for its safety and efficacy continues to grow.”
The Orsiro Hybrid Drug-Eluting Stent (DES), launched in 2011, features the latest development in BIOTRONIK stent technology – a unique hybrid solution that 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 Energy1 stent platform, renowned for its advanced ultrathin-strut stent design and outstanding deliverability.
A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris6, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar1, the world’s first 4 F compatible stent for treating long lesions; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.
- CAUTION – Investigational device. Limited by United States law to investigational use.
- von Birgelen C et al. Lancet. 2016; published online Oct 30, 2016: http://dx.doi.org/10.1016/S0140-6736(16)31920-1
- Pilgrim T et al. Lancet. 2014, 384.
- Jensen LO et al. Circ Cardiovasc Interv. 2016, 9.
- SCAAR registry data available online: http://www.ucr.uu.se/swedeheart/images/stories/stent_reports/20160420/Slide12.GIF
- Not currently available in the United States