Biotronik has announced three-year data from the Bioflow-V trial, which was presented recently at the 2020 Cardiovascular Research Technologies (CRT) conference. The three-year follow-up data demonstrates consistently lower clinical event rates and improvement in patient outcomes, reinforcing the differentiation of the Orsiro coronary drug-eluting stent (DES)—the first and only ultrathin strut DES to outperform Xience. Orsiro received FDA approval in 2019 and has been used to treat more than two million patients worldwide to date. The study results have been simultaneously published in JACC: Cardiovascular Interventions.
Orsiro’s clinical performance in the pivotal Bioflow-V trial demonstrated significantly lower rates for target lesion failure (TLF) and target vessel myocardial infarction (MI) at 12 months in comparison to Xience in a large, complex patient population (n=1,334). At two years, treatment with Orsiro further improved event rates in comparison to Xience, including a significant reduction in target lesion revascularisation (TLR) and spontaneous MI.
The three-year results show Orsiro’s ability to outperform Xience, long considered the benchmark for clinical performance, across the most important three-year secondary endpoints of Bioflow-V:
- 40% lower TLF rate in favor of Orsiro (8.6% versus 14.4% TLF rate, p=0.003)
- a 52% lower ischemia-driven TLR rate (3.4% versus 6.9%, p=0.008)
- a 46% lower rate of TV-MI (5.5% versus 10.1%, p=0.004)
- a 90% lower late/very late definite/probable stent thrombosis (ST) rate (0.1% vs. 1.2%, p=0.018)
“Orsiro sets a new standard for safety and efficacy in long-term clinical endpoints, including statistically lower target lesion revascularisation and target vessel MI rates,” said David Kandzari, Bioflow-V US principal investigator, Piedmont Heart Institute, Atlanta, USA. “Bioflow-V data are the best clinical outcomes observed among comparative clinical trials with contemporary DES. It was widely believed that safety and efficacy with DES had plateaued, but Orsiro has surpassed the limits. Year after year the results have been impressive.”
The Orsiro cobalt chromium metal stent elutes sirolimus via Biolute, Biotronik’s bioabsorbable polymer coating. Beneath the bioabsorbable layer is Biotronik’s Probio coating, a silicon carbide layer covering the bare metal surface and designed to reduce nickel ion release. The Orsiro stent system provides ultrathin stent struts without compromising radial strength and a low crossing profile for easier lesion cross in complex PCI.
“Orsiro’s consistently better long-term outcomes completely alter the dynamic of what had become a highly commoditised DES market,” said Ryan Walters, president at Biotronik. “We designed Orsiro with a focus on efficacy, even in challenging cases. Hospital administrators have the option to choose a DES that shows improved clinical event rates, and interventionalists can rely on Orsiro’s deliverability to treat complex lesions and challenging subgroups to achieve outstanding patient outcomes. Orsiro is proving to be exactly what physicians need for best-in-class performance and what patients deserve.”