Biotronik has announced three-year data from the BIOFLOW-V trial, which were presented at the Cardiac Resynchronisation Therapy meeting (CRT 2020; 23–25 February, Washington DC, USA). A statement from the company says the three-year findings demonstrate 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 (Abbott).
Orsiro received FDA approval in 2019 and has been used to treat more than two million patients worldwide to date. The study results were 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.
A statement from Biotronik details that 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:
- 40% lower TLF rate in favour of Orsiro (8.6% versus 14.4% TLF rate, p=0.003)
- a 52% lower ischaemia-driven target lesion revascularisation (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% versus 1.2%, p=0.018).
David Kandzari (Piedmont Heart Institute, Atlanta, USA), BIOFLOW-V US principal investigator, states in the press release: “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. 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.”
“Orsiro’s consistently better long-term outcomes completely alter the dynamic of what had become a highly commoditised DES market,” adds Ryan Walters, president at Boitronik. 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.”
The statement also points out that the Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex percutaneous coronary intervention (PCI).