Three-year data from the BIOFLOW-V trial, presented Feb. 23 at the 2020 CRT Congress in National Harbor, Md., reinforce the status of Biotronik’s Orsiro drug-eluting stent as superior to the popular Xience stent.
At TCT 2018 in San Diego, Biotronik researchers announced that the Orsiro stent, which elutes sirolimus, continued to outperform Xience two years after 1,344 percutaneous coronary intervention (PCI) patients were randomized to treatment with either the Orsiro or Xience stent. While mortality outcomes were similar among the patients, those who received the Orsiro saw significant advantages in terms of target vessel MI, target lesion revascularization and late stent thrombosis.
“Historically, the Xience stent has been associated with the most favorable safety and efficacy outcomes in interventional cardiology,” principal investigator David Kandzari, of the Piedmont Heart Institute in Atlanta, told Cardiovascular Business at the time. “Now, with the superiority demonstrated for the Orsiro stent, it really raises the question of whether there’s a new standard for comparison in drug-eluting stents.”
Three years into BIOFLOW-V, Kandzari and colleagues maintain that Orsiro has an edge over Xience. Patients implanted with the Orsiro stent experienced:
- A 40% lower target lesion failure rate
- A 52% lower ischemia-driven target lesion revascularization rate
- A 46% lower rate of target vessel MI
- A 90% lower rate of late stent thrombosis
“Orsiro sets a new standard for safety and efficacy in long-term clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates,” Kandzari said in a Feb. 24 statement. “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.”