Biotronik Orsiro DES Evaluated in 5-Year Data From BIOFLOW-V

February 28, 2022—Biotronik announced that 5-year follow-up data from the pivotal BIOFLOW-V trial demonstrated consistently lower clinical event rates in target lesion failure (TLF) and significantly lower rates of target-vessel myocardial infarction (TV-MI) for the company’s Orsiro ultrathin strut drug-eluting stent (DES) versus the Xience DES (Abbott).

Biotronik noted that the Orsiro DES received FDA approval in 2019. It was approved in Europe in 2011.

United States Principal Investigator David Kandzari, MD, presented the BIOFLOW-V findings during a late-breaking clinical trial session at CRT 2022, the Cardiovascular Research Technologies annual meeting held February 26 to March 1 in Washington, DC.

According to the company, the large randomized BIOFLOW-V trial has shown improved long-term outcomes versus the Xience DES. The Orsiro DES previously demonstrated significantly lower rates for both TLF and TV-MI compared to Xience DES at 12 months follow up in the BIOFLOW-V trial. The device continued to show significant differences across the most important secondary endpoints at 36 months follow up.

As outlined in the company’s press release, the international study included 1,334 patients. A sizable percentage of these patients were complex: 50.8% of patients presented with acute coronary syndrome, 35.0% of patients were diabetic, and 73.8% of lesions were American College of Cardiology/American Heart Association Class B2/C.

The 5-year results from BIOFLOW-V compared the Orsiro (n = 884) versus Xience (n = 450) in TLF (13.2% vs 16.5%; P = .136); TV-MI (7.3% vs 11.5%; P = .021; definite stent thrombosis events (0.7% vs 1.8%; P = .12); and probable stent thrombosis (0% vs 0%). Additionally, the study showed early definite/probable stent thrombosis (0.3% vs 0.2%; P = 1.0); late (> 30 days and ≤ 1 year) definite/probable stent thrombosis (0.1% vs 0.5%; P =.265); and very late (> 1 year and ≤ 5 years) definite/probable stent thrombosis (0.1% vs 1.0%; P = .047).

Dr. Kandzari, who is with Piedmont Heart Institute in Atlanta, Georgia, commented in Biotronik’s press release, “The final 5-year follow up data confirms Orsiro’s superior safety profile and low TLF rates. The ultrathin strut Orsiro stent significantly reduces the risk for TV-MI and shows a low rate of stent thrombosis, and specifically a significant reduction in late and very late stent thrombosis. These long-term results confirm that the Orsiro DES sets a new clinical benchmark in percutaneous coronary intervention treatment options.”

In September 2021, Biotronik announced FDA approval of the next-generation Orsiro Mission bioabsorbable polymer coronary DES. In February 2020, the company announced European CE Mark approval for the Orsiro Mission.