Two-Year BIOFLOW-V Data Presented for Biotronik's Orsiro DES
September 24, 2018—Biotronik announced 2-year data from the BIOFLOW-V randomized trial at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California. The data were published simultaneously online by David E. Kandzari, MD, et al in Journal of the American College of Cardiology.
BIOFLOW-V is a pivotal United States investigational device exemption trial comparing the company's ultrathin bioresorbable Orsiro sirolimus-eluting stent versus the thin durable polymer Xience everolimus-eluting stent (Abbott Vascular) for percutaneous coronary interventions. The international study was composed of 1,334 patients, of which a sizable percentage were complex: 50.8% of patients presented with acute coronary syndrome, 35.0% were diabetic, and 73.8% of lesions were American College of Cardiology/American Heart Association class B2/C1. Patients will be followed for 5 years.
According to the company, the study showed statistically improved outcomes for patients treated with Orsiro across a range of clinical endpoints.
At 24 months, treatment with Orsiro versus Xience resulted in:
- 37% lower target lesion failure rate (7.5% vs 11.9%; P = .015)
- 44% lower target vessel myocardial infarction (5.3% vs 9.5%; P = .01)
- 47% lower ischemia-driven target lesion revascularization rate (2.6% vs 4.9%; P = .04)
Additionally, the stent thrombosis rate favored Orsiro (0.1% vs 1%; P =.045)
Dr. Kandzari, the United States Principal Investigator of the BIOFLOW-V trial, commented in the company's press release, “These 2-year results confirm the superior outcomes for Orsiro we identified at 1 year, now across an even broader range of clinical endpoints. Results from this trial establish a new standard for safety and efficacy among contemporary drug-eluting stents, demonstrating both maintenance of superior outcomes compared with the Xience stent at 1 year and emergence of new differences in both safety and efficacy events that favor Orsiro over what has been a benchmark for comparison." Dr. Kandzari is with Piedmont Heart Institute in Atlanta, Georgia.