Two-year data from the BIOFLOW-V randomised trial—which compared a sirolimus stent with a biodegradable polymer (Orsiro, Biotronik) with a everoliums-eluting stent with a permanent polymer (Xience, Abbott)—show improved outcomes for patients treated with Orsiro across a range of clinical endpoints including 24-month target lesion failure.
This pivotal US investigational device exemption trial included a large, complex patient population (n=1,334) and was designed to rigorous FDA premarket approval standards. The results showed a 7.5% (Orsiro) vs. 11.9% (Xience) 24-month target lesion failure rate (p=0.015), demonstrating significantly improved outcomes with Orsiro in percutaneous coronary intervention (PCI).
Patients treated with Orsiro in BIOFLOW-V benefited from a significant reduction of events across a wide range of clinical endpoints, including:
- 37% lower target lesion failure rate (p=0.015)
- 44% lower target vessel myocardial infarction rate (p=0.01)
- 47% lower ischaemia-driven target lesion revascularisation) (p= 0.04)
Highlights of the BIOFLOW-V study include the following 24-month data points comparing Orsiro to Xience: target lesion failure 7.5% vs. 11.9, respectively (p=0.015), target vessel myocardial infarction rate 5.3% vs. 9.5% (p=0.01), target lesion revascularisation (2.6% vs. 4.9%; p=0.04), and stent thrombosis (late/very late/definite/probable)0.1% vs. 1.0% (p=0.045).
David Kandzari (Piedmont Heart Institute, Atlanta, Georgia, USA), US principal investigator of BIOFLOW-V, comments: “These two-year results confirm the superior outcomes for Orsiro we identified at one 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 one year and emergence of new differences in both safety and efficacy events that favour Orsiro over what has been a benchmark for comparison.”
BIOFLOW-V is the first large randomised trial to show improved outcomes of any drug-eluting stent over Xience. The international study included 1,334 patients, of which a sizable percentage were complex: 50.8% of patients presented with acute coronary syndrome, 35% of patients were diabetic and 73.8% of lesions were ACC/AHA Class B2/C. Patients will be followed for five years.
Alexander Uhl, senior vice president, Corporate Marketing at Biotronik, comments: “These results confirm that Orsiro’s unique combination of ultrathin struts and a bioresorbable polymer can deliver consistent, superior patient outcomes.”
The BIOFLOW-V 24-month data were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA).