Author + information
- Johannes Waltenberger1,
- Stefan Hoffmann2,
- Johannes Brachmann3,
- Jan van der Heyden4,
- Gert Richardt5,
- Ole Frobert6 and
- Andrejs Erglis7
- 1University of Muenster, Muenster, Germany
- 2Werner Forßmann Klinik, Eberswalde, Germany
- 3Department of Cardiology and Pneumology, Klinimkum Coburg, Coburg, Germany
- 4St. Antonius hospital, Nieuwegein, Netherlands
- 5Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- 6Universitetssjukhuset Orebro, Orebro, Sweden
- 7P. Stradins Clinical University Hospital, Riga, Latvia
BIOFLOW-III is a prospective, non-randomized, open-label registry evaluating clinical outcomes and safety of a new generation Sirolimus eluting stent system (Orsiro) in a large patient population in standard clinical care. Orsiro is a hybrid solution that combines passive and active components. PROBIO® passive coating encapsulates the stent and minimizes interaction between the metal stent and surrounding tissue. BIOlute® active coating contains a highly biocompatible and biodegradable polymer.
In total, 1356 patients were enrolled in this registry. Clinical follow-ups at 6, 12, 36 and 60 months were scheduled. All serious and device-related adverse events were adjudicated by an independent clinical event committee. Statistical analysis of primary (Target Lesion Failure at 12 months) and secondary endpoints was performed for the entire patient cohort and for pre-specified subgroups: diabetes, small vessels, chronic total occlusion and acute myocardial infarction.
Nine hundred seventy one men (72%) and 385 women were enrolled at 43 sites in 14 countries. The mean age was 66.1±10.7 years. Seventy six percent of subjects had hypertension, 60% - hypercholesteremia, 30% - diabetes and 55% were smokers. Number of treated lesions was 1738; the mean lesion length 15.8±9.1 mm; the mean reference diameter 3.0±0.4 mm. Orsiro device and procedural success were 99.2% and 98.3%, respectively. At 12 months, 5.0% of the patients had target lesion failure (TLF). At 60 months, 9.2% of the patients had TLF. Slightly higher TLF rates were observed in pre-defined small vessels (9.4%; total number of lesions - 828), acute myocardial infarction (10.6%; 551) and diabetes (13.0%; 517) study subgroups, but not in chronic total occlusion subgroup (1.8%). Stent thrombosis occurred in 0.7% of patients within 60 months.
Five-year preliminary data for the BIOFLOW-III registry demonstrated an excellent device and procedure success with the Orsiro stent. Low TLF rate, observed already for the primary endpoint, was confirmed in this long-term follow up. Importantly, rates of definite and probable stent thrombosis remained low during 5 years, indicating safety of the Orsiro stent system.
CORONARY: Stents: Drug-Eluting