Author + information
- Johannes Waltenberger1,
- Stefan Hoffmann2,
- Johannes Brachmann3,
- Jan van der Heyden4,
- Gert Richardt5,
- Ole Fröbert6,
- Markus Seige7,
- Otmar Pachinger8,
- Andrejs Erglis9 and
- Willem de Wilde10
The aim of this registry is to evaluate the clinical performance of a new generation Sirolimus eluting stent system (Orsiro) in a large patient population in standard clinical care.
The Orsiro is a unique 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.
Between August 2011 and March 2012, 1,356 subjects were enrolled consecutively in this international, multicentric BIOFLOW-III all-comers registry using the Orsiro Sirolimus eluting stent.
Primary endpoint is Target Lesion Failure (TLF) at twelve months follow-up. Pre-specified subgroups were diabetes, small vessels, chronic total occlusion and acute myocardial infarction. In addition subjects with B2/C lesions, which are known to have a higher risk for cardiac complications or restenosis have been evaluated.
Nine hundred seventy one men (72%) and three hundred eighty five women were enrolled at 43 sites in 14 countries. The mean age was 66.1 ± 10.7, ranging from 29 - 91 years. The majority of subjects presented with hypertension 76%, hypercholesterolemia 60%, smoker 55%, and diabetes 30%. 48% of all stented vessels had a diameter ≤2.75mm, 4% presented with chronic total occlusion. Eleven percent of the subjects experienced unstable angina, 47% stable angina. Acute MI was seen in 33% of the subjects (NSTEMI 22%, STEMI 11%). The portion of elderly subjects (≥75 years) is represented by 25%. An unbiased patient population was seen in the registry with more than 52% type B2/C lesions. Moderate and severe calcification was observed in 31%. The Orsiro hybrid stent system demonstrated excellent device (98.7%) and procedure success (98.2%). In this all-comers setting a TLF rate of 5.1% was observed within the first 12 months. The low TLF rate was also confirmed for the subgroups: diabetics (7.7%), acute MI (7.2%), small vessel (5.8%), CTO (1.8%) and complex B2/C lesions (5.1%).
The results observed in this “real world” population demonstrate a low TLF rate comparable to other state of the art DES at 6- and 12-months.