Author + information
- Ton Slagboom1,
- Thierry Lefevre2,
- Michael Haude3,
- Michael Gross4,
- Karl Stangl5,
- Franz-Josef Neumann6,
- Manel Sabate7,
- Gert Richardt8,
- Bela Merkely9,
- Javier Goicolea10,
- Paul Barragan11,
- Ron Waksman12 and
- Stephan Windecker13
- 1OLVG, Amsterdam, Netherlands
- 2Ramsay Générale de Santé, Institut Cardiovasculaire Paris-Sud, Massy, France
- 3Lukaskrankenhaus Neuss, Neuss, Germany
- 4Heart and Vascular Center Hansestadt Stendal, Hansestadt Stendal, Germany
- 5Charite - Universitatsmedizin Berlin Medizinische Klinik fiir Kardiologie und Angiologie, Berlin, Germany
- 6Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
- 7Hospital Clínic; University of Barcelona, Barcelona, Spain
- 8Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- 9Semmelweis University Heart and Vascular Center, Budapest, Hungary
- 10Hospital Universitario Puerta de Hierro de Majadahonda, Madrid, Spain
- 11Polyclinique Les Fleurs, Ollioules, France
- 12Medstar Washington Hospital Center, Washington, District of Columbia, United States
- 13University Hospital Bern, Bern, Switzerland
The aim of this study is to compare clinical outcomes and efficacy of the Orsiro Drug Eluting Stent with the Xience Prime™ Everolimus Eluting Stent in a prospective, randomized, controlled, non-inferiority setting in total patient cohort as well as in the diabetic and small vessel subgroups.
Totally, 452 patients across 24 sites in 8 European countries were enrolled in this study. All subjects were randomly assigned 2:1 to receive the Orsiro or the Xience Prime stent, respectively. The randomization was stratified for diabetes. The diabetic subgroup accounted for 28.3% (Orsiro N=84, Xience Prime N=44) of all subjects. The small vessel subgroup included all subjects with a reference vessel diameter ≤2.75mm, accounting for N=259 (57.3%) of the cohort (Orsiro N=168, Xience Prime N=91). Clinical follow up visits were performed at 1, 6, and 12 months and annually thereafter up to 5 years post index procedure. All angiographic images were analyzed by an independent Corelab. All clinical events were adjudicated by an independent clinical events committee. Statistical analysis was performed for total study population and for the pre-specified subgroups.
All three study groups showed comparable populations in both randomization arms in terms of demographics, current risk factors, clinical history and lesion/vessel characteristics. The TLF rate at 60 months for the overall cohort of patients was 10.4% in Orsiro and 12.8% in Xience study groups (p = 0.4702). In diabetic subgroup TLF was detected in 15.9% of patients (Orsiro) vs 11.6% (Xience) (p = 0.5017). In small vessel subgroup 11.1% patients had TLF (Orsiro) vs 15.5% (Xience) (p = 0.3010). No definite or probable stent thrombosis occurred out to 60 months in the Orsiro group. In Xience group definite thrombosis was detected in 0.7% of patients at 5 years.
The ultrathin Orsiro demonstrates an excellent long term safety and clinical performance in the overall cohort, as well as in the diabetic and small vessel subgroup and results are comparable to Xience.
CORONARY: Stents: Drug-Eluting