The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

A Randomized, Intercontinental, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects with de novo Coronary Artery Lesions BIOFLOW IV – Primary Outcome Target Vessel Failure at 12 Months.

DOI: 10.4244/EIJ-D-18-01214

1. Okinawa Tokushukai Shonan Kamakura General Hospital, Japan, JAPAN
2. Segeberger Kliniken, Herzzentrum, Bad Segeberg, Germany
3. Helios Amper Klinikum, Department of Cardiology and Pneumology, Dachau, Germany
4. Städtische Kliniken Neuss, Lukaskrankenhaus Medizinische Klinik I, Neuss, Germany
5. Hospital Clinic, Cardiology Department, Barcelona, Spain
6. Hospital Universitario Virgen de la Macarena, Hemodynamic Unit, Sevilla, Spain
7. National Institute of Cardiology, Warsaw, Poland
8. Kansai Rosai Hospital Cardiovascular Centre, Japan
9. Sakurakai Takahashi Hospital, Japan
10. MedStar Health Research Institute,Washington DC, USA
11. OLVG Cardiology Unit, Amsterdam, Netherlands
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Aims: The BIOFLOW-IV clinical trial was designed for regulatory submission in Japan. It assessed the safety and efficacy of a new third generation sirolimus-eluting stent system with bioresorbable polymer (Orsiro, BP-SES) compared with an everolimus-eluting stent system with permanent polymer (Xience Prime/Xpedition, PP-EES)

Methods and results: This prospective, international, multicenter, 2:1 randomized, non-inferiority trial enrolled 575 patients (385 BP-SES and 190 PP-EES) with 659 stenotic de novo lesions. Of these, 137 patients (23.8%) were Japanese. Follow-up until 5 years is ongoing, we herein report outcomes at 12 months. Baseline parameters were well balanced. Device success was 98.9% for BP-SES versus 99.6% for PP-EES, p=0.670. Non-inferiority related to 12-month target vessel failure  was met (pnon-inferiority<0.001). Further, there was no significant difference in clinical outcomes between the groups. Target vessel failure rate was 5.5% for BP-SES and 7.5% for PP-EES, target lesion failure rate was 4.2% versus 5.4%, and the definite or probable stent thrombosis rate was 0.8% versus 0%

Conclusions: The randomized BIOFLOW-IV trial provides further evidence on the safety and efficacy of the Orsiro BP-SES and its non-inferiority to the current benchmark, an everolimus-eluting permanent polymer stent.

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