Coronary interventions

BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months

EuroIntervention 2019;15:e1006-e1013. DOI: 10.4244/EIJ-D-18-01214

Shigeru Saito
Shigeru Saito1, MD; Ralph Toelg2, MD; Bernhard Witzenbichler3, MD; Michael Haude4, MD; Monica Masotti5, MD; Ruiz Salmeron6, MD; Adam Witkowski7, MD; Masaaki Uematsu8, MD; Akihiko Takahashi9, MD; Ron Waksman10, MD; Ton Slagboom11, MD; BIOFLOW-IV investigators
1. Okinawa Tokushukai Shonan Kamakura General Hospital, Kanagawa, Japan; 2. Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany; 3. Department of Cardiology and Pneumology, Helios Amper Klinikum, Dachau, Germany; 4. Lukaskrankenhaus Medizinische Klinik I, Städtische Kliniken Neuss, Neuss, Germany; 5. Department of Cardiology, Hospital Clinic, Barcelona, Spain; 6. Hemodynamic Unit, Hospital Universitario Virgen de la Macarena, Seville, Spain; 7. National Institute of Cardiology, Warsaw, Poland; 8. Kansai Rosai Hospital Cardiovascular Centre, Amagasaki, Japan; 9. Sakurakai Takahashi Hospital, Kobe, Japan; 10. MedStar Health Research Institute, Washington, DC, USA; 11. Cardiology Unit, OLVG, Amsterdam, the Netherlands

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, multicentre, 2:1 randomised, 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 five 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. The target vessel failure rate was 5.5% for BP-SES and 7.5% for PP-EES, the 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 randomised 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. NCT01939249

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