Safety and Efficacy of BioMime Sirolimus-Eluting Stent System in All-Comers Real-World Population With Coronary Artery Stenosis: MILES Global Registry

Hudec M 1 , Jeong MH 2 , Trillo R 3 , Ijsselmuiden AJJ 4 , Gwon HC 5 , Chae IH 6 Show all authors , Wang YC 7 , de Costa JM 8 , Charng MJ 9 , Maskon O 10 , Burgos JM 11 , Mayurathan G 12 , Mateev H 13 , Serra A 14 , Merkely B 15 , Cale R 16 , Hwang SJ 17 , Mar GY 18 , Lawand S 19 , Khokhlov A 20 , Montilla BV 21 , Valdes M 22 , Sadeghian M 23

Affiliations 

  • 1 Department of Acute Cardiology, Middle-Slovak Institute of Cardiovascular Diseases (SUSCCH), Banska Bystrica, Slovakia
  • 2 Department of Cardiology, Chonnam National University, Gwangju, Korea
  • 3 Department of Cardiology, Complexo Hospitalario Universitario de Santiago de Compostela, Spain and Centro de Investigacion Biomedica en Red Enfermedades Cardiovasculares CIBER-CV, Madrid, Spain
  • 4 Department of Interventional Cardiology, Albert Schweitzer Hospital, The Netherlands
  • 5 Department of Cardiology, Samsung Medical Centre, Seoul, Korea
  • 6 Department of Internal Medicine, Bundang Seoul National University Hospital, Seongnam, Korea
  • 7 Department of Internal Medicine, National Taiwan University Hospital, Taiwan, Republic of China
  • 8 Hospital Santa Maria, Lisbon, Portugal
  • 9 Division of Cardiology, Shin Kong Wu Ho-Su Memorial Hospital, Taiwan, Republic of China
  • 10 Department of Medicine (Cardiology Unit), Universiti Kebangsaan Malaysia Medical Centre, Cheras, Malaysia
  • 11 Department of Cardiology, Hospital Virgen de la Salud, Toledo, Spain
  • 12 Department of Cardiology, Teaching Hospital Kandy, Sri Lanka
  • 13 Department of Interventional Cardiology, National Heart Hospital, Sofia, Bulgaria
  • 14 Department of Cardiology, Hospital de Sant Pau, Barcelona, Spain
  • 15 Department of Cardiology, University of Semmelweis, Budapest, Hungary
  • 16 Department of Cardiology, Hospital Garcia Orta, Almada, Portugal
  • 17 Taipei Medical University Hospital (TMUH), Taiwan, Republic of China
  • 18 Department of Critical Care Medicine, Veteran General Hospital (KVGH), Taiwan, Republic of China
  • 19 Cardiovascular Department, Dallah Hospital, Riyadh, Saudi Arabia
  • 20 Heart Institute of The Ministry of Healthcare of Ukraine, Kyiv, Ukraine
  • 21 Department of Cardiology, Hospital Del Mar, Barcelona, Spain
  • 22 Department of Cardiology, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain
  • 23 Department of Forensic Medicine, Imam Khomeini Hospital, Tehran, Iran
Cardiol Res, 2024 Dec;15(6):439-452.
PMID: 39698009 DOI: 10.14740/cr1724

Abstract

BACKGROUND: This study evaluated the safety and efficacy of BioMime sirolimus-eluting stent (SES) system, with an ultra-low strut thickness (65 µm), in real-world all-comers population with coronary artery stenosis (CAD).

METHODS: This was a post-marketing, multicenter, single-arm, observational clinical registry among patients undergoing intervention for CAD. Patients were clinically followed up at 1, 9, 12, and 24 months after the index percutaneous coronary intervention. Four major indications, namely long stents of > 30 mm, stents with diameters of 4 and 4.5 mm, bifurcation subgroup, and chronic total occlusion (CTO) were evaluated as pre-specified subsets.

RESULTS: A total of 771 patients (1,079 treated lesions) from 23 sites were included in this study. The mean length and diameter of the implanted stents were 25.57 ± 9.35 mm and 3.00 ± 0.44 mm, respectively. The mean minimum lumen diameter before and after the procedure was 1.00 ± 1.69 mm and 2.96 ± 1.35 mm, respectively. The cumulative rates of major adverse cardiovascular events (MACEs) and stent thrombosis (ST) at 1, 9, 12, and 24 months were 1.05%, 3.13%, 4.04%, 5.64% and 0%, 0.13%, 0.28%, 0.28%, respectively. In a subset with > 30 mm long stents, the cumulative rate of MACEs was 0.4%, 4.6%, 5.12%, and 7.01% at 1, 9, 12, and 24 months, respectively. The corresponding rates of ST were 0%, 0.42%, 0.43%, and 0.44%, indicating constant rate of ST after 9 months. In a subset of 4 and 4.5 mm diameter stents, the cumulative rate of MACEs was high (0%, 6.25%, 6.25%, and 10.41%) at 1, 9, 12, and 24 months, respectively. However, there was no case of ST until 24 months. In patients with bifurcation lesions, the cumulative rates of MACEs and ST were 2.46%, 6.32%, 11.53%, 16.21% and 0%, 1.27%, 1.28%, 1.35% at 1, 9, 12, and 24 months follow-up. In patients with chronic total occlusion, the cumulative rates of MACEs and ST were 0.79%, 5.04%, 6.83%, 7.07% and 0%, 0.84%, 0.85%, 0.88% at 1, 9, 12, and 24 months, respectively, indicating constant rate of ST after 9 months.

CONCLUSIONS: The BioMime SES demonstrated good safety and efficacy outcomes at 24-month follow-up, with low rates of MACEs and ST in patients with CAD in the real-world setting.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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