Agostoni Pierfrancesco, Van Kuijk Jan-Peter, Knaapen Paul, Fouladvand Farhat, Hudec Martin, Nicosia Antonino, Kervinen Kari, Tomasello Salvatore Davide, Singh Ramesh Singh Arjan, Vishwanathan Girish N, Merkely Béla, Liew Houng Bang, Al Faraidy Khalid, Corbett Clive, Dawood Saleem, Choudhury Anirban, Alhaddad Imad Abdelhafiz, Zaman Azfar, Kraaijeveld Adriaan O, Pepe Martino
HartCentrum, Ziekenhuis Aan de Stroom (ZAS) Middelheim, Antwerp, Belgium.
Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Cardiovasc Revasc Med. 2025 Feb 23. doi: 10.1016/j.carrev.2025.02.010.
Percutaneous coronary intervention (PCI) of long coronary artery lesions (CAL) presents a puzzle, often requiring multiple stents. As the arteries twist and narrow, this becomes even more challenging with issues like potential distal overexpansion and proximal under expansion, and edge dissections. The study aims to assess the safety and performance of BioMime™ Morph sirolimus-eluting stent (SES) in individuals with long CAL.
This prospective, single-arm, multi-center, observational, real-world registry, included 565 patients with long CAL (length 30 to ≤56 mm) in native coronary arteries (reference vessel diameters: 2.25 mm to 3.50 mm). Based on lesion length, patients were implanted with 30 mm, 40 mm, 50 mm, or 60 mm BioMime™ Morph SES. Primary endpoint was freedom of target lesion failure (TLF) at 6-month and up to 36-month.
Over 65 % of patients had lesions requiring 50 mm and 60 mm stents. The follow-up length was up to 24-month for the whole cohort and up to 36-month only for 211 patients from seven selected centers. The freedom from TLF rate was 97.86 %, 97.26 %, 96.27 %, and 95.15 % at 6-, 12-, 24-, and 36-month follow-ups, respectively. The cumulative rates of major adverse cardiac events (MACE) were 2.74 % at 12-month, 3.73 % at 24-month and 4.85 % at 36-month. Additionally, the rates of ischemia-driven target lesion revascularization were 2.01 % at 12-month, 2.16 % at 24-month, and 3.88 % at 36-month. Lastly, stent thrombosis (ST) was reported in only 2 cases (0.97 %) at 36-month.
The lower incidences of MACE and ST up to three-year follow-up indicate BioMime™ Morph SES is an effective and safe option for PCI in long CAL.
长冠状动脉病变（CAL）的经皮冠状动脉介入治疗（PCI）是一个难题，通常需要多个支架。随着动脉扭曲和变窄，这会变得更具挑战性，存在潜在的远端过度扩张和近端扩张不足以及边缘夹层等问题。本研究旨在评估BioMime™ Morph西罗莫司洗脱支架（SES）在长CAL患者中的安全性和性能。
这项前瞻性、单臂、多中心、观察性、真实世界注册研究纳入了565例天然冠状动脉（参考血管直径：2.25毫米至3.50毫米）存在长CAL（长度30至≤56毫米）的患者。根据病变长度，为患者植入30毫米、40毫米、50毫米或60毫米的BioMime™ Morph SES。主要终点是6个月及长达36个月时的无靶病变失败（TLF）。
超过65%的患者病变需要50毫米和60毫米的支架。整个队列的随访时长可达24个月，仅来自七个选定中心的211例患者随访时长可达36个月。在6个月、12个月、24个月和36个月随访时，无TLF率分别为97.86%、97.26%、96.27%和95.15%。主要不良心脏事件（MACE）的累积发生率在12个月时为2.74%，24个月时为3.73%，36个月时为4.85%。此外，缺血驱动的靶病变血运重建率在12个月时为2.01%，24个月时为2.16%，36个月时为3.88%。最后，仅在36个月时报告了2例（0.97%）支架血栓形成（ST）。
长达三年随访时MACE和ST的发生率较低，表明BioMime™ Morph SES是长CAL患者PCI的一种有效且安全的选择。
