Cardiovascular revascularization medicine : including molecular interventions · 2025
Clinical outcomes of the BioMime™ morph coronary stent system for long (30 to ≤56 mm length) coronary lesions: Three-year follow-up of the Morpheus Global Registry.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.