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.