Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study.

BACKGROUND

The short-term clinical outcomes of first-generation thicker-strut durable polymer-based drug-eluting stents (DES) have been widely examined. However, there is a scarcity on qualitative research on the long-term usage of DES that evaluated the thinner strut biodegradable stents for coronary artery disease. Hence, we sought to investigate the long-term safety and performance of thinner strut biodegradable polymer-based BioMime sirolimus-eluting coronary stent system in real-world patients with symptomatic ischemic heart disease.

METHODS

This was a retrospective, observational, single-center, post-marketing clinical follow-up study. The primary endpoints were the incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction (MI) attributed to target vessel revascularization (TVR), and target lesion revascularization (TLR) at 1-, 2-, 3- and 4-year follow-ups. The secondary endpoints were cardiac death, MI, TLR, TVR, device and procedural success rates, and stent thrombosis (ST).

RESULTS

In all, 1,188 consecutive patients were enrolled, and 1,333 (1,257 and 76 in-stent restenotic lesions) out of 1,565 lesions were treated with the study device. The mean age of patients was 53.26 ± 10.31 years and 86.2% were male. The quantitative coronary angiographic derived mean lesion length and diameter were 29.62 ± 9.62 mm and 3.01 ± 0.29 mm, respectively. The average length and diameter of the study device implanted were 30.89 ± 6.31 mm and 3.17 ± 0.25 mm, respectively. The cumulative incidence of MACE at 1-, 2-, 3-, and 4 years was 0.61%, 1.47%, 2.08%, and 3.40%, respectively, and cumulative deaths due to cardiac causes were 0.61%, 1.13%, 1.22%, and 1.83%, respectively. There were no cases of TLR or TVR at 1-year follow-up. The cumulative rate of TLR at 2-, 3-, and 4 years was 0.35%, 0.87%, and 1.57%, respectively, while that of TVR was 0.61%, 1.47%, and 2.35%, respectively. Three (0.3%) incidences of probable ST occurred during the 6-month follow-up; no new cases were reported further. In subgroup analysis, MACEs were comparable across the long- and short-length stent groups through 4-year follow-up.

CONCLUSIONS

This long-term study demonstrates the safety and performance of the ultra-thin BioMime sirolimus-eluting stent with satisfactory clinical outcomes in patients with symptomatic ischemic heart disease in real-world scenario.