Ultrathin bioresorbable polymer sirolimus‐eluting stents in US patients undergoing coronary revascularization: 1‐Year outcomes from the BIOFLOW VII trial

Kandzari, David E.; García‐García, Héctor M.; Stoler, Robert C.; Wang, John; Picone, Mark; Ben‐Dor, Itsik; García, Santiago

doi:10.1002/ccd.30783

Cited by 2 publications

(1 citation statement)

References 30 publications

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“…The rates of TLR are also lower with BioMime SES (0%) when compared with FLEX registry (0.7%) [ 20 ], Tetriflex SES (1.72%) [ 21 ], T-FLEX registry (1.9%) [ 22 ], Genoss DES prospective registry (0.5%) [ 25 ], BIOFLOW-VII registry (0.9%) [ 26 ], e-Cobra study (4.3%) [ 27 ] and LEADERS FREE III study (4.3%) [ 28 ], while the TLR rates are comparable with Thailand Orsiro registry (0%) [ 23 ] and FlexyRap ® DES study (0%) [ 24 ]. Comparable ST rates are observed with FlexyRap ® DES study [ 24 ] and BIOFLOW-VII registry [ 26 ], while lower rate of ST is observed when compared with other contemporary device studies [ 20 - 23 , 25 , 27 , 28 ]. BioMime SES also showed lower MACE rates (0.61%) [ 20 - 23 , 25 - 28 ] while the rates are comparable with FlexyRap ® DES study (0.4%) [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

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

Meennahalli Palleda,

Gupta,

Bansal

et al. 2023

Cardiol Res

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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 de novo 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.

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