若生智能
Drug Database
BI

biolimus (biolimus, Terumo / Nobori / Nobori)

✓ Approved

Biosensors · MTOR · 小分子

什么是 biolimus？

biolimus 是一种小分子，由Biosensors研发。该药已获批，用于治疗相关适应症，给药途径：Surgical Implantation。

药物档案

商品名biolimus, Terumo, Nobori, Nobori
公司Biosensors
药物类别小分子
分子靶点MTOR
给药途径Surgical Implantation
状态Approved
来源： ClinicalTrials.gov, Biosensors

作用机制

分子靶点

biolimus 作用于 1 个分子靶点：

MTORmechanistic target of rapamycin kinase (FRAP2, RAPT1)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

biolimus 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Injury, poisoning and procedural complicationsRestenosis✓ Approved

相关研究文献

PubMedCardiology in review2026-07-28

Long-Term Outcomes With Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents for Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials.

Sayed Mohamed Saad MS, Gadelmawla Ahmed Farid AF, Atta Karim K, Madyan Ahmed M AM et al.

Recent randomized controlled trials (RCTs) have reported long-term outcomes comparing biodegradable polymer biolimus-eluting stents (BP-BES) with durable polymer everolimus-eluting stents (DP-EES). This meta-analysis aims to evaluate the long-term outcomes of BP-BES versus DP-EES in patients undergoing percutaneous coronary intervention (PCI). Electronic databases were systematically searched through August 2025 to identify RCTs comparing BP-BES with DP-EES in PCI. The primary outcome was major adverse cardiovascular events (MACE). Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random-effects model. Fourteen RCTs totaling 14,504 patients were included; 7684 (52.9%) received BP-BES, and 6820 (47.1%) received DP-EES. BP-BES was associated with a similar risk of MACE compared with DP-EES (RR 1.09, 95% CI 0.96-1.23; P = 0.17; I2 = 0.0%). No significant differences were observed for all-cause mortality (RR 1.06, 95% CI 0.94-1.18; P = 0.34), cardiovascular mortality (RR 1.11, 95% CI 0.93-1.32; P = 0.24), or myocardial infarction (RR 1.09, 95% CI 0.92-1.29; P = 0.31), with low heterogeneity across outcomes (I2 = 0.0%). Rates of target lesion failure, target vessel revascularization, and target lesion revascularization were also comparable between groups. Subgroup analyses by follow-up duration (≤1 year, 1-3 years, 5 years, and 10 years) demonstrated consistent results with no significant differences in MACE. In patients undergoing PCI, BP-BES demonstrates long-term clinical outcomes comparable to DP-EES. These findings support the long-term safety and effectiveness of BP-BES.

PMID 42509634
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PubMedHellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese2026-06-13

Clinical efficacy and safety of paclitaxel-coated vs. limus-coated balloons in coronary interventions: a review of the literature.

Tsiamis Nikolaos N, Afendoulis Dimitrios D, Papanikolaou Aggelos A, Tsakirian Flora F et al.

The principle of complete vessel restoration in percutaneous coronary intervention (PCI) has highlighted the significance of drug-coated balloons (DCBs) as a crucial alternative to permanent metallic stents, which are associated with potential risks such as neoatherosclerosis and delayed stent thrombosis. Although paclitaxel-coated balloons (PCBs) are widely accepted as the preferred option for managing in-stent restenosis (ISR) due to their lipophilic and cytotoxic characteristics, sirolimus-coated balloons (SCBs) have emerged as a potentially less risky alternative, using a cytostatic mode of action. This review synthesizes clinical evidence from 10 randomized controlled trials (RCTs) and 7 meta-analyses published between 2020 and 2025. The analysis focuses on comparative safety and efficacy across major indications: in-stent restenosis (ISR), de novo small vessel disease (SVD), and bifurcation lesions. In-Stent Restenosis (ISR): Multiple trials (such as Scheller et al., 2022, BIO ASCEND ISR) demonstrated the non-inferiority of limus-based platforms compared to PCBs. For instance, late lumen loss (LLL) was nearly identical between groups (0.25 mm for the PCB group vs. 0.26 mm for the SCB group). However, the REFORM trial failed to show non-inferiority for a biolimus-coated balloon, highlighting that outcomes often reflect device-specific effects rather than a class effect. De Novo Small Vessel Disease: Outcomes in this category were more heterogeneous. In the TRANSFORM I trial, the MagicTouch SCB failed to meet non-inferiority for net lumen gain compared to the SeQuent Please Neo PCB. Conversely, other studies observed comparable LLL between the two platforms. Safety Profile: Across most indications, Major Adverse Cardiovascular Events (MACE) and Target Lesion Failure (TL F) rates were comparable between paclitaxel and sirolimus platforms at 12-month follow-up. PCBs demonstrated a higher frequency of "late lumen enlargement" compared to SCBs. Both paclitaxel and sirolimus-based DCBs are effective for treating in-stent restenosis. However, in de novo lesions, PCBs currently maintain a more consistent evidence base. Clinical performance appears heavily dependent on device-specific factors, such as coating technology and excipient formulation, rather than a general class effect. Extended follow-up data of 3-5 years are still required to fully evaluate long-term safety and the risk of very late thrombosis.

PMID 42285438
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PubMedInternational journal of cardiology2026-04-19

Impacts of stent characteristics on periprocedural ischemic events in elective PCI: the ALPHEUS-stents study.

Giovachini Louis L, Ferrante Arnaud A, Guedeney Paul P, Rahoual Ghilas G et al.

Stents characteristics can have a tremendous impact on the incidence of periprocedural ischemic events following percutaneous coronary intervention (PCI) in patients with chronic coronary syndrome (CCS). The ALPHEUS-stents study aimed to describe the association between stents lengths and characteristics on the occurrence of periprocedural ischemic events. The study included patients with CCS undergoing elective PCI with at least one high-risk feature. The primary endpoint of the study was the composite of type 4a/4b myocardial infarction (MI) and periprocedural major myocardial injury evaluated at 48 h or discharge. First, we evaluated the association between total stent length and primary outcome using a multivariate logistic regression considering stent length as a continuous variable and adjusting for relevant covariates. Then we evaluated the associations between stent diameter, strut thickness, platform composition, polymer type, coating distribution and eluted drugs with the primary endpoint using a multivariable logistic regression model, with stent length categorized within the aforementioned subgroups. The primary endpoint occurred in 639 patients (35.8%). After adjustment, total stent length was significantly associated with the primary endpoint (adjusted Odds Ratio (aOR) 1.028 95%CI [1.028-1.029] per millimeter). No significant associations were observed across categories of stent diameter, strut thickness, platform composition or coating distribution. However, biolimus-eluting stents (aOR 1.051 [1.035-1.067], p = 0.006 vs other eluted drugs) were independently associated with an increased risk of the primary outcome. In patients undergoing elective PCI, the risk of periprocedural ischemic events is adequately captured by the total stent length. Biolimus-eluted stents might confer a higher risk of periprocedural ischemic events. gov number: NCT02617290.

PMID 41999954
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PubMedThe American journal of cardiology2026-03-27

Limus- Versus Paclitaxel-Coated Balloons for In-Stent Restenosis Treatment: A Systematic Review and Study-Level Meta-Analysis of Randomized Controlled Trials.

Suruagy-Motta Ricardo F O RFO, Carvalho Pedro E P PEP, da Silva Leonardo Dexheimer LD, de Oliveira Oldra Leonardo Galvão LG et al.

Drug-coated balloons are the preferred treatment for in-stent restenosis (ISR), avoiding the need for a second metallic layer. While both paclitaxel-coated balloons (PCB) and limus-coated balloons (LCB, typically sirolimus or biolimus) are used, direct comparative evidence is limited, particularly regarding their long-term angiographic efficacy and clinical safety. We conducted a systematic review and study-level meta-analyzis of studies comparing LCB with PCB for coronary ISR. A comprehensive search was performed across PubMed, Embase, Cochrane, Scopus, Web of science for randomized controlled trials. Outcomes were compared using risk ratios (RR) for categorical data and mean differences for continuous data in a random-effects model. Heterogeneity was assessed using the I2 statistic. Six randomized controlled trials involving 1,038 patients were included (552 in the LCB group and 481 in the PCB group). Compared with PCB, LCB were associated with a significantly higher risk of clinically driven target lesion revascularization (RR: 1.48; 95% CI: 1.02 to 2.14; p = 0.04; I2 = 0%) and target lesion failure (RR: 1.19; 95% CI: 0.87 to 1.62; p = 0.27; I2 = 0%). In contrast, both platforms demonstrated no differences in all-cause mortality (RR: 0.98; p = 0.96), myocardial infarction (RR: 0.73; p = 0.46), stent thrombosis (RR: 0.66; p = 0.57), or MACE (RR: 1.09; p = 0.58). Angiographic outcomes were comparable, including late lumen loss (mean differences: -0.00 mm; p = 0.65; I2 = 74.7%) and minimal lumen diameter (mean differences: -0.12 mm; p = 0.07). In patients with ISR, PCB reduced repeat revascularization compared with LCB. These data suggest a modest advantage for PCB in preventing restenosis following drug-coated balloon angioplasty for ISR.

PMID 41887557
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PubMedCirculation journal : official journal of the Japanese Circulation Society2026-03-26

Assessment of and Factors Contributing to Adequate Endothelization After Drug-Eluting Stent Implantation.

Nishino Masami M, Egami Yasuyuki Y, Nohara Hiroaki H, Kawanami Shodai S et al.

Adequate endothelization after drug-eluting stent (DES) implantation is essential to reduce thrombotic risk. Adequate strut coverage (ASC) is defined as ≥40 μm on optical coherence tomography, but its functional significance remains uncertain. Coronary angioscopy can assess neointimal function by detecting thrombus and plaque color. This study evaluated functionally adequate endothelization and contributing factors after DES implantation. Post hoc analyses of the COLLABORATION 1 and 2 studies were performed using serial optical coherence tomography and coronary angioscopy 1 and 12 months after DES implantation. Four DES types were examined: durable polymer everolimus-eluting stent (DP-EES); sirolimus-eluting stent (SES); polymer-free biolimus-coated stent (PF-BCS); and dual-therapy sirolimus-eluting stent (DTS). PF-BCS and DTS were classified as "ingenious" DES, and DP-EES and SES were classified as "fundamental." The correlation between the percentage of struts with ≥40 μm coverage (%ASC) and functional neointima (i.e., no thrombus and white plaque) was assessed. Among 150 patients (177 lesions), thrombus and yellow plaque were inversely correlated with %ASC at 12 months. Cut-off values of %ASC were 67% for thrombus prevention and 90% for plaque stabilization. Multivariable analysis identified the use of ingenious DES, prasugrel therapy, and hypertension as independent predictors of chronic adequate endothelization. Functional protection against thrombus requires %ASC ≥67%, and plaque stabilization requires ≥90%. The use of ingenious DESs and prasugrel contributes to improved chronic adequate endothelization.

PMID 41882828
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PubMedHeart & lung : the journal of critical care2026-03-20

Outcomes with limus-coated vs. paclitaxel-coated balloons for percutaneous coronary intervention: An updated meta-analysis and reconstructed time-to-event analysis of randomized controlled trials.

Sayed Mohamed Saad MS, Abdelraouf Mohamed R MR, Kedwany Ahmed M AM, Hageen Ahmed W AW et al.

Paclitaxel drug-coated balloons (DCBs) are an established option for treating coronary in-stent restenosis (ISR) and small vessel disease. However, randomized controlled trials (RCTs) comparing limus-DCBs with paclitaxel-DCBs have reported inconsistent findings. This updated meta-analysis compared clinical and angiographic outcomes of limus- versus paclitaxel-DCBs in patients undergoing percutaneous coronary intervention (PCI). Electronic databases were searched through July 2025 to identify RCTs comparing limus-DCBs with paclitaxel-DCBs in PCI. The primary outcome was target lesion failure (TLF). Summary estimates were generated using a random-effects model. Subgroup analyses were performed based on lesion type and limus agent. Ten RCTs, including 1471 patients, were analyzed. At a mean follow-up of 11.7 months, no significant difference was found in TLF (risk ratio [RR] 1.11; 95% confidence interval [CI] 0.84-1.47). Subgroup analyses showed no interaction for de novo lesions versus ISR (Pinteraction = 0.26) or for biolimus- versus sirolimus-DCBs (Pinteraction = 0.32). No significant differences were observed in major adverse cardiac events (RR 1.10; 95% CI 0.86-1.41), target lesion revascularization (RR 1.18; 95% CI 0.88-1.57), cardiac mortality (RR 0.71; 95% CI 0.25-2.04), or target vessel myocardial infarction (RR 0.71; 95% CI 0.30-1.69). Angiographic outcomes-including binary restenosis, late lumen loss, minimal lumen diameter, acute gain, net gain, and diameter stenosis-were also comparable. Among patients undergoing DCB-only PCI, there was no statistically significant difference between limus and paclitaxel-DCBs regarding clinical and angiographic outcomes. Larger RCTs with extended follow-up duration are needed to confirm these findings.

PMID 41855742
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