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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

PubMedAsiaIntervention2026-10-25

Biolimus- versus sirolimus-eluting stents in percutaneous coronary intervention: a comprehensive systematic review and meta-analysis of randomised controlled trials.

Suruagy-Motta Ricardo F O RFO, Dexheimer da Silva Leonardo L, Rezende Neves Gabriel G, Farias Carlos Alexandre CA et al.

Sirolimus-eluting stents (SES) are a benchmark in percutaneous coronary intervention (PCI), while biolimus-eluting stents (BES), which combine a more lipophilic analogue with a biodegradable polymer, may enhance healing and reduce thrombosis. Whether these BES features translate into improved survival and cardiac outcomes compared with SES remains uncertain. We sought to perform a meta-analysis of randomised controlled trials evaluating BES compared with SES in adult patients undergoing PCI. This meta-analysis encompassed randomised and controlled clinical trials that directly compared BES with SES in the setting of percutaneous coronary intervention. A comprehensive literature search was performed across PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials up to June 2025. The main outcomes assessed were all-cause and cardiac mortality, while secondary endpoints included major adverse cardiovascular events (MACE), myocardial infarction, target lesion revascularisation (TLR), and stent thrombosis (ST). Outcomes were evaluated at <=1 year (early) and >1-5 years (midterm) using pooled risk ratios (RRs) with 95% confidence intervals (CIs) in random-effects models, with heterogeneity assessed by the I2 test. Six trials (12,109 patients: 6,088 BES, 6,021 SES) were analysed. BES reduced 1-year cardiac death by 30% (RR 0.70, 95% CI: 0.52-0.93) and showed a non-significant 19% reduction in all-cause death (RR 0.81; p=0.058). MACE, myocardial infarction, and TLR were similar between stents across timepoints. BES showed a non-significant early increase in ST (RR 1.85; p=0.12) but a 46% reduction in late ST (RR 0.54, 95% CI: 0.33-0.88). Mortality rates converged after 1 year. BES offer a short-term reduction in cardiac mortality and late stent thrombosis compared with SES, with otherwise similar morbidity outcomes. These results support the short-term safety of BES and indicate a possible long-term thrombotic and cardiac survival benefit, warranting confirmation in longer-term trials.

PMID 42923777
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PubMedCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2026-08-17

Final 2-Year Results of the REFORM Study: A Randomized Trial of Biolimus DCB Versus Paclitaxel DCB for In-Stent Restenosis.

O'Callaghan Daniel D, Coughlan J J JJ, Alfonso Fernando F, Hahn Joo-Yong JY et al.

In the REFORM trial, treatment of coronary in-stent restenosis with a Biolimus A9™ drug-coated balloon (BCB) was found to be inferior with respect to in-segment percentage stenosis at 6-months in comparison to treatment with a standard paclitaxel coated paclitaxel-coated balloon (PCB). In this manuscript, the final prespecified 2-year clinical follow up follow-up of the REFORM trial is reported. The Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the Biolimus A9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM) was a multicenter, single blind, non-inferiority, randomized controlled trial comparing the BCB and PCB in the treatment of coronary in-stent restenosis (ISR). The primary angiographic endpoint of the trial was in-segment % diameter stenosis (%DS) at 6 months, which has previously been reported. A total clinical follow-up duration of 2 years was planned. Prespecified clinical outcomes at 2 years were: target lesion failure (TLF), target vessel failure (TVF), and their individual components. At 24 months, complete follow-up data was available for 93% (n = 188) of the intention to treat (ITT) population. The mean age was 68.7 years, and patients were predominantly male (80.2%). Comorbidities were well balanced between the 2 groups, including diabetes mellitus, which was present in 31% of the BCB group and 29.2% of the PCB group. ISR lesions were predominantly DES-ISR in both groups (BCB 80.7% vs. PCB 85.1%). Through to 2 year follow up, target lesion failure (TLF) occurred in 36 of 135 patients (27.8%) of patients in the BCB group and in 15 of 67 patients (23.5%) in the PCB group (HR: 1.25; 95% CI: 0.69-2.29). Clinically driven target lesion revascularization (CD-TLR) occurred in 31 of 135 patients (24.2%) in the BCB group versus 13 of 67 patients (20.4%) in the PCB group (HR: 1.26; 95% CI: 0.66-2.40). Target vessel myocardial infarction and cardiac death were comparable in both groups. In patients with coronary ISR, the final 2-year results from the REFORM study show that TLF rates were 27.8% in the biolimus-coated balloon BCB group and 23.5% in the paclitaxel-coated balloon PCB group. However, given the limited sample size and wide confidence intervals, the present analysis does not permit reliable inference regarding comparative event rates between treatment strategies. The results should be interpreted against the background of demonstrated inferior angiographic performance of the biolimus DCB at 6 months. The trial was registered prospectively at www. gov (identifier: NCT04079192).

PMID 42605897
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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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