Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes
Abstract Background The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolim...
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BMC
2025-07-01
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| Series: | BMC Medicine |
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| Online Access: | https://doi.org/10.1186/s12916-025-04254-0 |
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| author | Jun Jiang Changling Li Delong Chen Lei Song Zhanqian Cui Ping Li Lijun Gan Yundai Chen Hui Li Shaobin Jia Shenghu He Wen Lu Runlin Gao Jianan Wang on behalf of the FUTURE III Investigators |
| author_facet | Jun Jiang Changling Li Delong Chen Lei Song Zhanqian Cui Ping Li Lijun Gan Yundai Chen Hui Li Shaobin Jia Shenghu He Wen Lu Runlin Gao Jianan Wang on behalf of the FUTURE III Investigators |
| author_sort | Jun Jiang |
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| description | Abstract Background The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolimus-eluting Firesorb BRS in patients with de novo coronary lesions. Methods Patient-level data derived from 1205 patients in the FUTURE-II RCT (n = 215) and FUTURE-III registry (n = 990) were prospectively collected, pooled, and analyzed. The primary endpoint of 1-year target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization was also analyzed. Results At 1-year follow-up, the cumulative rate of TLF was 1.67%, with an upper 95% confidence interval of 2.57%, significantly lower than the objective performance criterion goal of 6.6% (P < 0.001). The rate of single TLF components was 0.42% for cardiac death, 0.92% for target vessel myocardial infarction, and 0.42% for ischemia-driven target lesion revascularization. The cumulative rate of POCE at 1 year was 3.34%. No patient experienced definite or probable device thrombosis during 1-year follow-up. Conclusions This pooled, patient-level analysis indicates that the thinner strut Firesorb BRS exhibits promising 1-year efficacy and safety profiles with regard to TLF. However, our findings are only applicable to non-complex lesions; large-scale randomized clinical trials powered to assess clinical endpoints are necessary to evaluate the strategy of Firesorb BRS compared to drug-eluting stents. Trial registration ClinicalTrials.gov Identifier: NCT02890160 and NCT03660202. |
| format | Article |
| id | doaj-art-2bbc5e3342aa4e318ac650625d5d5d64 |
| institution | Kabale University |
| issn | 1741-7015 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
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| series | BMC Medicine |
| spelling | doaj-art-2bbc5e3342aa4e318ac650625d5d5d642025-08-20T03:46:09ZengBMCBMC Medicine1741-70152025-07-0123111010.1186/s12916-025-04254-0Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomesJun Jiang0Changling Li1Delong Chen2Lei Song3Zhanqian Cui4Ping Li5Lijun Gan6Yundai Chen7Hui Li8Shaobin Jia9Shenghu He10Wen Lu11Runlin Gao12Jianan Wang13on behalf of the FUTURE III InvestigatorsDepartment of Cardiology, The Second Affiliated Hospital, Zhejiang University School of MedicineDepartment of Cardiology, The Second Affiliated Hospital, Zhejiang University School of MedicineDepartment of Cardiology, The Second Affiliated Hospital, Zhejiang University School of MedicineDepartment of Cardiology, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeDepartment of Cardiology, Inner Mongolia Autonomous Region People’s HospitalDepartment of Cardiology, The First People’s Hospital of YulinDepartment of Cardiology, Affiliated Hospital of Jining Medical UniversityDepartment of Cardiology, Chinese PLA General HospitalDepartment of Cardiology, Daqing Oilfield General HospitalDepartment of Cardiology, General Hospital of Ningxia Medical UniversityDepartment of Cardiology, Northern Jiangsu People’s HospitalDepartment of Cardiology, Xuzhou Central HospitalDepartment of Cardiology, National Center for Cardiovascular Diseases, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeDepartment of Cardiology, The Second Affiliated Hospital, Zhejiang University School of MedicineAbstract Background The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolimus-eluting Firesorb BRS in patients with de novo coronary lesions. Methods Patient-level data derived from 1205 patients in the FUTURE-II RCT (n = 215) and FUTURE-III registry (n = 990) were prospectively collected, pooled, and analyzed. The primary endpoint of 1-year target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization was also analyzed. Results At 1-year follow-up, the cumulative rate of TLF was 1.67%, with an upper 95% confidence interval of 2.57%, significantly lower than the objective performance criterion goal of 6.6% (P < 0.001). The rate of single TLF components was 0.42% for cardiac death, 0.92% for target vessel myocardial infarction, and 0.42% for ischemia-driven target lesion revascularization. The cumulative rate of POCE at 1 year was 3.34%. No patient experienced definite or probable device thrombosis during 1-year follow-up. Conclusions This pooled, patient-level analysis indicates that the thinner strut Firesorb BRS exhibits promising 1-year efficacy and safety profiles with regard to TLF. However, our findings are only applicable to non-complex lesions; large-scale randomized clinical trials powered to assess clinical endpoints are necessary to evaluate the strategy of Firesorb BRS compared to drug-eluting stents. Trial registration ClinicalTrials.gov Identifier: NCT02890160 and NCT03660202.https://doi.org/10.1186/s12916-025-04254-0Bioresorbable scaffoldsCoronary artery diseasesPercutaneous coronary interventionTarget lesion failure |
| spellingShingle | Jun Jiang Changling Li Delong Chen Lei Song Zhanqian Cui Ping Li Lijun Gan Yundai Chen Hui Li Shaobin Jia Shenghu He Wen Lu Runlin Gao Jianan Wang on behalf of the FUTURE III Investigators Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes BMC Medicine Bioresorbable scaffolds Coronary artery diseases Percutaneous coronary intervention Target lesion failure |
| title | Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes |
| title_full | Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes |
| title_fullStr | Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes |
| title_full_unstemmed | Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes |
| title_short | Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes |
| title_sort | firesorb bioresorbable scaffold for de novo coronary artery disease 1 year clinical outcomes |
| topic | Bioresorbable scaffolds Coronary artery diseases Percutaneous coronary intervention Target lesion failure |
| url | https://doi.org/10.1186/s12916-025-04254-0 |
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