Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients : one-year clinical and eight-month angiographic outcomes from the FIREMAN registry
BACKGROUND: Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.
METHODS: The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.
RESULTS: Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21 ± 0.40) mm in-segment and (0.23 ± 0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.
CONCLUSIONS: The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2011 |
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| Erschienen: |
2011 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:124 |
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| Enthalten in: |
Chinese medical journal - 124(2011), 6 vom: 26. März, Seite 817-24 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Li, Yan [VerfasserIn] |
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| Themen: |
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| Anmerkungen: |
Date Completed 30.09.2011 Date Revised 07.12.2022 published: Print ClinicalTrials.gov: NCT00552656 Citation Status MEDLINE |
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NLM207717702 |
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| 100 | 1 | |a Li, Yan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients |b one-year clinical and eight-month angiographic outcomes from the FIREMAN registry |
| 264 | 1 | |c 2011 | |
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| 500 | |a Date Completed 30.09.2011 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT00552656 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry | ||
| 520 | |a METHODS: The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted | ||
| 520 | |a RESULTS: Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21 ± 0.40) mm in-segment and (0.23 ± 0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST | ||
| 520 | |a CONCLUSIONS: The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656) | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Li, Cheng-xiang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Hai-chang |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Fang, Wei-yi |e verfasserin |4 aut | |
| 700 | 1 | |a Ge, Jun-bo |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Wei-min |e verfasserin |4 aut | |
| 700 | 1 | |a Qiao, Shu-bin |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jack-P |e verfasserin |4 aut | |
| 700 | 1 | |a Shen, Wen-kuang |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Cong, Hong-liang |e verfasserin |4 aut | |
| 700 | 1 | |a Pu, Xiao-qun |e verfasserin |4 aut | |
| 700 | 1 | |a Qin, Yong-wen |e verfasserin |4 aut | |
| 700 | 1 | |a Jin, Hui-gen |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, He |e verfasserin |4 aut | |
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