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Two-year safety evaluation of a biodegradable polymer sirolimus-eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort

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机构: [1]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China [2]Department of Cardiology, Chinese PLA 252 Hospital, Baoding, China [3]Department of Cardiology, Kaifeng Central Hospital, Kaifeng, China [4]Department of Cardiology, Yunnan St. John's Hospital, Kunming, China [5]Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China [6]Department of Cardiology, Affiliated Anzhen Hospital of CapitalMedical University, Beijing, China [7]Department of Statistical Analysis, China Cardiovascular Research Foundation Inc, Beijing, China [8]Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands
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关键词: clinical outcome drug eluting stent randomized controlled trial

摘要:
Objectives: The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions. Background: The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF). Methods: In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients. Results: Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01). Conclusions: Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population. Clinical Trial: ClinicalTrial.gov, Identifier—NCT02017275. © 2019 Wiley Periodicals, Inc.

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出版当年[2018]版:
大类 | 3 区 医学
小类 | 4 区 心脏和心血管系统
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
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出版当年[2017]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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第一作者机构: [1]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
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通讯机构: [1]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China [*1]Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167, Beilishi Road, Xicheng District, Beijing, 100037, China. [*2]Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167, Beilishi Road, Xicheng District, Beijing, 100037, China.
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