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Biodegradable Polymer-Based Sirolimus-Eluting Stents with Differing Elution and Absorption Kinetics the PANDA III Trial

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机构: [a]Department of Cardiology, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, A 167, Beilishi Road, Beijing, 100037, China [b]Department of Cardiology, Chinese PLA 252 Hospital, Baoding, China [c]Department of Cardiology, Kaifeng Central Hospital, Kaifeng, China [d]Department of Cardiology, Yunnan St. John's Hospital, Kunming, China [e]Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China [f]Department of Cardiology, Fourth Affiliated Hospital of Haerbin Medical University, Haerbin, China [g]Department of Cardiology, Dalian Municipal Central Hospital, Dalian, China [h]Department of Cardiology, Dazhou Central Hospital, Dazhou, China [i]Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China [j]Department of Cardiology, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [k]Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China [l]Research and Development Sino Medical, Tianjin, China [m]Department of Medicine, Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY, United States
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关键词: coronary artery disease drug-eluting stents randomized controlled trial thrombosis

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Background Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics. Objectives The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population. Methods PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048). Conclusions The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275) © 2016 American College of Cardiology Foundation.

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出版当年[2015]版:
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
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出版当年[2014]版:
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

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