title: Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial.
abstract: 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.
  
  
  OBJECTIVE
  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).
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. Electronic address: gaorunlin@citmd.com.
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Cardiology, Chinese PLA 252 Hospital, Baoding, China.
authors.forename: Xuebin
authors.initials: X
authors.lastname: Cao
authors.affiliation: Department of Cardiology, Kaifeng Central Hospital, Kaifeng, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Qin
authors.affiliation: Department of Cardiology, Yunnan St. John's Hospital, Kunming, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China.
authors.forename: Zhanquan
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Cardiology, The Fourth Affiliated Hospital of Haerbin Medical University, Haerbin, China.
authors.forename: Xueqi
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Cardiology, Dalian Municipal Central Hospital, Dalian, China.
authors.forename: Hailong
authors.initials: H
authors.lastname: Lin
authors.affiliation: Department of Cardiology, Dazhou Central Hospital, Dazhou, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Guo
authors.affiliation: Department of Cardiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
authors.forename: Yitong
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Department of Cardiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Jian'an
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.
authors.forename: Shaoping
authors.initials: S
authors.lastname: Nie
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Liang
authors.initials: L
authors.lastname: Xu
authors.affiliation: Research and Development Sino Medical, Tianjin, China.
authors.forename: Eric
authors.initials: E
authors.lastname: Cao
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Changdong
authors.initials: C
authors.lastname: Guan
authors.affiliation: Department of Medicine, Columbia University Medical Center, New York-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D020341:Absorbable Implants; D003324:Coronary Artery Disease / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention; D011091:Polyesters / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus; D013927:Thrombosis / Q000209:etiology
chemical_list: D011091:Polyesters; D011108:Polymers; C033616:poly(lactide); D020123:Sirolimus
keywords: coronary artery disease; drug-eluting stents; randomized controlled trial; thrombosis