title: Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial.
abstract: BACKGROUND
  The everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are noninferior to current-generation drug-eluting stents has not been established.
  
  
  OBJECTIVE
  This study sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China.
  
  
  METHODS
  Eligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in a 1:1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for noninferiority with a margin of 0.15 mm.
  
  
  RESULTS
  A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device success (98.0% vs. 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES-treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 ± 0.38 mm for BVS versus 0.13 ± 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (pnoninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0%, respectively; p = 1.00).
  
  
  CONCLUSIONS
  In the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year. (A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT]; NCT01923740).
authors.affiliation: 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: 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: General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Huo
authors.affiliation: Guangdong General Hospital, Guangzhou, China.
authors.forename: Jiyan
authors.initials: J
authors.lastname: Chen
authors.affiliation: The 2nd Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia of Chinese Ministry of Education, Harbin, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Yu
authors.affiliation: Wuhan Asia Heart Hospital, Wuhan, China.
authors.forename: Xi
authors.initials: X
authors.lastname: Su
authors.affiliation: The 1st Affiliated Hospital of Guangxi Medical University, Nanning, China.
authors.forename: Lang
authors.initials: L
authors.lastname: Li
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Hai-Chien
authors.initials: HC
authors.lastname: Kuo
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Shih-Wa
authors.initials: SW
authors.lastname: Ying
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Wai-Fung
authors.initials: WF
authors.lastname: Cheong
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Yunlong
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Xiaolu
authors.initials: X
authors.lastname: Su
authors.affiliation: 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: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffery J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: 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 / Q000592:standards* / Q000639:trends; D000368:Aged; D002681:China / Q000453:epidemiology; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000601:surgery*; D054855:Drug-Eluting Stents / Q000592:standards* / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals / Q000592:standards*; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D015607:Stents / Q000592:standards / Q000639:trends; D054457:Tissue Scaffolds / Q000592:standards* / Q000639:trends; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: bioresorbable vascular scaffold; everolimus; randomized controlled trial; stent