title: Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.
abstract: BACKGROUND
  The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, whereas understanding their comparability across geographic populations could enhance global DES evaluation.
  
  
  OBJECTIVE
  The East-West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss, as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8-13 months of follow-up.
  
  
  METHODS
  Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow-up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements.
  
  
  CONCLUSIONS
  Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow-up for novel stent designs.
authors.affiliation: Duke University Medical Center/Duke Clinical Research Institute, Durham, NC. Electronic address: robert.w.harrison@duke.edu.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Harrison
authors.affiliation: Duke-NUS Graduate Medical School Singapore, Singapore.
authors.forename: Vaishnavi
authors.initials: V
authors.lastname: Radhakrishnan
authors.affiliation: Boston Scientific, Marlborough, MA.
authors.forename: Peter S
authors.initials: PS
authors.lastname: Lam
authors.affiliation: Boston Scientific, Marlborough, MA.
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.affiliation: Medtronic, Inc., Santa Rosa, CA.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Brar
authors.affiliation: Medtronic, Inc., Santa Rosa, CA.
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.affiliation: Duke University Medical Center/Duke Clinical Research Institute, Durham, NC.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Fisher
authors.affiliation: Stanford University, Stanford, CA.
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Ikeno
authors.affiliation: Cardiovascular Research Foundation, New York, NY.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: Kyoto University, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.affiliation: Medtronic, Inc., Santa Rosa, CA.
authors.forename: Minglei
authors.initials: M
authors.lastname: Liu
authors.affiliation: Duke-NUS Graduate Medical School Singapore, Singapore.
authors.forename: Weng Kit
authors.initials: WK
authors.lastname: Lye
authors.affiliation: Cardiovascular Research Foundation, New York, NY.
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.affiliation: Terumo Corporation, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Nagai
authors.affiliation: Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Yuka
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: Abbott Vascular, Santa Clara, CA.
authors.forename: Roseann
authors.initials: R
authors.lastname: White
authors.affiliation: Duke-NUS Graduate Medical School Singapore, Singapore.
authors.forename: John C
authors.initials: JC
authors.lastname: Allen
authors.affiliation: Duke University Medical Center/Duke Clinical Research Institute, Durham, NC.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy; D023903:Coronary Restenosis / Q000175:diagnosis / Q000208:ethnology / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000592:standards; D019544:Equipment Failure Analysis / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D064887:Observational Studies as Topic; D010043:Outcome and Process Assessment, Health Care / Q000379:methods; D057216:Propensity Score; D011475:Prosthesis Failure / Q000009:adverse effects / Q000209:etiology; D044469:Racial Groups / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies