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

Robert W. Harrison, Vaishnavi Radhakrishnan, Peter S. Lam, Dominic J. Allocco, Sandeep Brar, Martin Fahy, Rebecca Fisher, Fumiaki Ikeno, Philippe Genereux, Takeshi Kimura, Minglei Liu, Weng Kit Lye, Gary S. Mintz, Hirofumi Nagai, Yuka Suzuki, Roseann White, John C. Allen, Mitchell W. Krucoff

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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. Conclusion 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.

Original languageEnglish (US)
Pages (from-to)103-110
Number of pages8
JournalAmerican Heart Journal
Volume182
DOIs
StatePublished - Dec 1 2016
Externally publishedYes

Fingerprint

Drug-Eluting Stents
Cohort Studies
Coronary Angiography
Stents
Angiography
Population
Propensity Score
Geography
Clinical Protocols
Documentation
Hyperplasia
Biomarkers
Observation
Clinical Trials
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Harrison, Robert W. ; Radhakrishnan, Vaishnavi ; Lam, Peter S. ; Allocco, Dominic J. ; Brar, Sandeep ; Fahy, Martin ; Fisher, Rebecca ; Ikeno, Fumiaki ; Genereux, Philippe ; Kimura, Takeshi ; Liu, Minglei ; Lye, Weng Kit ; Mintz, Gary S. ; Nagai, Hirofumi ; Suzuki, Yuka ; White, Roseann ; Allen, John C. ; Krucoff, Mitchell W. / 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. In: American Heart Journal. 2016 ; Vol. 182. pp. 103-110.
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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 = "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. Conclusion 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.",
author = "Harrison, {Robert W.} and Vaishnavi Radhakrishnan and Lam, {Peter S.} and Allocco, {Dominic J.} and Sandeep Brar and Martin Fahy and Rebecca Fisher and Fumiaki Ikeno and Philippe Genereux and Takeshi Kimura and Minglei Liu and Lye, {Weng Kit} and Mintz, {Gary S.} and Hirofumi Nagai and Yuka Suzuki and Roseann White and Allen, {John C.} and Krucoff, {Mitchell W.}",
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Harrison, RW, Radhakrishnan, V, Lam, PS, Allocco, DJ, Brar, S, Fahy, M, Fisher, R, Ikeno, F, Genereux, P, Kimura, T, Liu, M, Lye, WK, Mintz, GS, Nagai, H, Suzuki, Y, White, R, Allen, JC & Krucoff, MW 2016, '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', American Heart Journal, vol. 182, pp. 103-110. https://doi.org/10.1016/j.ahj.2016.07.011

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. / Harrison, Robert W.; Radhakrishnan, Vaishnavi; Lam, Peter S.; Allocco, Dominic J.; Brar, Sandeep; Fahy, Martin; Fisher, Rebecca; Ikeno, Fumiaki; Genereux, Philippe; Kimura, Takeshi; Liu, Minglei; Lye, Weng Kit; Mintz, Gary S.; Nagai, Hirofumi; Suzuki, Yuka; White, Roseann; Allen, John C.; Krucoff, Mitchell W.

In: American Heart Journal, Vol. 182, 01.12.2016, p. 103-110.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rationale and design of the East-West late lumen loss study

T2 - Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts

AU - Harrison, Robert W.

AU - Radhakrishnan, Vaishnavi

AU - Lam, Peter S.

AU - Allocco, Dominic J.

AU - Brar, Sandeep

AU - Fahy, Martin

AU - Fisher, Rebecca

AU - Ikeno, Fumiaki

AU - Genereux, Philippe

AU - Kimura, Takeshi

AU - Liu, Minglei

AU - Lye, Weng Kit

AU - Mintz, Gary S.

AU - Nagai, Hirofumi

AU - Suzuki, Yuka

AU - White, Roseann

AU - Allen, John C.

AU - Krucoff, Mitchell W.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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. Conclusion 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.

AB - 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. Conclusion 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.

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