The East–West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts

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

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to be generalizable across jurisdictions and geographies. The objectives were to assess the comparability of in-segment LLL in Eastern and Western DES populations using the world's largest compilation of follow-up quantitative coronary angiography data. Methods: Data from 4 manufacturers involving 29 DES clinical trials in Eastern and Western hemispheres were compiled. “East” and “West” cohorts were defined by trial location. Independent core laboratories quantified in-segment LLL for all studies. East and West were compared before and after adjustment for clinical and anatomic covariates known to correlate with LLL via conditioning on propensity score quintiles. An international panel of experts and regulators prospectively established a clinically meaningful difference between East and West mean in-segment LLL of ±0.40 mm. Results: The data set comprised 2,047 East and 4,456 West patients. Unadjusted mean ± SD for West and East in-segment LLL (mm) was 0.25 ± 0.46 and 0.12 ± 0.42, respectively (difference 0.13 mm; 95% CI 0.11-0.16). Propensity score–adjusted in-segment LLL East and West least squares means were 0.11 and 0.26 mm, respectively (difference 0.15 mm; 95% CI 0.13-0.18). Conclusions: In the world's largest compilation of DES protocol 8- to 13-month angiographic follow-up data, clinically meaningful comparability of in-segment LLL by independent core laboratory quantitative coronary angiography in East and West cohorts was demonstrated in both unadjusted and adjusted comparisons. These findings suggest that DES LLL, once characterized, could be generalized across regulatory jurisdictions over the course of global registration efforts.

Original languageEnglish (US)
Pages (from-to)61-71
Number of pages11
JournalAmerican Heart Journal
Volume206
DOIs
StatePublished - Dec 1 2018
Externally publishedYes

Fingerprint

Drug-Eluting Stents
Cohort Studies
Coronary Angiography
Device Approval
Protective Devices
Propensity Score
Geography
Patient Safety
Least-Squares Analysis
Clinical Trials
Population

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Harrison, Robert W. ; Radhakrishnan, Vaishnavi ; Allen, John C. ; Lam, Peter S. ; Allocco, Dominic J. ; Brar, Sandeep ; Fahy, Martin ; Zhang, Zhen ; Fisher, Rebecca ; Ikeno, Fumiaki ; Généreux, Philippe ; Kimura, Takeshi ; Liu, Minglei ; Lye, Weng Kit ; Nagai, Hirofumi ; Suzuki, Yuka ; White, Roseann ; Krucoff, Mitchell W. / The East–West late lumen loss study : Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts. In: American Heart Journal. 2018 ; Vol. 206. pp. 61-71.
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title = "The East–West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts",
abstract = "Background: Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to be generalizable across jurisdictions and geographies. The objectives were to assess the comparability of in-segment LLL in Eastern and Western DES populations using the world's largest compilation of follow-up quantitative coronary angiography data. Methods: Data from 4 manufacturers involving 29 DES clinical trials in Eastern and Western hemispheres were compiled. “East” and “West” cohorts were defined by trial location. Independent core laboratories quantified in-segment LLL for all studies. East and West were compared before and after adjustment for clinical and anatomic covariates known to correlate with LLL via conditioning on propensity score quintiles. An international panel of experts and regulators prospectively established a clinically meaningful difference between East and West mean in-segment LLL of ±0.40 mm. Results: The data set comprised 2,047 East and 4,456 West patients. Unadjusted mean ± SD for West and East in-segment LLL (mm) was 0.25 ± 0.46 and 0.12 ± 0.42, respectively (difference 0.13 mm; 95{\%} CI 0.11-0.16). Propensity score–adjusted in-segment LLL East and West least squares means were 0.11 and 0.26 mm, respectively (difference 0.15 mm; 95{\%} CI 0.13-0.18). Conclusions: In the world's largest compilation of DES protocol 8- to 13-month angiographic follow-up data, clinically meaningful comparability of in-segment LLL by independent core laboratory quantitative coronary angiography in East and West cohorts was demonstrated in both unadjusted and adjusted comparisons. These findings suggest that DES LLL, once characterized, could be generalized across regulatory jurisdictions over the course of global registration efforts.",
author = "Harrison, {Robert W.} and Vaishnavi Radhakrishnan and Allen, {John C.} and Lam, {Peter S.} and Allocco, {Dominic J.} and Sandeep Brar and Martin Fahy and Zhen Zhang and Rebecca Fisher and Fumiaki Ikeno and Philippe G{\'e}n{\'e}reux and Takeshi Kimura and Minglei Liu and Lye, {Weng Kit} and Hirofumi Nagai and Yuka Suzuki and Roseann White and Krucoff, {Mitchell W.}",
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Harrison, RW, Radhakrishnan, V, Allen, JC, Lam, PS, Allocco, DJ, Brar, S, Fahy, M, Zhang, Z, Fisher, R, Ikeno, F, Généreux, P, Kimura, T, Liu, M, Lye, WK, Nagai, H, Suzuki, Y, White, R & Krucoff, MW 2018, 'The East–West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts', American Heart Journal, vol. 206, pp. 61-71. https://doi.org/10.1016/j.ahj.2018.08.017

The East–West late lumen loss study : Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts. / Harrison, Robert W.; Radhakrishnan, Vaishnavi; Allen, John C.; Lam, Peter S.; Allocco, Dominic J.; Brar, Sandeep; Fahy, Martin; Zhang, Zhen; Fisher, Rebecca; Ikeno, Fumiaki; Généreux, Philippe; Kimura, Takeshi; Liu, Minglei; Lye, Weng Kit; Nagai, Hirofumi; Suzuki, Yuka; White, Roseann; Krucoff, Mitchell W.

In: American Heart Journal, Vol. 206, 01.12.2018, p. 61-71.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The East–West late lumen loss study

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

AU - Harrison, Robert W.

AU - Radhakrishnan, Vaishnavi

AU - Allen, John C.

AU - Lam, Peter S.

AU - Allocco, Dominic J.

AU - Brar, Sandeep

AU - Fahy, Martin

AU - Zhang, Zhen

AU - Fisher, Rebecca

AU - Ikeno, Fumiaki

AU - Généreux, Philippe

AU - Kimura, Takeshi

AU - Liu, Minglei

AU - Lye, Weng Kit

AU - Nagai, Hirofumi

AU - Suzuki, Yuka

AU - White, Roseann

AU - Krucoff, Mitchell W.

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Background: Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to be generalizable across jurisdictions and geographies. The objectives were to assess the comparability of in-segment LLL in Eastern and Western DES populations using the world's largest compilation of follow-up quantitative coronary angiography data. Methods: Data from 4 manufacturers involving 29 DES clinical trials in Eastern and Western hemispheres were compiled. “East” and “West” cohorts were defined by trial location. Independent core laboratories quantified in-segment LLL for all studies. East and West were compared before and after adjustment for clinical and anatomic covariates known to correlate with LLL via conditioning on propensity score quintiles. An international panel of experts and regulators prospectively established a clinically meaningful difference between East and West mean in-segment LLL of ±0.40 mm. Results: The data set comprised 2,047 East and 4,456 West patients. Unadjusted mean ± SD for West and East in-segment LLL (mm) was 0.25 ± 0.46 and 0.12 ± 0.42, respectively (difference 0.13 mm; 95% CI 0.11-0.16). Propensity score–adjusted in-segment LLL East and West least squares means were 0.11 and 0.26 mm, respectively (difference 0.15 mm; 95% CI 0.13-0.18). Conclusions: In the world's largest compilation of DES protocol 8- to 13-month angiographic follow-up data, clinically meaningful comparability of in-segment LLL by independent core laboratory quantitative coronary angiography in East and West cohorts was demonstrated in both unadjusted and adjusted comparisons. These findings suggest that DES LLL, once characterized, could be generalized across regulatory jurisdictions over the course of global registration efforts.

AB - Background: Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to be generalizable across jurisdictions and geographies. The objectives were to assess the comparability of in-segment LLL in Eastern and Western DES populations using the world's largest compilation of follow-up quantitative coronary angiography data. Methods: Data from 4 manufacturers involving 29 DES clinical trials in Eastern and Western hemispheres were compiled. “East” and “West” cohorts were defined by trial location. Independent core laboratories quantified in-segment LLL for all studies. East and West were compared before and after adjustment for clinical and anatomic covariates known to correlate with LLL via conditioning on propensity score quintiles. An international panel of experts and regulators prospectively established a clinically meaningful difference between East and West mean in-segment LLL of ±0.40 mm. Results: The data set comprised 2,047 East and 4,456 West patients. Unadjusted mean ± SD for West and East in-segment LLL (mm) was 0.25 ± 0.46 and 0.12 ± 0.42, respectively (difference 0.13 mm; 95% CI 0.11-0.16). Propensity score–adjusted in-segment LLL East and West least squares means were 0.11 and 0.26 mm, respectively (difference 0.15 mm; 95% CI 0.13-0.18). Conclusions: In the world's largest compilation of DES protocol 8- to 13-month angiographic follow-up data, clinically meaningful comparability of in-segment LLL by independent core laboratory quantitative coronary angiography in East and West cohorts was demonstrated in both unadjusted and adjusted comparisons. These findings suggest that DES LLL, once characterized, could be generalized across regulatory jurisdictions over the course of global registration efforts.

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