Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions: A post-hoc analysis of a randomized trial

Maik J. Grundeken, Yuki Ishibashi, Philippe Genereux, Laura Lasalle, Javaid Iqbal, Joanna J. Wykrzykowska, Marie Angèle Morel, Jan G. Tijssen, Robbert J. De Winter, Chrysafios Girasis, Hector M. Garcia-Garcia, Yoshinobu Onuma, Martin B. Leon, Patrick W. Serruys

Research output: Contribution to journalArticle

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Abstract

Objectives This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. Background QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis. Methods The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort. Results In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: -26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: -16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340). Conclusions Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

Original languageEnglish (US)
Pages (from-to)305-314
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume8
Issue number2
DOIs
StatePublished - Feb 1 2015
Externally publishedYes

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Coronary Angiography
Stents
Balloon Angioplasty
Pathologic Constriction
Therapeutics
Safety
Research

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Grundeken, Maik J. ; Ishibashi, Yuki ; Genereux, Philippe ; Lasalle, Laura ; Iqbal, Javaid ; Wykrzykowska, Joanna J. ; Morel, Marie Angèle ; Tijssen, Jan G. ; De Winter, Robbert J. ; Girasis, Chrysafios ; Garcia-Garcia, Hector M. ; Onuma, Yoshinobu ; Leon, Martin B. ; Serruys, Patrick W. / Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions : A post-hoc analysis of a randomized trial. In: JACC: Cardiovascular Interventions. 2015 ; Vol. 8, No. 2. pp. 305-314.
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title = "Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions: A post-hoc analysis of a randomized trial",
abstract = "Objectives This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. Background QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis. Methods The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort. Results In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95{\%} limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis ({\%}DS) of the side branch, was 5.5{\%} (95{\%} limits of agreement: -26.7{\%} to 37.8{\%}). After reanalysis, the bias of the in-segment {\%}DS of the side branch reduced to 1.8{\%} (95{\%} limits of agreement: -16.7{\%} to 20.4{\%}). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups ({\%}DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4{\%} vs. 32.4 ± 16.1{\%}, p = 0.340). Conclusions Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)",
author = "Grundeken, {Maik J.} and Yuki Ishibashi and Philippe Genereux and Laura Lasalle and Javaid Iqbal and Wykrzykowska, {Joanna J.} and Morel, {Marie Ang{\`e}le} and Tijssen, {Jan G.} and {De Winter}, {Robbert J.} and Chrysafios Girasis and Garcia-Garcia, {Hector M.} and Yoshinobu Onuma and Leon, {Martin B.} and Serruys, {Patrick W.}",
year = "2015",
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doi = "10.1016/j.jcin.2014.12.002",
language = "English (US)",
volume = "8",
pages = "305--314",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
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Grundeken, MJ, Ishibashi, Y, Genereux, P, Lasalle, L, Iqbal, J, Wykrzykowska, JJ, Morel, MA, Tijssen, JG, De Winter, RJ, Girasis, C, Garcia-Garcia, HM, Onuma, Y, Leon, MB & Serruys, PW 2015, 'Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions: A post-hoc analysis of a randomized trial', JACC: Cardiovascular Interventions, vol. 8, no. 2, pp. 305-314. https://doi.org/10.1016/j.jcin.2014.12.002

Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions : A post-hoc analysis of a randomized trial. / Grundeken, Maik J.; Ishibashi, Yuki; Genereux, Philippe; Lasalle, Laura; Iqbal, Javaid; Wykrzykowska, Joanna J.; Morel, Marie Angèle; Tijssen, Jan G.; De Winter, Robbert J.; Girasis, Chrysafios; Garcia-Garcia, Hector M.; Onuma, Yoshinobu; Leon, Martin B.; Serruys, Patrick W.

In: JACC: Cardiovascular Interventions, Vol. 8, No. 2, 01.02.2015, p. 305-314.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions

T2 - A post-hoc analysis of a randomized trial

AU - Grundeken, Maik J.

AU - Ishibashi, Yuki

AU - Genereux, Philippe

AU - Lasalle, Laura

AU - Iqbal, Javaid

AU - Wykrzykowska, Joanna J.

AU - Morel, Marie Angèle

AU - Tijssen, Jan G.

AU - De Winter, Robbert J.

AU - Girasis, Chrysafios

AU - Garcia-Garcia, Hector M.

AU - Onuma, Yoshinobu

AU - Leon, Martin B.

AU - Serruys, Patrick W.

PY - 2015/2/1

Y1 - 2015/2/1

N2 - Objectives This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. Background QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis. Methods The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort. Results In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: -26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: -16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340). Conclusions Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

AB - Objectives This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. Background QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis. Methods The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort. Results In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: -26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: -16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340). Conclusions Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

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