+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

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

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

Jacc. Cardiovascular Interventions 8(2): 305-314

This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis. 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. 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). 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).

Please choose payment method:

(PDF emailed within 0-6 h: $19.90)

Accession: 058133728

Download citation: RISBibTeXText

PMID: 25700754

DOI: 10.1016/j.jcin.2014.12.002

Related references

Comparison between two- and three-dimensional quantitative coronary angiography bifurcation analyses for the assessment of bifurcation lesions: A subanalysis of the TRYTON pivotal IDE coronary bifurcation trial. Catheterization and Cardiovascular Interventions 86(3): E140-E149, 2016

Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI). Jacc. Cardiovascular Interventions 8(4): 536-546, 2016

Segmental comparison between a dedicated bifurcation stent and balloon angioplasty using intravascular ultrasound and three-dimensional quantitative coronary angiography: A subgroup analysis of the Tryton IDE randomized trial. Catheterization and Cardiovascular Interventions 89(2): E53-E63, 2016

The need for dedicated bifurcation quantitative coronary angiography (QCA) software algorithms to evaluate bifurcation lesions. Eurointervention 11 Suppl V: V44-V49, 2016

Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions. Eurointervention 3(5): 546-552, 2008

A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. Journal of the American College of Cardiology 65(6): 533-543, 2015

Diagnostic accuracy in coronary stenosis: comparison between visual score and quantitative analysis (quantitative computed tomographic angiography) in coronary angiography by multidetector computed tomography-coronary angiography and quantitative analysis (quantitative coronary angiography) in conventional coronary angiography. Journal of Computer Assisted Tomography 34(5): 652-659, 2010

Comparison between two-dimensional and three-dimensional quantitative coronary angiography for the prediction of functional severity in true bifurcation lesions: Insights from the randomized DK-CRUSH II, III, and IV trials. Catheterization and Cardiovascular Interventions 87 Suppl 1: 589-598, 2016

Variability of quantitative coronary angiography: an evaluation of on-site versus core laboratory analysis. International Journal of Cardiovascular Imaging 19(6): 457-464, 2003

Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation 121(10): 1235-1243, 2010

A comparison of the distribution of necrotic core in bifurcation and non-bifurcation coronary lesions: an in vivo assessment using intravascular ultrasound radiofrequency data analysis. Eurointervention 6(3): 321-327, 2011

Randomized comparison of conservative versus aggressive strategy for provisional side branch intervention in coronary bifurcation lesions: results from the SMART-STRATEGY (Smart Angioplasty Research Team-Optimal Strategy for Side Branch Intervention in Coronary Bifurcation Lesions) randomized trial. Jacc. Cardiovascular Interventions 5(11): 1133-1140, 2013

Comparison of two and three dimensional quantitative coronary angiography to intravascular ultrasound in the assessment of left main coronary artery bifurcation lesions. Chinese Medical Journal 127(6): 1012-1021, 2015

A Y-shaped bifurcation-dedicated stent for the treatment of de novo coronary bifurcation lesions: an IVUS analysis from the BRANCH trial. Eurointervention 10(11): E1-E8, 2015

Interventional therapy of bifurcation lesions: a TIMI flow-guided concept to treat side branches in bifurcation lesions--a prospective randomized clinical study (Thueringer bifurcation study, THUEBIS study as pilot trial). Circulation. Cardiovascular Interventions 2(6): 535-542, 2010