Abstract
To assess the validity of locally performed off-line quantitative coronary angiography (QCA) measurement in clinical trials, we carried out a comparative study between on-site QCA analysis and analysis performed at an independent external core laboratory. One local operator analyzed the pre, post and follow-up angiograms of 116 patients participating in the Stenting in Small Coronary Arteries Study (SISCA) prior to final QCA analysis in the core laboratory. The mean values of the reference diameter (RD), minimal lumen diameter (MLD) and diameter stenosis (DS) showed acceptable agreement between study site and core laboratory. However, on the level of individuals the interobserver differences were large, affecting the outcome of restenosis rate significantly, and in a such way that the conclusions in the SISCA trial might have come out differently if a core laboratory had not been used. This emphasizes the importance of using independent core laboratories in coronary interventional trials.
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References
Scanlon PJ, Faxon DP, Audet AM, et al. ACC/AHA guidelines for coronary angiography. A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on Coronary Angiography). Developed in collaboration with the Society for Cardiac Angiography and Interventions. J Am Coll Cardiol 1999; 33: 1756–1824.
Moer R, Myreng Y, Molstad P, et al. Stenting in small coronary arteries (SISCA) trial. A randomized comparison between balloon angioplasty and the heparin-coated beStent. J Am Coll Cardiol 2001; 38: 1598–1603.
Hausleiter J, Nolte CW, Jost S, Wiese B, Sturm M, Lichtlen PR. Comparison of different quantitative coronary analysis systems: ARTREK, CAAS, and CMS. Cathet Cardiovasc Diagn 1996; 37: 14–22.
Reimers B, di Mario C, Di Francesco L, et al. New approach to quantitative angiographic assessment after stent implantation. Cathet Cardiovasc Diagn 1997; 40: 343–347.
Van Weert AW, Lesperance J, Reiber JH. Standardization of central off-line quantitative image analysis: implications from experiences with quantitative coronary angiography. Heart Drug 2001; 1: 44–51.
Tuinenburg JC, Koning G, Hekking E, et al. One core laboratory at two international sites, is that feasible? An inter-core laboratory and intra-observer variability study. Catheter Cardiovasc Interv 2002; 56: 333–340.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1: 307–310.
Reiber JHC, Serruys PW, Kooijman CJ, et al. Assessment of short-, medium-, and long term variations in arterial dimensions from computer-assisted quantitation of coronary cineangiograms. Circulation 1985; 71: 280–288.
Sirnes PA, Myreng Y, Molstad P, Golf S. Reproducibility of quantitative coronary analysis, Assessment of variability due to frame selection, different observers, and different cinefilmless laboratories. Int J Card Imaging 1996; 12: 197–203.
Beauman GJ, Reiber JH, Koning G, Van Houdt RCM, Vogel R. Angiographic core laboratories analyses of arterial phantom images: comparative evaluations of accuracy and precision. In: Reiber JH, Serruys P, editors. Progress in Quantitative Coronary Angiography, 1994 ed. Dordrecht: Kluwer Academic Publishers, 1994; p. 87–104.
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Moer, R., van Weert, A.W., Myreng, Y. et al. Variability of quantitative coronary angiography: an evaluation of on-site versus core laboratory analysis. Int J Cardiovasc Imaging 19, 457–464 (2003). https://doi.org/10.1023/B:CAIM.0000004327.52633.d2
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DOI: https://doi.org/10.1023/B:CAIM.0000004327.52633.d2