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Low Resolution Limits and Inaccurate Algorithms Decrease Significantly the Value of Late Loss in Current Drug-Eluting Stent Trials

DOI: 10.1155/2012/417250

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Abstract:

Quantitative coronary and vascular angiography (QCA resp., QVA) remains the current gold standard for evaluation of restenosis. Late loss as one of the most commonly accepted parameters to highlight efficacy of the various devices has shown high correlation to clinical parameters but, surprisingly, has no impact on the evaluation of the remaining amount of restenostic tissue. The current clinical practice leads to unrealistic late loss calculations. Smaller late loss differences are usually not greater than the inherited resolution limits of QCA, which is especially the case in small differences between the various stents in the drug-eluting stent era. Late loss include additional systematic and random errors, due to the fact that measurements were taken at two different time points including the inherited resolution and calibration limits of QCA on two occasions. Due to the limited value of late loss in discriminating the small differences between the one and other DES, late lumen area loss and clearly defined calculation algorithms (e.g., MLD-relocation) should be used in future DES studies also to fulfill the more stringent regulatory requirements. 1. Text Endovascular therapy is a rapidly evolving field for the treatment of patients with peripheral arterial occlusive disease (PAOD) or coronary artery disease (CAD), and a magnitude of studies on technical improvements and innovative developments have been published during the last 15 to 20 years. Studies assessing endovascular therapy of peripheral or coronary arteries are tending to hover however on uniformly defined clinical and QCA-derived endpoints, which became clinical practice on the basis of positive correlations to clinical parameters over the last years. Although these QCA-derived parameters were predominantly used to reflect on the neointimal process and to predict restenosis, their values were never evaluated or validated independently. Unfortunately, in order to provide a comparison with the already published studies, most of the subsequently conducted studies used exactly the same QCA-derived study endpoints. Moreover, because the guideline-relevant studies are frequently based on exactly these QCA-derived study endpoints, not only the outcomes of the studies but also the guidelines themselves could therefore be biased by the limitations of these surrogate parameters described in this paper. In this paper we highlight the algorithm and limitations of late loss as one of the most frequently used QCA-derived surrogate study endpoint in the description of restenosis after interventional

References

[1]  J. P. Beregi, C. Martin-Teule, S. Trogrlic, J. C. Meunier, and D. Crochet, “Quantitative angiography: state of the art for peripheral vascular applications,” Journal de Radiologie, vol. 80, no. 8, pp. 835–841, 1999.
[2]  P. W. Serruys, D. P. Foley, and P. J. de Feyter, Quantitative Coronary Angiography in Clinical Practice, Kluwer Academic, Dordrecht, The Netherlands, 1994.
[3]  M. J. Pentecost, M. H. Criqui, G. Dorros et al., “Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels,” Journal of Vascular and Interventional Radiology, vol. 14, no. 9, pp. S495–S515, 2003.
[4]  A. T. Hirsch, Z. J. Haskal, N. R. Hertzer et al., “ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional,” Journal of the American College of Cardiology, vol. 47, no. 6, pp. 1239–1312, 2006.
[5]  G. S. Mintz, M. K. Hong, A. E. Raizner et al., “Comparison of quantitative angiographic parameters with the magnitude of neointimal hyperplasia measured by volumetric intravascular ultrasound in patients treated with bare metal and nonpolymeric paclitaxel-coated stents,” American Journal of Cardiology, vol. 95, no. 1, pp. 105–107, 2005.
[6]  K. Tsuchida, H. M. García-García, A. T. L. Ong et al., “Revisiting late loss and neointimal volumetric measurement in a drug-eluting stent trial: analysis from the SPIRIT FIRST trial,” Catheterization and Cardiovascular Interventions, vol. 67, no. 2, pp. 188–197, 2006.
[7]  K. Tsuchida, P. W. Serruys, N. Bruining et al., “Two-year serial coronary angiographic and intravascular ultrasound analysis of in-stent angiographic late lumen loss and ultrasonic neointimal volume from the TAXUS II trial,” American Journal of Cardiology, vol. 99, no. 5, pp. 607–615, 2007.
[8]  S. Kasaoka, J. M. Tobis, T. Akiyama et al., “Angiographic and intravascular ultrasound predictors of in-stent restenosis,” Journal of the American College of Cardiology, vol. 32, no. 6, pp. 1630–1635, 1998.
[9]  S. A. De Winter, R. Hamers, M. Degertekin et al., “Retrospective image-based gating of intracoronary ultrasound images for improved quantitative analysis: the intelligate method,” Catheterization and Cardiovascular Interventions, vol. 61, no. 1, pp. 84–94, 2004.
[10]  C. Von Birgelen, E. A. De Vrey, G. S. Mintz et al., “ECG-gated three-dimensional intravascular ultrasound: feasibility and reproducibility of the automated analysis of coronary lumen and atherosclerotic plaque dimensions in humans,” Circulation, vol. 96, no. 9, pp. 2944–2952, 1997.
[11]  O. Semeraro, P. Agostoni, S. Verheye et al., “Re-examining minimal luminal diameter relocation and quantitative coronary angiography–intravascular ultrasound correlations in stented saphenous vein grafts: methodological insights from the randomised RRISC trial,” EuroIntervention, vol. 4, no. 5, pp. 633–640, 2009.
[12]  R. E. Kuntz, C. M. Gibson, M. Nobuyoshi, and D. S. Baim, “Generalized model of restenosis after conventional balloon angioplasty, stenting and directional atherectomy,” Journal of the American College of Cardiology, vol. 21, no. 1, pp. 15–25, 1993.
[13]  S. G. Ellis, J. J. Popma, J. M. Lasala et al., “Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: analysis from the TAXUS-IV trial,” Journal of the American College of Cardiology, vol. 45, no. 8, pp. 1193–1200, 2005.
[14]  L. Mauri, E. J. Orav, A. J. O'Malley et al., “Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents,” Circulation, vol. 111, no. 3, pp. 321–327, 2005.
[15]  P. Agostoni, M. Valgimigli, A. Abbate, J. Cosgrave, M. Pilati, and G. G. L. Biondi-Zoccai, “Is late luminal loss an accurate predictor of the clinical effectiveness of drug-eluting stents in the coronary arteries?” American Journal of Cardiology, vol. 97, no. 5, pp. 603–605, 2006.
[16]  P. Agostoni, J. Cosgrave, G. G. L. Biondi-Zoccai et al., “Angiographic analysis of pattern of late luminal loss in sirolimus- and paclitaxel-eluting stents,” American Journal of Cardiology, vol. 99, no. 5, pp. 593–598, 2007.
[17]  P. Agostoni, “Letter regarding article by Mauri et al, "late loss in lumen diameter and binary restenosis for drug-eluting stent comparison",” Circulation, vol. 112, no. 24, p. e358, 2005.
[18]  M. Sabaté, M. A. Costa, K. Kozuma et al., “Methodological and clinical implications of the relocation of the minimal luminal diameter after intracoronary radiation therapy,” Journal of the American College of Cardiology, vol. 36, no. 5, pp. 1536–1541, 2000.
[19]  M. A. Costa, M. Sabaté, D. J. Angiolillo et al., “Relocation of minimal luminal diameter after bare metal and drug-eluting stent implantation: incidence and impact on angiographic late loss,” Catheterization and Cardiovascular Interventions, vol. 69, no. 2, pp. 181–188, 2007.

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