This Article Full Text Full Text (PDF) Data Supplement Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mauri, L. Articles by Kuntz, R. E. Search for Related Content PubMed PubMed Citation Articles by Mauri, L. Articles by Kuntz, R. E. Related Collections Restenosis Restenosis Catheter-based coronary interventions: stents

(Circulation. 2005;112:2833-2839.)
© 2005 American Heart Association, Inc.

Interventional Cardiology

Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials

Laura Mauri, MD, MSc; E. John Orav, PhD; Susana C. Candia, BSc; Donald E. Cutlip, MD; Richard E. Kuntz, MD, MSc

From the Brigham and Women’s Hospital (L.M., E.J.O., S.C.C., R.E.K.), Beth Israel Deaconess Hospital (D.E.C.), Harvard Clinical Research Institute (L.M., D.E.C., R.E.K.), and Harvard Medical School (L.M., E.J.O., D.E.C., R.E.K.), Boston, Mass.

Correspondence to Laura Mauri, MD, MSc, BC 3-012K, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02116. E-mail lmauri1{at}partners.org

Received June 25, 2005; revision received August 4, 2005; accepted August 11, 2005.

Background— Binary angiographic and clinical restenosis rates can vary widely between clinical studies, even for the same stent, influenced heavily by case-mix covariates that differ among observational and randomized trials intended to assess a given stent system. We hypothesized that mean in-stent late loss might be a more stable estimator of restenosis propensity across such studies.

Methods and Results— In 46 trials of drug-eluting and bare-metal stenting, increasing mean late loss was associated with higher target lesion revascularization (TLR) rates (P<0.001). When the class of bare-metal stents was compared with the class of effective drug-eluting stents, late loss was more discriminating than TLR as measured by the high intraclass correlation coefficient () (late loss, =0.71 versus TLR, =0.22; 95% CI of difference=0.33, 0.65). When the individual drug-eluting stents and bare-metal stents were compared, late loss was a better discriminator than TLR (0.68 versus 0.19; 95% CI of difference=0.24, 0.60). Greater adjustments of study covariates are needed to stabilize assessments of TLR compared with late loss because of greater influence of reference vessel diameter on TLR than on in-stent late loss. Optimization of late loss with the use of a novel method of standardization according to diabetes prevalence and mean lesion length resulted in minor adjustments in late loss (<0.08 mm for 90% of reported trials) and an ordered array of mean late loss values for the stent systems studied.

Conclusions— Late loss is more reliable than restenosis rates for discriminating restenosis propensity between new drug-eluting stent platforms across studies and might be the optimum end point for evaluating drug-eluting stents in early, nonrandomized studies.

Key Words: angioplasty • coronary disease • restenosis • stents • trials

This article has been cited by other articles:

				M. Werk, S. Langner, B. Reinkensmeier, H.-F. Boettcher, G. Tepe, U. Dietz, N. Hosten, B. Hamm, U. Speck, and J. Ricke Inhibition of Restenosis in Femoropopliteal Arteries: Paclitaxel-Coated Versus Uncoated Balloon: Femoral Paclitaxel Randomized Pilot Trial Circulation, September 23, 2008; 118(13): 1358 - 1365. [Abstract] [Full Text] [PDF]

				S.-W. Lee, S.-W. Park, Y.-H. Kim, S.-C. Yun, D.-W. Park, C. W. Lee, M.-K. Hong, H.-S. Kim, J.-K. Ko, J.-H. Park, et al. Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus: The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients) J. Am. Coll. Cardiol., March 25, 2008; 51(12): 1181 - 1187. [Abstract] [Full Text] [PDF]

				S. J. Pocock, A. J. Lansky, R. Mehran, J. J. Popma, M. P. Fahy, Y. Na, G. Dangas, J. W. Moses, T. Pucelikova, D. E. Kandzari, et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J. Am. Coll. Cardiol., January 1, 2008; 51(1): 23 - 32. [Abstract] [Full Text] [PDF]

				M. Togni, S. Eber, J. Widmer, M. Billinger, P. Wenaweser, S. Cook, R. Vogel, C. Seiler, F. R. Eberli, W. Maier, et al. Impact of Vessel Size on Outcome After Implantation of Sirolimus-Eluting and Paclitaxel-Eluting Stents: A Subgroup Analysis of the SIRTAX Trial J. Am. Coll. Cardiol., September 18, 2007; 50(12): 1123 - 1131. [Abstract] [Full Text] [PDF]

				B. Scheller, C. Hehrlein, W. Bocksch, W. Rutsch, D. Haghi, U. Dietz, M. Bohm, and U. Speck Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter N. Engl. J. Med., November 16, 2006; 355(20): 2113 - 2124. [Abstract] [Full Text] [PDF]

				Y.-H. Kim, S.-W. Park, S.-W. Lee, D.-W. Park, S.-C. Yun, C. W. Lee, M.-K. Hong, H.-S. Kim, J.-K. Ko, J.-H. Park, et al. Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent for Patients With Long Coronary Artery Disease Circulation, November 14, 2006; 114(20): 2148 - 2153. [Abstract] [Full Text] [PDF]

				A. Kastrati, A. Dibra, J. Mehilli, S. Mayer, S. Pinieck, J. Pache, J. Dirschinger, and A. Schomig Predictive Factors of Restenosis After Coronary Implantation of Sirolimus- or Paclitaxel-Eluting Stents Circulation, May 16, 2006; 113(19): 2293 - 2300. [Abstract] [Full Text] [PDF]

				J. Mehilli, A. Dibra, A. Kastrati, J. Pache, J. Dirschinger, A. Schomig, and for the Intracoronary Drug-Eluting Stenting to Abr Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels Eur. Heart J., February 1, 2006; 27(3): 260 - 266. [Abstract] [Full Text] [PDF]