doi: 10.1161/hc3701.096064
(Circulation. 2001;104:1343.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Comparison of Coronary Stent Implantation Under Ultrasound or Angiographic Guidance to Reduce Stent Restenosis (OPTICUS Study)
From the Universitätsklinikum Innenstadt, München, Germany (H.M., E.R., K.-H.H.); Centro Cuore Columbus, Milan, Italy (C.d.M.); Heart and Lung Institute, Utrecht, the Netherlands (P.d.J.); Universitätsklinikum Göttingen and Jena, Germany (H.R.F.); Hospital Clinico San Carlos, Madrid, Spain (C.M.); Herzzentrum, Ludwigshafen, Germany (R.Z.); Sahlgrenska University, Göteborg, Sweden (B.W.); Universitätsklinikum Charité, Berlin, Germany (W.R.); Onassis Cardiac Surgery Center, Athens, Greece (V.V.); and Universitätsklinikum, Frankfurt, Germany (V.S., A.Z.).
Correspondence to Prof Dr med Harald Mudra, 2. Medizinische Abteilung, Krankenhaus Neuperlach, Oskar-Maria-Graf-Ring 51, D-81737 München, Germany. E-mail mudra.kh-neuperlach{at}extern.lrz-muenchen.de
Background—— Observational studies in selected patients have shown remarkably low restenosis rates after ultrasound-guided stent implantation. However, it is unknown whether this implantation strategy improves long-term angiographic and clinical outcome in routine clinical practice.
Methods and Results—— A total of 550 patients with a symptomatic coronary lesion or silent ischemia were randomly assigned to either ultrasound-guided or angiography-guided implantation of 
2 tubular stents. The primary end points were angiographic dichotomous restenosis rate, minimal lumen diameter, and percent diameter stenosis after 6 months as determined by quantitative coronary angiography. Secondary end points were the occurrence rates of major adverse cardiac events (death, myocardial infarction, coronary bypass surgery, and repeat percutaneous intervention) after 6 and 12 months of follow-up. At 6 months, repeat angiography revealed no significant differences between the groups with ultrasound- or angiography-guided stent implantation with respect to dichotomous restenosis rate (24.5% versus 22.8%, P=0.68), minimal lumen diameter (1.95±0.72 mm versus 1.91±0.68 mm, P=0.52), and percent diameter stenosis (34.8±20.6% versus 36.8±19.6%, P=0.29), respectively. At 12 months, neither major adverse cardiac events (relative risk, 1.07; 95% CI 0.75 to 1.52; P=0.71) nor repeat percutaneous interventions (relative risk 1.04; 95% CI 0.64 to 1.67; P=0.87) were reduced in the ultrasound-guided group.
Conclusions—— This study does not support the routine use of ultrasound guidance for coronary stenting. Angiography-guided optimization of tubular stents can be performed with comparable angiographic and clinical long-term results.
Key Words: coronary disease • restenosis • stents • ultrasonics • angiography
This article has been cited by other articles:
 |
|
 |
|
  H. G. Bezerra, M. A. Costa, G. Guagliumi, A. M. Rollins, and D. I. Simon Intracoronary Optical Coherence Tomography: A Comprehensive Review: Clinical and Research Applications J. Am. Coll. Cardiol. Intv., November 1, 2009; 2(11): 1035 - 1046. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. W. Stone and G. S. Mintz Unprotected Left Main Intervention: The Light at the End of the Tunnel? Circ Cardiovasc Interv, June 1, 2009; 2(3): 156 - 158. [Full Text] [PDF]
|
|
|
|
|
|
S.-J. Park, Y.-H. Kim, D.-W. Park, S.-W. Lee, W.-J. Kim, J. Suh, S.-C. Yun, C. W. Lee, M.-K. Hong, J.-H. Lee, et al. Impact of Intravascular Ultrasound Guidance on Long-Term Mortality in Stenting for Unprotected Left Main Coronary Artery Stenosis Circ Cardiovasc Interv, June 1, 2009; 2(3): 167 - 177. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. J. Russo, P. D. Silva, P. S. Teirstein, M. J. Attubato, C. J. Davidson, A. C. DeFranco, P. J. Fitzgerald, S. L. Goldberg, J. B. Hermiller, M. B. Leon, et al. A Randomized Controlled Trial of Angiography Versus Intravascular Ultrasound-Directed Bare-Metal Coronary Stent Placement (The AVID Trial) Circ Cardiovasc Interv, April 1, 2009; 2(2): 113 - 123. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. Di Mario, G. R. Heyndrickx, F. Prati, and N. H.J. Pijls CHAPTER 8 Invasive Imaging and Haemodynamics ESC Textbook of Cardiovascular Medicine, January 1, 2009; 2(1): med-9780199566990-chapter - med-9780199566990-chapter. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. V. Kelly, M. J. Gillespie, M. G. Cohen, D. P. McLaughlin, E. Magnus Ohman, and G. A. Stouffer The Contrast Media Iohexol Causes Vasoconstriction of the Proximal Left Anterior Descending Coronary Artery: Implications for Appropriate Stent Sizing Angiology, October 1, 2008; 59(5): 574 - 580. [Abstract] [PDF]
|
|
|
|
|
|
C. Di Mario and P. Barlis Optical Coherence Tomography: A New Tool to Detect Tissue Coverage in Drug-Eluting Stents J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 174 - 175. [Full Text] [PDF]
|
|
|
|
|
|
E. Romagnoli, G. M. Sangiorgi, J. Cosgrave, E. Guillet, and A. Colombo Drug-eluting stenting the case for post-dilation. J. Am. Coll. Cardiol. Intv., February 1, 2008; 1(1): 22 - 31. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. De Benedetti and P. Urban Coronary stenting: why size matters Heart, December 1, 2007; 93(12): 1500 - 1501. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. Ilkay, L. Tirikli, I. Ozercan, M. Yavuzkir, I. Karaca, A. Rahman, and N. Arslan Oral Mycophenolate Mofetil Prevents In-Stent Intimal Hyperplasia Without Edge Effect Angiology, October 1, 2006; 57(5): 577 - 584. [Abstract] [PDF]
|
|
|
|
 |
|
 E. Escolar, G. Weigold, A. Fuisz, and N. J. Weissman New imaging techniques for diagnosing coronary artery disease. Can. Med. Assoc. J., February 14, 2006; 174(4): 487 - 495. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 N. Marx, J. Wohrle, T. Nusser, D. Walcher, A. Rinker, V. Hombach, W. Koenig, and M. Hoher Pioglitazone Reduces Neointima Volume After Coronary Stent Implantation: A Randomized, Placebo-Controlled, Double-Blind Trial in Nondiabetic Patients Circulation, November 1, 2005; 112(18): 2792 - 2798. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]
|
|
|
|
|
|
V Klauss, P Erdin, J Rieber, M Leibig, H-U Stempfle, A Konig, M Baylacher, K Theisen, M C Haufe, G Sroczynski, et al. Fractional flow reserve for the prediction of cardiac events after coronary stent implantation: results of a multivariate analysis Heart, February 1, 2005; 91(2): 203 - 206. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. Choi, S.-K. Kim, S.-H. Choi, Y.-G. Ko, C.-W. Ahn, Y. Jang, S.-K. Lim, H.-C. Lee, and B.-S. Cha Preventative Effects of Rosiglitazone on Restenosis After Coronary Stent Implantation in Patients With Type 2 Diabetes Diabetes Care, November 1, 2004; 27(11): 2654 - 2660. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. L. Orford, A. Lerman, and D. R. Holmes Routine intravascular ultrasound guidance of percutaneous coronary intervention: A critical reappraisal J. Am. Coll. Cardiol., April 21, 2004; 43(8): 1335 - 1342. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. N. Giedd and S. R. Bergmann Myocardial perfusion imaging following percutaneous coronary intervention: the importance of restenosis, disease progression, and directed reintervention J. Am. Coll. Cardiol., February 4, 2004; 43(3): 328 - 336. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A L Gaster, U Slothuus Skjoldborg, J Larsen, L Korsholm, C von Birgelen, S Jensen, P Thayssen, K E Pedersen, and T H Haghfelt Continued improvement of clinical outcome and cost effectiveness following intravascular ultrasound guided PCI: insights from a prospective, randomised study Heart, September 1, 2003; 89(9): 1043 - 1049. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. Cheneau, L. Leborgne, G. S. Mintz, J.-i. Kotani, A. D. Pichard, L. F. Satler, D. Canos, M. Castagna, N. J. Weissman, and R. Waksman Predictors of Subacute Stent Thrombosis: Results of a Systematic Intravascular Ultrasound Study Circulation, July 8, 2003; 108(1): 43 - 47. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B E Bouma, G J Tearney, H Yabushita, M Shishkov, C R Kauffman, D DeJoseph Gauthier, B D MacNeill, S L Houser, H T Aretz, E F Halpern, et al. Evaluation of intracoronary stenting by intravascular optical coherence tomography Heart, March 1, 2003; 89(3): 317 - 320. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. V. Oemrawsingh, G. S. Mintz, M. J. Schalij, A. H. Zwinderman, J. W. Jukema, and E. E.v.d. Wall Intravascular Ultrasound Guidance Improves Angiographic and Clinical Outcome of Stent Implantation for Long Coronary Artery Stenoses: Final Results of a Randomized Comparison With Angiographic Guidance (TULIP Study) Circulation, January 7, 2003; 107(1): 62 - 67. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
V. Spanos, G. Stankovic, J. Tobis, and A. Colombo The challenge of in-stent restenosis: insights from intravascular ultrasound Eur. Heart J., January 2, 2003; 24(2): 138 - 150. [Full Text] [PDF]
|
|
|
|
|
|
M. N. Babapulle and M. J. Eisenberg Coated Stents for the Prevention of Restenosis: Part I Circulation, November 19, 2002; 106(21): 2734 - 2740. [Full Text] [PDF]
|
|
|
|
|
|
N. H.J. Pijls, V. Klauss, U. Siebert, E. Powers, K. Takazawa, W. F. Fearon, J. Escaned, Y. Tsurumi, T. Akasaka, H. Samady, et al. Coronary Pressure Measurement After Stenting Predicts Adverse Events at Follow-Up: A Multicenter Registry Circulation, June 25, 2002; 105(25): 2950 - 2954. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M.-C. Morice, P. W. Serruys, J. E. Sousa, J. Fajadet, E. Ban Hayashi, M. Perin, A. Colombo, G. Schuler, P. Barragan, G. Guagliumi, et al. A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization N. Engl. J. Med., June 6, 2002; 346(23): 1773 - 1780. [Abstract] [Full Text] [PDF]
|
|