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(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)

Harald Mudra, MD; Carlo di Mario, MD; Peter de Jaegere, MD; Hans Reiner Figulla, MD; Carlos Macaya, MD; Ralf Zahn, MD; Bertil Wennerblom, MD; Wolfgang Rutsch, MD; Vasilj Voudris, MD; Evelyn Regar, MD; Karl-Heinz Henneke, MD; Volker Schächinger, MD; Andreas Zeiher, MD; , for the OPTICUS (OPTimization with ICUS to reduce stent restenosis) Study Investigators

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

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