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Randomized Comparison Of Coronary Stent Implantation Under Ultrasound Or Angiographic Guidance To Reduce Stent Restenosis (OPTICUS Study)

Harald Mudra, Carlo di Mario, Peter de Jaegere, Hans Reiner Figulla, Carlos Macaya, Ralf Zahn, Bertil Wennerblom, Wolfgang Rutsch, Vasilj Voudris, Evelyn Regar, Karl-Heinz Henneke, Volker Schächinger, Andreas Zeiher,

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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.