Copyright © 1998 by the European Society of Cardiology.
Intravascular ultrasound-guided optimized stent deployment
Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)
a Department of Cardiology, Thoraxcenter, Rotterdam, The Netherlands
b Klinikum Innenstadt der Ludwigs-Maximilians Universität, Munich, Germany
c Klinikum der Universität Göttingen, Göttingen, Germany
d Shaare Zedek Medical Center, Jerusalem, Israel
e Institut de Cardiologie de Montreal, Montreal, Canada
f Vancouver General Hospital, Vancouver, Canada
g Casa di Cura Columbus, Milano, Italy
h Universitätskrankenhaus Eppendorf, Hamburg, Germany
i Insitute of the Cardiology of the University of Milan, Milan, Italy
j London Chest Hospital, London, U.K.
k Kokura Memorial Hospital, Kitakyushu, Japan
l Ohashi Hospital, Tokyo, Japan
m Onassis Cardiac Surgery Center, Athens, Greece
n Hôpital Broussais, Paris, France
o Medizinische Hochschule, Hanover, Germany
p Johnson & Johnson, International System, Warren, New Jersey, U.S.A.
q Cardialysis, Rotterdam, The Netherlands
accepted February 4, 1998
Objectives A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate.
Methods The study was designed to be multicentred, prospective, and observational.
Results One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz–Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100mg.day–1), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2·5–3·5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1·3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3·2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198±38 days, complete for all patients, except one), one patient (0·6%) sustained a Q-wave myocardial infarction, one (0·6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5·7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4·5% (seven patients).At quantitative coronary angiography, the minimal lumen diameter (mean±SD) increased from 1·12± 0·34mm before to 2·89±0·35mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2·12±0·67mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8·3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 9·7%.
Conclusions These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intra-vascular ultrasound coupled with the Palmaz–Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months.
Key Words: Stents • ultrasonics • imaging • coronary disease
f1 Correspondence: Peter de Jaegere, Department of Cardiac Catheterization and Interventional Cardiology, Heart Lung Institute, University Hospital Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
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