Intravascular ultrasound-guided optimized stent deployment: Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)

Objectives A study was set up to validate the safety and feasibilityof intravascular ultrasound-guided stenting without subsequentanticoagulation, 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 anginaand a de novo coronary artery lesion were enrolled. In fourpatients, the implantation of a Palmaz–Schatz (with spiralbridge) stent had failed. One of these four patients died 3days following bypass surgery. In two other patients, intravascularultrasound assessment was not performed. One hundred and twenty-fiveof the remaining 155 patients (81%) were treated with aspirin(100mg.day^–1), because all three criteria for optimizedstent expansion were met. Twenty-two of the remaining 38 patients(25%), in whom at least one criterion was not met were treatedwith aspirin and acenocoumarol (3 months, INR 2·5–3·5),while 16 patients only received aspirin. Stent thrombosis wasdocumented in two patients (1·3%) for which repeat angioplastywas performed. During the hospital stay, there were no deathsor Q-wave myocardial infarctions. Five patients (3·2%)sustained a non-Q-wave myocardial infarction. During the follow-upperiod (198±38 days, complete for all patients, exceptone), one patient (0·6%) sustained a Q-wave myocardialinfarction, one (0·6%) underwent bypass surgery, andrepeat angioplasty was performed in nine patients (5·7%).In two of the nine patients, repeat angioplasty involved anotherlesion. Therefore, the target lesion revascularization rateduring follow-up was 4·5% (seven patients).At quantitativecoronary angiography, the minimal lumen diameter (mean±SD)increased from 1·12± 0·34mm before to 2·89±0·35mmafter stenting. Repeat angiography at 6 months was performedin 144 patients (92%). The minimal lumen diameter at follow-upwas 2·12±0·67mm. Restenosis (diameter stenosisof 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, stentscan safely be implanted without the use of systemic anticoagulation,provided optimal stent expansion is achieved. The exact roleof intravascular ultrasound in the achievement of these resultsneeds to be established by appropriately designed studies. Inthe meantime, intra-vascular ultrasound coupled with the Palmaz–Schatzstent incorporating a spiral bridge, may have contributed considerablyto the immediate angiographic outcome, which in turn may explainthe favourable clinical and angiographic outcome at 6 months.