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 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 (100 mg x 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+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. 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 97%. 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, intravascular 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.

The safety of intracoronary ultrasound. A multicenter survey of 2207 examinations.

BACKGROUND: Intracoronary ultrasound (ICUS) is increasingly used in clinical practice to study the natural history of coronary artery disease and to assess the effects of intracoronary, catheter-based interventions. However, the risk associated with the procedure is not well documented. METHODS AND RESULTS: ICUS studies performed in 28 centers were retrospectively included; these centers agreed to contribute to the study among a total of 60 centers initially invited. Among the 2207 ICUS studies, 505 (23%) were performed in heart transplant recipients and 1702 (77%) in nontransplant patients. Indication for ICUS was diagnostic imaging in 915 (41%), drug testing in 244 (11%), and guidance for intracoronary interventions in 1048 patients (47%). There were no complications in 2034 patients (92.2%). In 87 patients (3.9%), complications occurred but were judged to be "not related" to ICUS by the operator. In 63 patients (2.9%), spasm occurred during ICUS imaging. In 9 patients (0.4%), complications other than spasm were judged to have a "certain relation" to ICUS, including acute procedural events in 6 (3 acute occlusion, 1 embolism, 1 dissection, and 1 thrombus) and major events in 3 patients (2 occlusion and 1 dissection; all resulting in myocardial infarction). In 14 patients (0.6%), complications with "uncertain relation" to ICUS were recorded, including acute procedural events in 9 (5 acute occlusion, 3 dissection, and 1 arrhythmia) and major events in 5 patients (2 myocardial infarction and 3 emergency coronary artery bypass surgery). The incidence of acute procedural or major complications judged to be associated with ICUS (uncertain relation or certain relation to ICUS) was compared in different patient groups. The complication rate was higher in patients with unstable angina or acute myocardial infarction (2.1% events) as compared with patients with stable angina pectoris and asymptomatic patients (0.8% and 0.4%, respectively; chi 2 = 10.9, P < .01). These complications were also more frequent in patients undergoing interventions (1.9%) as compared with transplant and nontransplant patients undergoing diagnostic ICUS imaging (0% and 0.6%, respectively; chi 2 = 13.5, P < .001). Adverse events were few, and no association was detected between these events and the size or type of ICUS catheter used. CONCLUSIONS: ICUS is associated with (but not necessarily the direct cause of) a minor acute clinical risk. Vessel spasm is the most frequent event occurring during ICUS. Other complications predominantly occur in patients with acute coronary syndromes and during guidance for intervention.

Perceived aluminum-related disease in a dialysis population. A report from the End-Stage Renal Disease Network 28.

A survey to assess the perceived prevalence of aluminum-related disease was conducted by the Medical Review Board of the End-Stage Renal Disease Network 28 from 1986 to 1987. Responses were obtained for 855 of 3000 patients on dialysis representing 17 of 39 participating dialysis units within the network. Almost 40% of the patients surveyed had been receiving dialysis therapy for over 3 years. Patients on hemodialysis (83% of the study group) had the water used to prepare the dialysate pretreated. Serum aluminum determinations were obtained in 240 (28%) of the 855 patients; other methods of assessing body aluminum burden were performed in less than 10% of the survey population. When obtained, elevated serum aluminum measurements were more likely to be found with each year patients were given dialysis and with each year patients were treated with oral aluminum gels. With the exception of patients with bone pain, clinical signs and symptoms did not correlate with elevated serum aluminum. However, the prevalence of muscle weakness, bone pain, fractures, and dementia in the survey group did correlate with years on dialysis and/or years receiving oral aluminum gels. Data gathered from this survey are consistent with the view that signs and symptoms suggestive of an increased body aluminum burden occur in the minority of patients on dialysis. Nevertheless, patients at risk for aluminum intoxication (years on dialysis, years receiving gels, patients with clinical signs) may not be adequately identified.