First in-human randomized comparison of an anodized niobium stent versus a standard stainless steel stent--an intravascular ultrasound and angiographic two-center study: the VELA study.

OBJECTIVES: The purpose of this study was to test the hypothesis that a niobium stent might lower the restenosis rate in de novo coronary lesions as compared to a bare metal stent. BACKGROUND: Recent data have suggested that inflammatory and allergic reactions to certain compounds in metal stents may play a role in the onset of restenosis. Thus, niobium as an inert material might be beneficial in lowering the rate of restenosis. METHODS: In this single blind, two-center prospective trial patients were randomized into two groups; the first group (n=32) received a niobium stent (VELA STF), the second group (n=33) a bare metal stent (Antares STF). Clinical follow-up was performed at 1 and 6 months, angiographic and intravascular ultrasound analyses were performed at the 6-month follow-up. RESULTS: All stents were successfully deployed. There was one stent thrombosis in each group. There were no significant differences concerning minimal lumen diameter, percent stenosis, and late lumen loss as assessed by intravascular ultrasound (IVUS) at the 6- month follow-up. At 30 days and at 6 months, there were no differences observed between the two groups regarding the rate of major cardiac adverse events. Immediately after stent implantation minimal lumen diameter was significantly larger (p=0.01) and residual percent stenosis significantly lower (p=0.01) in the niobium stent group. CONCLUSION: The use of a niobium stent showed comparable results with other non-drug-eluting stents; however the inert qualities of this first generation niobium stent did not translate into a mid- or long-term benefit.

Three-dimensional visualization of coronary arteries in excised hearts.

OBJECTIVE: We sought to image coronary arteries in excised hearts. METHODS: Twelve excised pigs' hearts were imaged in a water bath. The aortic valve was closed surgically. A contrast agent (Echovist) was injected into the aortic root and selectively into single coronary arteries. Three-dimensional (3D) imaging was performed with TomTec Echoscan equipment. Mechanical rotations were performed at 1 degrees intervals. The hearts were visualized by InVivo software. Selective coloring of coronary arteries in 3D data sets was obtained by using color superpositioning, which differentiates information before and after injection of contrast. Distance measurements were performed in conventional 3D echocardiograms of coronary arteries and color-superimposed echocardiograms and compared with those from angiograms and casts. RESULTS: After a learning curve, during which optimal conditions for the visualization of coronary arteries were determined, a quick display of all major parts of the coronary tree was obtained. Distance measurements (n >400) revealed that fundamental contrast echocardiography overestimated angiography by 25% +/- 5% and casts by 28% +/- 6%. However, distances in color-superimposed echocardiograms (flow mode 4) were not significantly different from those obtained from angiograms and casts. In harmonic contrast echocardiograms, color super-positioning gave smaller distances compared with those from fundamental contrast echocardiograms, though they were still significantly larger than the reference diameters. CONCLUSIONS: The 3D imaging of epicardial coronary arteries under ideal conditions in a water bath seems feasible and provides insight into coronary visualization with the use of ultrasonography.