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.

RCT Entities:   Population Interventions Outcomes