STEALTH - STEALTH

Description:

The goal of the STEALTH study was to evaluate the safety and efficacy of an eluting-stent with a new rapamycin derivative, biolimus A9, among patients with a single de novo lesion.

Study Design

Study Design:

Patients Enrolled: 120
Mean Follow Up: 12 months
Mean Patient Age: Mean age 62 years
Female: 33

Patient Populations:

Age ≥18 years with a single de novo lesion

Primary Endpoints:

Late loss at 6 months

Secondary Endpoints:

In-stent restenosis; binary restenosis; major adverse coronary events (MACE), defined as death, MI or target lesion revascularization

Drug/Procedures Used:

Patients were randomized in a 2:1 manner to IVUS guided stenting with a bare metal stent (n=40) or the biolimus A9 eluting stent (n=80). The drug was eluted via a PLA polymer. Patients underwent angiographic and IVUS follow-up at 6 months.

Concomitant Medications:

Aspirin and at least 2 months of clopidogrel

Principal Findings:

Mean lesion length at baseline was slightly larger in the eluting stent group (15.37 mm vs 13.75 mm, p=0.06). Reference vessel diameter was 2.95 mm in the eluting-stent group and 2.97 mm in the bare stent group. At 30 day follow-up, there was no difference in overall MACE rates (3.8% for eluting stent group vs 2.5% for bare metal stent group) or any component of MACE (non-Q-wave MI 2.5% each, target lesion revascularization 1.3% in eluting stent group and 0 in the bare metal group). There were no deaths and Q-wave MIs by 30 days. There were no additional MACE events between 30 day and 6 month follow-up. At 6 month angiographic follow-up, in-stent late loss was smaller in the eluting stent group (0.26 mm vs 0.74 mm, p<0.001) as was percent diameter stenosis (11.9% vs 27.4%, p<0.001) but there was no significant difference in binary restenosis (3.9% vs 7.7%, p=0.40). Among patients who underwent IVUS, neointima volume index was lower in the eluting stent group (0.20 vs 1.90 mm3/mm, p<0.001) as was percent neointima volume (2.6% vs 23.5%, p<0.001). Late incomplete apposition occurred in 3% of patients in each group.

Interpretation:

Among patients with single de novo lesions, treatment with an eluting-stent with a new rapamycin derivative, biolimus A9, was associated with a reduction in late loss at 6 month angiographic follow-up compared with use of a bare metal stent. The present trial was too small to fully evaluate clinical MACE rates. However, given the favorable angiographic and IVUS findings, larger clinical trials are warranted. The in-stent late loss was similar to late loss rates seen in other drug-eluting stent trials.

References:

Presented by Dr. Abizaid at the 2005 Cardiovascular Research Therapeutics Sessions, Washington, DC.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Neointima, Coronary Artery Disease, Follow-Up Studies, Metals, Drug-Eluting Stents, Polymers, Constriction, Pathologic, Sirolimus, Stents


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