Multicenter Evaluation of the Biosbsorbable Polymer-based Everolimus-Eluting Stent - FUTURE II

Description:

This is a drug eluting stent trial using the Biosensors (Guidant) S stent coated with everolimus, an approved drug in the United States for the treatment of organ rejection.

Study Design

Study Design:

Patients Enrolled: 64
Mean Follow Up: 6 months

Patient Populations:

This is a multicenter-randomized (2:1) German trial involving 64 patients with de novo lesions.

Lesion Diameter is 2.5 to 4.0mm

Lesion length is <18mm

Diabetes 25.1%

Primary Endpoints:

Endpoints were MACE, TLR at 1 month and 6 months.

Drug/Procedures Used:

Patients were randomized 2:1 to the coated stent arm or bare stent arm. The S stent is a proprietary stainless steel stent from Biosensors utilizing a sinusoidal pattern of struts.

Principal Findings:

There was one myocardial infarction at 1 in the control group.

There was 1 TLR in the DES group (4.8%) and 6 in the control group (15%).

Angiographic percent diameter stenosis was 2.9% in DES group and 30.4% in the control group. Restenosis rate was 4.8% and 31% respectively.

Late loss was 0.12 mm in stent and 0.17 mm in segment as compared to 0.85 mm in the control group.

Neointimal intima volume was 1.1% of the stent volume.

Interpretation:

The Biosensor (Guidant) drug eluting stent seems to be very effective in lowering restenosis rate. The inhibitoring effect is similar to the sirolimus program.

References:

Presented at Late-breaking Clinical Trials, TCT 2003, Washington, DC.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Biosensing Techniques, Stainless Steel, Coronary Restenosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Balloon, Coronary, United States


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