Multicenter Evaluation of the Biosbsorbable Polymer-based Everolimus-Eluting Stent - FUTURE II
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.
Patients Enrolled: 64
Mean Follow Up: 6 months
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
Endpoints were MACE, TLR at 1 month and 6 months.
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.
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.
The Biosensor (Guidant) drug eluting stent seems to be very effective in lowering restenosis rate. The inhibitoring effect is similar to the sirolimus program.
Presented at Late-breaking Clinical Trials, TCT 2003, Washington, DC.
Keywords: Myocardial Infarction, Biosensing Techniques, Stainless Steel, Coronary Restenosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Balloon, Coronary, United States
< Back to Listings