TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release @entity1311 -eluting stent for de novo XXXX .

@entity1 @entity301 @entity75 @entity1373 @entity1311 @entity256 @entity715
BACKGROUND: The TAXUS NIRx stent (Boston Scientific Corp) provides local delivery of @entity1311 via a slow-release polymer coating. The TAXUS I trial was the first in- @entity1 experience evaluating safety and feasibility of the TAXUS NIRx stent system compared with bare NIR stents (control) (Boston Scientific Corp) for treatment of @entity301 . METHODS AND RESULTS:                 <AbstractText Label="METHODS AND RESULTS" NlmCategory="RESULTS">The TAXUS I trial was a prospective, double-blind, three-center study randomizing 61 @entity1 with de novo or @entity75 (< or =12 mm) to receive a TAXUS (n=31) versus control (n=30) stent (diameter 3.0 or 3.5 mm). Demographics, lesion characteristics, clinical outcomes were comparable between the groups. The 30-day major adverse cardiac event (MACE) rate was 0% in both groups (P=NS). No stent @entity715 were reported at 1, 6, 9, or 12 months. At 12 months, the MACE rate was 3% (1 event) in the TAXUS group and 10% (4 events in 3 @entity1 ) in the control group (P=NS). Six-month angiographic @entity256 rates were 0% for TAXUS versus 10% for control (P=NS) @entity1 . There were significant improvements in minimal lumen diameter (2.60+/-0.49 versus 2.19+/-0.65 mm), diameter stenosis (13.56+/-11.77 versus 27.23+/-16.69), and late lumen loss (0.36+/-0.48 versus 0.71+/-0.48 mm) in the TAXUS group (all P<0.01). No evidence of edge @entity256 was seen in either group. Intravascular ultrasound analysis showed significant improvements in normalized neointimal @entity1373 in the TAXUS (14.8 mm3) group compared with the control group (21.6 mm3) (P<0.05). CONCLUSIONS: In this feasibility trial, the TAXUS slow-release stent was well tolerated and showed promise for treatment of @entity301 , with significant reductions in angiographic and intravascular ultrasound measures of @entity256 .
