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

BACKGROUND: The TAXUS NIRx stent (Boston Scientific Corp) provides local delivery of paclitaxel via a slow-release polymer coating. The TAXUS I trial was the first in-human experience evaluating safety and feasibility of the TAXUS NIRx stent system compared with bare NIR stents (control) (Boston Scientific Corp) for treatment of coronary lesions. METHODS AND RESULTS: METHODS AND RESULTS: The TAXUS I trial was a prospective, double-blind, three-center study randomizing 61 patients with de novo or restenotic lesions (< 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 thromboses 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 patients) in the control group (P=NS). Six-month angiographic restenosis rates were 0% for TAXUS versus 10% for control (P=NS) patients. 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 restenosis was seen in either group. Intravascular ultrasound analysis showed significant improvements in normalized neointimal hyperplasia 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 coronary lesions, with significant reductions in angiographic and intravascular ultrasound measures of restenosis.

Trial
Journal Ref. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME: Circulation 2003, 107:38-42.
Intervention Drug - Slow-release Packlitaxel-eluting stent
Number of sites 3
Countries involved Germany
Sample size 61
Type of statistical analyses Probability values are 2 sided from Student t test for continuous variables and Fisher's exact test for categorical variables
Risk of bias Overall: Low Risk details
Participant characteristics Age: TAXUS: 66±6.8 NIR: 63.8±7.8
Condition: Single de novo or restenotic coronary lesions
Baseline severity: ≤ 12mm, 50-99% diameter stenosis, and vessel diameter 3.0mm and 3.5 mm.
Duration of trial 6 months: Between October 2000 and March 2001
Primary outcome MACE rate 6 months, 12 months
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
1 30 3 30 -6.67 %
Risk Diff for 12 months. TLRs Target Lesion Revascularisation p = NS 6 months: MACE 0% (0 out of 31) in TAXUS vs 7% (2/30) P=NS
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
2 3 3 5 3 -1 2 4 5