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.


RESULTS



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.
Grube
Eberhard
E
Department of Cardiology/Angiology, Heart Center Siegburg, Siegburg, Germany. GrubeE@aol.com
Silber
Sigmund
S
Hauptmann
Karl Eugen
KE
Mueller
Ralf
R
Buellesfeld
Lutz
L
Gerckens
Ulrich
U
Russell
Mary E
ME
D000368:Aged; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control*; D003328:Coronary Thrombosis / Q000453:epidemiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D003710:Demography; D004311:Double-Blind Method; D004343:Drug Implants; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects; D014463:Ultrasonography
D004343:Drug Implants; D017239:Paclitaxel