An overview of the TAXUS Express, paclitaxel-eluting stent clinical trial program.
Restenosis remains a problem following percutaneous coronary intervention in patients with coronary artery disease. Drug-eluting stents (DES), which combine mechanical and pharmacologic properties, have been shown to prevent or reduce neointimal growth after deployment. This review describes the TAXUS paclitaxel-eluting stent clinical trial expansion program (TAXUS Express, Boston Scientific, Natick, MA). This program comprises the largest data set of randomized controlled trials (RCTs) of DES to date, with over 6,200 patients enrolled since 2000. The program includes treatment of de novo lesions, as well as higher-risk lesion and patient populations. In this review, we discuss the results from the TAXUS family of randomized clinical trials, and compare the findings with data from TAXUS registries. The data from the randomized clinical trials suggest that the paclitaxel-eluting stent provides consistent and durable benefits across multiple lesion and patient types. Evidence from peri-and post-approval registries, where patient populations are more heterogeneous than those eligible and included in the RCTs, corroborate these findings, with overall low rates of cardiac events, including reinterventions.
Lasala
John M
JM
Division of Cardiology, Washington University School of Medicine, St. Louis, Missouri 63110, USA. jlasala@im.wustl.edu
Stone
Gregg W
GW
Dawkins
Keith D
KD
Serruys
Patrick W
PW
Colombo
Antonio
A
Grube
Eberhard
E
Koglin
Joerg
J
Ellis
Stephen
S
D015906:Angioplasty, Balloon, Coronary; D019917:Blood Vessel Prosthesis Implantation; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000628:therapy; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D006801:Humans; D017239:Paclitaxel / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015607:Stents; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel