One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial.
BACKGROUND
The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown.


RESULTS
In the TAXUS-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or an identical-appearing bare-metal EXPRESS stent. By actuarial analysis, the TAXUS stent compared with the bare-metal stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting stent than in the control stent group, respectively.


CONCLUSIONS
The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting TAXUS stent compared with the EXPRESS stent is preserved and continues to increase at 1 year, with no safety concerns apparent.
Stone
Gregg W
GW
The Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, 55 E 59th St, 6th Floor, New York, NY 10022, USA. gstone@crf.org
Ellis
Stephen G
SG
Cox
David A
DA
Hermiller
James
J
O'Shaughnessy
Charles
C
Mann
James Tift
JT
Turco
Mark
M
Caputo
Ronald
R
Bergin
Patrick
P
Greenberg
Joel
J
Popma
Jeffrey J
JJ
Russell
Mary E
ME
D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000628:therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D011108:Polymers / Q000737:chemistry; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D011108:Polymers; D017239:Paclitaxel