Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial.
OBJECTIVE
We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI).


BACKGROUND
Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown.


METHODS
In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome.


RESULTS
Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04).


CONCLUSIONS
The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.
Moses
Jeffrey W
JW
Columbia University Medical Center, New York, New York, USA.
Mehran
Roxana
R
Nikolsky
Eugenia
E
Lasala
John M
JM
Corey
Woodrow
W
Albin
Glenn
G
Hirsch
Cary
C
Leon
Martin B
MB
Russell
Mary E
ME
Ellis
Stephen G
SG
Stone
Gregg W
GW
D000970:Antineoplastic Agents / Q000008:administration & dosage*; D003327:Coronary Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017566:Microvascular Angina / Q000628:therapy; D008875:Middle Aged; D009204:Myocardial Revascularization; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D015607:Stents
D000970:Antineoplastic Agents; D017239:Paclitaxel