Comparative clinical outcomes of paclitaxel- and sirolimus-eluting stents: results from a large prospective multicenter registry--STENT Group.
OBJECTIVE
The purpose of this study was to compare the 9-month clinical outcomes of patients treated with paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES) for coronary artery stenosis.


BACKGROUND
The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is the first multicenter registry in the U.S. to collect long-term outcomes of drug-eluting stents from "real-world" practice.


METHODS
Data on all percutaneous coronary interventions in 8 U.S. hospital centers were collected in the STENT registry between 2003 and 2005. In this prospective, nonrandomized, observational study, the choice of procedures was at the physicians' discretion. Patients who only received a PES (n = 4,671) or SES (n = 4,555) and completed 9-month follow-up (93.8% of eligible) were included for analysis. Primary end points were death, myocardial infarction (MI), and target vessel revascularization (TVR) at 9 months. Secondary outcomes included major adverse cardiac events (MACE) (any of the 3 primary end points) and stent thrombosis.


RESULTS
At 9 months, death, MI, and TVR occurred in 2.2%, 2.0%, and 4.1%, respectively, of the PES group and 2.5%, 2.2%, and 4.3%, respectively, of the SES group (p = NS); MACE occurred in 7.5% of the PES group and 8.0% of the SES group (p = 0.37). After adjustments for group differences in baseline characteristics, TVR (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.70 to 1.32; p = 0.26) and MACE (HR 0.95, 95% CI 0.81 to 1.12; p = 0.56) were similar for PES and SES. Stent thrombosis at 9 months occurred in 0.7% of both groups.


CONCLUSIONS
The results of this study show that clinical restenosis and MACE events after PES and SES procedures in "real-world" patients are infrequent and similar at 9 months.
Simonton
Charles A
CA
Carolinas Heart Institute, Carolinas Medical Center, Charlotte, North Carolina, USA. Charles.Simonton@carolinashealthcare.org
Brodie
Bruce
B
Cheek
Barrett
B
Krainin
Fred
F
Metzger
Chris
C
Hermiller
James
J
Juk
Stanley
S
Duffy
Peter
P
Humphrey
Angela
A
Nussbaum
Marcy
M
Laurent
Sherry
S
D015906:Angioplasty, Balloon, Coronary; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology; D003328:Coronary Thrombosis / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D017063:Outcome Assessment, Health Care; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D014481:United States / Q000453:epidemiology
D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus