The unrestricted use of paclitaxel- versus sirolimus-eluting stents for coronary artery disease in an unselected population: one-year results of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry.
OBJECTIVE
We investigated the efficacy of paclitaxel-eluting stents (PES) compared to sirolimus-eluting stents (SES) when used without restriction in unselected patients.


BACKGROUND
Both SES and PES have been separately shown to be efficacious when compared to bare stents. In unselected patients, no direct comparison between the two devices has been performed.


METHODS
Paclitaxel-eluting stents have been used as the stent of choice for all percutaneous coronary interventions in the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry. A total of 576 consecutive patients with de novo coronary artery disease exclusively treated with PES were compared with 508 patients treated with SES from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.


RESULTS
The PES patients were more frequently male, more frequently treated for acute myocardial infarction, had longer total stent lengths, and more frequently received glycoprotein IIb/IIIa inhibitors. At one year, the raw cumulative incidence of major adverse cardiac events was 13.9% in the PES group and 10.5% in the SES group (unadjusted hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.95 to 1.88, p = 0.1). Correction for differences in the two groups resulted in an adjusted HR of 1.16 (95% CI 0.81 to 1.64, p = 0.4, using significant univariate variables) and an adjusted HR of 1.20 (95% CI 0.85 to 1.70, p = 0.3, using independent predictors). The one-year cumulative incidence of clinically driven target vessel revascularization was 5.4% versus 3.7%, respectively (HR 1.38, 95% CI 0.79 to 2.43, p = 0.3).


CONCLUSIONS
The universal use of PES in an unrestricted setting is safe and is associated with a similar adjusted outcome compared to SES. The inferior trend in crude outcome seen in PES was due to its higher-risk population. A larger, randomized study enrolling an unselected population may assist in determining the relative superiority of either device.
Ong
Andrew T L
AT
Thoraxcenter, Erasmus Medical Center, Dr. Molewaterplein 40, 3015-GD Rotterdam, the Netherlands.
Serruys
Patrick W
PW
Aoki
Jiro
J
Hoye
Angela
A
van Mieghem
Carlos A G
CA
Rodriguez-Granillo
Gaston A
GA
Valgimigli
Marco
M
Sonnenschein
Karel
K
Regar
Evelyn
E
van der Ent
Martin
M
de Jaegere
Peter P T
PP
McFadden
Eugene P
EP
Sianos
Georgios
G
van der Giessen
Willem J
WJ
de Feyter
Pim J
PJ
van Domburg
Ron T
RT
D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000401:mortality; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D012042:Registries; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents / Q000706:statistics & numerical data*; D016019:Survival Analysis; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus