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J Am Coll Cardiol, 2005; 45:1135-1141, doi:10.1016/j.jacc.2005.01.008
© 2005 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

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

Andrew T.L. Ong, MBBS, FRACP, Patrick W. Serruys, MD, PhD, FACC*, Jiro Aoki, MD, Angela Hoye, MBChB, MRCP, Carlos A.G. van Mieghem, MD, Gaston A. Rodriguez-Granillo, MD, Marco Valgimigli, MD, Karel Sonnenschein, Evelyn Regar, MD, PhD, Martin van der Ent, MD, PhD, Peter P.T. de Jaegere, MD, PhD, Eugene P. McFadden, MBChB, MD, FRCPI, FACC, Georgios Sianos, MD, PhD, Willem J. van der Giessen, MD, PhD, Pim J. de Feyter, MD, PhD, FACC and Ron T. van Domburg, PhD

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands

Manuscript received November 26, 2004; revised manuscript received January 10, 2005, accepted January 18, 2005.

* Reprint requests and correspondence: Prof. Patrick W. Serruys, Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015-GD Rotterdam, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).

OBJECTIVES: 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.

Abbreviations and Acronyms
  BMS = bare-metal stent
  CI = confidence interval
  CK-MB = creatine kinase-MB
  DES = drug-eluting stent
  HR = hazard ratio
  MACE = major adverse cardiac event
  MI = myocardial infarction
  PES = paclitaxel-eluting stent
  RESEARCH = Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital
  SES = sirolimus-eluting stent
  TIMI = Thrombolysis In Myocardial Infarction
  T-SEARCH = Taxus-Stent Evaluated At Rotterdam Cardiology Hospital
  TVR = target vessel revascularization




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