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In-Hospital and 1-Year Outcomes Among Unselected Percutaneous Coronary Intervention Patients Treated With Either Sirolimus- or Paclitaxel-Eluting Stents

Results From the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) Registry

Victor Novack, MD, PhD^_*, Donald Cutlip, MD^_*,, Neal Kleiman, MD, Michael Pencina, PhD^_*, Laura Mauri, MD, MSc^_*,, Chen-Hsing Yen, MS^_*, Peter Berger, MD^||, Steven Goldberg, MD^¶, Mirle Kellett, MD^#, Ronald Waksman, MD^_**, Mun Hong, MD, Albert E. Raizner, MD, David J. Cohen, MD, MSc^,_*

^_* Harvard Clinical Research Institute, Boston, Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts
The Methodist DeBakey Heart Center, Houston, Texas
Brigham Women's Hospital, Boston, Massachusetts
^|| Geisinger Clinic, Danville, Pennsylvania
^¶ University of Washington Medical Center, Seattle, Washington
^# Maine Medical Center, Portland, Maine
^_** Washington Hospital Center, Washington, DC
St. Luke's-Roosevelt Hospital Center, New York, New York
Saint-Luke's Mid America Heart Institute, Kansas City, Missouri

^_* Reprint requests and correspondence: Dr. David J. Cohen, Cardiovascular Division, Saint Luke's Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111 (Email: dcohen{at}saint-lukes.org).

Objectives: The aim of this study was to compare outcomes among unselected patients undergoing percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES).

Background: Although the benefits of both SES and PES are well-established, studies comparing these stents directly have yielded conflicting results.

Methods: We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing nonemergent PCI with either SES or PES implantation.

Results: Between July 2004 and June 2006, 6,035 patients underwent PCI with either SES (n = 3,443) or PES (n = 2,592) at 47 U.S. centers. Baseline clinical and angiographic characteristics were generally similar for the 2 stent types. At 1-year, there were no differences in the primary end point of cardiac death or myocardial infarction (MI) between the SES and PES groups (9.1% vs. 10.0%, p = 0.11) or in any individual end points including cardiac death, nonfatal MI, or stent thrombosis. In unadjusted analyses, target lesion revascularization (TLR) was slightly more common with SES than with PES (4.4% vs. 3.3%, p = 0.048), but this difference was no longer apparent after adjusting for baseline characteristics as well as site-related factors (adjusted hazard ratio: 1.09, 95% confidence interval: 0.78 to 1.50).

Conclusions: Among unselected patients undergoing PCI, adjusted rates of both ischemic complications as well as clinically important restenosis were similar for SES and PES. The unexpected finding that TLR was influenced by site characteristics suggests that the correlation between TLR and angiographic restenosis might be weaker than previously described and warrants further study.

Key Words: drug-eluting stent • paclitaxel • sirolimus

Abbreviations and Acronyms   ACS = acute coronary syndrome   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   DM = diabetes mellitus   HR = hazard ratio   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization

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Pieter J. Vlaar and Felix Zijlstra
J. Am. Coll. Cardiol. Intv. 2009 2: 776-778. [Full Text] [PDF]

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