American Journal of Cardiology
Volume 106, Issue 6 , Pages 774-779, 15 September 2010

Effect of Coronary Target Lesion Revascularization on Late Cardiac Events After Insertion of Sirolimus-Eluting or Bare Metal Stents

  • Victor Novack, MD, PhD

      Affiliations

    • Harvard Clinical Research Institute, Boston, Massachusetts
    • Dr. Novack and Dr. Nguyen contributed equally to this article.
  • ,
  • Michael C. Nguyen, MBBS

      Affiliations

    • Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
    • Dr. Novack and Dr. Nguyen contributed equally to this article.
  • ,
  • Meredith Rooney, MD

      Affiliations

    • Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
  • ,
  • Riya Chacko, MD

      Affiliations

    • Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
  • ,
  • Lena Novack, PhD

      Affiliations

    • Harvard Clinical Research Institute, Boston, Massachusetts
  • ,
  • Michael Pencina, PhD

      Affiliations

    • Harvard Clinical Research Institute, Boston, Massachusetts
  • ,
  • Patricia Apruzzese, MA

      Affiliations

    • Harvard Clinical Research Institute, Boston, Massachusetts
  • ,
  • Laura Mauri, MD, MSc

      Affiliations

    • Harvard Clinical Research Institute, Boston, Massachusetts
  • ,
  • Sidney A. Cohen, MD, PhD

      Affiliations

    • Cordis Inc., Warren, New Jersey; Division of Cardiology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania
  • ,
  • Jeffrey Moses, MD

      Affiliations

    • Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
  • ,
  • Martin B. Leon, MD

      Affiliations

    • Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
  • ,
  • Donald E. Cutlip, MD

      Affiliations

    • Harvard Clinical Research Institute, Boston, Massachusetts
    • Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
    • Corresponding Author InformationCorresponding author: Tel: (617) 632-7455; fax: (617) 632-7460

Received 14 March 2010; accepted 26 April 2010. published online 02 August 2010.

Restenosis is associated with acute myocardial infarction (MI) either at presentation or related to complications of target lesion revascularization (TLR). The cumulative late effect of TLR after drug-eluting or bare metal stent placement on cardiac death or MI is uncertain. Of the 1,057 patients with one native coronary lesion randomized to a sirolimus-eluting stent or bare metal stent in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) trial, the 983 who survived free of MI for the first 30 days were evaluated for the primary outcome of cardiac death or MI for 5 years. Patients with events occurring at or after TLR were assigned to TLR group. Cox proportional hazards regression analysis with TLR as a time-dependent variable and adjustment for baseline clinical and demographic covariates was used to assess the independent effect of TLR on the primary outcome. TLR occurred in 160 patients (16.3%) and was an independent predictor of the primary end point (hazard ratio 2.8, 95% confidence interval 1.7 to 4.5). This association was significant for sirolimus-eluting stents and bare metal stents. TLR was also associated with an increased risk of subsequent stent thrombosis and nontarget vessel revascularization. Intracoronary brachytherapy in the TLR group was associated with an increased risk of cardiac death or MI. In conclusion, restenosis requiring TLR was associated with an increased risk of cardiac death or MI occurring at TLR and during the subsequent 5 years.

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 Funding for the conduct of the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) trial, including management and analysis of the 5-year follow-up was provided by the Cordis Corporation, Warren, New Jersey, through a services contract with the Harvard Clinical Research Institute (Boston, Massachusetts). Funding for the statistical analysis of this substudy was provided by Cordis Corporation (Warren, New Jersey) through a research grant to the Harvard Clinical Research Institute (Boston, Massachusetts).

 Dr. Mauri has received honoraria from Abbott Vascular, Redwood City, California, Boston Scientific, Natick, Massachusetts, Cordis Corporation, Warren, New Jersey, and Medtronic Vascular, Santa Rosa, California, and either consulting fees or honoraria from Cordis, Warren, New Jersey, Boston Scientific, Natick, Massachusetts, Medtronic, Santa Rosa, California, and Abbott Vascular, Redwood City, California. Dr. Cohen is a full-time employee of Cordis Corporation, Warren, New Jersey. Dr. Moses has received consulting fees from Johnson & Johnson, Warren, New Jersey. Dr. Leon has received either consulting fees or honoraria from Cordis (Warren, New Jersey), Boston Scientific (Natick, Massachusetts), Medtronic (Santa Rosa, California), and Abbott Vascular (Redwood City, California).

PII: S0002-9149(10)01035-0

doi:10.1016/j.amjcard.2010.04.039

American Journal of Cardiology
Volume 106, Issue 6 , Pages 774-779, 15 September 2010