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3-Year Follow-Up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) Trial

David R. Holmes, Jr, MD^_*,_*, Paul S. Teirstein, MD, Lowell Satler, MD, Michael H. Sketch, Jr, MD, Jeffery J. Popma, MD^||, Laura Mauri, MD, MSc^||, Hong (Patrick) Wang, MD, MPH^¶, Patricia A. Schleckser, BS^¶, Sidney A. Cohen, MD, PhD^¶ SISR Investigators

^_* Department of Cardiology, Mayo Clinic, Rochester, Minnesota
Scripps Memorial Hospital, La Jolla, California
Washington Hospital Center, Washington, DC
Duke University Medical Center, Durham, North Carolina
^|| Brigham & Women's Hospital, Boston, Massachusetts
^¶ Cordis Corporation, Warren, New Jersey.

^_* Reprint requests and correspondence: Dr. David R. Holmes Jr., Mayo Clinic, 200 First Street SW, SMH MB 4-523, Rochester, Minnesota 55905. (Email: holmes.david{at}mayo.edu).

Objectives: The aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS).

Background: Treatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.

Methods: We evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.

Results: Target vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).

Conclusions: At 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions.

Key Words: bare-metal stent restenosis • vascular brachytherapy • Cypher stent

Abbreviations and Acronyms   ARC = academic research consortium   DES = drug-eluting stent(s)   MACE = major adverse cardiac events   MI = myocardial infarction   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization   VBT = vascular brachytherapy