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JAMA-EXPRESS
Sirolimus-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal StentsThe SISR Randomized Trial
David R. Holmes Jr, MD;
Paul Teirstein, MD;
Lowell Satler, MD;
Michael Sketch, MD;
James O’Malley, PhD;
Jeffery J. Popma, MD;
Richard E. Kuntz, MD, MSc;
Peter J. Fitzgerald, MD, PhD;
Hong Wang, MD, MPH;
Eileen Caramanica, BA, MS;
Sidney A. Cohen, MD, PhD; for the SISR Investigators
JAMA. 2006;295:1264-1273. Published online March 12, 2006 (doi:10.1001/jama.295.11.1264).
Context Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited.
Objective To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare-metal stent.
Design, Setting, and Patients Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005.
Interventions Vascular brachytherapy (n = 125) or the sirolimus-eluting stent (n = 259).
Main Outcome Measure Target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months postprocedure.
Results Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients (mean [SD], 16.76 [8.55] mm vs 17.22 [7.97] mm, respectively; P = .61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group (P = .28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent (relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P = .02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group (RR, 2.3 [95% CI, 1.3-3.9]; P = .004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group (RR, 1.5 [95% CI, 1.0-2.2]; P = .07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up (mean [SD], 1.52 [0.63] mm vs 1.80 [0.63] mm; P<.001), reflecting greater net lumen gain in the analysis segment (0.68 [0.60] vs 1.0 [0.61] mm; P<.001) due to stenting and no edge restenosis.
Conclusion Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent.
Trial Registration ClinicalTrials.gov Identifier: NCT00231257
Author Affiliations: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn (Dr Holmes); Scripts Clinic, La Jolla, Calif (Dr Teirstein); Department of Cardiology, Washington Hospital Center, Washington, DC (Dr Satler); Department of Cardiology, Duke University Medical Center, Durham, NC (Dr Sketch); Department of Health Care Policy, Harvard Medical School, Boston, Mass (Dr O’Malley); Department of Cardiology, Brigham and Women's Hospital, Boston, Mass (Drs Popma and Kuntz); Department of Cardiology, Stanford University Medical Center, Stanford, Calif (Dr Fitzgerald); Cordis Corporation, Warren, NJ (Drs Wang and Cohen and Ms Caramanica); and Department of Cardiology, Hospital of the University of Pennsylvania, Philadelphia (Dr Cohen).
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