Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial.
BACKGROUND
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.


METHODS
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.


METHODS
Vascular brachytherapy (n = 125) or the sirolimus-eluting stent (n = 259).


METHODS
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.


CONCLUSIONS
Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00231257.
Holmes
David R
DR
Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn 55905, USA. holmes.david@mayo.edu
Teirstein
Paul
P
Satler
Lowell
L
Sketch
Michael
M
O'Malley
James
J
Popma
Jeffery J
JJ
Kuntz
Richard E
RE
Fitzgerald
Peter J
PJ
Wang
Hong
H
Caramanica
Eileen
E
Cohen
Sidney A
SA
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001499:Bayes Theorem; D001918:Brachytherapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
D020123:Sirolimus