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SISR: Sirolimus stent bested intravascular brachytherapy
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WASHINGTON — A sirolimus-eluting stent was superior to intravascular brachytherapy in patients with in-stent restenotic lesions. The stent outperformed brachytherapy on nearly all endpoints in the randomized trial.
The Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions (SISR) trial compared the sirolimus-eluting Cypher stent and intravascular brachytherapy for treatment of patients with in-stent restenotic coronary artery lesions. Vascular brachytherapy is currently the only approved treatment for in-stent restenosis, but drug-eluting stents have demonstrated potential as treatments for this problem.
The study, designed to demonstrate either superiority or noninferiority, was presented by David R. Holmes Jr., MD, of the Mayo Clinic in Rochester, Minn.
A total of 384 patients presenting with in-stent restenosis with native coronary artery lesions were randomized at a 2:1 ratio to either the Cypher sirolimus-eluting stent (259 patients) or to intravascular brachytherapy (125 patients).
Target vessel failure, the study’s primary endpoint, was identified in 12.4% of patients after nine months in the drug-eluting stent group and in 21.6% in the brachytherapy group (P=.023). Target lesion revascularization and target vessel revascularization were similarly better in the Cypher group.
After six months, angiographic analyses showed similar late lumen loss for the analysis segment and the proximal edge, but at the distal edge, patients in the brachytherapy group had significantly more loss (0.04 mm vs. 0.21 mm, P<.001).
Holmes said that this distal-edge difference drove the results of the trial.
For the analysis segment, patients in the Cypher group had 32.35% diameter stenosis vs. 40.97% in the brachytherapy group (P<.001); for the injury segment, the diameter stenosis was 21.13% vs. 29.73%, respectively (P=.004). There were two cases of stent thrombosis in the Cypher group and none in the other group.