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ISAR-DESIRE 2: Paclitaxel-, sirolimus-eluting stents comparable for treating in-stent restenosis
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Patients who experienced sirolimus-eluting stent restenosis had similar outcomes after treatment with either repeat sirolimus-eluting stent implantation or a switch to paclitaxel-eluting stent, results from the ISAR-DESIRE 2 trial indicated.
Researchers from Munich, Germany enrolled 450 patients with clinically significant in-sirolimus–eluting stent (SES; Cypher, Cordis) restenosis and randomly assigned 225 to SES and 225 to paclitaxel-eluting stent (PES; Taxus, Boston Scientific) implantation. They measured primary endpoints including late lumen loss on angiography at six- to eight-month follow-up. Secondary endpoints were comprised of binary angiographic restenosis (diameter stenosis >50%) at six to eight months, target lesion revascularization, composite death or MI rates and definite stent thrombosis at 12 months.
The researchers found no differences between the SES and PES late loss (0.40 mm vs. 0.38 mm; P=.85), binary restenosis (19.6% vs. 20.6%; P=.69) or target lesion revascularization (16.6% vs. 14.6%; P=.52), suggesting similar anti-restenotic efficacy among the two treatments. Rates of death/MI (6.1% vs. 5.8%; P=.86) and stent thrombosis (0.4% vs. 0.4%; P >.99) were also similar.
“The findings of the ISAR-DESIRE 2 study demonstrate that, in cases of SES restenosis, both SES and PES are associated with a comparable degree of anti-restenotic efficacy and clinical safety,” the researchers wrote.
However, they warned that SES drug resistance at the patient level is a concern, as neointimal inhibition observed in the SES group was lower than expected.
Mehilli J. J Am Coll Cardiol. 2010;doi:10.1016/j.jacc.2010.02.009.
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