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ISAR-TEST-2: Polymer-free, second-generation stents bested first-generation stents at two years
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American College of Cardiology 59th Annual Scientific Sessions
ATLANTA – A polymer-free, dual siroliumus- and probucol-eluting stent and second-generation zirolimus-eluting stent were associated with superior long-term benefits compared with a first-generation sirolimus-eluting stent, new study findings indicate.
Researchers presented two-year outcomes data from ISAR-TEST-2 today. They compared the antirestenotic efficacy of a polymer-free sirolimus- plus probucol-eluting stent (n=333) with a first-generation permanent polymer sirolimus-eluting stent (Cypher, Cordis; n=335) and a second-generation permanent polymer zotarolimus-eluting stent (Endeavor, Medtronic; n=339) in 1,007 patients with coronary artery disease (mean age, 67 years). The groups were well matched at baseline; one-quarter were women, 30% had diabetes, 12% to 15% had acute MI, 25% to 30% had unstable angina and the remainder had stable CAD.
The level of antirestenotic benefits of both the sirolimus- plus probucol-eluting stent and zotarolimus-eluting stent at one year were maintained out to two years after stent implantation. There was evidence of a slight decrement in antirestenotic efficacy with the siroliumus-eluting stent, Robert Byrne, MB, BCh, said at a presentation. The researchers also noted evidence of a slight gradual increase in angiographic and clinical antirestenotic benefits with the sirolimus-eluting stent.
Incident cases requiring revascularization between one and two years in the sirolimus- plus probucol-eluting stent group (0.9%) was significantly lower than the sirolimus-eluting stent (3.6%), but comparable with the zotarolimus-eluting stent (0.7%).
Overall, cases requiring revascularization at two years were 7.7% in the sirolimus- plus probucol-eluting stent group, 10.7% in the sirolimus-eluting stent group and 14.3% in the zotarolimus-eluting stent group.
The incidence of definite stent thrombosis was 0.6% for the zotarolimus-eluting stent and 0.9% for both the sirolimus- and sirolimus- plus probucol-eluting stents.
Binary restenosis at two years was 13.9% with the sirolimus- plus probucol-eluting stent, 18.8% with the sirolimus-eluting stent and 20.9% with the zotarolimus-eluting stent.
Byrne said the occurrence of safety events beyond one year in ISAR-TEST-2 was rare, and “there was no signal of a differential safety profile between the Cypher, the dual drug-eluting stent and Endeavor out to two years,” he said at the presentation.
The researchers cautioned that more research is needed to fully understand the costs and benefits of various stents.
“The comparative safety results of this study should be interpreted with caution, as this was not a trial powered to detect differences in relatively rarely occurring safety events,” Byrne said in a press release. “This is a matter to be investigated with long-term follow-up of larger patient numbers.” – by Katie Kalvaitis
It is very important to look beyond the primary endpoint out to two years. In particular, when looking at a new drug-eluting stent platform, it is critically important to look at long-term outcomes because we are interested in finding out if there is a mechanism to preserve efficacy, but then perhaps improve safety. This trial obviously is not powered to determine if there is some incremental benefit in terms of safety, but I think it is an interesting question.
- Laura Mauri, MD
Chief Scientific Office of Harvard Clinical Research Institute
For more information:
- Byrne R. LBCT III. Presented at: American College of Cardiology 59th Annual Scientific Sessions; March 13-16, 2010; Atlanta.
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