September 01, 2011
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Sirolimus- and probucol-eluting stent shows promise

Massberg S. Circulation. 2011;124:624-632.

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A sirolimus- and probucol-eluting stent demonstrated noninferiority to a zotarolimus-eluting stent regarding a host of clinical endpoints, according to study results.

The current trial involved 3,002 patients randomly assigned to the dual-drug stent or the zotarolimus-eluting stent. The aim was to demonstrate noninferiority of the dual-drug stent by evaluating for a composite primary endpoint of the combined incidence of cardiac death, target vessel-related MI or target lesion revascularization. The overall follow-up period was 1 year, with angiography scheduled at 6 to 8 months.

The sirolimus- and probucol-eluting stent yielded a 13.1% incidence rate for the combined primary endpoint vs. 13.5% for the zotarolimus-eluting stent, which the researchers said was noninferior (HR=0.97, 95% CI, 0.78-1.19).

The dual-drug stent was linked to a 1.1% incidence rate of definite/probable stent thrombosis vs. a 1.2% rate in the zotarolimus group (HR=0.91; 95% CI, 0.45-1.84).

No differences were observed in terms of angiographic efficacy. In-segment binary angiographic restenosis was 13.3% in the dual-drug group and 13.4% in the zotarolimus group (P=.95); in-stent late luminal loss was 0.31 ± 0.58 mm in the dual-drug group and 0.29 ± 0.56 mm in the zotarolimus group (P=.46).

Researchers from sites in Germany said two stents — the polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent — have demonstrated encouraging results in light of adverse events associated with durable polymer coatings after drug-eluting stent implantation.

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