https://immattersacp.org/weekly/archives/2010/05/11/5.htm

New drug-eluting stents outperform old ones except in diabetics

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Second-generation drug-eluting stents that released everolimus lowered rates of stent thrombosis and restenosis compared to paclitaxel-eluting stents, a new trial found.

The trial randomized 3,687 patients to receive one or the other drug-eluting stent without routine follow-up angiography. Over the next year, rates of cardiac death, target-vessel myocardial infarction and ischemia-driven target-lesion revascularization (combined as target-lesion failure) were compared between the two groups. The study was published in the May 6 New England Journal of Medicine.

Everolimus-eluting stents performed significantly better than paclitaxel-eluting ones on the composite endpoint of target-lesion failure (4.2% vs. 6.8% of patients; relative risk, 0.62, 95% CI, 0.46 to 0.82; P=0.001). The newer stents also significantly reduced the risk of ischemia-driven target-lesion revascularization (P=0.001), myocardial infarction (1.9% vs. 3.1%, P=0.02) and stent thrombosis (0.17% vs. 0.85%, P=0.004). Study authors noted that the rate of stent thrombosis was among the lowest ever reported for a drug-eluting stent. The everolimus stents also showed a benefit that didn't reach the point of significance in reducing cardiac death and target-vessel myocardial infarction.

The newer stents did not show any significant benefit in patients with diabetes, however, which suggests that the mechanism of restenosis and/or the response to antiproliferative agents may differ in diabetic patients, said an accompanying editorial. Therefore, the paclitaxel-eluting stent may be more appropriate for these patients, the editorialist concluded.

In patients without diabetes, more data about cost-effectiveness are needed to determine whether the higher cost of the everolimus-eluting stents (about $300 extra) is justified by the reduction in adverse events, the editorialist concluded. He also called for additional research on the stents' effect on stent thrombosis and MI when prasugrel instead of clopidogrel is used as anti-platelet therapy.