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Drug-Eluting Stents Appear Superior to Bare Metal in Diabetics

Feb 20, 2007
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Both paclitaxel- and sirolimus-eluting stents show “a trend toward more favorable outcome” in diabetics with occluded coronary arteries compared with bare-metal stents, Dutch investigators reported. Dr. Patrick W. Serruys and colleagues at Erasmus Medical Center in Rotterdam analyzed 2-year outcomes of 708 patients with diabetes mellitus enrolled in the RESEARCH and T-SEARCH registries. One in four of the diabetics were insulin-dependent.
The patients received a bare-metal stent, a paclitaxel-eluting stent or a sirolimus-eluting stent to open occluded coronary vessels.
The investigators report that the relative risk for target vessel revascularization and major adverse events was not significantly different in the paclitaxel-eluting stent compared with the bare-metal stent, after adjusting for independent predictors of adverse events.

The paclitaxel-eluting stent had a non-significant lower incidence of target vessel revascularization and major adverse events compared with sirolimus-eluting stent in non-insulin-dependent diabetics at 2 years. The rate of adverse events was higher with sirolimus-eluting stent at 1 year.

 

The 2-year cumulative mortality was comparable in all three groups. However, mortality rate during the second year was 5.8% in the sirolimus-eluting stent group compared with 1.2% in the paclitaxel-eluting stent group (p = 0.007).

The investigators observed that the incidence of stent thrombosis was 4.4% in the sirolimus-eluting stent group compared with 2.4% in the paclitaxel-eluting stent group and 0.8% in patients who received bare metal stents. The higher mortality rate with sirolimus-eluting stent may be related to the increased incidence of stent thrombosis in patients treated with the sirolimus-eluting stent.

The Dutch team notes that, overall, "there was no significant difference between sirolimus-eluting stent and paclitaxel-eluting stent in each of the clinical endpoints, and neither in the non-insulin-dependent diabetes mellitus group, which are hypothesized to be better off with paclitaxel-eluting stent."

"The present study suffers from the inherent limitations of a non-randomized trial," Dr. Serruys’ team notes. "More larger-scale and randomized trials are needed to elucidate the best treatment for patients with diabetes mellitus and the possible superiority of one drug-eluting stent compared to another, also taking into account the long-term adverse events like stent thrombosis," the Dutch investigators conclude.

As reported in the January issue of the European Heart Journal. However, the question of whether one drug-eluting stent is superior to the other remains unclear.

Eur Heart J 2007;28:26-32.

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