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Data expand understanding of DES in patients with diabetes
Briguori C. Circ Cardiovasc Interv. 2011;4:121-129.
Ndrepepa G. Circ Cardiovasc Interv. 2011;4:115-117.
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A new study has compared outcomes of three different drug-eluting stents in patients with diabetes and found the highest rate of major adverse cardiac events in patients treated with zotarolimus-eluting stents.
The study, called the Naples-Diabetes trial, was a randomized, single-center pilot study that included 226 patients with type 2 diabetes and without previous myocardial revascularization. The Italy-based researchers randomly assigned patients into treatment with one of three drug-eluting stents (DES): sirolimus-eluting (Cypher, Cordis; n=76), paclitaxel-eluting (Taxus, Boston Scientific; n=75) or zotarolimus-eluting (Endeavor, Medtronic; n=75). They defined the primary endpoint as a 3-year composite of major adverse cardiac events, which incorporated all-cause mortality, nonfatal MI and clinically driven target lesion revascularization (TLR) or target vessel revascularization.
At follow-up, the primary endpoint was 13.2% in the sirolimus group, 17.5% in the paclitaxel group and 35.6% in the zotarolimus group (P=.006 by log-rank test). Although post hoc analysis revealed no significant difference between sirolimus- and paclitaxel-eluting stents, a higher major adverse cardiac event rate was reported when zotarolimus-eluting stents were compared with sirolimus- (adjusted P=.012) and paclitaxel-eluting (adjusted P=.075) stents, which researchers said was mostly driven by TLR.
Further analysis also indicated the following independent predictors of major adverse cardiac events: zotarolimus- vs. sirolimus-eluting stents (adjusted HR=2.35), multivessel disease (adjusted HR=1.78), diabetic retinopathy (adjusted HR=1.6) and poor metabolic control (adjusted HR=1.6).
Despite the clear indication of a higher 3-year major adverse cardiac event rate in the zotarolimus-eluting group, the researchers wrote that it is still necessary that the results of the pilot study be confirmed in larger studies.
In an accompanying editorial, Gjin Ndrepepa, MD, Lamin King, MD, and Adnan Kastrati, MD, with the Deutsches Herzzentrum, Technische Universität, Munich, Germany, said the results suggest that being a member of the limus drug family alone is not sufficient to predict a good or poor response of coronary vessels in patients with diabetes.
“The most relevant lesson from this study is, however, that at least two independent determinants of treatment results in diabetic patients — the type of DES and metabolic control — are largely under the physician’s control, which gives hope for our ability to favorably affect on the outcomes of these patients,” they said.
Disclosure: Dr. Kastrati reports having received honoraria from Abbott, Biosensors, Biotronic and Cordis. Drs. King and Ndrepepa report no relevant financial disclosures.
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