Real-world registry supports safety of DES in diabetic patients
MedWire News: Drug-eluting stents (DES) are associated with half the risk for restenosis and an equivalent risk for death and myocardial infarction (MI) compared with bare-metal stents (BMS) in patients with diabetes and coronary artery disease (CAD), a Swedish registry study suggests.
The results support the long-term safety and efficacy of DES in diabetic patients, who tend to have more extensive CAD and higher rates of disease progression and restenosis than their nondiabetic counterparts.
The national Swedish Coronary Angiography and Angioplasty Registry (SCAAR) records data on all patients undergoing coronary angiography and percutaneous coronary intervention. It also allows analysis of patient outcomes through linkage with other national databases.
For the present study, Stefan James (Uppsala Clinical Research Center) and fellow members of the SCAAR/SWEDEHEART study group evaluated long-term outcomes in patients with diabetes undergoing coronary angiography and stenting with either DES or BMS.
A total of 9710 diabetic patients underwent coronary stenting between 2003 and 2006, and were followed-up for a median of 2.5 years.
Analysis revealed that the composite outcome of death or MI was similar irrespective of the type of stent used, with a relative risk (RR) of 0.91 for DES versus BMS.
However, rates of both MI and restenosis were significantly lower in patients who received a DES, with RRs of 0.80 and 0.50, respectively, versus BMS. The reduction in restenosis was observed in patients with either stable or unstable CAD, and was most pronounced in those with a stent diameter of less than 3 mm or a stent length of more than 20 mm.
Importantly, the presence of restenosis was associated with a five-fold increased risk for MI (RR=50.3), irrespective of type of stent received.
“The use of DES in diabetic patients is considered off-label by the US Food and Drug Administration, because adequate numbers of diabetic patients have not been evaluated in clinical trials,” remark the authors.
“Despite this categorization, our real-life study shows that DES is safe and effective in reducing clinical restenosis in patients with diabetes mellitus.”
The study is reported in the European Heart Journal.
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By Joanna Lyford