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.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

Free abstract

Results from the CARDia trial suggest that percutaneous coronary intervention (PCI) has similar efficacy to coronary artery bypass grafting (CABG) for diabetic patients with coronary artery disease (CAD), but results in higher rates of repeat revascularization.

Patients with Type 2 diabetes and multivessel CAD are significantly more prone to complications following revascularization than nondiabetics, and CABG is currently the revascularization method of choice for these individuals.

However, recent developments in PCI, in particular the use of drug eluting stents (DES), have made the choice of the most optimum revascularization technique for diabetics less certain, say researchers.

In the CARDia (Coronary Artery Revascularization in Diabetes) trial, 510 diabetic patients with multivessel or complex single-vessel CAD were randomly assigned to undergo CABG (n=254) or PCI (n=256).

Of note, bare metal stents were initially used in the PCI patients, but DES were used when they became available (69% of patients).

Kevin Beatt (Mayday University Hospital, London, UK) and colleagues report the 1-year follow-up results in the Journal of the American College of Cardiology.

They found that the rate of the composite cardiovascular (CV) endpoint of death, myocardial infarction (MI), and stroke in the CABG and PCI groups was 10.5% and 13.0%, respectively, a non-significant difference. When the CABG group were compared with those who received DES alone, the rates were 12.4% and 11.6%, respectively. All-cause mortality was the same in both groups, at 3.2%.

Rates of repeat revascularization, death, MI, or stroke were 11.3% in the CABG and 19.3% in the PCI group, with repeat revascularization being significantly more likely to occur in those who underwent PCI.

“The 1-year results of the CARDia trial did not demonstrate the noninferiority of PCI versus CABG for revascularization of diabetic patients,” conclude Beatt et al.

“However, the results suggest that there could be greater equipoise between the two strategies, with the decision to use CABG or PCI being based on information from clinical trials, clinician judgment, and patient preference.”

They add: “Longer-term follow-up of the CARDia trial and data from other ongoing trials such as FREEDOM (Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) will provide further information on optimal strategies for coronary revascularization in diabetic patients.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

Free abstract