Paclitaxel-Eluting Stent v. Sirolimus-Eluting Stent for the Prevention of Restenosis in Diabetic Patients with Coronary Artery Disease (ISAR DIABETES)
Presented at ACC, 2005
The aim of the present randomized, single center trial was to evaluate role of paclitaxel-eluting stent, Taxus compared with sirolimus-eluting stent, Cypher among diabetic patients with symptomatic coronary artery disease with de novo lesions. Patients were randomized to stent implantation with either the Taxus stent (n=125) or Cypher stent (n=125). Patients underwent angiographic follow-up at 6-8 months. Baseline clinical and angiographic characteristics were comparable between the treatment groups, with a lesion length of 12.4 mm in the Taxus group and 13.8 mm in the Cypher group. The primary endpoint of late in-stent lumen loss at angiographic follow-up at 6 to 8 months was 0.67 mm in the Taxus group and 0.43 mm in the Cypher (p=0.86 for non-inferiority; p=0.002 for superiority of the Cypher v. the Taxus group). Angiographic restenosis occurred more frequently in the Taxus group (16.5% v. 6.9%, p=0.03). Target lesion revascularization at 9 months was performed in 12.0% of the Taxus group and 6.4% of the Cypher group (p=0.13). There was no difference in 9-month mortality (4.8% for Taxus v. 3.2% for Cypher, p=0.52) or myocardial infarction (2.4% v. 4.0%, p=NS). Among diabetic patients with coronary artery disease, treatment with the sirolimuseluting stent was associated with a lesser late lumen loss at 6-8 months angiographic follow-up compared to treatment with the paclitaxel-eluting stent. Whether the angiographic benefits will also lead to clinical improvement needs to be further evaluated. The results of the present trial should be restricted to high-risk population of diabetic patients, and should not be extrapolated to other patient subgroups.