Paclitaxel-Eluting Stent Versus Sirolimus-Eluting Stent for the Prevention of Restenosis in Diabetic Patients With Coronary Artery Disease - ISAR DIABETES
The goal of the trial was to evaluate treatment with paclitaxel-eluting stents compared with sirolimus-eluting stents among diabetic patients with coronary artery disease.
Treatment with paclitaxel-eluting stents will be noninferior to treatment with sirolimus-eluting stents among diabetic patients with coronary artery disease.
Patients Enrolled: 250
Mean Follow Up: Nine months
Mean Patient Age: Mean age 68 years
Mean Ejection Fraction: Mean baseline ejection fraction 51%
Diabetic patients with angina and diameter stenosis ≥50%
Acute MI, left main disease, in-stent restenosis, or allergy to study medication
Noninferiority by treatment group in late lumen loss at 6-8-month angiographic follow-up
Angiographic restenosis (stenosis ≥50%) at follow-up; and need for target lesion revascularization
Patients were randomized to stent implantation with either the paclitaxel-eluting stent (n=125) or the sirolimus-eluting stent (n=125). Patients underwent angiographic follow-up at 6-8 months.
Baseline clinical and angiographic characteristics were well matched between the treatment groups, with a lesion length of 12.4 mm in the paclitaxel-eluting stent group and 13.8 mm in the sirolimus-eluting stent group. The left anterior descending artery was treated in 51% of the paclitaxel-eluting stent group and 46% of the sirolimus-eluting stent group.
The primary endpoint of late lumen loss at angiographic follow-up was 0.67 mm in the paclitaxel-eluting stent group and 0.43 mm in the sirolimus-eluting stent group, which did not meet the predefined criteria for noninferiority of the paclitaxel-eluting stent, but did meet superiority criteria (p=0.86 for noninferiority; p=0.002 for superiority of the sirolimus-eluting stent vs. the paclitaxel-eluting stent group). Angiographic restenosis occurred more frequently in the paclitaxel-eluting stent group (16.5% vs. 6.9%, p=0.03).
Target lesion revascularization was performed in 12.0% of the paclitaxel-eluting stent group and 6.4% of the sirolimus-eluting stent group (p=0.13). There was no difference in nine-month mortality (4.8% for paclitaxel-eluting stent vs. 3.2% for sirolimus-eluting stent, p=0.52) or myocardial infarction (MI) (2.4% vs. 4.0%, p=NS).
Among diabetic patients with coronary artery disease, treatment with the sirolimus-eluting stent was associated with a reduction in late lumen loss on 6-8-month angiographic follow-up compared to treatment with the paclitaxel-eluting stent.
Similar results were reported in the ISAR-DESIRE trial among patients with in-stent restenosis, which demonstrated that use of the sirolimus drug-eluting stent was associated with a lower target vessel revascularization rate and smaller late lumen loss than use of the paclitaxel drug-eluting stent. While the present study addresses an important high-risk population, diabetic patients, the results should not be extracted to other populations. Additionally, whether these angiographic benefits will result in clinical benefits are unknown and would need to be answered in a larger trial.
The much larger REALITY trial compared the sirolimus versus paclitaxel drug-eluting stent in patients with de novo lesions, and demonstrated improvements in angiographic parameters of minimum lumen diameter, late lumen loss, and diameter stenosis with sirolimus-eluting stents, but no difference in the primary endpoint of binary restenosis or in clinical major adverse cardiac event (MACE) rates. The SIRTAX trial, however, did show a reduction in MACE associated with sirolimus-eluting stents compared with paclitaxel-eluting stents, a finding that was particularly notable in the diabetic subgroup.
Dibra A, et al. Paclitaxel-Eluting or Sirolimus-Eluting Stents to Prevent Restenosis in Diabetic Patients. N Engl J Med 2005;353:663-70.
Presented by Dr. Adnan Kastrati at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Keywords: Paclitaxel, Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus
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