Interpretation:

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.