SES-SMART: Drug-Eluting Stents Efficacious in Diabetic Patients With Small Arteries

December 13, 2005

By Josh Murphy

Post-hoc diabetic results from the Sirolimus-Eluting Versus Uncoated Stents for Prevention of Restenosis in Small Coronary Arteries (SES-SMART) trial indicate that sirolimus-eluting stents (Cordis Corporation) significantly reduce angiographic markers of restenosis compared to bare metal stents in diabetic patients with small coronary arteries.¹

SES-SMART investigators randomized patients with and without diabetes and one or more de novo native coronary lesions <2.75 mm in diameter to treatment with sirolimus-eluting or bare metal stents (N=260). The present analysis compares rates of binary in-segment restenosis (primary outcome) as well as procedural success, in-segment minimal lumen diameter, late lumen loss, and major adverse cardiac events (MACE: death, MI, or repeat revascularization) at 8 months in diabetic participants (n=74). Diabetes was defined by patient reported history. Binary restenosis was defined as >50% diameter stenosis of the target lesion.

There was a significant reduction in rates of in-segment restenosis in patients in the DES group compared to BMS (25% vs 63%, P=0.003). This was driven by a significant reduction in in-stent restenosis in the DES group (11% vs 59%, P<0.001). Significant reductions in diffuse and occlusive restenosis were also noted in the SES group.

With respect to secondary outcomes, patients in the SES group had significantly larger minimal lumen diameter at 8 months, both in-segment and in-stent, as well as smaller in-segment and in-stent late loss (Figure 1). Although there was 15% absolute reduction in MACE at 8 months in the SES group, this difference was not significant (86% vs 71%, P=0.35).

In patients with insulin-dependent diabetes, there were significant reductions in rates of in-segment and in-stent restenosis in patients randomized to SES (Figure 2). However, there were no significant differences in either in-segment or in-stent restenosis rates in patients with insulin-dependent diabetes (Figure 3).

Investigators summarize that although SES indicate better angiographic outcomes for patients with diabetes and small vessels, restenosis rates from SES-SMART were greater than those in diabetic patients in the RAVEL2 and SIRIUS3 trials. This finding is likely due to the use of predilation procedures in patients in SES-SMART, thus the use of pre- and post-dilatation should be avoided in patients with diabetes and small vessels, they note.

References

1. Ortolani P, Ardissino D, Cavallini C, et al. Effect of Sirolimus-Eluting Stent in Diabetic Patients With Small Coronary Arteries (A SES-SMART Substudy). Am J Cardiol 2005;96:1393-1398.
2. Abizaid, A, Costa MA, Blanchard D, et al. Sirolimus-Eluting Stents Inhibit Neointimal Hyperplasia in Diabetic Patients. Insights from the RAVEL Trial. Eur Heart J 2004;25:107-112.
3. Moussa I, Leon, M, Baim D, et al. Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients. Circulation 2004;109:2273-2278.