Two-year intravascular ultrasound observations in diabetic patients treated with single and double dose sirolimus-eluting stents: results of the double dose diabetes (3D) study

Abstract

Background: Diabetes mellitus has been reported an independent predictor of restenosis after drug-eluting stent implantation in patients with coronary artery disease. We assessed the impact of increased drug dose in sirolimus-eluting stent (SES) on neointimal hyperplasia (NIH) inhibition in diabetic patients.

Methods: The 3D trial is a multicenter, prospective feasibility study of 56 diabetic patients randomized to double dose (280μg/cm2) or conventional single dose (140μg/cm2) SESs. To evaluate long-term efficacy, complete serial volumetric analyses (baseline, 6-month and 2-year follow-up) were performed in 39 diabetic patients (17 single dose and 22 double dose). In each case, the volume was divided by stent length to acquire volume index, expressed as mm3/mm. Percent neointimal volume was calculated as (neointimal volume/stent volume)*100 at follow-up.

Results: The two groups had similar baseline clinical and angiographic characteristics. Volumetric analysis showed similar results over time between the 2 stent groups (p=NS for all). At 2-year follow-up, minimal increase in NIH area and percent NIH were observed, which translated into a decreased lumen volumen index (p<0.05 for all) (table⇓). No late-acquired incomplete stent apposition was observed in either group.

Conclusion: SES is highly effective in inhibiting NIH in diabetic patients up to 2 years. However, double dose of SES did not confer additional NIH inhibition at 2-year follow-up.