Original title: Sirolimius-eluting versus paclitaxel-eluting stents in diabetic and non-diabetic patients within sirolimus-eluting stents restenosis: Results from the ISAR-DESIRE 2 trial. Reference: Sebastian Kufner, et al. Cardiovascular Revascularization Medicine 2014, 15:69-75.
DES restenosis has always generated a challenge and a puzzle when defining the strategy of revascularization by angioplasty: A quite used concept was to switch to another drug. While this has not been tested in major randomized studies, is often a common practice.
In this randomized study, symptomatic patients experiencing angina or myocardial ischemia and restenosis ≥ 50 % of sirolimus – eluting stents (Cypher SES) were included. Patients were randomized to angioplasty with a new sirolimus – eluting stent (Cypher SES group) or switch to a paclitaxel – eluting stent (Taxus PES group). The study primary endpoint was in-stent late lumen loss, and the secondary the binary restenosis, both at 12 months. Of the 450 patients registered, 162 (36 %) were diabetics of whom 86 received SES and 76 PES. Among the 288 non-diabetics, 139 received SES and 149 PES. There were no differences in clinical, angiographic or morphological restenosis characteristics within different groups, being the focal restenosis the most common type. After 12 months no difference in the primary endpoint were observed (in-stent late lumen loss) both among diabetics (SES 0.38±0.59 mm versus PES 0.37±0.59mm; p=0.97) as in non-diabetics (SES 0.41±0.67mm versus PES 0.38±0.60mm; p=0.89). The secondary end point (binary restenosis) was not different between groups beyond being diabetic or not (SES 19% versus PES 26%; p=0.32 in the diabetic group and SES 19.9 % versus PES 17.8 %, P = 0.36 in non-diabetics).
The most frequent morphological pattern of restenosis was the focal again. There was no difference in the rate of target lesion revascularization between groups (SES 16.3% versus PES15.8% in diabetics and SES 14.1% versus PES 12.1% in non-diabetic). Safety endpoints such as death, myocardial infarction and stent thrombosis considered separately or compound thereof also showed similar results.
Conclusion:
In the restenosis case caused by SES, the treatment with a new SES implant or rotate a PES, was associated with comparable efficacy in both diabetic and nondiabetic patients.
Editorial comment
This randomized and controlled trial shows us that in first generation SES restenosis, performing an angioplasty with another SES of the same generation with the same or different drug is feasible in both, diabetic and nondiabetic patients getting good results and maintaining safety and effectiveness of the procedure. While this is about first generation of DES, would be good to test them with the second generation.
Courtesy of Carlos Fava, MD
Interventional cardiologist
Fundacion Favaloro – Buenos Aires
Dr. Carlos Fava para SOLACI.ORG