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To compare the efficacy of amphilimus-eluting stents (AES) vs everolimus-eluting stents (EES) in patients with diabetes mellitus (DM).
The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM.
This was a multicenter, randomized, non-inferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin, and de novo coronary lesions were randomized in a 1:1 fashion to AES vs EES. The primary endpoint was the neointimal volume obstruction assessed by optical coherence tomography at 9-month follow-up.
A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with median hemoglobin A1c 7.3% (interquartile range 6.7-8.0). The primary endpoint, neointimal volume obstruction, was 11.97 ± 5.94% for AES vs 16.11 ± 18.18% for EES, reaching the non-inferiority criteria (p=0.0003). Prespecified subgroup analyses showed a significant interaction between stent type and glycaemic control (p=0.02), with a significant reduction of neointimal hyperplasia in the AES group in patients with the higher hemoglobin A1c (p=0.03). By QCA, in-stent late loss was 0.14 ± 0.24 for AES vs 0.24 ± 0.57mm for EES (p=0.27), with a larger minimal lumen diameter at follow-up for AES (p=0.02), mainly driven by 2 cases of occlusive restenosis in the EES group.
AES are non-inferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and it may support the potential benefit of this stent in patients with DM. Clinical trial info: NCT01710748.