Randomized clinical trial of abluminus DES+ sirolimus‐eluting stent versus everolimus‐eluting DES for percutaneous coronary intervention in patients with diabetes mellitus: An optical coherence tomography study

Background Diabetic patients are at higher risk of recurrent adverse events following percutaneous coronary intervention (PCI) than the nondiabetics. Despite the introduction of new generation drug‐eluting stents, their efficacy in the diabetics is still limited. Aims To evaluate the efficacy of the Abluminus DES+ biodegradable polymer sirolimus‐eluting stent in reducing neointimal hyperplasia in diabetic patients, compared to a durable polymer everolimus‐eluting stent (DP‐EES). Methods A total of 131 patients with diabetes and coronary artery disease were enrolled in six Italian centers and randomized in a 2:1 fashion to PCI with Abluminus DES+ or DP‐EES: 85 were assigned to Abluminus DES+ and 46 to DP‐EES. The primary endpoint was optimal coherence tomography (OCT)‐derived neointimal volume at 9–12 months. Secondary endpoints included OCT‐derived neointimal area, neointimal volume obstruction and adverse clinical events. Results The primary endpoint, neointimal volume, did not differ between Abluminus DES+ and DP‐EES (29.11 ± 18.90 mm3 vs. 25.48 ± 17.04 mm3, p = 0.40) at 9–12‐month follow‐up. This finding remained consistent after weighing for the sum of stents lengths (1.14 ± 0.68 mm3 vs. 0.99 ± 0.74 mm3 for Abluminus DES+ and DP‐EES, respectively, p = 0.38). Similarly, other OCT‐derived and clinical secondary endpoints did not significantly differ between the two groups. Rate of target lesion failure was high in both groups (21.2% for Abluminus DES+ and 19.6% for DP‐EES). Conclusions This preliminary study failed to demonstrate the superiority of the Abluminus DES+ over the DP‐EES in diabetic patients in terms of neointimal proliferation.