Affiliation: | 1. Department of Biomedical Sciences, Humanitas University, Milan, Pieve Emanuele, Italy;2. Department of Biomedical Sciences, Humanitas University, Milan, Pieve Emanuele, Italy Cardio Center, IRCCS Humanitas Research Hospital, Milan, Rozzano, Italy;3. Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy;4. Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute, Milan, Italy;5. Department of Advanced Biomedical Sciences, Division of Cardiology, University of Naples Federico II, Naples, Italy UNESCO Chair on Health Education and Sustainable Development, University of Naples Federico II, Naples, Italy;6. Department of Cardiology, Ospedale San Pietro Fatebenefratelli, Rome, Italy;7. Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;8. Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, New York, Bronx, USA |
Abstract: | 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. |