Author + information
- Received September 9, 2015
- Accepted September 24, 2015
- Published online January 11, 2016.
- Rafael Romaguera, MD∗∗ (, )
- Joan A. Gómez-Hospital, MD, PhD∗,
- Josep Gomez-Lara, MD, PhD∗,
- Salvatore Brugaletta, MD, PhD†,
- Eduardo Pinar, MD‡,
- Pilar Jiménez-Quevedo, MD§,
- Montserrat Gracida, MD∗,
- Gerard Roura, MD∗,
- Jose L. Ferreiro, MD∗,
- Luis Teruel, MD∗,
- Eduard Montanya, MD, PhD‖,
- Antonio Fernandez-Ortiz, MD§,
- Fernando Alfonso, MD, PhD¶,
- Marco Valgimigli, MD#,
- Manel Sabate, MD, PhD† and
- Angel Cequier, MD, PhD∗
- ∗Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain
- †Thorax Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
- ‡Department of Cardiology, Hospital Virgen de la Arrixaca, Murcia, Spain
- §Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain
- ‖Endocrine Unit, Hospital de Bellvitge-IDIBELL, CIBERDEM, University of Barcelona, Barcelona, Spain
- ¶Department of Cardiology, Hospital la Princesa, Madrid, Spain
- #Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands
- ↵∗Reprint requests and correspondence:
Dr. Rafael Romaguera, Hospital Universitari de Bellvitge, Feixa llarga s/n, L’Hospitalet de Llobregat, 08907 Barcelona, Spain.
Objectives The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM).
Background 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.
Methods This was a multicenter, randomized, noninferiority 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 or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up.
Results A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm 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.
Conclusions AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748).
This study was funded by the Spanish Heart Foundation and the Spanish Society of Cardiology, Madrid, Spain. The Spanish Heart Foundation received an unrestricted grant from Biomenco, a company that distributes Alvimedica products in Spain. Dr. Brugaletta has received speaker fees from AstraZeneca, Abbott, BioVentrix, and Boston Scientific. Dr. Sabate has received a research grant and speaker fees from Abbott. Dr. Gracida was awarded an educational grant from the Spanish Society of Cardiology. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 9, 2015.
- Accepted September 24, 2015.
- 2016 American College of Cardiology Foundation