title: A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial.
abstract: OBJECTIVE
  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).
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain. Electronic address: rafaromaguera@gmail.com.
authors.forename: Rafael
authors.initials: R
authors.lastname: Romaguera
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Joan A
authors.initials: JA
authors.lastname: Gómez-Hospital
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Gomez-Lara
authors.affiliation: Thorax Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.affiliation: Department of Cardiology, Hospital Virgen de la Arrixaca, Murcia, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pinar
authors.affiliation: Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Gracida
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Gerard
authors.initials: G
authors.lastname: Roura
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Jose L
authors.initials: JL
authors.lastname: Ferreiro
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Teruel
authors.affiliation: Endocrine Unit, Hospital de Bellvitge-IDIBELL, CIBERDEM, University of Barcelona, Barcelona, Spain.
authors.forename: Eduard
authors.initials: E
authors.lastname: Montanya
authors.affiliation: Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Fernandez-Ortiz
authors.affiliation: Department of Cardiology, Hospital la Princesa, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Thorax Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabate
authors.affiliation: Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives; D013030:Spain; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D002317:Cardiovascular Agents; D000068338:Everolimus; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D011108:Polymers; D020123:Sirolimus; C517652:hemoglobin A1c protein, human
keywords: diabetes mellitus; drug-eluting stents; optical coherence tomography; restenosis