title: Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis: Insights from the Atherosclerosis Lesion Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial.
abstract: BACKGROUND
  Intermediate saphenous vein graft (SVG) lesions have high rates of progression. The purpose of this study was to examine the impact of extended-release niacin (ER-niacin) vs placebo on intermediate SVG lesions.
  
  
  METHODS
  Patients with intermediate (30%-60% diameter stenosis) SVG lesions were randomized to ER-niacin vs placebo for 12 months. Quantitative coronary angiography (QCA), intravascular ultrasonography (IVUS), and optical coherence tomography (OCT) were performed at baseline and at 12 months. The primary endpoint was change in percent atheroma volume (ΔPAV). Enrollment was planned for 138 patients for 90% power to detect ≥2.5% difference in the primary endpoint of ΔPAV, but stopped early after publication of two negative outcome trials of ER-niacin, with enrolled patients completing the 12-month trial protocol.
  
  
  RESULTS
  Thirty-eight patients were randomized to niacin (n = 19) or placebo (n = 19), yielding power of 47% to detect the primary planned treatment effect of 2.5 ± 4.0% difference in ΔPAV. Between baseline and 12-month follow-up, no significant difference was found between study groups in ΔPAV (-1.31 ± 6.05% vs 1.05 ± 17.8%; P=.60). By OCT, the ER-niacin vs placebo group had less plaque rupture within the intermediate SVG lesion (0.0% vs 36.0%; P=.01).
  
  
  CONCLUSIONS
  Administration of ER-niacin did not significantly impact intermediate SVG disease, with the notable limitation of compromised statistical power due to early termination of enrollment.
authors.forename: Anna P
authors.initials: AP
authors.lastname: Kotsia
authors.forename: Bavana V
authors.initials: BV
authors.lastname: Rangan
authors.forename: Georgios
authors.initials: G
authors.lastname: Christopoulos
authors.forename: Ameka
authors.initials: A
authors.lastname: Coleman
authors.forename: Michele
authors.initials: M
authors.lastname: Roesle
authors.forename: Daisha
authors.initials: D
authors.lastname: Cipher
authors.forename: James A
authors.initials: JA
authors.lastname: de Lemos
authors.forename: Darren K
authors.initials: DK
authors.lastname: McGuire
authors.forename: Milton
authors.initials: M
authors.lastname: Packer
authors.forename: Subhash
authors.initials: S
authors.lastname: Banerjee
authors.affiliation: VA North Texas Health Care System, The University of Texas Southwestern Medical Center at Dallas, Division of Cardiology (111A), 4500 S. Lancaster Rd, Dallas, TX 75216 USA. esbrilakis@gmail.com.
authors.forename: Emmanouil S
authors.initials: ES
authors.lastname: Brilakis
mesh_terms: D000368:Aged; D050197:Atherosclerosis / Q000175:diagnosis / Q000188:drug therapy*; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D023921:Coronary Stenosis / Q000175:diagnosis / Q000601:surgery*; D003692:Delayed-Action Preparations; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage*; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000637:transplantation*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014665:Vasodilator Agents / Q000008:administration & dosage
chemical_list: D003692:Delayed-Action Preparations; D014665:Vasodilator Agents; D009525:Niacin