title: Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results.
abstract: The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years.
  
  
  
  The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients.
  
  
  
  The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m.
  
  
  
  Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p < 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio: 3.2 [95% confidence interval: 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 ± 5% vs. 41 ± 5%; p < 0.001), but there was no difference in intent-to-treat survival (70 ± 5% vs. 63 ± 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias.
  
  
  
  Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802).
authors.affiliation: Cleveland Clinic, Cleveland, Ohio. Electronic address: starlir@ccf.org.
authors.forename: Randall C
authors.initials: RC
authors.lastname: Starling
authors.affiliation: Houston Methodist Hospital, Houston, Texas.
authors.forename: Jerry D
authors.initials: JD
authors.lastname: Estep
authors.affiliation: Integris Baptist Medical Center, Oklahoma City, Oklahoma.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Horstmanshof
authors.affiliation: Duke University, Durham, North Carolina.
authors.forename: Carmelo A
authors.initials: CA
authors.lastname: Milano
authors.affiliation: University of Utah, Salt Lake City, Utah.
authors.forename: Josef
authors.initials: J
authors.lastname: Stehlik
authors.affiliation: Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Keyur B
authors.initials: KB
authors.lastname: Shah
authors.affiliation: Houston Methodist Hospital, Houston, Texas.
authors.forename: Brian A
authors.initials: BA
authors.lastname: Bruckner
authors.affiliation: Spectrum Health, Grand Rapids, Michigan.
authors.forename: Sangjin
authors.initials: S
authors.lastname: Lee
authors.affiliation: Integris Baptist Medical Center, Oklahoma City, Oklahoma.
authors.forename: James W
authors.initials: JW
authors.lastname: Long
authors.affiliation: University of Utah, Salt Lake City, Utah.
authors.forename: Craig H
authors.initials: CH
authors.lastname: Selzman
authors.affiliation: Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Vigneshwar
authors.initials: V
authors.lastname: Kasirajan
authors.affiliation: Abington Memorial Hospital, Abington, Pennsylvania.
authors.forename: Donald C
authors.initials: DC
authors.lastname: Haas
authors.affiliation: Thomas Jefferson University, Philadelphia, Pennsylvania.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Boyle
authors.affiliation: Abbott, Pleasanton, California.
authors.forename: Joyce
authors.initials: J
authors.lastname: Chuang
authors.affiliation: Abbott, Pleasanton, California.
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.affiliation: Duke University, Durham, North Carolina.
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Rogers
mesh_terms: D002316:Cardiotonic Agents / Q000627:therapeutic use; D005080:Exercise Test; D017079:Exercise Tolerance; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects / Q000706:statistics & numerical data*; D006801:Humans; D011446:Prospective Studies; D011788:Quality of Life; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D002316:Cardiotonic Agents
keywords: heart failure; left ventricular assist device; pharmacological therapy