Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results.
OBJECTIVES
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.


BACKGROUND
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.


METHODS
The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m.


RESULTS
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.


CONCLUSIONS
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).
['Starling|Randall C|RC|', 'Estep|Jerry D|JD|', 'Horstmanshof|Douglas A|DA|', 'Milano|Carmelo A|CA|', 'Stehlik|Josef|J|', 'Shah|Keyur B|KB|', 'Bruckner|Brian A|BA|', 'Lee|Sangjin|S|', 'Long|James W|JW|', 'Selzman|Craig H|CH|', 'Kasirajan|Vigneshwar|V|', 'Haas|Donald C|DC|', 'Boyle|Andrew J|AJ|', 'Chuang|Joyce|J|', 'Farrar|David J|DJ|', 'Rogers|Joseph G|JG|', '|||']
D002316:Cardiotonic Agents D005080:Exercise Test D017079:Exercise Tolerance D006333:Heart Failure D006353:Heart-Assist Devices D006801:Humans D011446:Prospective Studies D011788:Quality of Life D018570:Risk Assessment D016896:Treatment Outcome
left ventricular assist device heart failure pharmacological therapy