The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy.
The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF.
University of Michigan, Ann Arbor, Michigan. Electronic address: fpagani@umich.edu.
Francis D
FD
Pagani
University of Michigan, Ann Arbor, Michigan.
Keith D
KD
Aaronson
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Robert
R
Kormos
University of Washington in St. Louis, St. Louis, Missouri.
Douglas L
DL
Mann
University of Michigan, Ann Arbor, Michigan.
Cathie
C
Spino
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Neal
N
Jeffries
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Wendy C
WC
Taddei-Peters
Columbia University, New York, New York.
Donna M
DM
Mancini
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Dennis M
DM
McNamara
Northwestern University, Chicago, Illinois.
Kathleen L
KL
Grady
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
John
J
Gorcsan
Drexel University, Philadelphia, Pennsylvania.
Ralph
R
Petrucci
Northwestern University, Chicago, Illinois.
Allen S
AS
Anderson
University of Pennsylvania, Philadelphia, Pennsylvania.
Henry A
HA
Glick
University of Pennsylvania, Philadelphia, Pennsylvania.
Michael A
MA
Acker
University of Pennsylvania, Philadelphia, Pennsylvania.
J
J
Eduardo Rame
Albert Einstein College of Medicine, New York, New York.
Daniel J
DJ
Goldstein
University of Alabama at Birmingham, Birmingham, Alabama.
Salpy V
SV
Pamboukian
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Marissa A
MA
Miller
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
J
J
Timothy Baldwin
D002986:Clinical Trials as Topic / Q000379:methods*; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D054555:National Heart, Lung, and Blood Institute (U.S.); D010865:Pilot Projects; D011788:Quality of Life; D014481:United States; D028761:Withholding Treatment
assisted circulation; clinical trials; heart failure; mechanical circulatory support; ventricular assist device