PMID- 10226901
OWN - NLM
STAT- MEDLINE
DCOM- 19990618
LR  - 20190921
IS  - 1053-2498 (Print)
IS  - 1053-2498 (Linking)
VI  - 18
IP  - 4
DP  - 1999 Apr
TI  - Bridging to heart transplantation: prostaglandin E1 versus prostacyclin versus 
      dobutamine.
PG  - 358-66
AB  - BACKGROUND: Prostaglandin E1 (PGE1) and prostacyclin have potent pulmonary and 
      systemic vasodilating properties. This prospective, randomized trial compared 
      PGE1 vs prostacyclin vs. low-dose dobutamine in patients with low-output heart 
      failure awaiting heart transplantation (HTx) who were refractory to oral 
      treatment. METHODS: Patients in advanced heart failure in New York Heart 
      Association (NYHA) Class IV, with a cardiac index < or = 2.5 L/minute/m2 and a 
      pulmonary capillary wedge pressure > or = 20 mmHg, who were listed for HTx were 
      studied. In an inpatient study phase of 12 hours duration, therapy was aimed to 
      increase cardiac output by 20% or more, when compared to baseline values, and to 
      achieve a reduction of pulmonary vascular resistance below 550 dyn.s/cm-5m-2. 
      During a long-term outpatient phase, the drugs were continuously infused to 
      bridge these patients to HTx using three combined negative endpoints (worsening 
      heart failure, serious adverse events, death) for analysis. RESULTS: Sixty-eight 
      patients were enrolled, 30 patients on PGE1, 8 patients on prostacyclin, and 30 
      patients on dobutamine. During the inpatient study phase, maximum doses were 22 
      +/- 1.8 ng/kg/minute for PGE1, 7 +/- 1 ng/kg/minute for prostacyclin and 5 +/- 
      0.4 micrograms/kg/minute for dobutamine. During the inpatient study phase 21 
      patients failed, 4/30 (13%) patients on PGE1, 4/8 patients on prostacyclin (50%), 
      and 13/30 (43%) on dobutamine (p < 0.05). Long-term continuous intravenous drug 
      infusion in outpatients was begun in 26 patients on PGE1, in 4 patients on 
      prostacyclin, and in 17 patients on dobutamine. Infusion therapy lasted for 88 
      +/- 14 days in the PGE1 group with 31 +/- 22 days in the prostacyclin group, and 
      30 +/- 8 days in the dobutamine group (NS). During the outpatient phase 23 
      patients reached a negative endpoint with 16 patients developing worsening heart 
      failure, 5 severe adverse events and 2 deaths. Seven out of 26 (27%) failed on 
      PGE1, 4/4 (100%) failed on prostacyclin, and 12/17 (71%) failed on dobutamine (p 
      < 0.05, log rank test). Because prostacyclin treatment was ineffective in the 
      first 8 patients, this trial arm was stopped prematurely. CONCLUSIONS: The 
      findings from this prospective open pilot trial suggest that continuous PGE1 
      infusions at individualized dosages can be useful in certain patients as a 
      pharmacologic bridging procedure with reduced risk to develop worsening heart 
      failure before HTx compared to prostacyclin and dobutamine. Further comparative 
      studies are warranted to investigate the effects of PGE1 among other bridging 
      agents.
FAU - Stanek, B
AU  - Stanek B
AD  - Second Department of Internal Medicine, University of Vienna, Austria.
FAU - Sturm, B
AU  - Sturm B
FAU - Frey, B
AU  - Frey B
FAU - Hulsmann, M
AU  - Hulsmann M
FAU - Bojic, A
AU  - Bojic A
FAU - Berger, R
AU  - Berger R
FAU - Rodler, S
AU  - Rodler S
FAU - Locker, G
AU  - Locker G
FAU - Grimm, M
AU  - Grimm M
FAU - Laufer, G
AU  - Laufer G
FAU - Pacher, R
AU  - Pacher R
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Heart Lung Transplant
JT  - The Journal of heart and lung transplantation : the official publication of the 
      International Society for Heart Transplantation
JID - 9102703
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Cardiotonic Agents)
RN  - 0 (Vasodilator Agents)
RN  - 3S12J47372 (Dobutamine)
RN  - DCR9Z582X0 (Epoprostenol)
RN  - F5TD010360 (Alprostadil)
SB  - IM
MH  - Alprostadil/administration & dosage/*therapeutic use
MH  - Ambulatory Care
MH  - Antihypertensive Agents/administration & dosage/*therapeutic use
MH  - Cardiac Output/drug effects
MH  - Cardiac Output, Low/*drug therapy/surgery
MH  - Cardiotonic Agents/therapeutic use
MH  - Cause of Death
MH  - Disease Progression
MH  - Dobutamine/administration & dosage/therapeutic use
MH  - Epoprostenol/administration & dosage/*therapeutic use
MH  - Female
MH  - Heart Failure/*drug therapy/surgery
MH  - *Heart Transplantation
MH  - Hospitalization
MH  - Humans
MH  - Infusions, Intravenous
MH  - Lung/blood supply
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Pulmonary Wedge Pressure/drug effects
MH  - Risk Factors
MH  - Treatment Outcome
MH  - Vascular Resistance/drug effects
MH  - Vasodilator Agents/administration & dosage/*therapeutic use
EDAT- 1999/05/05 00:00
MHDA- 1999/05/05 00:01
CRDT- 1999/05/05 00:00
PHST- 1999/05/05 00:00 [pubmed]
PHST- 1999/05/05 00:01 [medline]
PHST- 1999/05/05 00:00 [entrez]
AID - S1053249898000643 [pii]
AID - 10.1016/s1053-2498(98)00064-3 [doi]
PST - ppublish
SO  - J Heart Lung Transplant. 1999 Apr;18(4):358-66. doi: 
      10.1016/s1053-2498(98)00064-3.