PMID- 26814686
OWN - NLM
STAT- MEDLINE
DCOM- 20170224
LR  - 20170817
IS  - 1573-7241 (Electronic)
IS  - 0920-3206 (Linking)
VI  - 30
IP  - 2
DP  - 2016 Apr
TI  - Design and Rationale for the Endothelin-1 Receptor Antagonism in the Prevention 
      of Microvascular Injury in Patients with non-ST Elevation Acute Coronary Syndrome 
      Undergoing Percutaneous Coronary Intervention (ENDORA-PCI) Trial.
PG  - 169-75
LID - 10.1007/s10557-016-6641-x [doi]
AB  - PURPOSE: Peri-procedural myocardial infarction (PMI) occurs in a small but 
      significant portion of patients undergoing percutaneous intervention (PCI). The 
      underlying mechanisms are complex and may include neurohormonal activation and 
      release of vasoactive substances resulting in disruption of the coronary 
      microcirculation. Endothelin in particular has been found in abundance in 
      atherosclerotic plaques and in systemic circulation following PCI, and may be a 
      potential culprit for PMI through its action on microvascular vasoconstriction, 
      and platelet and neutrophil activation. In this study we aim to characterize the 
      behavior of the coronary microcirculation during a PCI with the index of 
      microvascular resistance (IMR) and the effect of peri-procedural endothelin 
      antagonism. METHODS: The ENDORA-PCI trial is a randomized, double-blind, 
      placebo-controlled, single-center clinical trial designed to evaluate the 
      efficacy of endothelin antagonism in attenuating the peri-procedural rise in IMR 
      as a surrogate marker for PMI. The patients of interest are those with non-ST 
      elevation acute coronary syndrome (NSTEACS) undergoing PCI, and we aim to recruit 
      52 patients overall to give the study a power of 80 % at an alpha level of 5 %. 
      Patients will be randomized in a 1:1 fashion to either Ambrisentan, an endothelin 
      antagonist, or placebo, prior to their PCI. IMR will be measured before and after 
      PCI. The primary endpoint is the difference in peri-procedural changes in 
      patients' IMR between the two groups. CONCLUSION: The ENDORA-PCI study will 
      investigate whether endothelin antagonism with Ambrisentan attenuates the 
      peri-procedural rise in IMR in patients with NSTEACS undergoing PCI, and thus 
      potentially the risk of PMI.
FAU - Liou, Kevin
AU  - Liou K
AD  - Eastern Heart Clinic, Prince of Wales Hospital, Level 3, Campus Center, Barker 
      Street, Randwick, Sydney, NSW, 2031, Australia. 
      kevin.liou@sesiahs.health.nsw.gov.au.
AD  - Prince of Wales Clinical School, University of New South Wales, Sydney, 
      Australia. kevin.liou@sesiahs.health.nsw.gov.au.
FAU - Jepson, Nigel
AU  - Jepson N
AD  - Eastern Heart Clinic, Prince of Wales Hospital, Level 3, Campus Center, Barker 
      Street, Randwick, Sydney, NSW, 2031, Australia.
AD  - Prince of Wales Clinical School, University of New South Wales, Sydney, 
      Australia.
FAU - Buckley, Nicolas
AU  - Buckley N
AD  - Prince of Wales Clinical School, University of New South Wales, Sydney, 
      Australia.
AD  - School of Medical Sciences, Sydney Medical School, University of Sydney, Sydney, 
      Australia.
FAU - Chen, Vivien
AU  - Chen V
AD  - Prince of Wales Clinical School, University of New South Wales, Sydney, 
      Australia.
AD  - Lowy Cancer Research Center, University of New South Wales, Sydney, Australia.
FAU - Thomas, Shane
AU  - Thomas S
AD  - Redox Cell Signaling Group, Center for Vascular Research & School of Medical 
      Sciences, University of New South Wales, Sydney, Australia.
FAU - Russell, Elizabeth Anne
AU  - Russell EA
AD  - Eastern Heart Clinic, Prince of Wales Hospital, Level 3, Campus Center, Barker 
      Street, Randwick, Sydney, NSW, 2031, Australia.
FAU - Ooi, Sze-Yuan
AU  - Ooi SY
AD  - Eastern Heart Clinic, Prince of Wales Hospital, Level 3, Campus Center, Barker 
      Street, Randwick, Sydney, NSW, 2031, Australia.
AD  - Prince of Wales Clinical School, University of New South Wales, Sydney, 
      Australia.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Cardiovasc Drugs Ther
JT  - Cardiovascular drugs and therapy
JID - 8712220
RN  - 0 (Endothelin A Receptor Antagonists)
RN  - 0 (Receptor, Endothelin A)
SB  - IM
MH  - Acute Coronary Syndrome/*drug therapy/metabolism
MH  - Adolescent
MH  - Coronary Angiography/methods
MH  - Coronary Circulation/drug effects
MH  - Coronary Vessels/drug effects/metabolism
MH  - Double-Blind Method
MH  - Endothelin A Receptor Antagonists/*therapeutic use
MH  - Humans
MH  - Microcirculation/*drug effects
MH  - Myocardial Infarction/drug therapy/metabolism
MH  - Percutaneous Coronary Intervention/methods
MH  - Receptor, Endothelin A/*metabolism
MH  - Treatment Outcome
MH  - Vascular Resistance/drug effects
OTO - NOTNLM
OT  - Endothelin
OT  - Index of microvascular resistance
OT  - Peri-procedural myocardial infarction
OT  - Trial design
EDAT- 2016/01/28 06:00
MHDA- 2017/02/25 06:00
CRDT- 2016/01/28 06:00
PHST- 2016/01/28 06:00 [entrez]
PHST- 2016/01/28 06:00 [pubmed]
PHST- 2017/02/25 06:00 [medline]
AID - 10.1007/s10557-016-6641-x [pii]
AID - 10.1007/s10557-016-6641-x [doi]
PST - ppublish
SO  - Cardiovasc Drugs Ther. 2016 Apr;30(2):169-75. doi: 10.1007/s10557-016-6641-x.