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.

What Was Tested

Researchers studied Endothelin A Receptor Antagonists in this randomized controlled trial publication.

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 the researchers 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.

Who Took Part

According to the abstract, 52 patients were involved.

The age groups tagged for this paper are teenagers.

Patients will be randomized in a 1:1 fashion to either Ambrisentan, an endothelin antagonist, or placebo, prior to their PCI.

The primary endpoint is the difference in peri-procedural changes in patients' IMR between the two groups.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this Endothelin A Receptor Antagonists study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the patients and researchers unaware of who received Endothelin A Receptor Antagonists.

A placebo (an inactive look-alike) gave the Endothelin A Receptor Antagonists group a baseline to be compared against.

IMR will be measured before and after PCI.

What Was Measured

Topics PubMed links to this paper include Acute Coronary Syndrome, Coronary Angiography, Coronary Circulation, Coronary Vessels, Endothelin A Receptor Antagonists, Microcirculation and Myocardial Infarction.

The authors tagged it with the keywords Index of microvascular resistance, Peri-procedural myocardial infarction and Trial design.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Endothelin A Receptor Antagonists in 52 patients.

The abstract goes on to report its results in about 1 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2016 (Cardiovascular drugs and therapy), a journal based in United States.

More context: all human trials.