Product News: Investigational Blood Test Predicts Patients at Risk of Imminent Heart Attack or Death

15 Aug 2012

Beckman Coulter, Inc. has announced publication of research results demonstrating that elevated levels of pregnancy associated plasma protein-A (PAPP-A), as measured by the company’s investigative test cPAPP-A*, can predict risk of imminent heart attack or death in patients with non-ST segment elevation (NSTE) Acute Coronary Syndrome (ACS).1 The results of this robust, pivotal study were recently published in the Journal of the American College of Cardiology.

This study of nearly 4,000 patients enrolled at 440 institutions in 17 countries demonstrated that patients with NSTE ACS and an elevated cPAPP-A result were at twice the risk for heart attack or death within 30 days of an initial coronary event compared to patients without an elevated cPAPP-A result. Moreover, patients with a high cPAPP-A result plus elevated values of other blood tests currently used for evaluation of patients in the emergency department with chest pain, were at fivefold risk for heart attack or death within 30 days compared to patients without an elevated cPAPP-A result, but with elevation in other blood markers suggestive of acute myocardial infarction (AMI).

“These results are remarkable and potentially of great clinical significance,” said Paula Southwick, PhD, co-author and group manager of Clinical Research at Beckman Coulter, the company that developed the blood test. “Emergency department physicians and cardiologists do not want to discharge patients who are at imminent risk of heart attack or death. This test predicted cardiac events that were missed by other blood tests and traditional risk factors. The profound prognostic value of this test may assist in discerning patients who require hospital admission from those who may be managed less aggressively in an outpatient environment, potentially saving patient lives and at the same time reducing healthcare costs.”

PAPP-A is an enzyme — first identified in the placenta of pregnant women but also found at lower concentration in non-pregnant women and men — associated with coronary plaque destabilization or rupture. Plaque rupture and the ensuing thrombosis which occurs at the site of rupture is the leading cause of heart attack. While clinical models for the prediction of CV mortality after ACS are currently in use, prediction of recurrent ischemic events with high discrimination has been difficult. The cPAPP-A test appears to address this major unmet patient need and would provide physicians with a blood test to predict these events.

Principal investigators David A. Morrow, MD, MPH, and Marc Bonaca, MD, MPH, of Brigham and Women’s Hospital, TIMI Study Group, Cardiovascular Division, Harvard Medical School, concluded that “our findings add to emerging evidence supporting cPAPP-A as a candidate prognostic marker of recurrent coronary events, and support continued investigation. Hospitalization for recurrent events occurs in up to one in every five patients, but prediction of these events has been difficult. In this context, our findings with cPAPP-A are intriguing for its potential role as a clinical risk predictor.”

1. Bonaca MP, Scirica BM, Sabatine MS, Jarolim P, Murphy SA, Chamberlin JS, Rhodes DW, Southwick PC, Braunwald E, Morrow DA. Prospective evaluation of pregnancy-associated plasma protein-a (PAPP-A) and outcomes in patients with acute coronary syndromes. J Am Coll Cardiol 60:332-338 (July 24, 2012).

*The cPAPP-A assay is for research use only. Not for use in diagnostic procedures.