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PRESERVATION I Trial findings presented at the European Society of Cardiology Congress showed that Bioabsorbable Cardiac Matrix (BCM), an investigational material injected through the coronary artery to prevent cardiac remodeling in patients who have sustained a heart attack, had no significant effect when compared with a saline placebo.
Study investigator Uwe Zeymer, MD, of the Institut für Herzinfarktforschung in Ludwigshafen, Germany, expressed his disappointment in the “somewhat surprising” findings regarding BCM. “Based on encouraging results in experimental studies and a previous pilot trial in humans . . . we had expected to find a reduction in left ventricular enlargement and an improvement in clinical symptoms compared to saline control,” he said.
The PRESERVATION I Trial was a placebo-controlled, multicenter, prospective, randomized, double-blind trial. It included 303 patients from 9 countries who were randomly assigned to receive an intracoronary injection of BCM or a saline control. Patients were injected with 4 mL of either BCM or saline control 2 to 5 days after a primary percutaneous coronary intervention.
Typically associated with both the degradation of patients’ extracellular matrix (ECM) and a calcium overload, large infarcts can lead to cardiac remodeling. To treat this, BCM—a liquid mixture of sodium alginate and calcium gluconate—is injected through the coronary artery during percutaneous coronary intervention. The liquid flows into the heart, where it reacts with ionized calcium and turns into a flexible hydrogel “matrix,” replaces the degraded ECM, thickens the infarct zone, and reduces wall stress. This flexible matrix supports the heart during repair and then dissolves, Dr. Zeymer explained.
The study’s primary endpoint was the measurable change in the left ventricular end diastolic volume index from baseline to 6 months. Researchers observed no significant difference in either group. A 24-hour Holter electrocardiogram showed similar rates of arrhythmia, while patients who were assigned to BCM had a 9% rate of ischemia versus 7.8% for those in the control group. Angiographic assessment of coronary artery flow showed 5 occlusions in the BCM group and only 1 occlusion in the control group.
Researchers acknowledged several possible explanations for the results, including patient selection and intervention timing. They recommend additional studies to determine optimal intervention timing and the ideal target population for BCM intervention.
Disclosures: The study was funded by Bellerophon Therapeutics, Inc. Dr. Zeymer has received honoraria for serving as a member of the executive committee of PRESERVATION I.
Reference
- Zeymer U, Rao SV, and Krucoff MW. FP Number 6007: PRESERVATION I: Bioabsorbable Cardiac Matrix for the Prevention of Remodeling of the Ventricle After Large ST-Segment Elevation Myocardial Infarction. Presented at: European Society of Cardiology Congress 2015; August 29–September 2, 2015; London, UK.
