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PRESERVATION I: Bioabsorbable cardiac matrix does not prevent LV remodeling, HF
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LONDON — Deployment of an inert bioabsorbable cardiac matrix did not prevent left ventricular remodeling or occurrence of HF in patients with acute MI and large infarcts, according to the results of the PRESERVATION I study.
The bioabsorbable cardiac matrix (IK-5001, Bellerophon BCM, LLC) is a combination of 1% sodium alginate and 0.3% calcium gluconate in water that does not undergo metabolism and turns into a flexible hydrogel in the presence of free calcium, Uwe Zeymer, MD, of Klinikum Ludwigshafen in Ludwigshafen, Germany, said at a European Society of Cardiology Congress press conference.
Uwe Zeymer
In studies of animals with large infarcts, which are associated with a degraded extracellular matrix and calcium overload, the bioabsorbable cardiac matrix (BCM) was able to replace degraded extracellular matrix, thicken the infarct zone, reduce wall stress, provide mechanical support and prevent consistent LV remodeling, Zeymer said.
The results of the animal studies had been confirmed in a human pilot study, so Zeymer and colleagues randomly assigned 303 patients with large infarcts who underwent successful PCI for STEMI in the PRESERVATION I trial.
All patients underwent a procedure 2 to 5 days after primary PCI. They received an intracoronary injection via a dedicated catheter proximal to the stent in the artery where the infarct occurred of BCM 4 mL or saline.
The primary endpoints were change in LV end-diastolic volume index (LVEDVI) at 6 months and 3-D echocardiographic assessment of LV dilation. Secondary endpoints included Kansas City Cardiomyopathy Questionnaire score, change in 6-minute walk distance, NYHA classification, time to death or nonfatal HF events and time to first rehospitalization for any CV event.
Zeymer reported no significant difference between the groups in LVEDVI change (6-month point estimate, 3.8; 95% CI, –0.5 to 8) nor in any of the secondary outcomes, although there was a trend toward better improvement in 6-minute walk distance in the BCM group (P = .051).
There groups also had similar rates of a composite outcome of CV death, acute MI, revascularization, stent thrombosis, arrhythmia or myocardial rupture (P = .5), he said.
Zeymer said the next step is to investigate why the data in humans did not correspond to the data in animals.
“It might be that our patients were especially sick and had too large infarcts,” he said. “Or it might be that the timing [of the procedure] was too late. We may have had to deploy the device earlier to prevent remodeling. It might be that we had technical problems with the device deployment strategy or that microvascular construction prevented it [from going] where it needed to go.” – by Erik Swain
Reference:
Zeymer U, et al. Hot Line VI: Coronary Artery Disease. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.
Disclosures: The study was funded by Bellerophon BCM LLC. Zeymer reports receiving honoraria from Bellerophon BCM LLC.
Perspective
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Michael Maeng, MD, PhD
This study is one of a larger number of studies that have tested treatment strategies to reduce reperfusion injury or remodeling in the period after STEMI. In my opinion, so far there have not been any positive or convincing results in that field. This study was well performed but neutral. Unfortunately we didn’t see any indication in this study that this technology will work in the future.
We are still in the dark about what can be done to reduce reperfusion injury or remodeling, but there is an ongoing, multicenter, multinational study that holds the potential to produce very interesting findings. The CONDI-2 study is examining remote ischemic perconditioning. Remote ischemic perconditioning seems to protect the heart during reperfusion and the first data based on imaging and long-term clinical follow-up showed very promising results that are now being tested using hard clinical endpoints.
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