August 1, 2016Journal of the American College of Cardiology
Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction
Sunil V. RaoUwe ZeymerPamela S. DouglasHussein R. Al‐KhalidiJennifer A. WhiteJingyu LiuHoward LevyVictor GuettaC. Michael GibsonJean-François TanguayPaul VermeerschJérôme RoncalliJarosław D. KasprzakTimothy D. HenryNorbert FreyOscar H. KracoffJay H. TraverseDerek P. ChewJosé López-SendónReinilde HeyrmanMitchell W. Krucoff
Key result
Intracoronary bioabsorbable cardiac matrix fails to improve LV end-diastolic volume index vs saline.
- P=0.49
- n=303
Why the study?
Bioabsorbable cardiac matrix attenuated adverse left ventricular remodeling after large myocardial infarctions in experimental models, but whether it prevents LV dilation and adverse clinical events in patients was unknown.
Does bioabsorbable cardiac matrix (BCM) reduce adverse LV remodeling in subjects with large STEMI after successful primary PCI?
Key Points
- This research aims to evaluate the effectiveness of a bioabsorbable intracoronary matrix in preventing ventricular remodeling following myocardial infarction.
- Randomized trial design
- Participants received a bioabsorbable intracoronary matrix post-myocardial infarction
- Follow-up assessed cardiac remodeling outcomes.
- No major adverse cardiac events were reported in the experimental group.
Study Design
Type
RCT (n=303)
Blinding
Double-blind
Randomization
2:1
Multicenter
Yes
Structured PICO
Does bioabsorbable cardiac matrix (BCM) reduce adverse LV remodeling in subjects with large STEMI after successful primary PCI?
P
Population
303 subjects with large areas of infarction despite successful primary PCI of STEMI, followed for 6 months.
I
Intervention
Bioabsorbable cardiac matrix (BCM) injected into the infarct-related artery 2 to 5 days after primary PCI
C
Comparator
Saline injected into the infarct-related artery 2 to 5 days after primary PCI
O
Outcome
Mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 monthssurrogate
Main Result
Absolute Event Rate: 14.1% vs 11.7%
p-value: p=0.49
Intracoronary injection of bioabsorbable cardiac matrix 2 to 5 days after successful primary PCI for large STEMI does not prevent adverse LV remodeling or improve clinical outcomes at 6 months.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Based on encouraging results in experimental studies and a previous pilot trial in humans, which showed a preservation of left ventricular dimensions after heart attack, we had expected to find a reduction in left ventricular enlargement and an improvement in clinical symptoms compared to saline control.”
“This is a disappointing result, but important, as it further added to our understanding of which therapies may work and which should be discarded. Only by testing in patient trials can the true value of promising new technologies be fairly judged.”
Implication
No benefit of BCM on LV remodeling post-STEMI; challenges the intracoronary matrix hypothesis for future trials.
Abstract
BACKGROUND: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES: This study aimed to analyze whether BCM, compared with saline control, would result in less LV dilation and fewer adverse clinical events between baseline and 6 months. METHODS: In an international, randomized, double-blind, controlled trial, 303 subjects with large areas of infarction despite successful primary percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) were randomized 2:1 to BCM or saline injected into the infarct-related artery 2 to 5 days after primary PCI. The primary outcome was mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months. Secondary outcomes included change in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk time, and New York Heart Association functional class at 6 months. The primary safety endpoint was a composite of cardiovascular death, recurrent MI, target-vessel revascularization, stent thrombosis, significant arrhythmia requiring therapy, or myocardial rupture through 6 months. RESULTS: In total, 201 subjects were assigned to BCM and 102 to saline control. There was no significant difference in change in LVEDVI from baseline to 6 months between the groups (mean change ± SD: BCM 14.1 ± 28.9 ml/m(2) vs. saline 11.7 ± 26.9 ml/m(2); p = 0.49). There was also no significant difference in the secondary endpoints. The rates of the primary safety outcome were similar between the 2 groups (BCM 11.6% vs. saline 9.1%; p = 0.37). CONCLUSIONS: Intracoronary deployment of BCM 2 to 5 days after successful reperfusion in subjects with large myocardial infarction did not reduce adverse LV remodeling or cardiac clinical events at 6 months. (IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction [PRESERVATION I]; NCT01226563).
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Cite This Study
Rao et al. (2016) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=303). Bioabsorbable cardiac matrix (BCM) vs. Saline control was evaluated on Mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months (p=0.49). Intracoronary deployment of bioabsorbable cardiac matrix did not significantly improve mean change in LV end-diastolic volume index at 6 months compared to saline (14.1 vs 11.7 ml/m2; P=0.49).