Effect of Recombinant ApoA-I Milano on Coronary Atherosclerosis in Patients With Acute Coronary Syndromes: A Randomized Controlled Trial
Open accessAbstract
CONTEXT: Although low levels of high-density lipoprotein cholesterol (HDL-C) increase risk for coronary disease, no data exist regarding potential benefits of administration of HDL-C or an HDL mimetic. ApoA-I Milano is a variant of apolipoprotein A-I identified in individuals in rural Italy who exhibit very low levels of HDL. Infusion of recombinant ApoA-I Milano-phospholipid complexes produces rapid regression of atherosclerosis in animal models. OBJECTIVE: We assessed the effect of intravenous recombinant ApoA-I Milano/phospholipid complexes (ETC-216) on atheroma burden in patients with acute coronary syndromes (ACS). DESIGN: The study was a double-blind, randomized, placebo-controlled multicenter pilot trial comparing the effect of ETC-216 or placebo on coronary atheroma burden measured by intravascular ultrasound (IVUS). SETTING: Ten community and tertiary care hospitals in the United States. PATIENTS: Between November 2001 and March 2003, 123 patients aged 38 to 82 years consented, 57 were randomly assigned, and 47 completed the protocol. INTERVENTIONS: In a ratio of 1:2:2, patients received 5 weekly infusions of placebo or ETC-216 at 15 mg/kg or 45 mg/kg. Intravascular ultrasound was performed within 2 weeks following ACS and repeated after 5 weekly treatments. MAIN OUTCOME MEASURES: The primary efficacy parameter was the change in percent atheroma volume (follow-up minus baseline) in the combined ETC-216 cohort. Prespecified secondary efficacy measures included the change in total atheroma volume and average maximal atheroma thickness. RESULTS: The mean (SD) percent atheroma volume decreased by -1.06% (3.17%) in the combined ETC-216 group (median, -0.81%; 95% confidence interval [CI], -1.53% to -0.34%; P =.02 compared with baseline). In the placebo group, mean (SD) percent atheroma volume increased by 0.14% (3.09%; median, 0.03%; 95% CI, -1.11% to 1.43%; P =.97 compared with baseline). The absolute reduction in atheroma volume in the combined treatment groups was -14.1 mm3 or a 4.2% decrease from baseline (P<.001). CONCLUSIONS: A recombinant ApoA-I Milano/phospholipid complex (ETC-216) administered intravenously for 5 doses at weekly intervals produced significant regression of coronary atherosclerosis as measured by IVUS. Although promising, these results require confirmation in larger clinical trials with morbidity and mortality end points.
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In a randomized clinical trial in patients with acute coronary syndromes, five weekly doses of ETC-216 resulted in statistically significant regression of coronary atherosclerosis measured by serial intravascular ultrasound.
“These studies led to the use of a formulation of ETC-216 in a randomized clinical trial (with a small sample size) in patients with acute coronary syndromes; five weekly doses of the formulation resulted in a statistically significant regression of coronary atherosclerosis measured by serial intravascular ultrasound examinations62,63 (FIG. 2a).”
From Perspectives and opportunities for nanomedicine in the management of atherosclerosis (2011) · cites this paper as [62]
In a clinical trial, infusion of reconstituted HDL demonstrated regression of coronary atherosclerosis as measured by intravascular ultrasound imaging.
“This article presents the results of a clinical trial with infusions of reconstituted HDL that demonstrated regression of coronary atherosclerosis as measured by intravascular ultrasound imaging.”
From Perspectives and opportunities for nanomedicine in the management of atherosclerosis (2011) · cites this paper as [62]
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- Authors
- Nissen, S. E., Tsunoda, T., Tuzcu, E. M., Schoenhagen, P., Cooper, C. J., Yasin, M., Eaton, G. M., Lauer, M. A., Sheldon, W. S., Grines, C. L., Halpern, S., Crowe, T., Blankenship, J. C., & Kerensky, R.
- Affiliations
- Cleveland Clinic (US)
- Toho University (JP)
- University of Toledo (US)
- INTEGRIS Baptist Medical Center (US)
- Beaumont Hospital, Troy (US)
- Radiant Research (United States) (US)
- Geisinger Medical Center (US)
- University of Florida (US)
- Corresponding author
- Nissen, Steven E.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2003-11-05
- Volume
- 290
- Issue
- 17
- Pages
- 2292
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2095507444
- Cited by
- 1,707
- References
- 26
- Citations by year
- 2026: 14 · 2025: 24 · 2024: 17 · 2023: 23 · 2022: 31 · 2021: 32 · 2020: 48 · 2019: 40 · 2018: 46 · 2017: 37 · 2016: 64 · 2015: 96 · 2014: 92 · 2013: 81 · 2012: 89
- FWCI
- 131.06
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- Locations
- JAMA (publishedVersion, public-domain)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
- Keywords
- HDL mimetics, acute coronary syndrome, coronary artery disease, atheroma volume, intravascular ultrasound, atheroma regression, HDL cholesterol, lipid-lowering therapy, statins, fibrates
- MeSH terms
- Adult, Aged, Aged, 80 and over, Angina, Unstable, Coronary Artery Disease, Double-Blind Method, Female, Humans, Male, Middle Aged, Myocardial Infarction, Phosphatidylcholines, Prospective Studies, Apolipoprotein A-I, Coronary Angiography, Ultrasonography, Interventional
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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