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3. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: a prospective, placebo-controlled randomized trial (EVAPORATE): interim results.

Author

Budoff, Matthew J, Muhlestein, Joseph B, Bhatt, Deepak L, Le Pa, Viet T, May, Heidi T, Shaikh, Kashif, Shekar, Chandana, Kinninger, April, Lakshmanan, Suvasini, Roy, Sion K, Tayek, John, and Nelson, John R

Subjects
Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology
Abstract

AimsThough statin therapy is known to slow coronary atherosclerosis progression and reduce cardiovascular (CV) events, significant CV risk still remains. In the REDUCE-IT study, icosapent ethyl (IPE) added to statin therapy reduced initial CV events by 25% and total CV events by 30%, but its effects on coronary atherosclerosis progression have not yet been fully investigated. Therefore, this study is to determine whether IPE 4 g/day will result in a greater change from baseline in plaque volume measured by serial multidetector computed tomography than placebo in statin-treated patients.Methods and resultsEVAPORATE is a randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis by coronary computed tomographic angiography (CCTA) (≥1 angiographic stenoses with ≥20% narrowing), on stable statin therapy with low-density lipoprotein cholesterol levels 40-115 mg/dL, and persistently high triglyceride levels (135-499 mg/dL). Patients underwent an interim scan at 9 months and were followed for an additional 9 months with CCTA at 0, 9, and 18 months. Here, we present the protocol-specified interim efficacy results. A total of 80 patients were enrolled, with 67 completing the 9-month visit and having interpretable CCTA at baseline and at 9 months (age = 57 ± 6 years, male = 36, 63%). At the 9-month interim analysis, there was no significant change in low attenuation plaque (LAP) between active and placebo groups (74% vs. 94%, P = 0.469). However, there was slowing of total non-calcified plaque (sum of LAP, fibrofatty, and fibrous plaque) (35% vs. 43%, P = 0.010), total plaque (non-calcified + calcified plaque) (15% vs. 26%, P = 0.0004), fibrous plaque (17% vs. 40%, P = 0.011), and calcified plaque (-1% vs. 9%, P = 0.001), after adjustment by baseline plaque, age, sex, diabetes, baseline triglyceride levels, and statin use.ConclusionEVAPORATE is the first study using CCTA to evaluate the effects of IPE as an adjunct to statin therapy on atherosclerotic plaque characteristics in a high-risk CV population with persistently high triglyceride levels. It provides important mechanistic data in regards to the reduction in CV events in the REDUCE-IT clinical trial.Clinicaltrials. govidentifierNCT029226027.

Published
2021

7. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial.

Author

Budoff, Matthew J, Bhatt, Deepak L, Kinninger, April, Lakshmanan, Suvasini, Muhlestein, Joseph B, Le, Viet T, May, Heidi T, Shaikh, Kashif, Shekar, Chandana, Roy, Sion K, Tayek, John, and Nelson, John R

Subjects
Atherosclerosis, Cardiac CT, Coronary artery disease, Prevention, Progression, Cardiovascular System & Hematology, Cardiorespiratory Medicine and Haematology, Clinical Sciences
Abstract

AimsDespite the effects of statins in reducing cardiovascular events and slowing progression of coronary atherosclerosis, significant cardiovascular (CV) risk remains. Icosapent ethyl (IPE), a highly purified eicosapentaenoic acid ethyl ester, added to a statin was shown to reduce initial CV events by 25% and total CV events by 32% in the REDUCE-IT trial, with the mechanisms of benefit not yet fully explained. The EVAPORATE trial sought to determine whether IPE 4 g/day, as an adjunct to diet and statin therapy, would result in a greater change from baseline in plaque volume, measured by serial multidetector computed tomography (MDCT), than placebo in statin-treated patients.Methods and resultsA total of 80 patients were enrolled in this randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis as documented by MDCT (one or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels. Patients underwent an interim scan at 9 months and a final scan at 18 months with coronary computed tomographic angiography. The pre-specified primary endpoint was change in low-attenuation plaque (LAP) volume at 18 months between IPE and placebo groups. Baseline demographics, vitals, and laboratory results were not significantly different between the IPE and placebo groups; the median TG level was 259.1 ± 78.1 mg/dL. There was a significant reduction in the primary endpoint as IPE reduced LAP plaque volume by 17%, while in the placebo group LAP plaque volume more than doubled (+109%) (P = 0.0061). There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P

Published
2020

10. Contemporary Predictors of Major Adverse Cardiovascular Events following Percutaneous Coronary Intervention: A Nationally Representative US Sample

Author

Horne, Benjamin D., primary, Atreja, Nipun, additional, Venditto, John, additional, Wilson, Thomas, additional, Muhlestein, Joseph B., additional, St. Clair, Joshua R. St., additional, Knowlton, Kirk U., additional, Khan, Naeem D., additional, Bhalla, Narinder, additional, and Anderson, Jeffrey L., additional

Published
2024
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22. Abstract 12122: Five-Year Serial Measurement of the Intermountain Mortality Risk Score for Population Health Assessment Reveals Personalized Temporal Trajectories of Differential Longevity Over Two Decades

Author

Horne, Benjamin D, Bledsoe, Joseph R, Muhlestein, Joseph B, Woller, Scott C, Knowlton, Kirk U, Majercik, Sarah, Bair, Tami L, Snow, Gregory L, Lloyd, James F, Le, Viet T, Bennett, Sterling T, Ronnow, Brianna S, May, Heidi T, and Anderson, Jeffrey L

Published
2022
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31. Comparison of Three Atherosclerotic Cardiovascular Disease Risk Scores With and Without Coronary Calcium for Predicting Revascularization and Major Adverse Coronary Events in Symptomatic Patients Undergoing Positron Emission Tomography-Stress Testing

Author

Anderson, Jeffrey L., Le, Viet T., Min, David B., Biswas, Santanu, Minder, C. Michael, McCubrey, Raymond O., Knight, Stacey, Horne, Benjamin D., Mason, Steve, Lappe, Donald L., Muhlestein, Joseph B., and Knowlton, Kirk U.

Published
2020
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32. Abstract 14841: Higher Than Daily RDA Recommended Vitamin D 3 Dosing and Multiple Titrations Are Required to Achieve >40 ng/mL 25-hydroxy Vitamin D Levels in Acute Coronary Syndrome (ACS) Participants Enrolled and Randomized to Targeted Vitamin D Treatment: The Target D Trial

Author

Le, Viet T, primary, Babcock, Daniel, additional, Wayman, Libby, additional, Maestas, Heather, additional, Anderson, Jeffrey L, additional, Knowlton, Kirk U, additional, Muhlestein, Joseph B, additional, and May, Heidi T, additional

Published
2023
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33. A genome-wide meta-analysis uncovers six sequence variants conferring risk of vertigo

Author

Skuladottir, Astros Th., Bjornsdottir, Gyda, Nawaz, Muhammad Sulaman, Petersen, Hannes, Rognvaldsson, Solvi, Moore, Kristjan Helgi Swerford, Olafsson, Pall I., Magnusson, Sigurður H., Bjornsdottir, Anna, Sveinsson, Olafur A., Sigurdardottir, Gudrun R., Saevarsdottir, Saedis, Ivarsdottir, Erna V., Stefansdottir, Lilja, Gunnarsson, Bjarni, Muhlestein, Joseph B., Knowlton, Kirk U., Jones, David A., Nadauld, Lincoln D., Hartmann, Annette M., Rujescu, Dan, Strupp, Michael, Walters, G. Bragi, Thorgeirsson, Thorgeir E., Jonsdottir, Ingileif, Holm, Hilma, Thorleifsson, Gudmar, Gudbjartsson, Daniel F., Sulem, Patrick, Stefansson, Hreinn, and Stefansson, Kari

Published
2021
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35. Prasugrel use and clinical outcomes by age among patients undergoing PCI for acute coronary syndrome: from the PROMETHEUS study

Author

Chandrasekhar, Jaya, Baber, Usman, Sartori, Samantha, Aquino, Melissa, Moalem, Kamilia, Kini, Annapoorna S., Rao, Sunil V., Weintraub, William, Henry, Timothy D., Vogel, Birgit, Ge, Zhen, Muhlestein, Joseph B., Weiss, Sandra, Strauss, Craig, Toma, Catalin, DeFranco, Anthony, Claessen, Bimmer E., Keller, Stuart, Baker, Brian A., Effron, Mark B., Pocock, Stuart, Dangas, George, Kapadia, Samir, and Mehran, Roxana

Published
2020
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37. Higher docosahexaenoic acid levels lower the protective impact of eicosapentaenoic acid on long-term major cardiovascular events

Author

Le, Viet T., primary, Knight, Stacey, additional, Watrous, Jeramie D., additional, Najhawan, Mahan, additional, Dao, Khoi, additional, McCubrey, Raymond O., additional, Bair, Tami L., additional, Horne, Benjamin D., additional, May, Heidi T., additional, Muhlestein, Joseph B., additional, Nelson, John R., additional, Carlquist, John F., additional, Knowlton, Kirk U., additional, Jain, Mohit, additional, and Anderson, Jeffrey L., additional

Published
2023
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38. Quantitative imaging biomarkers of coronary plaque morphology: insights from EVAPORATE

Author

Buckler, Andrew J., primary, Doros, Gheorghe, additional, Kinninger, April, additional, Lakshmanan, Suvasini, additional, Le, Viet T., additional, Libby, Peter, additional, May, Heidi T., additional, Muhlestein, Joseph B., additional, Nelson, John R., additional, Nicolaou, Anna, additional, Roy, Sion K., additional, Shaikh, Kashif, additional, Shekar, Chandana, additional, Tayek, John A., additional, Zheng, Luke, additional, Bhatt, Deepak L., additional, and Budoff, Matthew J., additional

Published
2023
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40. Associations Between Complex PCI and Prasugrel or Clopidogrel Use in Patients With Acute Coronary Syndrome Who Undergo PCI: From the PROMETHEUS Study

Author

Chandrasekhar, Jaya, Baber, Usman, Sartori, Samantha, Aquino, Melissa, Kini, Annapoorna S., Rao, Sunil, Weintraub, William, Henry, Timothy D., Farhan, Serdar, Vogel, Birgit, Sorrentino, Sabato, Ge, Zhen, Kapadia, Samir, Muhlestein, Joseph B., Weiss, Sandra, Strauss, Craig, Toma, Catalin, DeFranco, Anthony, Effron, Mark B., Keller, Stuart, Baker, Brian A., Pocock, Stuart, Dangas, George, and Mehran, Roxana

Published
2018
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42. A new ratio for better predicting future death/myocardial infarction than standard lipid measurements in women >50 years undergoing coronary angiography: the apolipoprotein A1 remnant ratio (Apo A1/ [VLDL3+IDL])

Author

May, Heidi T, Nelson, John R, Kulkarni, Krishnaji R, Anderson, Jeffrey L, Horne, Benjamin D, Bair, Tami L, and Muhlestein, Joseph B

Abstract

Abstract Background Women often lag behind men in their risk of cardiovascular events. However, with age and the onset of menopause, women’s cardiovascular risk eventually becomes similar to that of men. This change in risk may, in part, be attributable to a shift to a more atherogenic lipid profile. Our objective was to evaluate standard- and sub-lipid parameters and the apo A1 remnant ratio: (apo A1/[VLDL3-C+IDL-C]) for their associations with death/myocardial infarction among peri- and post-menopausal women. Methods Women (N=711) >50 years of age undergoing coronary angiography were evaluated. Baseline clinical and angiographic characteristics, lipids, and sub-lipid levels (Vertical Auto Profile method) were collected. Cox regression analysis, adjusted by standard cardiovascular risk factors, was utilized to determine associations of lipid and sub-lipid tertiles(T) with death/myocardial infarction at 1 and 3 years. Results Patients averaged 67.7±9.4 years and 53.6% had underlying severe (≥70% stenosis) coronary artery disease. The apo A1 remnant ratio was found to have stronger associations for 1 year (T1 vs. T3: HR=2.13, p=0.03, T2 vs. T3: HR=1.57, p=0.21) and 3 year (T1 vs. T3: HR=2.32, p=0.002, T2 vs. T3: HR=1.97, p=0.01) death/myocardial infarction than any individual lipid (LDL-C, HDL-C, triglycerides, non-HDL-C) or sub-lipid (apo A1, apo B, VLDL3-C+IDL-C) measure, or any other well-known ratio (triglyercies/HDL-C, apo B/A1, TChol/HDL-C, HDL-C/[VLDL3-C+IDL-C]). Conclusions The apo A1 remnant ratio was a significant predictor of short and intermediate-term death/myocardial infarction risk among women >50 years of age. Furthermore, this ratio was found to have greater predictive ability than traditional lipid and sub-lipid parameters and represents a potential new risk marker.

Published
2013

45. Associations Between Chronic Kidney Disease and Outcomes With Use of Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Report From the PROMETHEUS Study

Author

Baber, Usman, Chandrasekhar, Jaya, Sartori, Samantha, Aquino, Melissa, Kini, Annapoorna S., Kapadia, Samir, Weintraub, William, Muhlestein, Joseph B., Vogel, Birgit, Faggioni, Michela, Farhan, Serdar, Weiss, Sandra, Strauss, Craig, Toma, Catalin, DeFranco, Anthony, Baker, Brian A., Keller, Stuart, Effron, Mark B., Henry, Timothy D., Rao, Sunil, Pocock, Stuart, Dangas, George, and Mehran, Roxana

Published
2017
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