Clinical Trial Design for Triglyceride-Rich Lipoprotein-Lowering Therapies

Malick, Waqas; Waksman, Ori; Do, Ron; Köenig, Wolfgang; Pradhan, Aruna D.; Stroes, Erik S.G.; Rosenson, Robert S.

doi:10.1016/j.jacc.2023.02.034

Cited by 11 publications

(6 citation statements)

References 67 publications

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“…HDL-C is a lipoprotein that transports cholesterol from body tissues to the liver. Adequate research confirms the relationship between TG and cardiovascular disease; however, more importantly, there are conflicting conclusions about the ability of this intervention to achieve significant clinical benefit in randomized controlled studies [ 17 ]. The fibrates and omega-3 fatty acids, two classic types of TG-lowering drugs, exerted variable clinical results [ 18 – 20 ].…”

Section: Discussionmentioning

confidence: 99%

Triglyceride to high-density lipoprotein cholesterol ratio associated with long-term adverse clinical outcomes in patients deferred revascularization following fractional flow reserve

Li,

Zhou

et al. 2024

Lipids Health Dis

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Background Guidelines on coronary intermediate lesions strongly recommend deferred revascularization after detecting a normal fractional flow reserve (FFR). Researches about triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) on cardiovascular diseases has also been well conducted. However, the association of TG/HDL-C and long-term adverse clinical outcomes remains unknown for patients deferred revascularization following FFR. Methods This study retrospectively included 374 coronary artery disease (CAD) patients with non-significant coronary lesions diagnosed by coronary angiography (CAG) and FFR. The main outcome measure was the combination of major adverse cardiovascular and cerebrovascular events (MACCEs). All patients were categorized into three subgroups in terms of TG/HDL-C tertiles (T1 < 0.96, 0.96 ≤ T2 < 1.58, T3 ≥ 1.58). Three different Cox regression models were utilized to reveal the association between TG/HDL-C and prevalence of MACCEs. Results 47 MACCEs were recorded throughout a median monitoring period of 6.6 years. The Kaplan-Meier survival curves showed a higher MACCEs rate occurred in the higher TG/HDL-C group (5.6% vs. 12.9% vs. 19.4%, log-rank P < 0.01). After adjustment, patients in T3 suffered a 2.6-fold risk compared to the T1 group (T3 vs. T1: HR 2.55, 95% CI 1.05–6.21, P = 0.038; T2 vs. T1: HR 1.71, 95% CI 0.65–4.49, P = 0.075; P for trend = 0.001). The restricted cubic spline (RCS) analysis demonstrated that the HR for MACCEs rose as TG/HDL-C increased. Both the receiver operating characteristic (ROC) and time-dependent ROC proved the excellent predictive ability of TG/HDL-C. Conclusion The study illustrates that TG/HDL-C correlates with the risk of MACCEs in CAD patients deferred revascularization following FFR. TG/HDL-C could serve as a dependable predictor of cardiovascular events over the long term in this population.

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Section: Discussionmentioning

confidence: 99%

Triglyceride to high-density lipoprotein cholesterol ratio associated with long-term adverse clinical outcomes in patients deferred revascularization following fractional flow reserve

Li,

Zhou

et al. 2024

Lipids Health Dis

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“…Clinical trial design for a cardiovascular outcome trial on APOC3 inhibition will therefore be critical. Important considerations may be to utilize elevated levels of APOB, non-HDL-cholesterol and remnant-cholesterol measurements, rather than triglycerides, for inclusion, to enroll patients with adequate background LDL-lowering therapy, targeting LDL-cholesterol of 70 mg/dl or below, and to include a large number of subjects with diabetes as they might be likely to see a relatively greater CVD risk reduction ( 83 ). Another important consideration is the race and ethnicity of the participants.…”

Section: Clinical Implications and Future Directionsmentioning

confidence: 99%

Apolipoprotein C3: form begets function

Bornfeldt

2024

Journal of Lipid Research

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“…Furthermore, a third trial including individuals with type 2 diabetes (the PROMINENT trial), was also terminated prematurely due to futility [60]; although a significant reduction in triglycerides (26%) and remnant cholesterol was achieved during follow-up, an increase in the mass of atherogenic lipoproteins (LDL cholesterol and apoB) may explain the lack of treatment effect in this trial. Currently, well designed trials are underway with novel therapies that specifically target apoC-III and ANGPLT3 to lower remnant cholesterol [61–64].…”

Section: Preventive Strategies and Future Perspectivesmentioning

confidence: 99%

Remnant cholesterol and low-grade inflammation jointly in atherosclerotic cardiovascular disease: implications for clinical trials

Elías-López,

Doi,

Nordestgaard

et al. 2023

Current Opinion in Clinical Nutrition &Amp; Metabolic Care

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Purpose of review Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death despite the development of effective treatments. Recently, elevated remnant cholesterol and low-grade inflammation have emerged as factors explaining part of the residual ASCVD risk. Interestingly, the coexistence of both high remnant cholesterol and low-grade inflammation can further increase the risk of ASCVD. The aim of this review is to describe the role of elevated remnant cholesterol and low-grade inflammation, separately and combined, in ASCVD. Recent findings Results from recently published studies, including observational and genetic Mendelian randomization studies, support a causal relationship between elevated remnant cholesterol and low-grade inflammation on risk of ASCVD in both primary and secondary prevention settings. In addition, current evidence from observational studies suggests that the coexistence of elevated remnant cholesterol and low-grade inflammation further increases the risk of ASCVD. Summary Recent observational studies suggest that high remnant cholesterol combined with low-grade inflammation may confer a particular high risk for ASCVD. Attention on the dual threat from high remnant cholesterol and low-grade inflammation is necessary, and further research in this field is warranted. The effect of remnant cholesterol-lowering drugs and anti-inflammatory drugs on ASCVD risk alone and combined remains to be elucidated. Video abstract http://links.lww.com/COCN/A20

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Clinical Trial Design for Triglyceride-Rich Lipoprotein-Lowering Therapies

Cited by 11 publications

References 67 publications

Triglyceride to high-density lipoprotein cholesterol ratio associated with long-term adverse clinical outcomes in patients deferred revascularization following fractional flow reserve

Triglyceride to high-density lipoprotein cholesterol ratio associated with long-term adverse clinical outcomes in patients deferred revascularization following fractional flow reserve

Apolipoprotein C3: form begets function

Remnant cholesterol and low-grade inflammation jointly in atherosclerotic cardiovascular disease: implications for clinical trials

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