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April 9, 2022 – The CPC (Cororado Prevention Center) Clinical Research, in collaboration with the Hospital Israelita Albert Einstein and Uppsala Clinical Research, announced the launch of EVOLVE-MI (EVOLocumab Very Early After Myocardial Infarction, NCT05284747), which will evaluate the potential value of aggressive LDL-C lowering with evolocumab immediately post-MI. The trial’s primary outcomes are the composite total (first and subsequent) myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-case mortality. This is a pragmatic trial, designed to measure the effectiveness of this approach in real-life routine practice conditions.
To read more about this trial, please visit the press release by CPC here, and click here to view the study design
April 3, 2022 – The results of the PACMAN-AMI trial (ClinicalTrials.gov, NCT03067844), which evaluated the effects of alirocumab on plaque volume in patient with a recent ACS event undergoing PCI, were announced at the 2022 American College of Cardiology (ACC) scientific sessions and simultaneously published in the Journal of American Medical Association. In this trial, treatment with alirocumab in addition to high-intensity statins, resulted in significantly greater coronary plaque regression in these patients. Taken together, the results of PACMAN-AMI and HUYGENS suggest a strong mechanistic effect of PCSK9 inhibitors on plaque regression in high-risk post-MI patients.
To read the full results of the PACMAN-AMI trial, click here
August 27, 2021 – The HUYGENS study (ClinicalTrials.gov, NCT03570697) evaluated the effects of evolocumab on fibrous cap thickness (FCT), a measure of atherosclerosis in the carotid artery, in post-ACS patients who are taking maximally tolerated statin therapy. Results were announced at the 2021 European Society of Cardiology meeting, and showed that treatment with evolocumab significantly improved features of plaque stability in these patients, including an increase of the minimum FCT and a decrease in the maximum lipid arc, with the degree of lipid lowering being proportional to the observed beneficial effects.
August 18, 2021 – PCSK9 inhibitors (PCSK9i, despite showing great efficacy in preventing secondary adverse cardiovascular events in high-risk patients and have been adequately incorporated in several guidelines, remain vastly underutilized. Such was the conclusion of a real-world study, which used an outpatient registry to evaluate PCSK9i prescribing patterns among very high-risk patients that would meet the clinical criteria to be on these drugs (have existing ASCVD and an LDL-C <190 mg/dL). Of 2,148,100 eligible patients in the registry, only 27,249, or 1.3% received PCSK9i prescriptions. Data was analyzed from the periods between September 1, 2015 – September 30, 2019. Receiving a PCSK9i was associated with White race, higher household income, and urban or suburban (vs. rural) practice location. On the other hand, Hispanics had lower odds of receiving a PCSK9i prescription. Additionally, the study reported that no differences in PCSK9i prescription patterns were observed before and after price reductions for evolocumab and alirocumab were initiated (Q4 of 2018 and Q1 of 2019, respectively).
The full analysis can be accessed here
August 3, 2021 – Current guidelines recommend that for patients at very high-risk for major adverse cardiovascular events (MACE) and with an LDL-C ≥70 mg/dL on optimized statin treatment, that the addition of non-statin therapies should be considered. One of the key clinical questions is whether patients that have LDL-C levels close to 70 mg/dL on statins derive benefit from the addition of other lipid-lowering therapies. It is uncertain how residual risk may affect this decision, and lipoprotein(a) levels are considered a significant marker of residual risk. This question was posed in a recent sub-analysis of the ODYSSEY Outcomes trial, which evaluated the benefit of adding PCSK9 inhibitor alirocumab to maximally-tolerated statin therapy in patients with a recent acute coronary syndrome (ACS) event and an LDL-C near 70mg/dL. The results showed that an incremental clinical benefit to adding alirocumab in these patients is only apparent when lipoprotein(a) levels are at least mildly elevated (≥13.7 mg/dL). However, the authors noted that patients with higher LDL-C levels derived consistent benefit from alirocumab despite lipoprotein(a) levels. Taken together, this study seems to suggest that in patients with ACS and LDL-C levels near 70 mg/dL, that paying attention to both LDL-C and Lp(a) levels may be necessary to minimize the risk of MACE.
May 14, 2021 – A recent sub-analysis of the ODYSSEY Outcomes trial, presented at the American College of Cardiology (ACC) 2021 meeting, evaluated whether the benefit observed with alirocumab in this trial was influenced by a history of myocardial infarction (MI) prior to the qualifying acute coronary syndrome (ACS) event. Compared to patients without previous MI (n=15,291), patients with a history of MI (n=3,633) were older, had more cardiovascular risk factors, were more likely to have had other cardiovascular events, and predominantly male. Alirocumab treatment had a consistent effect on major adverse cardiovascular events (MACE) and all-cause mortality in patients with prior MI, and the absolute risk reductions for MACE and all-cause mortality were greater in patients with a history of MI vs. those without (1.91% and 1.35% risk reduction in MI vs. 1.42% and 0.41% in no MI, respectively). Taken together, these data indicate that protective effects of alirocumab seen in the ODYSSEY Outcomes trial are greater in patients with a history of MI.
The full results of this analysis can be accessed here
The full results of this study can be accessed here
Recap of Major Lipid-Lowering Trials at 2023 ACC
Watch Dr. Ballantyne and Dr. Michos discuss key trials in lipid lowering presented at 2023 ACC, including CLEAR Outcomes with bempedoic acid, a phase 2 trial with oral PCSK9 inhibitor MK-0616, as well as their potential implications. Recorded March 10, 2023
Expert Perspectives and Recent Developments in LDL-C Lowering
Watch Drs. Ballantyne, Michos, and Saseen discuss some practical pearls about recent developments in LDL-C lowering. They discussed combination therapy and constantly evolving lipid therapy, including data about monoclonals, and siRNA, also presented at 2022 AHA meeting. Recorded on Dec. 14, 2022.
Lipid Management in the Post-ACS Patient
Salim S. Virani,
Watch Drs. Ballantyne, Taub, and Virani discuss some practical pearls about the optimization of lipid-lowering therapy in patients with a recent MI or an acute coronary syndrome (ACS) event. They discuss suboptimal LDL-C levels in these patients, reasons for these gaps, and how to lower LDL-C levels early and effectively with evidence-based therapies in order to minimize the risk of recurrent events. (Recorded June 20, 2022).
CMHC Annual 2021 Lipid Management Panel
CMHC Chairs Christie Ballantyne, MD and Robert Eckel, MD, as well as CMHC faculty Matthew Budoff, MD recap the lipid sessions presented at the 16th Annual CMHC, including perspectives and clinical pearls on ASCVD risk assessment, residual ASCVD risk, and ASCVD management and prevention.
Lipid Management in Very High-Risk Patients Post-MI: Expert Perspectives with Drs. Taub, Desai, Shapiro
MD, MPH, FACC
DO, MCR, FACC, FAHA
Watch Drs. Taub, Desai, and Shapiro discuss some additional perspectives on the management of very high-risk, including:
- The safety of very low LDL-C
- Concerns with statins and new-onset diabetes and how to address overall patient concerns about lipid-lowering therapy
- Residual ASCVD risk beyond LDL-C