DYSLIPIDEMIA

CARDIOLOGY

Identifying and treating patients with high Lipidaemia risk post-ACS

Watch Prof. Pasquale Perrone-Filardi from Department of Clinical Medicine, Cardiovascular and Immunology Sciences, Federico II University, Naples sharing insights on Identifying and treating patients with high lipidaemia risk post-ACS.

Atherosclerosis: Identifying risks and improving outcomes

Watch Stephen Nicholls, Professor at Monash Medicine Health, Head of Victorian Heart Hospital, Melbourne, Australia sharing insights on the various atherosclerotic risk factors, and which one is the main culprit driving the development of atherosclerosis burden? And why? and as well discussing what is the clinical outcome of plaque formation in atherosclerosis?

Act Now for Your ACS Patients: Treat Aggressively, Combine and Start Early

Watch Professor Kausik Ray, Cardiologist and Professor of Public Health, Imperial College London, presenting the ACS and how to manage patients in alignment to the 2019 ESC/EAS guidelines using combination therapy, starting the changes immediately and aggressively in alignment with the recent aggressive LDL goals and recent studies outcomes that recommends early use of combination therapy to achieve target goals.

Act Now for Your ACS Patients: Summary

Watch Professor Kausik Ray, Cardiologist and Professor of Public Health, Imperial College London, summarizing the 3 chapters of the ESC/EAS 2019 guidelines and how to adopt them into the clinical practice easing the identification of patients with very high CV risk, especially post ACS.

Act Now for Your ACS Patients: Patient Identification

Watch Professor Kausik Ray, a Cardiologist and Professor of Public Health, Imperial College London, present the 2019 ESC/EAS guidelines, showing how to adapt recent strategies into the medical practice especially for the very high risk CV patients. Professor Kausik Ray provides various insights into how to identify the patient of a very high CV risk, bridging the gap between LDL target goals and actual levels through adopting more aggressive approaches.

A clinical consensus statement of Association for acute cardiovascular care (ACVC), in collaboration with European association of preventive cardiology (EAPC) and the European Society of Cardiology working group on cardiovascular Pharmacotherapy 
 Krychtiuk KA, et al. Eur Heart J Acute Cardiovasc Care. 2022;11(12):939–949.

<h2>Key Takeaway</h2>
Patients experiencing ACS are at high risk for recurrent ischemic CV events, in very early phase&nbsp;(within 1–3 months after index event)
Reduction in ASCVD risk is known to be proportional to absolute LDL-C reductions post-ACS&nbsp;("the lower, the better approach")
The ESC/EAS guidelines recommend a stepwise initiation and escalation of LLT, with re-evaluation of LDL-C goals after 4–6 weeks
Observational data showed,&nbsp;low rates of guidelinerecommended LLT adaptions and LDL-C target goal achievement, which leaves patients at residual risk&nbsp;(vulnerable post-ACS phase)
Even with LDL-C assessments and therapy escalations every 4–6 weeks: Achieving target goals might take up to 3 months, coinciding with the highest risk period for recurrent CV events
In addition to the well-established ‘the lower, the better’ principle, ‘<a href="https://pro.campus.sanofi/dam/jcr:f7398296-377c-4967-a216-c16d41a0774d/Lipid-lowering-Algorithm-Figure_1.pdf" target="_blank">strike early and strike strong approach</a>’, upfront initiation of a ‘combined lipid-lowering approach using high-intensity statins and ezetimibe’&nbsp;seems reasonable&nbsp;in the early post-ACS phase
<ul>
 <li>Therefore, a lipid-lowering strategy of ‘strike early and strike strong’ to be discussed in all patients with ACS, with immediate initiation of statin therapy and a dual lipid-lowering strategy as a default strategy</li>
</ul>
Acute PCSK9 inhibition is a novel strategy that needs to be considered, in patients with high-risk features*

<h2>Why This Matters</h2>
Despite current guidelines suggesting a stepwise lipidlowering approach, data suggest that after ACS:
<ul>
 <li>Few lipid-lowering drugs are prescribed and few dose adjustments are performed following hospital discharge</li>
 <li>Majority of patients do not achieve their goals</li>
</ul>
Even in ideal post-ACS scenario, it can take up to 12 weeks† for patients to receive optimal LLT when following the stepwise approach
‘Strike early and strong’ strategy using an optimal combination of effective and safe lipid-lowering agents may represent a therapeutic tool in these patients

<h2>Proposed lipid-lowering algorithm post-acs</h2>
Upfront initiation of a combined lipid-lowering approach using high-intensity statins and ezetimibe

*High intensity statin treatment defined as atorvastatin (40-) 80 mg; rosuvastatin 20 (-40) mg
**In patients with untreated LDL-C&lt;70 mg/dL, high intensity statin treatment only may be considered
***Lipoprotien(a) levels should be measured if unknown as part of overall risk estimation
****Particularly in pateints with very high (untreated) LDL-C (&gt;190 mg/dL) or high (untreated) LDL-C (&gt;160 mg/dL) in the presence of premature AMI or a family history of premature AMI
Please refer the source publication&nbsp;<a href="https://academic.oup.com/ehjacc/article/11/12/939/6961651?login=true" target="_blank">Krychtiuk KA, et al.</a>&nbsp;for additional details 
 *Multivessel CAD, polyvascular disease or FH 
 †The most vulnerable phase after a major coronary event

Abbreviations

Reference

Acute LDL-C Reduction Post ACS: Strike Early and Strike Strong: From Evidence to Clinical Practice

The Asian Pacific Society of Cardiology (APSC) consensus recommendations for management of dyslipidemia.
Koh N, Ference BA, Nicholls SJ, Navar AM, Chew DP, Kostner K, et al. Eur Cardiol. 2021;16:e54.

<h2>Key Takeaway</h2>
The APSC consensus recommendations tackled contemporary issues in the management of dyslipidemia, FH and Lp(a) in the Asia-Pacific region based on most updated evidence.
<ul>
 <li>These included 14 recommendations for 
 <ul>
 <li>Assessment of patients with chronic coronary syndrome (CCS)</li>
 <li>LDL-C treatment targets</li>
 <li>Therapy for high-risk and very high-risk CCS</li>
 <li>Criteria for identification, diagnosis, and cascade screening of suspected FH</li>
 <li>Measurement of Lp(a) in specific populations</li>
 </ul></li>
 <li>The recommendations by APSC intend to guide assessment and treatment of dyslipidemia to facilitate improved screening, early diagnosis, and treatment.</li>
 <li>Dyslipidemia should be managed on an individual basis.</li>
 <li>The clinicians should be conscious of the challenges that may limit the applicability of these consensus recommendations</li>
 <li>The recommendations should not substitute clinical judgement.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>The increasing prevalence of dyslipidemia in the Asia Pacific is associated with dietary changes and decreasing physical activity.</li>
 <li>While there has been substantial progress in dyslipidemia therapy, its management in the Asia-Pacific region is challenged by limitations in awareness, adherence, and healthcare costs.</li>
 <li>A unified approach for the management of dyslipidemia is needed.</li>
</ul>

<h2>Consensus Recommendations</h2>
6 Consensus Recommendations - Dyslipidemia
<ul>
 <li>Patients with CCS should be assessed according to the Coronary–Vascular–Disease system (<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC8251506/" target="_blank">APSC CCS consensus recommendations</a>) and categorized as having high-risk CCS (one risk factor) or very-high-risk CCS (&gt;1 risk factor) (level of evidence, low; consensus, 96.3% agree)</li>
 <li>High-intensity statins are recommended for all patients with clinically manifest CCS, regardless of risk (level of evidence, moderate; consensus, 88.9% agree)</li>
 <li>LDL-C treatment targets for high-risk CCS: Reduction from baseline LDL-C of ≥50% and achieving an on-treatment level of at least &lt;1.8 mmol/l (level of evidence, low; consensus, 96.3% agree)</li>
 <li>LDL-C treatment targets for very high-risk CCS: Reduction from baseline LDL-C of ≥50% and achieving an on-treatment level of at least &lt;1.4 mmol/l (level of evidence, low; consensus, 96.3% agree)</li>
 <li>For high-risk CCS on maximally tolerated statins: Ezetimibe and/or a PCSK9i may be added for those who do not achieve target (level of evidence, moderate; consensus, 100% agree)</li>
 <li>For very-high-risk CCS: 
 <ul>
 <li>Upfront initiation of combination therapy with high-intensity statins and ezetimibe may be considered</li>
 <li>A PCSK9i may be added for those who do not achieve target within 4 weeks of initial therapy (level of evidence, moderate; consensus, 96.3% agree)</li>
 </ul></li>
</ul>
5 Consensus Recommendations - Familial Hypercholesterolemia
<ul>
 <li>Consideration of FH should be in people with: 
 (1) Severely elevated LDL-C (in adults, &gt;4.9 mmol/l; in children [aged ≤19 years], &gt;3.9 mmol/l) (2) LDL-C of &gt;2.6 mmol/l while adherent to a high-intensity statin (3) Premature ASCVD (age: men, &lt;55 years; women, &lt;60 years) (4) Elevated LDL-C (in adults &gt;4.1 mmol/l) and a first-degree relative with premature CVD (5) A first-degree relative with FH, tendon xanthoma or arcus cornealis (level of evidence, low; consensus, 100% agree)</li>
 <li>Clinical criteria can be used to identify and diagnose suspected FH</li>
 <li>Choice of criteria may vary across and within countries) (level of evidence, low; consensus, 96.3% agree)</li>
 <li>Confirmation of FH via genetic testing is not necessary for treatment initiation but may be, for diagnostic confirmation and cascade screening to identify family members with FH (level of evidence, low; consensus, 100% agree)</li>
 <li>Once an index case is diagnosed, family cascade screening (lipid profile) is recommended (level of evidence, low; consensus, 96.3% agree)</li>
 <li>Patients with FH and ASCVD or another major CV risk factor are considered as very high risk 
 <ul>
 <li>All other patients with FH are considered as high risk</li>
 <li>These patients should be treated with LLTs in accordance with their risk profile (level of evidence, low; consensus, 96.3% agree)</li>
 </ul></li>
</ul>
3 Consensus Recommendations – Lipoprotein(a)
<ul>
 <li>Resources permitting Lp(a) measurement should be performed at least once in each adult person’s lifetime, especially those with family history of premature ASCVD</li>
 <li>Those with very high inherited Lp(a) levels &gt;430 nmol/l (&gt;180 mg/dl) may have a lifetime ASCVD risk equivalent to the risk associated with heterozygous FH (level of evidence, low; consensus, 92.6% agree)</li>
 <li>Consideration of Lp(a) measurement in selected patients with family history of premature CVD (level of evidence, low; consensus, 92.6% agree)</li>
 <li>As Lp(a) is a risk enhancer, measurement may be considered for between high- and very-high risk groups (level of evidence, low; consensus, 92.6% agree)</li>
</ul>

APSC Consensus Recommendations on Dyslipidemia

<h2>Venous thromboembolism incidence in patients recommended for pharmacologic prophylaxis after cesarean delivery based on different risk stratification guidelines</h2>

<h2>Main Takeaway</h2>
The proportion of patients at risk of VTE following cesarean delivery&nbsp;meeting the criteria for pharmacologic prophylaxis (from 0.2% to 73.4%) and the incidence of VTE (from 2.5 to 35.2 per 1,000 deliveries)&nbsp;varied widely based on the guideline criteria employed&nbsp;(2011 ACOG, 2012 ACCP, 2015 RCOG and 2018 ASH)

<h2>Why This Matters</h2>
In the US, VTE is a leading cause of pregnancy-related morbidity and mortality, particularly after cesarean delivery; however,&nbsp;guidelines differ in the criteria suggested for VTE Prophylaxis, possibly leading to notable differences in clinical practice

<h2>Study Design</h2>
This retrospective US cohort study used data from the Nationwide Readmissions Database from October 2015 through December 2017 to identify patients undergoing cesarean delivery.&nbsp;
<ul>
</ul>
<ul>
 <li>Key inclusion criteria:
 <ul>
 <li>cesarean delivery</li>
 <li>only first cesarean delivery in a calendar year for a given patient</li>
 <li>patients were to be followed within the same calendar year, and within the same US state</li>
 </ul></li>
</ul>
<ul>
 <li>Key exclusion criteria:
 <ul>
 <li>non-residents of the delivery state</li>
 <li>patients who delivered in December</li>
 </ul></li>
</ul>

<h2>Key Results</h2>
<h3>Patient Population</h3>
<ul>
 <li>Overall, 1,235,149 cesarean delivery hospitalizations from 4,620 hospitals were included in the analysis (mean age = 29.8 years; mean length of stay for hospitalization = 3.5 days)</li>
</ul>
<h3>VTE Prophylaxis</h3>
<ul>
 <li>There was a large variation in the percentage of patients meeting criteria for pharmacological prophylaxis: 
 <ul>
 <li>ASH 2018 (0.2%)</li>
 <li>ACOG 2011 (0.3%)</li>
 <li>ACCP 2012 (16.2%)</li>
 <li>RCOG 2015 (73.4%)</li>
 </ul></li>
</ul>
<h3>VTE Incidence</h3>
<ul>
 <li>The overall incidence of VTE at 330 days after cesarean delivery was 2.1 per 1,000 hospitalizations (95% CI: 2.0, 2.2)</li>
 <li>The incidence of VTE (per 1,000 deliveries) in patients at elevated risk post cesarean delivery varied widely according to the guideline criteria employed: 
 <ul>
 <li>RCOG 2015 (2.5%)</li>
 <li>ACCP 2012 (5.6%)</li>
 <li>ACOG 2011 (31.7%)</li>
 <li>ASH 2018 (35.2%)</li>
 </ul></li>
 <li>All criteria identified low- and elevated-risk populations whose risk of VTE were statistically significantly different from each other, with varying relative risks: 
 <ul>
 <li>ASH 2018 (RR = high risk/low risk: 17.3; 95% CI: 12.3, 22.2)</li>
 <li>ACOG 2011 (RR: 15.7; 95% CI: 11.7, 19.9)</li>
 <li>ACCP 2012 (RR: 3.9; 95% CI: 3.4, 4.3)</li>
 <li>RCOG 2015 (RR: 2.2; 95% CI: 1.9, 2.5)</li>
 </ul></li>
</ul>

<h2>Limitations</h2>
<ul>
 <li>Use of administrative (billing) data may have likely resulted in measurement errors in the recording of VTE incidences</li>
 <li>The use of VTE prophylaxis could not be observed in the available data and this could have impacted the incidence of VTE reported in this population</li>
 <li>The NRD is an inpatient-only dataset, hence any VTE identified/managed on an outpatient basis were excluded</li>
</ul>

VTE incidence after cesarean delivery

THROMBOSIS

In the first year of lipid lowering among patients with ACS, who are at the highest risk, half the relative benefit of later years can be achieved using a combination of statin and PCSK9i.

<h2>Key Takeaway</h2>
<ul>
 <li>Patients with ACS have the highest risk in the first year after the event and would need to achieve lower LDL-C levels.</li>
 <li>Statin monotherapy will be ineffective alone if the targeted goal is &lt;1.8 mmol/L (70 mg/dL) and certainly for &lt;1.4 mmol/L (55 mg/dL).</li>
 <li>Real-world data suggest that with high residual risk with life span exposure, there is poor goal attainment, and many events are preventable by correcting CV risk factors as well as environmental and genetic factors.</li>
 <li>Greater use of combination therapy, particularly statins + PCSK9i, will improve LDL-C control post-ACS, thus likely reducing CV events.</li>
</ul>

<h2>Key Highlights</h2>
<ul>
 <li>The impact of time should not be ignored on the underlining disease progress. Patients seen after an ASCVD event are 50–60 years old and have been exposed for decades to high LDL-C, blood pressure, smoking, and environmental and genetic factors, leading to this event. After the event, there is a need to target these factors rather than preserve health</li>
 <li>If treatment is delayed, patients will need to be treated with a more aggressive therapy in terms of absolute LDL-C lowering.</li>
 <li>Mendelian randomized studies and controlled trials showed a 22% reduction in relative risk over 5 years with a 38-40 mmol/dL reduction of LDL-C, but this number goes up to 33% if maintained over 12 years, and nearly 50% when projected to 50 years.</li>
 <li>Trials have showed no evidence of a threshold below which lowering LDL-C loses benefit. The lower the LDL-C reduction, the better. However, the amount of absolute benefit depends on the baseline risk.</li>
 <li>Guidelines suggest a stepwise approach (starting with statin, then adding ezetimibe, and then adding PCSK9i), which is largely based on trial data</li>
 <li>As per the Mendelian randomization studies, a similar benefit is achieved with 15 mg/dL LDL-C lowering over 50 years when treated with either statin, ezetimibe, or PCSK9i 
 <ul>
 <li>Thus, instead of following a stepwise approach, a combinatorial approach would prove helpful</li>
 </ul></li>
 <li>The absolute risk post-ACS is very high, especially early after an MI. 
 <ul>
 <li>The relative benefit per 1 unit change in LDL-C is lower in the first year of treatment than in later years; therefore, greater absolute reductions in LDL-C are needed during this early period</li>
 </ul></li>
 <li>The combination of statins plus PCSK9i (mAbs) is a natural choice for LDL-C reduction</li>
 <li>LDL-C goals of 2016 ESC/EAS and AHA/ACC guidelines are similar, i.e., &lt;70 mg/dL. 
 <ul>
 <li>With this approach, goal attainment was 45% with high-intensity statins, 54% with ezetimibe combination, and 67% with PCSK9i combination</li>
 </ul></li>
 <li>In contrast, the 2019 ESC/EAS guidelines suggest an LDL-C goal of &lt;55 mg/dL 
 <ul>
 <li>With this approach, goal attainment was 45% with high-intensity statins, 54% with ezetimibe combination, and 67% with PCSK9i combination</li>
 <li>Thus, approximately half the patients would require a PCSK9i</li>
 </ul></li>
 <li>In the Swedeheart&nbsp;study, three-fourth patients were statin-naïve, meaning they were assumed to not be at a risk high enough to benefit from evaluation; yet they had an MI 
 <ul>
 <li>In one-quarter of patients who were on statins from admission to discharge, not intensifying lipid-lowering therapy would lead to the worst outcomes among all patients</li>
 <li>A simulation study reported that 4 out of 5 patients with recent MI would be eligible for escalated lipid-lowering therapy according to the 2019 ESC/EAS guidelines (&lt;55 mg/dL) at 6–10 weeks after the event</li>
 <li>Of these, 50% would be eligible for additional treatment with PCSK9i after inadequate LDL-C control with maximally tolerated statins and ezetimibe therapy</li>
 </ul></li>
</ul>

Why compromise for less: Should PCSK9 inhibitors be initial therapy?

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