PINNACLE registry, guidelines not respected and use of stat

A contemporary snapshot of patients with atherosclerotic cardiovascular disease (ASCVD) suggests that only a third are reaching sufficiently low LDL cholesterol levels with statin therapy. as suggested by the PINNACLE registry, communicated in Philadelphia during the annual congress of the American Heart Association (AHA).

A contemporary snapshot of patients with atherosclerotic cardiovascular disease (ASCVD) suggests that only a third are reaching sufficiently low LDL cholesterol levels with statin therapy. This is what the PINNACLE registry data suggests, communicated in Philadelphia during the annual congress of the American Heart Association (AHA).Among the more than 1.3 million adults treated with statin with ASCVD enrolled in the US national ambulatory PINNACLE between 2013 and 2019, 32.9% had LDL cholesterol levels below 70 mg / dL and 25.9% had levels equal to or greater than 100 mg / dL or higher. The remaining 41.1% of patients had LDL cholesterol levels between 70 and 99 mg / dL.

"There is still a large residual risk and therapeutic gap in this population," the senior experimenter said Dharam Kumbhani, of the UT Southwestern Medical Center in Dallas. "This clearly shows that there is still a lot of work to do".

What the American College of Cardiology and the American Heart Association recommend
The new cross-sectional analysis also suggested that younger patients, women and African Americans were less likely to reach the LDL cholesterol threshold below 70 mg / dL.

In 2018, the American College of Cardiology (ACC) and the AHA published new guidelines for the treatment of cholesterol, assigning a Class I indication for the reduction of LDL cholesterol levels by 50% or more with a statin at high intensity (atorvastatin 40-80 mg and rosuvastatin 20-40 mg), or a maximally tolerated statin dose, in all patients with clinical ASCVD.

While the clinical guidelines do not adopt a specific "target treatment" approach to LDL cholesterol, the consensus of ACC / AHA experts is that "lower is better".
However, for patients at very high risk, including those who have had previous cardiovascular events, ezetimibe is a recommended addition to high intensity statin therapy if LDL cholesterol is 70 mg / dL or higher (class IIa) .

If the LDL remains = /> 70 mg / dL, the addition of a PCSK9 inhibitor such as alirocumab or evolocumab is considered reasonable (class IIa).

More than 20% of patients do not receive a lipid-lowering
From the ambulatory PINNACLE registry, which is part of the national registry of cardiovascular data of the ACC (NCDR), the researchers identified 1,897,204 individuals with ASCVD (defined as ACS, history of myocardial infarction, stable or unstable angina, arterial revascularization, stroke , TIA or peripheral arterial disease).

Of these, almost 400,000 patients, or 21.1%, were not taking any lipid-lowering therapy. Most of these untreated patients had LDL cholesterol levels = /> 100 mg / dL and only 15.6% had LDL levels below 70 mg / dL.

"For this 20% of patients who do not take statins, we do not know if they do not take statins because they are intolerant to these drugs, in which case a PCSK9 or ezetimibe inhibitor could be potentially useful," Kumbhani said.

«Or is it a implementation gap or knowledge on the part of the doctor who takes care of these patients? The latter should really be treated with a statin: there is a class I indication. Probably a combination of factors is at stake in this group, "he added.

While it is true that control of LDL cholesterol levels in 70% of patients with ASCVD who took statins did not seem particularly satisfactory, on the other hand Kumbhani pointed out that they did not have access to statin dose data. However, the study provides a current look at residual risk in ambulatory patients with ASCVD.

"It would be useful to understand how many patients are treated with a high-dose statin," he said. "I imagine that if the total statin use is 70%, a high-dose statin as recommended by the guidelines will certainly be much lower. Once the statin is maximized, if there is still a fair amount of risk, perhaps other agents would be important to consider from the point of view of public health ».

These provisional data, Kumbhani said, will be used as part of the "TRANSFORM LDL-C Risk" project. This ACC initiative, funded by Regeneron and Sanofi, aims to identify high-risk patients with a history of cardiovascular events related to ASCVD in order to identify obstacles to treatment and help them access the therapies they have proven to be able to reduce LDL cholesterol and ASCVD risk.

Allen JM, Arnold SV, Lohr NL, et al. Assessing low-density lipoprotein cholesterol risk within the PINNACLE national outpatient registry. Presented at: AHA 2019. November 17, 2019. Philadelphia, PA.