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More Work Needed to Achieve LDL Goals: SANTORINI

MANNHEIM — More patients with elevated cardiovascular risk are achieving their low-density lipoprotein (LDL) cholesterol targets likely thanks to combination lipid-lowering therapy, but there’s much more work to be done, suggest data from a European registry.

More than 7200 patients with cholesterol measurements at baseline and at 1 year from the SANTORINI registry were included in the current analysis.

Results showed that the proportion of patients achieving their LDL cholesterol target increased from 21% to 31%, with an average decrease in average levels of 0.4 mmol/L in both high- and very high–risk groups.

The research was presented at the 91st European Atherosclerosis Society (EAS) Congress on May 23.

This decrease in LDL cholesterol levels “is largely driven by, thankfully, those people not on lipid-lowering therapy going on to something, and also many more patients going on to combination therapies,” such as a statin plus ezetimibe, said study presenter Kausik Ray, MD, PhD, Professor of Public Health at Imperial College London, London, United Kingdom, and President of the EAS.

“However, at a population level, we’re not getting our population to goal because we’re not putting enough of our patients on to combination therapy. The mantra has to be to move to combination therapy rather than monotherapy, “and that starts with your assessment of risk,” Ray said.

He also conceded that the SANTORINI registry represents the “best case scenario” because it includes people who are willing to participate in research.

Ray noted that when looking at electronic health record data, the picture is “worse than this.”

‘Dismal Job’

Approached for comment, session co-chair Andreas Zirlik, MD, PhD, described the results as “very disappointing.”

“We now have so many good tools to curb LDL cholesterol, and we are still doing a dismal job,” Zirlik, Head of Department of Cardiology and Chairman of the University Heart Center Graz, LKH-University Hospital and Medical University of Graz, Graz, Austria, told | Medscape Cardiology.

Referring to the 10% overall increase in patients in the registry achieving goal, he said: “It’s a little bit better, but is it really worth celebrating? No.”

Zirlik suggested that, with most studies showing that only a “small fraction” of patients receive combination therapy, “we need a recommendation, as we have now in blood pressure therapy, to pre-emptively start with a combination.”

He also believes that although “the lower the better” and “the earlier the better” are “great slogans” for lipid management, “perhaps we need a little bit more granularity in the highest risk group because it’s like anyone with a vascular phenotype is highest risk.”

“But there are definitely patients out there, for example those who really had an event, that should have very stringent and rapid recommendations…for more aggressive therapy,” beyond a simple combination, Zirlik said.

Behavior Over Time

Ray began his presentation by noting that, ordinarily, registries provide a snapshot of current care practices, but with the 1-year follow-up from the SANTORINI registry, they were able to look at clinician behavior over time and ask some key questions.

He notes that these include: What care are healthcare professionals delivering at each of the participating sites? What did they change over that 1 year of follow-up? What did that change result in?

Ray also highlighted that SANTORINI is the first registry conducted in Europe since the updated 2019 ESC/EAS guidelines for the management of dyslipidemias. The guidelines “moved the goalposts” for three of the LDL cholesterol risk categories, with two of those being hard to achieve, he said.

Specifically, the targets became:

  • High-risk: < 1.8 mmol/L (< 70 mg/dL)

  • Very high–risk: < 1.4 mmol/L (< 55 mg/dL)

  • For both: ≥ 50% reduction in LDL cholesterol

“What we forgot to tell people is the goalposts have moved because of the use of combination therapy,” he said.

SANTORINI enrolled 9136 patients with high and very high cardiovascular risk between March 2020 and February 2021 at 623 sites across 14 European countries, and followed them until May 31, 2022.

For the current analysis, lipid management was assessed in 7120 patients who had LDL cholesterol levels available at both baseline and 1-year follow-up.

They had an average age of 65 years, and 72.1% were men. “Unsurprisingly, there’s a lot of people with established cardiovascular disease, smoking, hypertension,” Ray noted, and the mean LDL cholesterol level was 2.42 mmol/L (93.53 mg/dL).

Overall, the mean LDL cholesterol level decreased to 1.98 mmol/L, with the proportion of patients achieving their target increasing from 21.5% to 32.1%, with similar results seen in both the high- and very high–risk groups.

“Each group is shifting by about 0.4 mmol/L,” Ray said, “which is resulting in around an extra 10% of people getting to goal.”

“So, the question now is: Where is this coming from? Who are the ones that are moving?”

He showed that, over the course of the study, the proportion of patients receiving no lipid-lowering therapy decreased from 21.6% to 3.0%.

There was a small increase in the use of monotherapy, from 50.9% to 55.4% of patients, which was largely due to increased statin use.

There was, however, a much larger increase in the proportion of patients receiving combination therapy, from 27.5% to 41.7%. This was largely due to increased use of a statin plus ezetimibe, with smaller increases for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor combinations.

Again, similar patterns were seen in both the high- and very high–risk groups, albeit with a larger shift to combination therapies in the high-risk group, from 29.9% to 45.3%.

Turning to goal attainment, Ray showed that 28.2% of high-risk patients who achieved their LDL cholesterol target at baseline were receiving monotherapy, with statin therapy the most common, whereas 36.6% had combination therapy.

The most widely used combination was PCSK9 inhibition plus another drug, in 52.1% of patients, while 32.7% were taking a statin plus ezetimibe. This pattern was mirrored in the high-risk group.

The study was sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. Ray declares relationships with Amgen, Sanofi, Regeneron, Daiichi Sankyo, Pfizer, Viatris, Abbott, AstraZeneca, Lilly, Kowa, Novo Nordisk, Boehringer Ingelheim, Esperion, Cargene, Resverlogix, SCRIBE, Novartis, Silence Therapeutics, CRISPR, Bayer, New Amsterdam Pharma, BI, Vaxxinity, PEMI-31.

91st European Atherosclerosis Society Congress 2023. Presented May 23, 2023. Abstract 1536

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