Evidence map›Paper›PMID 41989103›Full record

Observational studyEuropean heart journal2026

PCSK9 inhibitor treatment and outcomes in patients with atherosclerotic cardiovascular disease but without prior ischaemic events: an observational study.

Deepak L Bhatt, Pasquale Perrone Filardi, Irfan Khan, José Tuñón, Nikolaus Marx, Manuel Castro Cabezas, Katherine Andrade, Alexandra Koumas, Zhouyang Lou, Lale Tokgözoğlu

Erratum issuedAbstract readObservational Study
In one paragraph

Observational study in European heart journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Deepak L BhattMount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, NewYork, NY 10029, USA.ORCID 0000-0002-1278-6245
Pasquale Perrone FilardiDepartment of Advanced Biomedical Sciences, Federico II University of Naples, Italy.
Irfan KhanIntegrated Evidence Generation, Sanofi, Morristown, NJ, USA.ORCID 0000-0002-9832-0904
José TuñónDepartment of Cardiology, Fundación Jiménez Díaz, Autónoma University, CIBERCV, Madrid, Spain.ORCID 0000-0002-1373-0999
Nikolaus MarxDepartment of Internal Medicine I, Cardiology, RWTH Aachen University, Aachen, Germany.ORCID 0000-0001-6141-634X
Manuel Castro CabezasDepartment of Internal Medicine, Endocrinology, Diabetes and Vascular Medicine, Franciscus Gasthuis & Vlietland, Rotterdam; Erasmus MC, Rotterdam, The Netherlands.ORCID 0009-0009-5164-2082
Katherine AndradeOptum Life Sciences, Optum, Eden Prairie, MN, USA.ORCID 0000-0002-5966-1140
Alexandra KoumasAxtria, Berkeley Heights, NJ, USA.ORCID 0000-0003-3680-306X
Zhouyang LouAxtria, Berkeley Heights, NJ, USA.
Lale TokgözoğluDepartment of Cardiology, Hacettepe University, Ankara, Turkey.ORCID 0000-0001-6441-3339

Funding

Sanofi
6 · The paper itself

Abstract

BACKGROUND AND

aimsLow-density lipoprotein cholesterol (LDL-C)-lowering therapies are proven effective in atherosclerotic cardiovascular disease (ASCVD), but real-world evidence for proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) monoclonal antibodies (mAb) remains limited. This study evaluated their impact in patients with ASCVD without prior ischaemic events.

methodsPatients initiating PCSK9i mAb from January 2016 to December 2022 were identified in the Optum Research Database. A 1:2 propensity score-matched comparator cohort of PCSK9i non-initiators was developed. The primary endpoint was a composite of non-fatal myocardial infarction, non-fatal ischaemic stroke, or all-cause mortality. Key outcomes from the parametric G-formula were 5-year event rates, relative risk reduction (RRR) and absolute risk reduction (ARR), with intention-to-treat (ITT) analysis. Additional outcomes for PCSK9i mAb initiators included absolute and percent LDL-C reduction from baseline.

resultsOverall, 19 670 patients met selection criteria (6545 PCSK9i mAb initiators; 13 125 non-initiators). Baseline characteristics were well-balanced. Under ITT, estimated 5-year event rates were 17.5% [95% confidence interval (CI) 15.5%, 19.5%] with PCSK9i mAb vs 25.4% (95% CI 23.6%, 27.1%) without PCSK9i, yielding a RRR of 30.9% and ARR of 7.8%. Individual endpoints showed RRRs of 28.3% for myocardial infarction (P < .0001), 26.4% for ischaemic stroke (P = .02), and 28.5% for all-cause mortality (P < .0001). Among initiators, mean baseline and follow-up LDL-C were 117.8 and 54.7 mg/dL (on-treatment analysis), respectively, representing an absolute reduction of 63.1 mg/dL and percent reduction of 53.6%.

conclusionsIn ASCVD patients without prior events in clinical practice, PCSK9i mAb treatment was associated with lower ischaemic event and mortality rates.

Indexed as

Antibodies, MonoclonalAnticholesteremic AgentsAtherosclerosisPCSK9 InhibitorsAgedAntibodies, Monoclonal, HumanizedCholesterol, LDLFemaleHumansIschemic StrokeMaleMiddle AgedMyocardial InfarctionProprotein Convertase 9Treatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9Atherosclerotic cardiovascular diseasePCSK9 inhibitor

Identifiers

PMID41989103
PMCPMC13472681

What OpenQuestion holds

Texttitle and abstract
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.