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The Impact of Preoperative Statin Therapy and and Its Intensity on Postoperative and Mortality and Morbidity (STIMM)

10 mei 2026 bijgewerkt door: Arman Valadkhani, Karolinska Institutet

Impact of Statin Therapy and Intensity on Postoperative and Mortality and Morbidity: A Prospective Observational Dual-Centre Cohort Study

Statins are among the most widely prescribed drugs worldwide, and their benefits in cardiovascular risk reduction are well established. Beyond lipid lowering, statins exert pleiotropic effects - including anti-inflammatory, antioxidant, and endothelial-stabilizing properties - that have generated longstanding interest in their potential to mitigate perioperative complications.

Major surgery provokes a systemic inflammatory response, endothelial activation, and hemodynamic stress that may precipitate myocardial injury, organ dysfunction, and death, particularly in patients with pre-existing cardiovascular disease.

Therefore, the aim is to examine the association between preoperative statin therapy and its intensity with postoperative all-cause mortality and days at home alive after major non-cardiac surgery in a large, contemporary, dual center-based cohort.

Studie Overzicht

Toestand

Voltooid

Conditie

Perioperatieve zorg

Gedetailleerde beschrijving

Research hypothesis: Preoperative statin use is independently associated with reduced 30-day and 365-day all-cause mortality compared with no statin use. Higher statin intensity (high vs. low or moderate) is independently associated with reduced 30-day and 365-day all-cause mortality. Statin use and intensity are independently associated with greater DAH30 and DAH365, reflecting reduced postoperative morbidity

Background: Early randomised trials suggested that initiating statin therapy before surgery could reduce cardiac complications and mortality. However, several pivotal trials were subsequently retracted following research misconduct, undermining the evidence base for perioperative statin initiation and rendering clinical guidelines equivocal. Importantly, these discredited trials examined de novo short-term statin initiation - a question distinct from whether patients on established, chronic statin therapy experience better postoperative outcomes.

Subsequent observational studies have reported associations between preoperative statin use and reduced postoperative morbidity and mortality, but most have been limited by narrow surgical populations, and an inability to examine dose-response relationships, residual confounding or patient-centred outcomes beyond mortality.

Data collection and analysis: Data is collected prospectively between 2016 and 2023 across two tertiary academic centres - Karolinska University Hospital Solna and Huddinge - from electronic health records. Statin exposure status and intensity were ascertained from based on registered Anatomical Therapeutic Chemical (ATC) classification codes The primary analytical approach uses inverse probability of treatment weighting, implemented across two pre-specified binary analyses - statin use versus no use in the full cohort, and high versus low-moderate intensity within statin users, for more details see attached statistical analysis plan.

Studietype

Observationeel

Inschrijving (Werkelijk)

70000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Zweden
- - Stockholm, Zweden
    - Karolinska University Hospital Huddinge
  - Stockholm, Zweden
    - Karolinska University Hospital Solna

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery

Beschrijving

Inclusion Criteria:

Adults aged ≥ 18 years at the time of surgery
Elective (non-emergency) surgical procedure
Non-cardiac surgery (all surgical specialties except cardiac surgery)

Exclusion Criteria:

Obstetric surgery
Transplant surgery
Planned day-case surgery (procedures with intended same-day discharge)
Anesthetic monitoring episodes not involving a surgical procedure (e.g., anesthetic support for central venous catheter insertion)
Urological brachytherapy
Stereotactic radiosurgery (Gamma Knife or equivalent)
Repeat or subsequent surgical procedures during the study period - only the index (chronologically first eligible) procedure per patient is included in the analysis

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
30- and 365-day mortality Tijdsspanne: 30 and 365 days respectively	Death within the time frames described	30 and 365 days respectively

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
DAH30 (Days At Home alive at 30 days) and DAH365 (Days At Home alive at 365 days) Tijdsspanne: 30 and 365 days after index surgery,	DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16. Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14. Anyone who dies within 30 days will have DAH30=0. This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS). We will further record DAH365, calculated as described above.	30 and 365 days after index surgery,

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 mei 2024

Primaire voltooiing (Werkelijk)

2 februari 2026

Studie voltooiing (Werkelijk)

2 februari 2026

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria