This nationwide observational cohort study compares the risk of major adverse cardiovascular events (MACE) and territory-specific arterial complications between patients with incident Takayasu arteritis and matched general-population controls, and identifies determinants of MACE within the Takayasu arteritis population, including cumulative glucocorticoid exposure, using the French National Health Data System (SNDS).
Study Design and Data Source This is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. All patients aged 15 to 60 years with an incident hospital diagnosis of Takayasu arteritis (ICD-10 M31.4, recorded as a principal, related, or associated diagnosis; validated algorithm with positive predictive value 93.9%) between 2010 and 2024 were identified and matched without replacement to up to four general-population controls Statistical Analysis Cumulative incidence was estimated as one minus the Kaplan-Meier estimate, with 95% confidence intervals. Hazard ratios comparing patients with Takayasu arteritis to matched controls were estimated from Cox proportional-hazards models stratified on the matched set. For non-fatal outcomes, competing-risk analyses treating death as a competing event were performed (Fine-Gray subdistribution hazard ratios and Aalen-Johansen cumulative incidence functions). Within the Takayasu arteritis cohort, cumulative prednisone-equivalent glucocorticoid dose was modelled as a time-dependent covariate in multivariable Cox models adjusted for cardiovascular and disease-related factors. Outcomes The primary outcome was the first major adverse cardiovascular event (MACE), a composite of coronary event (myocardial infarction or unstable angina), ischemic stroke, or all-cause death. Secondary outcomes included the individual MACE components and territory-specific arterial events: aortic events, visceral artery events, and major adverse limb events. Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
Study Type
OBSERVATIONAL
Enrollment
8,275
APHP_ Hôpital Pitié-Salpêtrière
Paris, France
APHP_ Hôpital Saint-Antoine
Paris, France
Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death
Time frame: Up to 15 years (January 2010 to December 2024)
Coronary events
Coronary events (myocardial infarction or unstable angina)
Time frame: Time Frame: Up to 15 years (2010-2024)
Ischemic stroke
Ischemic stroke
Time frame: Time Frame: Up to 15 years (2010-2024)
All-cause mortality
All-cause mortality
Time frame: Time Frame: Up to 15 years (2010-2024)
Aortic events
Aortic events (aortic dissection or aneurysm, or thoracic/abdominal aortic surgical or endovascular procedure) Time Frame: Up to 15 years (2010-2024)
Time frame: Up to 15 years (2010-2024)
Visceral artery events
Visceral artery events (digestive or renal artery dissection, aneurysm, or revascularization)
Time frame: Up to 15 years (2010-2024)
Major adverse limb events
Major adverse limb events (lower-limb revascularization or major amputation)
Time frame: Up to 15 years (2010-2024)
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