Arteritis, Takayasu Clinical Trial
Official title:
The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis. 30 Years of Experience in Mexico, Beyond Forefront Techniques
Takayasu Arteritis (TA) affects medium and large caliber arteries causing stenosis, occlusion
or aneurysms. It has great predilection for the aortic arch, subclavian and extracranial
arteries. The global prevalence is of 1 to 2% per million inhabitants, which varies by
geographical region. The main cause of death in TA is of cardiovascular origin and includes
ischemic cardiomyopathy and valvular disease. The aim of this study was to evaluate the
surgical experience according to the type of surgery in subjects with TA with and without
inflammatory activity.
Methods: This was a retrospective, descriptive, cross-sectional study run between 1977 and
2017. Patients with Takayasu arteritis with more than 3 classification criteria according to
the American College of Rheumatology (ACR) were included. The surgeries were classified as:
Organ preservation, cardiac, bypass, exclusion and replacement. Inflammatory activity was
evaluated.
A review of the clinical records of patients diagnosed with TA with more than 3 criteria of
the American College of Rheumatology (ACR) and undergoing some surgical procedure by the
Surgery Service of the National Institute of Cardiology "Ignacio Chávez", in a period of time
comprised between 1977 and 2016 was done. Patients of any gender and age who had been
operated on by a surgical procedure registered in their medical record were included.
Patients intervened in other institutions were excluded. The surgical event was classified
into 6 groups: 1) organ-preservation surgery (mainly renal autograft); 2) Bypass
(revascularization of affected organs or segments with Woven Dacron graft); 3) Replacement
(replacement of affected aortic segment with a Woven Dacron graft); 4) Cardiac Surgery
(direct procedures in heart); 5) Exclusion (resection of an affected organ (nephrectomy)),
and 6) Other.
Inflammatory activity was evaluated according to the Dabague-Reyes criteria, in which a score
greater than or equal to 5 is considered as active inflammation (9).
Statistical analysis: Variables with a loss of the sample data greater than 20% were
excluded. The categorical variables were described by percentages and prevalences and the
comparison were done by chi square or Fisher's exact test. A statistically significant level
was considered when an error α <0.05 was found. Parametric numerical variables are described
by measures of central tendency and the comparison is made by Student's T test. The survival
analysis was performed using Kaplan-Meier. Ethical aspects were considered according to the
Helsinky declaration.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03543527 -
Study of Refractory and/or Relapsing TAkayasu aRTeritis
|