The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654222
• Other study ID #: 20142018
• Status: Completed
• Start date: January 1, 1977
• Est. completion date: June 26, 2017

Study information

• Verified date: August 2018
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 26, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients of any gender regardless of age that has a diagnosis of TA established by a rheumatologist,

• Have a surgical procedure registered in your medical record

Exclusion Criteria:

• Not having a digital, physical or microfilmed medical record

• Surgical procedures performed at another institution

Related Conditions & MeSH terms

• Arteritis
• Arteritis, Takayasu
• Takayasu Arteritis

Locations

Country	Name	City	State
Mexico	Nacional Institute of Cardiology	Mexico City	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

References & Publications (21)

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Saadoun D, Lambert M, Mirault T, Resche-Rigon M, Koskas F, Cluzel P, Mignot C, Schoindre Y, Chiche L, Hatron PY, Emmerich J, Cacoub P. Retrospective analysis of surgery versus endovascular intervention in Takayasu arteritis: a multicenter experience. Circulation. 2012 Feb 14;125(6):813-9. doi: 10.1161/CIRCULATIONAHA.111.058032. Epub 2012 Jan 9. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term survival rate surgery event	Observed in our study in relation to the mortality associated with the surgical event	45 years
Primary	Long-term survival according from other causes	According to the type of surgery in relation to mortality from other causes	30 years
Secondary	Arterial lesions	According to Numano's classification	30 years
Secondary	Inflammatory activity	Evaluated according to the Dabague-Reyes criteria	30 years