Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR

Aortic Stenosis Clinical Trial

— TEAm-BR  

Official title:

Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04067089
• Other study ID #: TEAm-BR
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil. The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).

Description:

Transcatheter aortic valve implantation has been shown to be non-inferior to surgical aortic valve replacement in patients with severe aortic stenosis at high, intermediate and low surgical risk. In recent years, a concept of a simplified and optimized TAVR procedure (known as minimalist approach) has led experienced centers to perform the majority of these procedures using conscious sedation and local anesthesia only. From a clinical perspective, this approach is associated with better and faster recovery and mobilization, reduced need for a prolonged intensive care unit (ICU) stay and faster hospital discharge, as compared to general anesthesia. The cost-effectiveness of minimalist TAVR strategy - as compared to surgery - in Brazil is uncertain. Our objective is to conduct a cost-utility analysis comparing minimalist transcatheter aortic valve implantation with surgical aortic valve replacement in patients with severe aortic stenosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: December 31, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Age > 70 years;
• Symptoms of heart failure NYHA class > II;
• Severe aortic stenosis (as defined by echocardiography: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 1.0 cm2)
• Heart team (including examining cardiac surgeon) agree on eligibility including assessment that TAVR or SAVR is appropriate;
• The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
• The study patient agreed to comply with all required post-procedure follow-up visits including visits through 1 month and 1 year;
• Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present);
• Patient agreed to undergo surgical aortic valve replacement (SAVR) if randomized to control treatment.

Exclusion Criteria:

• Heart Team assessment of inoperability (including examining cardiac surgeon);
• Hostile chest
• Evidence of an acute myocardial infarction = 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB = twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)];
• Concomitant severe valvular disease (mitral, tricuspid or pulmonic) requiring surgical intervention;
• Preexisting mechanical or bioprosthetic aortic valve with dysfunction;
• Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization);
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an exclusion criteria;
• Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL);
• Hypertrophic cardiomyopathy with or without obstruction (HOCM);
• Severe ventricular dysfunction with LVEF < 20%;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Active upper GI bleeding within 3 months (90 days) prior to procedure;
• A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure;
• Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure;
• Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening;
• Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease;
• Currently participating in an investigational drug or another device study;
• Active bacterial endocarditis within 6 months (180 days) of procedure;
• Patient refuses surgery for aortic valve replacement.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• TAVR - Transcatheter aortic valve replacement
TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach
• Surgical aortic valve replacement
Surgical aortic valve replacement

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-utility of minimalist TAVR as compared to SAVR	Quality-adjusted life-years (QALYs). Quality of life will be assessed by EuroQol 5D.	1 year
Primary	Cost-utility of minimalist TAVR as compared to SAVR	Incremental cost-effectiveness ratio (ICER)	1 year
Secondary	Clinical outcomes	All-cause mortality, cardiovascular mortality, disabling stroke, acute renal failure, bleeding, major vascular complications, atrial fibrillation and permanent pacemaker implantation	30 days and 1 year