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

NCT04067089 | Unknown DMC

• 1 other identifier: TEAm-BR
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Aortic Stenosis

Keywords

aortic stenosis

Outcome Measures

Primary Outcomes (2)

• 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

• Cost-utility of minimalist TAVR as compared to SAVR

  Incremental cost-effectiveness ratio (ICER)

  1 year

Secondary Outcomes (1)

• Clinical outcomes

  30 days and 1 year

Study Arms (2)

TAVR - Transcatheter aortic valve replacement

EXPERIMENTAL

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

Procedure: TAVR - Transcatheter aortic valve replacement

Surgical aortic valve replacement

ACTIVE COMPARATOR

Surgical aortic valve replacement

Procedure: Surgical aortic valve replacement

Interventions

TAVR - Transcatheter aortic valve replacement PROCEDURE

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

Also known as: TAVR

TAVR - Transcatheter aortic valve replacement

Surgical aortic valve replacement PROCEDURE

Surgical aortic valve replacement

Also known as: SAVR

Surgical aortic valve replacement

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Alexandre A Abizaid, MD, PhD

  Hospital do Coracao

  STUDY CHAIR

• Fabio Jatene, MD, PhD

  Hospital do Coracao

  STUDY CHAIR

• Dimytri A Siqueira, MD PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Paulo P Fernandes, Md, PhD

  Hospital do Coracao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 26, 2019
• Study Start: December 10, 2018
• Primary Completion: September 13, 2023
• Study Completion: December 31, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 6 months and ending 24 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals. After 24 months, the database and accompanying documents will be publicly available in an institutional data repository (http://www.hcor.com.br).

Locations

BR (1)