Clinical trial NCT04067089: Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
Official title: Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Stenosis
Keywords: aortic stenosis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 126
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cost-utility of minimalist TAVR as compared to SAVR
timeFrame: 1 year
measure: Cost-utility of minimalist TAVR as compared to SAVR
timeFrame: 1 year
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Alexandre A Abizaid, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Fabio Jatene, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Dimytri A Siqueira, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Paulo P Fernandes, Md, PhD
role: STUDY_CHAIR
References: