Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease

Aortic Valve Disease Clinical Trial

— PCORI-AVR  

Official title:

Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266251
• Other study ID #: Pro00052757
• Secondary ID: CER-1306-04350
• Status: Completed
• Phase: N/A
• First received: October 13, 2014
• Last updated: October 12, 2017
• Start date: May 2014
• Est. completion date: May 30, 2017

Study information

• Verified date: October 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision making tools that will help patients understand the risks and benefits of each treatment alternative in the setting of their individual characteristics.

The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The corner-stone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries that has been linked to Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create and evaluate personalized decision assistance tools for all patients considering AVR. This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination.

Description:

Aortic valve disease is a common, progressively debilitating condition with no effective medical treatment. Surgical aortic valve replacement (AVR) has been the standard of care in the presence of valve-associated symptoms which include heart failure, chest pain, and syncope; however, in November 2011, long-standing treatment algorithms were disrupted with the United States Food and Drug Administration (U.S. FDA) approval of a less invasive transcatheter alternative to surgical aortic valve replacement (AVR) with a different profile of associated risks and benefits. This new technology has created a pressing clinical need for shared decision making tools to help translate the "average-patient" clinical trial results to more relevant "patient-specific" information that will empower individuals facing this important treatment decision.

The overarching goal of this study is to develop a broadly applicable patient-centered paradigm for the treatment of medical illness. The corner-stone of this model is an open-access, web-based resource to engage patients, their caregivers, and clinicians in a personalized treatment discussion. To achieve this goal for patients with aortic valve disease, we will use existing Medicare-linked clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries. This work will be accomplished in direct collaboration with patient and caregiver coinvestigators and a diverse stakeholder panel to ensure wide utility and dissemination.

Specifically, we will achieve the following three research aims:

Specific Aim 1. Compare contemporary health outcomes with surgical versus transcatheter AVR among operable patients in the United States; Specific Aim 2. Create and assess a personalized decision assistance tool to evaluate expected health outcomes with surgical vs. transcatheter AVR for operable patients with aortic valve disease; Specific Aim 3.Develop and assess a personalized risk assessment tool to evaluate expected health outcomes with transcatheter AVR for inoperable patients with aortic valve disease.

Additionally, we will achieve the general objective to create and evaluate web- and print-based educational resources for targeted dissemination to patients with aortic stenosis, their caregivers, and their healthcare providers.

The proposed research will facilitate a better match of patients with existing treatments and empower patients to actively participate in their own healthcare decisions, thereby improving the care of patients with aortic valve disease and reducing overall healthcare expenditures. This study will serve as a model to promote personalized medicine among both cardiovascular and non-cardiovascular disease states.

This study involves three primary comparisons. The first is a treatment comparison of surgical vs. transcatheter AVR on short and intermediate-term outcomes (stratified across important population subgroups)—important because the results will inform treatment discussions and decisions in vulnerable patients. The second is a comparison of outcomes across comorbidity sets using risk models—important because the resulting decision assistance tools will provide personalized estimates of risk to patients, caregivers, and providers as they select a treatment strategy. The third is an impact evaluation of an educational resource, including comparison of the change in treatment selection patterns and clinical outcomes across hospitals and geographic regions with high vs. low use of a web based educational resource—important because the comparison will provide critical pilot information to evaluate and tailor the resource impact.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273365
• Est. completion date: May 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013)

• surgical AVR patients with a STS perioperative risk of mortality (PROM) =4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013)

Exclusion Criteria:

• We will exclude patients with endocarditis or emergency/salvage status because these patients are rarely treated using transcatheter AVR in the United States (<0.2% incidence of either condition during the first year of TVT Registry data).

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	American College of Cardiology, Patient-Centered Outcomes Research Institute, The Society of Thoracic Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All-cause mortality will be analyzed in a time-to event analysis. Mortality follow-up will be considered to be administratively censored on the last date of Medicare follow-up which is expected to be 12/31/2013 for both surgical and transcatheter AVR.	one-year survival
Secondary	Stroke	incidence of a clinically apparent stroke	during 1st year after surgical or transcatheter AVR
Secondary	Discharged to home following the procedure (TAVR or SAVR)	The percentage of patients discharged to home after TAVR versus SAVR will be estimated.	STS ACSD (July 2011-June 2012) and STS/ACC TVT Registry (Nov 2011-March 2013)
Secondary	days alive and out of the hospital during the first post-operative year	Among patients who were admitted from home, number of days (out of 365) that patient is alive and out of hospital during the first year post-operatively	number of days (out of 365) that the patient is alive and out of hospital during the first year post-operatively