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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Economics methods in the Clinical Outcomes Utilizing percutaneous coronary Revascularization and Aggressive
William S Weintraub1, Paul Barnett, Shuo Chen
1Atlanta VA Medical Center, Decatur, GA, USA. wweintraub@christianacare.org
Insights
Percutaneous coronary intervention (PCI) offers a major treatment for chronic coronary artery disease. This study evaluates the cost-effectiveness of PCI versus medical management alone, considering survival and quality-adjusted life years.
Area of Science:
- Cardiology
- Health Economics
- Clinical Trials
Background:
- Percutaneous coronary intervention (PCI) is a primary treatment for chronic coronary artery disease.
- The COURAGE trial randomized 2287 patients to compare PCI with medical management versus medical management alone.
Purpose of the Study:
- To conduct a detailed economic analysis of PCI versus medical management alone within the COURAGE trial.
- To assess the cost-effectiveness of PCI across three diverse healthcare systems: US Veterans Administration, Canada, and US non-VA.
- To determine the incremental cost-effectiveness ratio (ICER) of PCI based on survival and quality-adjusted life years (QALYs).
Main Methods:
- Resource use and costs were collected across three healthcare systems.
- Survival was assessed internally (4.5-year mean follow-up) and projected long-term.
- Utility was measured using standard gamble to calculate QALYs.
- Cost-effectiveness was analyzed using ICER, bootstrap analysis, cost-effectiveness plane, cost-effectiveness acceptability curves, and multilevel regression for net benefit.
Main Results:
- Survival data was collected over a mean follow-up of 4.5 years.
- Utility measures were obtained at multiple time points to calculate QALYs.
- The study employed advanced statistical methods to determine the cost-effectiveness of PCI.
Conclusions:
- The study provides a comprehensive assessment of PCI cost-effectiveness in chronic coronary artery disease.
- Findings will inform clinical and policy decisions regarding PCI utilization.
- The detailed economic analysis aims to offer the most thorough evaluation of PCI's value in managing coronary artery disease.
Abstract:
Percutaneous coronary intervention (PCI) remains a major therapeutic option for the treatment of chronic coronary artery disease. In the COURAGE trial, 2287 patients with chronic coronary disease were randomized between PCI with medical management and medical management alone. Embedded within the COURAGE trial is a detailed economic analysis being conducted in three health care systems: the US Veterans Administration (VA), Canada, and the US non-VA. Resource use and costs are being collected for each system and overall. Survival is assessed internally in the trial with mean follow-up of 4.5 years. Long-term mean survival will be estimated by projecting survival beyond the trial period by extrapolating the in-trial hazard rates. Utility is being assessed at baseline and at 1, 3, and 6 months and annually thereafter, using a computer-administered standard gamble. Quality-adjusted life years are calculated by multiplying survival by utility. The incremental cost-effectiveness ratio of PCI will be defined as the additional cost of PCI divided by the gain in life years and quality-adjusted life years. The 95% confidence regions of efficacy and costs will be determined by bootstrap over a range of acceptability thresholds, which will then be displayed in the cost-effectiveness plane and as a cost-effectiveness acceptability curve. A multilevel regression model will assess cost-effectiveness from a net benefit perspective. These approaches should provide the most detailed assessment available of the cost-effectiveness of PCI for coronary artery disease.
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