Cost-effectiveness Of Percutaneous Coronary Intervention Research Articles

Do coronary stent policies affect the cost-effectiveness of percutaneous coronary intervention among patients with acute coronary syndrome in Shanghai? A retrospective cohort study based on real-world and propensity score-matched data

ObjectivesThis study aimed to assess whether the national centralised volume-based procurement policy and the Shanghai government’s supportive measures (coronary stent policies) implemented in Shanghai, China, on 20 January 2021 affected...

Cost-effectiveness of percutaneous coronary intervention versus medical therapy in patients with acute myocardial infarction: real-world and lifetime-horizon data from Taiwan

Although some studies have assessed the cost-effectiveness of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI), there has been a lack of nationwide real-world studies estimating life expectancy (LE), loss-of-LE, life-years saved, and lifetime medical costs. We evaluated the cost-effectiveness of PCI versus non-PCI therapy by integrating a survival function and mean-cost function over a lifelong horizon to obtain the estimations for AMI patients without major comorbidities. We constructed a longitudinal AMI cohort based on the claim database of Taiwan's National Health Insurance during 1999–2015. Taiwan's National Mortality Registry Database was linked to derive a survival function to estimate LE, loss-of-LE, life-years saved, and lifetime medical costs in both therapies. This study enrolled a total of 38,441 AMI patients; AMI patients receiving PCI showed a fewer loss-of-LE (3.6 versus 5.2 years), and more lifetime medical costs (US$ 49,112 versus US$ 43,532). The incremental cost-effectiveness ratio (ICER) was US$ 3488 per life-year saved. After stratification by age, the AMI patients aged 50–59 years receiving PCI was shown to be cost-saving. From the perspective of Taiwan's National Health Insurance, PCI is cost-effective in AMI patients without major comorbidities. Notably, for patients aged 50–59 years, PCI is cost-saving.

Cost-effectiveness analysis of percutaneous coronary intervention for single-vessel coronary artery disease: an economic evaluation of the ORBITA trial

ObjectiveTo evaluate the cost-effectiveness of percutaneous coronary intervention (PCI) compared with placebo in patients with single-vessel coronary artery disease and angina despite anti-anginal therapy.DesignA cost-effectiveness analysis comparing PCI with placebo....

PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design

Cardiovascular disease (CVD) currently claims nearly one million lives yearly in the US, accounting for nearly 40% of all deaths. Coronary artery disease (CAD) accounts for the largest number of these deaths. While efforts aimed at treating CAD in recent decades have concentrated on surgical and catheter-based interventions, limited resources have been directed toward prevention and rehabilitation. CAD is commonly treated using percutaneous coronary intervention (PCI), and this treatment has increased exponentially since its adoption over three decades ago. Recent questions have been raised regarding the cost-effectiveness of PCI, the extent to which PCI is overused, and whether selected patients may benefit from optimal medical therapy in lieu of PCI. One alternative therapy that has been shown to improve outcomes in CAD is exercise therapy; exercise programs have been shown to have numerous physiological benefits, and a growing number of studies have demonstrated reductions in mortality. Given the high volume of PCI, its high cost, its lack of effect on survival and the potential for alternative treatments including exercise, the current study is termed “PCI Alternative Using Sustained Exercise” (PAUSE). The primary aim of PAUSE is to determine whether patients randomized to exercise and lifestyle intervention have greater improvement in coronary function and anatomy compared to those randomized to PCI. Coronary function and anatomy is determined using positron emission tomography combined with computed tomographic angiography (PET/CTA). Our objective is to demonstrate the utility of a non-invasive technology to document the efficacy of exercise as an alternative treatment strategy to PCI.

Cost Effectiveness of Achieving Targets of Low-Density Lipoprotein Particle Number Versus Low-Density Lipoprotein Cholesterol Level

A recent analysis of a commercially insured US population found fewer cardiovascular disease (CVD) events in high-risk patients attaining low levels of low-density lipoprotein (LDL), as measured by LDL particle number (LDL-P) versus low LDL cholesterol (LDL-C). Here, we investigated the cost effectiveness of LDL-lowering therapy guided by LDL-P. Patients were selected from the HealthCore Integrated Research Database and followed for 12 to 36months. Patients who achieved LDL-P <1,000nmol/l were placed into the LDL-P cohort, whereas those without LDL-P tests, but who achieved LDL-C <100mg/dl, were placed into the LDL-C cohort. CVD-related costs included all health plan paid amounts related to CVD events or lipid management. Cost effectiveness was assessed through incremental cost-effectiveness ratios, defined as difference in total costs across the cohorts divided by difference in CVD events, measured over follow-up. Each cohort included 2,094, 1,242, and 705 patients over 12-, 24-, and 36-month follow-up. Patients in the LDL-P cohort received more aggressive lipid-lowering therapy and had fewer CVD events during follow-up compared to patients in the LDL-C cohort. This led to greater pharmacy costs and lower medical costs over time. Incremental cost-effectiveness ratio estimates ranged from $23,131 per CVD event avoided at 12months to $3,439 and-$4,555 at 24- and 36-month follow-up, suggesting a high likelihood that achieving LDL-P <1,000nmol/l is cost effective. In conclusion, LDL-lowering therapy guided by LDL-P was demonstrated to be cost effective, with greater clinical and economic benefit seen over longer time horizons and with the increased use of generic statins.

Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective

AimsRecent cost-effectiveness analyses of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) have been limited by a short time horizon or were restricted to the US healthcare perspective....

Letter by Fan and He Regarding Article, “Cost-Effectiveness of Percutaneous Coronary Intervention in Patients With Stable Coronary Disease and Abnormal Fractional Flow Reserve”

We take great interest in the article by Fearon et al1 with regard to the economic and quality of life implications of percutaneous coronary intervention among patients with stable angina. The study assessed patient utility with the use of the EQ-5D health survey in the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) trial and found that percutaneous coronary intervention of coronary lesions with abnormal fractional flow reserve was more economically attractive than best medical therapy. However, we have some concerns with the statistical analysis. Cost–utility analysis is a common comparative effectiveness methodology in current health economics research, and quality-adjusted life-year …

Response to Letter Regarding Article, “Cost-Effectiveness of Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease and Abnormal Fractional Flow Reserve”

We thank Drs Fan and He for their interest in our article.1 They raise a number of issues that have both philosophical and technical dimensions. We agree that patients may vary in the degree to which their symptoms reduce quality of life, and that an individual may be more (or less) willing to have a procedure to relieve angina. Although individuals do vary in their preferences, the average in preferences in the target population is still the best metric to evaluate procedures that apply to populations. Our analysis was performed …

Cost-Effectiveness of Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease and Abnormal Fractional Flow Reserve

The Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 2 trial demonstrated a significant reduction in subsequent coronary revascularization among patients with stable angina and at least 1 coronary lesion with a fractional flow reserve ≤0.80 who were randomized to percutaneous coronary intervention (PCI) compared with best medical therapy. The economic and quality-of-life implications of PCI in the setting of an abnormal fractional flow reserve are unknown. We calculated the cost of the index hospitalization based on initial resource use and follow-up costs based on Medicare reimbursements. We assessed patient utility using the EQ-5D health survey with US weights at baseline and 1 month and projected quality-adjusted life-years assuming a linear decline over 3 years in the 1-month utility improvements. We calculated the incremental cost-effectiveness ratio based on cumulative costs over 12 months. Initial costs were significantly higher for PCI in the setting of an abnormal fractional flow reserve than with medical therapy ($9927 versus $3900, P<0.001), but the $6027 difference narrowed over 1-year follow-up to $2883 (P<0.001), mostly because of the cost of subsequent revascularization procedures. Patient utility was improved more at 1 month with PCI than with medical therapy (0.054 versus 0.001 units, P<0.001). The incremental cost-effectiveness ratio of PCI was $36 000 per quality-adjusted life-year, which was robust in bootstrap replications and in sensitivity analyses. PCI of coronary lesions with reduced fractional flow reserve improves outcomes and appears economically attractive compared with best medical therapy among patients with stable angina.

Establishing the cost-effectiveness of percutaneous coronary intervention for chronic total occlusion in stable angina: a decision-analytic model

BackgroundIn the setting of chronic stable angina, successful percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) has been shown to produce significant symptom improvement with some evidence for survival...

COST-EFFECTIVENESS OF PERCUTANEOUS CORONARY INTERVENTION WITH TAXUS STENTS IN PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASE COMPARED WITH AORTOCORONARY BYPASS SURGERY 5 YEARS AFTER INTERVENTION

Cost-effectiveness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) was compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease in the first 5 years follow-up (FUP). 199 patients with multivessel DES-PCI (n=114,

The Cost-Effectiveness of Percutaneous Coronary Intervention as a Function of Angina Severity in Patients With Stable Angina

The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial compared percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) to OMT alone in reducing the risk of cardiovascular events in 2287 patients with stable coronary disease. We examined the cost-effectiveness of PCI as a function of angina severity at the time of randomization. Angina severity was assessed with the Seattle Angina Questionnaire (SAQ). Patients were grouped into tertiles based on the distribution of baseline scores such that higher tertiles represented better health status. Clinically significant improvement from baseline within individual patients was defined as score increases of >8 for physical limitation, >20 for angina frequency, and >16 for quality-of-life domains. The incremental cost-effectiveness ratio for PCI was calculated as the difference in costs divided by the difference in proportion of patients with clinically significant improvement. Improvement in angina severity was significantly greater for PCI patients in the lowest and middle tertiles. The number of patients needed to treat was much larger for the highest tertile. The added in-trial cost of PCI ranged from $7300 to $13 000. Incremental cost-effectiveness ratios ranged from $80 000 to $330 000 for the lowest and middle tertiles and from $520 000 to >$3 million for the highest tertile for 1 additional patient to achieve significant clinical improvement in health status. The incremental cost of PCI to provide meaningful clinical benefit above that achieved by OMT alone was lower for patients with severe angina than for those with mild or no angina. However, it is uncertain that at any level of angina severity that PCI as an initial strategy would achieve a socially acceptable cost threshold. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.

Medicine Should Be More Like Missouri

Missouri is the “Show Me” State. Although the origins of the term are uncertain, it seems that it might have been etched into the national consciousness during a speech by U.S. Congressman Willard Duncan Vandiver. In an 1899 speech he stated, “I come from a state that raises corn and cotton and cockleburs and Democrats, and frothy eloquence neither convinces nor satisfies me. I am from Missouri. You have got to show me.”1 The “Show Me” spirit is sometimes lacking in the field of Medicine, where we seem intent on integrating new tests and procedures before they are thoroughly vetted. Although we bemoan the slow adoption of effective treatments, we often prematurely adopt unproven strategies. Our quality measures are focused on underuse—the missed opportunity to provide a strongly indicated test or treatment. National registries, often industry-sponsored, also are commonly oriented toward addressing undertreatment, further fueling a national preoccupation on having not done enough rather than on having done too much. It is true that this emphasis on undertreatment has improved quality of care. In the mid-1990s, for example, only about half of the patients nationally, and in several states only about one-third, who were ideal candidates for β-blocker therapy after having survived an acute myocardial infarction were prescribed the medication. Ideal candidates were identified by careful chart reviews that determined a group with no documented absolute or relative contraindications.2 This pattern of care was described almost 15 years after clinical trials provided evidence of the benefit. Moreover, those who were treated had better survival, concordant with what would be expected based on the trials. Studies that revealed similarly stark patterns for the prescription of aspirin and angiotensin converting-enzyme inhibitors2–5 led to quality measures that tracked undertreatment, …

Questioning Conventional Wisdom

In science, what seems obvious may not be true, and what is accepted as conventional wisdom, may sometimes be based on flawed assumptions. What is more obvious than the fact that the sun revolves around the earth? Each day the sun rises in the eastern horizon, and we observe it moving across the sky until it retires in the west. And yet, it is not true that the earth is the center of the universe. Galileo de’ Galilei, the scientist born in Pisa, was persecuted for questioning such conventional wisdom and supporting the theory proposed by Nicolaus Copernicus of a heliocentric universe. Ultimately, the truth could not be suppressed. We have many examples of progress that resulted from the questioning of strongly held beliefs that once seemed so obvious. Who anticipated that a gastric ulcer could be considered an infectious disease?1 Who expected that drugs that effectively suppressed premature ventricular beats in patients with ischemic heart disease would cause harm?2 Who believed that treatment strategies associated with substantial risk reduction might be poorly adopted into practice even 10 years after the publication of the trials establishing their efficacy?3 Who could …

Cost-Effectiveness of Alternative Approaches to the Management of Chronic Obstructive Coronary Artery Disease

Chronic obstructive coronary artery disease (CAD) is a highly prevalent condition that results in premature mortality as well as substantial morbidity due to angina and reduced quality of life. Various treatment and revascularization strategies are available for managing this condition, including medical therapy, percutaneous coronary intervention, and coronary artery bypass grafting. These treatments are expensive and, given the high prevalence of chronic CAD, there is substantial cost involved in the management of this condition. Recent clinical trials comparing percutaneous coronary intervention with medical management and/or coronary artery bypass grafting, and their associated economic analyses, have generated new information regarding the relative value of these alternative treatment strategies. In this article, we review the basic concepts of cost-effectiveness analysis and the current evidence as it relates to the cost-effectiveness of percutaneous coronary intervention in the management of chronic obstructive coronary artery disease.

The Limits of Cost-Effectiveness Analysis

The competitive worldwide economic environment and ever-increasing costs of health care have created a setting in which understanding costs and making sure that we achieve good value in health care are paramount. One approach to seeking value is through the use of cost-effectiveness analysis. Although this science is now several decades old, it has been refined over the last several years, with increasingly sophisticated statistical and standardized methods.1,2 Is cost-effectiveness analysis useful? Does it help in medical decision making and in allocation of scarce resources? In the accompanying article, “Cost, Effectiveness, and Cost-Effectiveness” Diamond and Kaul3 argue that cost-effectiveness analysis is not a useful approach. Although we agree with many of the points that Diamond and Kaul raise, we do not agree with their conclusion. Cost-effectiveness analysis involves an assessment of both cost and effectiveness. The distribution of each needs to be understood. A cost-effectiveness analysis is only as valid as its underlying measures of effectiveness and cost, a discussion that is beyond the scope of this article. However, the methods to make these assessments vary considerably. There are standards for cost-effectiveness, but at times, perfectly adhering to these standards is not realistic, and compromises are often made that may be entirely scientifically legitimate.4 Cost-effectiveness is, by nature, incremental. Thus, it is necessary to look at the added costs compared with a control group. Selection of the appropriate control group is a challenge itself. At times, the appropriate control is placebo, and at other times, it is active therapy; the appropriate control is dependent on the clinical question being asked. However, when cost-effectiveness analysis is conducted using data from a clinical trial, the selection of the control group will not be a decision that the analyst can affect (at least after the trial has been completed). When …

Cost-Effectiveness of Percutaneous Coronary Intervention in Optimally Treated Stable Coronary Patients

The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluations) trial compared the effect of percutaneous coronary intervention (PCI) plus optimal medical therapy with optimal medical therapy alone on cardiovascular events in 2287 patients with stable coronary disease. After 4.6 years, there was no difference in the primary end point of death or myocardial infarction, although PCI improved quality of life. The present study evaluated the relative cost and cost-effectiveness of PCI in the COURAGE trial. Resource use was assessed by diagnosis-related group for hospitalizations and by current procedural terminology code for outpatient visits and tests and then converted to costs by use of 2004 Medicare payments. Medication costs were assessed with the Red Book average wholesale price. Life expectancy beyond the trial was estimated from Framingham survival data. Utilities were assessed by the standard gamble method. The incremental cost-effectiveness ratio was expressed as cost per life-year and cost per quality-adjusted life-year gained. The added cost of PCI was approximately $10,000, without significant gain in life-years or quality-adjusted life-years. The incremental cost-effectiveness ratio varied from just over $168,000 to just under $300,000 per life-year or quality-adjusted life-year gained with PCI. A large minority of the distributions found that medical therapy alone offered better outcome at lower cost. The costs per patient for a significant improvement in angina frequency, physical limitation, and quality of life were $154,580, $112,876, and $124,233, respectively. The COURAGE trial did not find the addition of PCI to optimal medical therapy to be a cost-effective initial management strategy for symptomatic, chronic coronary artery disease.

Abstract 3506: Cost Effectiveness of Adding PCI to Optimal Medical Therapy in Patients with Stable Coronary Artery Disease: Economic Outcomes from the COURAGE Trial

Background: The main results of COURAGE showed no differences in all-cause mortality or non-fatal MI (primary endpoint), the composite of death, MI or stroke, or hospitalization for ACS (secondary endpoints) during 4.6 year median follow-up in the 2,287 patients with stable coronary artery disease (CAD) randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). There was a benefit to PCI in quality of life measured with the Seattle Angina Questionnaire. This study focuses on cost-effectiveness of PCI. Methods: Resource utilization including initial and follow-up hospitalizations were assigned a DRG and then costs assigned from Medicare reimbursement. Medication costs were assessed from Redbook average wholesale price. Survival was estimated for patients from Framingham data. Survival was quality adjusted from utility measured by standard gamble. Cost and outcome were discounted 3%. Costs after the trial period are Medicare average costs. Cost-effectiveness is expressed as an incremental cost effectiveness ratio (ICER), of cost per life year (LY) or quality adjusted life year (QALY) gained. The distribution of the ICER was assessed by bootstrap. Results: The added cost of PCI is approximately $10,000, without significant gain in LY or QALYs. The ICER varied from just over $150,000 to just under $300,000 per LY or QALY gained with PCI. A large minority of the distributions of the ICERs found PCI to be dominated by OMT, that is OMT offering better outcome at lower cost. Conclusions: The addition of PCI to OMT as an initial management strategy costs significantly more without offering an advantage in survival or QALYs. The ICER is high compared to conventional benchmarks, and the distribution includes infinity and low probability of being below $50,000/QALY gained. PCI in addition to OMT is not a cost-effective initial management strategy for symptomatic, chronic coronary artery disease.

Economics methods in the Clinical Outcomes Utilizing percutaneous coronary Revascularization and Aggressive Guideline-driven drug Evaluation (COURAGE) trial

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.

Bidirectional Ventricular Tachycardia Caused by Digitalis Toxicity

A 70-year-old black man with a history of hypertension and idiopathic cardiomyopathy was admitted to our hospital after presenting to the emergency department with cellulitis, sepsis, respiratory failure, and acute renal failure. The initial ECG revealed atrial fibrillation with a rapid ventricular response and a left bundle-branch block (LBBB). The ventricular response was accelerated by vasopressor agents administered for septic shock. He received intravenous esmolol …