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COURAGE TRIAL C linical O utcomes U tilizing R evascularization and A ggressive Dru g E valuation (Veterans Affairs

COURAGE TRIAL C linical O utcomes U tilizing R evascularization and A ggressive Dru g E valuation (Veterans Affairs Cooperative Studies Program no. 424). Presented by: Dr. Shrinivasan R. Iyenger Dietitian Nandini Panchamiya. Global Mortality and Burden of Disease Attributable to CVD.

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COURAGE TRIAL C linical O utcomes U tilizing R evascularization and A ggressive Dru g E valuation (Veterans Affairs

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  1. COURAGE TRIAL Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (Veterans Affairs Cooperative Studies Program no. 424) Presented by: Dr. Shrinivasan R. Iyenger Dietitian Nandini Panchamiya

  2. Global Mortality and Burden of Disease Attributable to CVD

  3. CHD:The Response To Injury Hypothesis Diabetes HL HT Stress LDL Oxidation Injury to the Coronary Artery wall Pro-inflammatory factors Fat depositing factors Build up of a Fatty Fibrous Plaque Formation of a Blood Clot If a Clot Forms in an Artery which is Already Narrowed by Atherosclerosis, a Heart Attack can Occur

  4. Average values of various measures of obesity in South Asians/ Asian Indians and other ethnic groups

  5. Characteristics of Asian Indian Phenotype Greater ethnic/ genetic susceptibility to type 2 diabetes Lower threshold for BMI ↑ inflammatory markers; CRP ↓ serum insulin levels/insulin resistance ↑ abdominal obesity and abdominal fat ASIAN INDIAN PHENOTYPE Characteristic dyslipidemia ↓ HDL-C, ↑ TG & ↑ small dense LDL ↓ levels of adiponectin ↑ prevalence of type 2 diabetes and CAD

  6. Introduction • More than 1 million percutaneous coronary interventions (PCIs) are performed in the USA each year, the great majority of which are performed electively in patients with stable coronary artery disease(CAD). • PCI in patients with acute coronary syndrome (ACS) has been shown to reduce the incidence of death and myocardial infarction (MI). • However, the effects of PCI in patients with stable CAD have not been well studied, with prior studies in this patient population suggesting that PCI only reduces the frequency of angina and improves short-term exercise performance with no impact on mortality.

  7. Background for study Major improvements in medical therapyandpercutaneous coronary intervention (PCI) for coronary heart disease have occurred during the past decade, but no randomized trial has compared these 2 strategies for the “hard” clinical end points of death or myocardial infarction nor have earlier studies incorporated the use of coronary stents and aggressive multifaceted medical therapy during long-term follow-up.

  8. Study Design • Multicenter, randomized, controlled trialof patients with documented myocardial ischemia and angiographically confirmed single or multivessel CAD. • A total of 2287 patients screened at 50 centers in the USA and Canada were randomized to PCI (n = 1149) or to Optimal Medical Therapy (OMT) (n = 1138).

  9. Study Designcontinue… • Patients were followed for 2.5-7.0 years (mean, 4.6 years). • Patients with 1-, 2-, or 3-vessel disease (> 70% visual stenosis of proximal segment), with anatomy suitable for PCI, and Canadian Cardiovascular Society (CCS) class I-III angina were enrolled in the study. • Patients with unstable angina, post-MI, revascularization within the last 6 months, cardiogenic shock, or heart failure were excluded. • Baseline clinical and angiographic characteristics were well balanced between the 2 groups

  10. Methods Medical therapy in both groups is guideline-driven and includes: aspirin, clopidogrel, simvastatin (low-density lipoprotein cholesterol target 60-85 mg/dL), long-acting metoprolol and/or amlodipine, lisinopril or losartan, and long-acting nitrates, as well as lifestyle interventions. More than half of all patients in the PCI arm were treated with 1 stent and 41% received ≥ 2 stents.

  11. Methods continue… • Quality of life was assessed with 3 questionnaires : • The Seattle Angina Questionnaire (SAQ) • RAND 36-Item Health Survey • Utility by Standards Gamble Data were collected at 1, 3, 6, and 12 months, and then annually. • An incremental cost-efficacy analysis was calculated as the additional cost of PCI divided by the gain in life-years and quality-adjusted life-years (QALYs). QALYs were calculated by multiplying survival by utility.

  12. Hypothesis PCI plus aggressive medical therapy (projected event rate 16.4%) will be superior to aggressive medical therapy alone (projected event rate 21%) during a 2.5- to 7-year (median of 5 years) follow-up. Primary:PCI would reduce all-cause mortality or nonfatal MIrelative to Optimal Medical Therapy (OMT) alone. Secondary:PCI would yield superior outcomes related toresource utilization and quality-of-life outcomes.

  13. End point • Primary : Death or nonfatal MI. • Secondary : • Death, MI, or stroke • Hospitalization for biomarkers • Cost, resource utilization • Quality of life, including angina and • Cost-effectiveness.

  14. Results of Primary Hypothesis • After a mean follow-up of 4.6 years, there was no difference in the rate of freedom from death of any cause or nonfatal MI between the PCI and OMT-alone groups (19.0% vs 18.5%, respectively; P =62). • There were also no differences in the individual rates of all-cause mortality, MI, stroke, or hospitalization for ACS

  15. Results of Primary Hypothesis continue… • The number of patients in the PCI group who underwent revascularization was significantly lower than the number of first procedures performed in the OMT group, at an average of 10 and 11 months, respectively (21.1% vs 32.6% ; P <001). • In addition, freedom from angina was higher in the PCI group than OMT alone at 1- and 3-year follow-up; by 5 years, the rates were similar between the 2 groups.

  16. Freedom from angina

  17. Conclusions: Primary Hypothesis • As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk for death, MI, or other major cardiovascular events when added to OMT. • PCI resulted in better angina relief during most of the follow-up period, but OMT was also effective, with no between-group difference in angina-free status at 5 years.

  18. Conclusions: Primary Hypothesis continue… • PCI can be safely deferred in patients with stable CAD, even in those with extensive, multivessel involvement and inducible ischemia, provided that intensive, multifaceted OMT is instituted and maintained. • OMT and aggressive management of multiple treatment targets without initial PCI can be implemented safety in the majority of patients with stable CAD, 2/3rds of whom may not require even a first revascularization during long-term follow-up.

  19. Results of Secondary Hypothesis – Quality of life (QOL) • At baseline, there was no difference between the 2 groups in SAQ scores that measured physical limitations, angina frequency, and quality of life. • However, evidenced as early as 3 months and sustained out to 36 months, patients in the PCI group had higher SAQ scores, suggesting improved status in all measures studied. • RAND 36 scores were higher in the PCI group, but by 24 months, the difference was not significant.

  20. Results of Secondary Hypothesis – Resource utilization • At each follow-up period, cost were significantly lower with OMT than with PCI (P <0001). • There was no difference in utility between the 2 groups at any time during follow-up. • The difference in calculated QALYs was 0.024, equating to about 8 days. This difference translated into a cost of $217,000 per QALY gained. • Given that the cost-effective benchmark for such therapies is $50,000, the overall cost of QALY gained suggests that PCI would only be considered a cost-effective approach in < 1% of patients.

  21. Conclusions : Secondary Hypothesis • Compared with OMT alone, PCI plus OMT is associated with improved QOL measures over long-term follow-up. • PCI plus OMT as a first-choice therapy for stable CAD is not cost-effective compared with OMT alone.

  22. Viewpoint • COURAGE is a landmark trial in stable angina patients with CAD. • The results reinforce that OMT can be as effective & safe as PCI in the prevention of hard endpoints, such as death, MI, & stroke. • However, PCI provided better anginal relief in the initial years of follow-up. • Evaluating QOL and cost-effectiveness, provides important information on how we treat our patients.

  23. Viewpoint • The study showed that PCI + OMT does a better job in controlling physical limitation, angina, and improves QOL, but at a significantly higher cost. • These results have spawned considerable attention, and at times, controversy, over the way that we treat patients with stable CAD. • The results are telling, but are they sufficiently conclusive to deny early PCI in all stable patients?

  24. Thank You

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