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ABSTRACT: The EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure and Survival Study) showed that the use of aldosterone blockade with eplerenone decreased mortality in patients with heart failure after acute myocardial infarction, and a subsequent analysis showed eplerenone to be highly cost effective in this population.
To assess the cost effectiveness of eplerenone in an EPHESUS subgroup population who were taking both ACE inhibitors and beta-blockers (beta-adrenoceptor antagonists) at baseline. In the EPHESUS, a total of 6632 patients were randomized to receive eplerenone 25-50 mg/day (n = 3319) or placebo (n = 3313) concurrently with standard therapy and were followed for up to 2.5 years. Of these, 4265 (64.3%) patients (eplerenone: n = 2113; placebo: n = 2152) were taking both ACE inhibitors and beta-blockers at baseline.
Resource use after the initial hospitalization included additional hospitalizations, outpatient services, emergency room visits, and medications. Eplerenone was priced at an average wholesale price of $US3.60 per day (year 2004 value). Bootstrap methods were used to estimate the fraction of the joint distribution of the cost and effectiveness. A net-benefit regression model was used to derive the propensity score-adjusted cost-effectiveness curve. The incremental cost effectiveness of eplerenone in cost per life-year gained (LYG) and cost per quality-adjusted life-year (QALY) gained beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. Both costs and effectiveness were discounted at 3%. Although not all resource use could be accounted for, the overall perspective was societal.
As in the overall EPHESUS population, the total direct treatment costs were higher in the eplerenone arm than the placebo arm for patients who were taking both ACE inhibitors and beta-blockers ($US14,563 vs $US12,850, difference = $US1713; 95% CI 721, 2684). The number of LYGs with eplerenone compared with placebo was 0.1665 based on the Framingham data, 0.0979 using the Saskatchewan data, and 0.2172 using the Worcester data. The incremental cost-effectiveness ratio (ICER) was $US10,288/LYG with the Framingham data, $US17,506/LYG with the Saskatchewan data, and $US7888/LYG with the Worcester data (99% <$US50,000/LYG for all three sources). The ICERs were systematically higher when calculated as the cost per QALY gained ($US14,926, $US25,447, and $US11,393, respectively) as the utilities were below 1 with no difference between the treatment arms.
As for the overall EPHESUS population, aldosterone blockade with eplerenone is effective in reducing mortality and is cost effective in increasing years of life for the EPHESUS subgroup of patients who were taking both ACE inhibitors and beta-blockers.
American Journal of Cardiovascular Drugs 01/2010; 10(1):55-63. · 1.77 Impact Factor
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ABSTRACT: Although a variety of prognostic tools have been shown to predict rehospitalization and mortality in heart failure patients, their utility in assessing future costs is less clear. We assessed whether health status assessment with the Kansas City Cardiomyopathy Questionnaire (KCCQ) predicts future costs in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction.
We evaluated 12-month cost utilization data from 1516 heart failure outpatients enrolled in the Quality-of-Life Substudy of the Eplerenone Post-Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS). Multivariable hierarchical models assessed whether the KCCQ (categorized as 0 to <25, 25 to <50, 50 to <75, and 75 to 100) was an independent predictor of future resource use. At baseline, 685 patients (45.2%) had good health status (KCCQ scores > or =75), whereas 510 (33.6%), 262 (17.3%), and 59 (3.9%) had fair (KCCQ, 50 to 74), poor (KCCQ, 25 to 49), and the worst (KCCQ <25) health status, respectively. After multivariable adjustment, compared with patients with good health status, patients with fair health status incurred incremental 1-year costs of $1520 (cost ratio, 1.23; 95% confidence interval, 1.05 to 1.43), whereas patients with poor and the worst health status incurred incremental 1-year costs of $4265 (cost ratio, 1.63; 95% confidence interval, 1.34 to 1.99) and $8999 (cost ratio, 2.34; 95% confidence interval, 1.62 to 3.38), respectively (P<0.0001 for association with KCCQ). Further adjustment for New York Heart Association class led to only partial attenuation of this relationship (P=0.0002).
Health status assessment predicts resource use and costs over the next year in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction.
Circulation 02/2009; 119(3):398-407. · 14.74 Impact Factor
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William S Weintraub,
William E Boden,
Zugui Zhang,
Paul Kolm, Zefeng Zhang,
John A Spertus,
Pamela Hartigan,
Emir Veledar,
Claudine Jurkovitz,
Jim Bowen,
David J Maron,
Robert O'Rourke,
Marcin Dada,
Koon K Teo,
Ron Goeree,
Paul G Barnett
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ABSTRACT: 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.
Circulation Cardiovascular Quality and Outcomes 09/2008; 1(1):12-20. · 4.91 Impact Factor
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William S Weintraub,
John A Spertus,
Paul Kolm,
David J Maron, Zefeng Zhang,
Claudine Jurkovitz,
Wei Zhang,
Pamela M Hartigan,
Cheryl Lewis,
Emir Veledar,
Jim Bowen,
Sandra B Dunbar,
Christi Deaton,
Stanley Kaufman,
Robert A O'Rourke,
Ron Goeree,
Paul G Barnett,
Koon K Teo,
William E Boden,
G B J Mancini
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ABSTRACT: It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease.
We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]).
At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (+/-SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66+/-25 for physical limitations, 54+/-32 for angina stability, 69+/-26 for angina frequency, 87+/-16 for treatment satisfaction, and 51+/-25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76+/-24 versus 72+/-23 for physical limitation (P=0.004), 77+/-28 versus 73+/-27 for angina stability (P=0.002), 85+/-22 versus 80+/-23 for angina frequency (P<0.001), 92+/-12 versus 90+/-14 for treatment satisfaction (P<0.001), and 73+/-22 versus 68+/-23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups.
Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657.)
New England Journal of Medicine 08/2008; 359(7):677-87. · 53.30 Impact Factor
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ABSTRACT: The COMMIT trial demonstrated that clopidogrel produced a 9% relative reduction in death, reinfarction or stroke (9.2% vs. 10.1%, 95% CI: 0.86-0.97) in ST-elevated myocardial infarction (STEMI) patients.
Between 08/1999 and 05/2005, 45,852 STEMI patients were randomized to clopidogrel (n=22,961) or matching placebo (n=22,891) in addition to aspirin. The rate of initial hospitalizations for death, non-fatal myocardial infarction with/without major complications and PCI within 28 days was calculated based on the COMMIT clinical paper. Three CURE papers, concerning non-STEMI patients, were used to estimate the event rates between 29 days and 1 year. Hospitalizations were assigned a diagnosis-related group (DRG). Costs for each DRG were estimated from the Medicare reimbursement rate. Clopidogrel was assumed to be given for 1 year, priced at $4.22/day. Life expectancy gain as a result of the prevention of death, myocardial infarction, and stroke was estimated using Framingham data.
Within 28 days, adding clopidogrel to aspirin is likely a dominant strategy, lowering the event rate (9.2% vs. 10.1%) without an increase in cost ($7791 vs. $7797). Over a lifetime, treating for 1 year with clopidogrel-plus-aspirin produced a gain of 0.1187 life years at an incremental cost of $1269 compared to aspirin alone, resulting in an incremental cost-effectiveness ratio (ICER) of $10,691/life year gained. Sensitivity analyses showed that ICERs for clopidogrel are well below the common benchmark ceiling ratio of $50,000/life year gained.
Addition of clopidogrel to aspirin, given up to 1 year, in the setting of STEMI is a highly cost-effective strategy.
International journal of cardiology 07/2008; 135(3):353-60. · 7.08 Impact Factor
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ABSTRACT: For economic evaluations of chronic heart failure (CHF) management strategies, utilities are not currently available for disease proxies commonly used in Markov models. Our objective was to estimate utilities for New York Heart Association (NYHA) classification and number of cardiovascular rehospitalizations.
EuroQol 5D data from the Eplerenone Post-acute Myocardial Infarction Heart Failure Efficacy and Survival Study trial were used to estimate utilities as a function of NYHA classification and number of cardiovascular rehospitalizations.
In multivariate regression analyses adjusted for age (60 years), female sex and absence of further comorbidities, utilities for NYHA classes I-IV were 0.90, 0.83, 0.74, and 0.60 (P-value < 0.001 for trend). For cardiovascular rehospitalizations 0, 1, 2 and >or=3, the associated utilities were 0.88, 0.85, 0.84, and 0.82 (P-value < 0.001 for trend).
NYHA class and number of cardiovascular rehospitalizations are established proxies for CHF progression and can be linked to utilities when used as health states in a Markov model. NYHA class should be used when feasible.
Value in Health 07/2008; 12(1):185-7. · 2.19 Impact Factor
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ABSTRACT: The ACUTE II study demonstrated that transesophageal echocardiographically guided cardioversion with enoxaparin in patients with atrial fibrillation was associated with shorter initial hospital stay, more normal sinus rhythm at 5 weeks, and no significant differences in stroke, bleeding, or death compared with unfractionated heparin (UFH). The present study evaluated resource use and costs in enoxaparin (n=76) and UFH (n=79) during 5-week follow-up. Resources included initial and subsequent hospitalizations, study drugs, outpatient services, and emergency room visits. Two costing approaches were employed for the hospitalization costing. The first approach was based on the UB-92 formulation of hospital bill and diagnosis-related group. The second approach was based on UB-92 and imputation using multivariable linear regression. Costs for outpatient and emergency room visits were determined from the Medicare fee schedule. Sensitivity analysis was performed to assess the robustness of the results. A bootstrap resample approach was used to obtain the confidence interval (CI) for the cost differences. Costs of initial and subsequent hospitalizations, outpatient procedures, and emergency room visits were lower in the enoxaparin group. Average total costs remained significantly lower for the enoxaparin group for the 2 costing approaches ($5,800 vs $8,167, difference $2,367, 95% CI 855 to 4,388, for the first approach; $7,942 vs $10,076, difference $2,134, 95% CI 437 to 4,207, for the second approach). Sensitivity analysis showed that cost differences between strategies are robust to variation of drug costs. In conclusion, the use of enoxaparin as a bridging therapy is a cost-saving strategy (similar clinical outcomes and lower costs) for atrial fibrillation.
The American Journal of Cardiology 03/2008; 101(3):338-42. · 3.37 Impact Factor
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ABSTRACT: We sought to examine the comparative improvement in health status after primary mitral valve repair versus replacement in patients with mitral valve regurgitation in a longitudinal setting.
We prospectively followed 267 patients with mitral valve regurgitation who underwent primary mitral valve repair (n = 163) and replacement (n = 104) between January 2002 and January 2005. Health status was evaluated at baseline and 1, 3, and 12 months after surgery with the validated short-form 36 and analyzed using generalized estimating equations with adjustment for propensity scores.
Compared with patients undergoing mitral valve replacement, patients requiring valve repair were younger and more likely to be male. The probability of postsurgical readmission because of cardiac events was low and similar between the two treatment groups. New York Heart Association functional class was significantly improved after both procedures, with better improvement achieved by mitral valve repair (P < .01). For both treatment groups, scores for most of the short-form 36 domains were depressed at 1 month; however, after 3- and 12-month lags, dramatic improvements were achieved in most of the domains. Adjusted changes in the physical component score were similar between the two arms at each follow-up. For the mental component score, patients who underwent repair showed significant improvements compared with patients who underwent replacement at both 3 months (difference: 4.84 points, P = .005) and 12 months (difference: 5.92 points, P < .001).
Our study suggests that after mitral valve surgery, there is significant improvement in New York Heart Association functional class and health status, especially in patients undergoing mitral valve repair.
The Journal of thoracic and cardiovascular surgery 05/2007; 133(5):1257-63. · 3.41 Impact Factor
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ABSTRACT: Relative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) may differ between younger and older patients. There are no data comparing the age-related CABG versus PCI outcomes in the stent era.
The SoS trial compared CABG (n = 500) and stent-assisted PCI (n = 488). The impact of treatment assignment on 1-year outcomes was evaluated by age < or = 65 years (n = 295, CABG; n = 298, PCI) and > 65 years (n = 205, CABG; n = 190, PCI).
One-year procedural outcomes were similar between treatment groups regardless of age, with the exception of more repeat revascularizations after PCI (age < or = 65, 16.1% vs 4.8%; age > 65, 19.5% vs 3.4%; both P < .001). Six and 12-month Seattle Angina Questionnaire scores improved from baseline in both age and treatment groups. However, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life in younger patients at 6 and 12 months (12-month difference in improvement between CABG and PCI: 5.6, 4.8, and 3.9 points for 3 domains), whereas in the elderly a significant benefit of CABG observed at 6 months did not persist at 12 months (12-month difference: 0.9, 1.9, and 1.4). One-year costs were significantly higher after CABG regardless of age.
Although PCI and CABG result in similar rates in clinical outcomes irrespective of age, younger patients reported more health status benefits from CABG as compared with PCI, whereas in older patients the 2 approaches resulted in similar 1-year health status benefits.
American heart journal 01/2007; 152(6):1153-60. · 4.65 Impact Factor
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ABSTRACT: The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST.
A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences.
For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9% <1000 dollars per restenosis averted).
Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.
American heart journal 10/2006; 152(4):770-6. · 4.65 Impact Factor
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ABSTRACT: The EPHESUS study demonstrated that aldosterone blockade with eplerenone decreased mortality in patients with left ventricular systolic dysfunction (LVSD) and heart failure after acute myocardial infarction (AMI). The EPHESUS pharmacoeconomic analysis was performed to evaluate the cost-effectiveness of eplerenone in the Swiss setting.
A total of 6,632 patients with LVSD and heart failure after AMI were randomized to eplerenone or placebo and followed for a mean of 16 months. The co-primary endpoints were all-cause death and the composite of cardiovascular death/cardiovascular hospitalization. The evaluation of resource use included hospitalizations, outpatient services, and medications. Survival beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. The incremental cost-effectiveness of eplerenone in cost per life-year and quality-adjusted life-year gained was estimated. The perspective of the Swiss third party payers was used. Daily treatment costs of eplerenone were set at CHF 3.88. All other resources were valued on the basis of official tariffs. Discounting of the results was performed at a rate of 3%.
The number of life-years gained with eplerenone was 0.1083 based on Framingham, 0.0661 with Saskatchewan and 0.1518 with Worcester survival estimates. Total costs were CHF 1,028 higher over the trial period in the eplerenone arm, due to drug cost. The incremental cost-effectiveness ratio was CHF 10,145 per life-year gained with Framingham, CHF 16,178 with Saskatchewan, and CHF 7,693 with Worcester survival estimates. The corresponding costs per QALY were CHF 15,219, CHF 23,965 and CHF 11,337, respectively.
Eplerenone is effective in reducing mortality and, in Switzerland, is also cost-effective in increasing years of life for patients with LVSD after AMI.
Cardiovascular Drugs and Therapy 07/2006; 20(3):193-204. · 3.13 Impact Factor
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Sean C Beinart,
Paul Kolm,
Emir Veledar, Zefeng Zhang,
Elizabeth M Mahoney,
Olivier Bouin,
Sylvie Gabriel,
Joseph Jackson,
Roland Chen,
Jaime Caro,
Steven Steinhubl,
Eric Topol,
William S Weintraub
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ABSTRACT: This study sought to evaluate the long-term cost effectiveness of a clopidogrel loading strategy before percutaneous coronary intervention (PCI) followed by continued treatment for one year.
The Clopidogrel for the Reduction of Events During Observation (CREDO) trial, a randomized trial of 2,116 patients, showed the effectiveness of antiplatelet therapy with clopidogrel 300 mg before PCI and 75 mg daily for one year afterward compared with placebo load and placebo days 29 to 365 in reducing the combined risk of death, myocardial infarction, and stroke. All patients received clopidogrel on days 1 to 28 and aspirin on days 1 to 365.
All hospitalizations were assigned a diagnosis-related group. Associated costs were estimated three ways (including professional costs): 1) Medicare costs, 2) MEDSTAT costs, and 3) blend with Medicare for those age > or = 65 years and MEDSTAT for those age <65 years. Clopidogrel 75 mg cost 3.22 dollars. Life expectancy in trial survivors was estimated using external data. Confidence intervals were assessed by bootstrap.
The primary composite end point occurred in 89 (8.45%) clopidogrel patients and in 122 (11.48%) placebo patients (relative risk reduction [RRR] 26.9%; 95% confidence interval [CI] 3.9% to 44.4%). The number of life-years gained (LYG) with clopidogrel was 0.1526 (95% CI 0.0263 to 0.2838) using Framingham data and 0.1920 (95% CI 0.054 to 0.337) using Saskatchewan data. Average total costs were 664 dollars higher for the clopidogrel arm (95% CI -461 dollars to 1,784 dollars). The incremental cost-effectiveness ratios (ICERs) based on Framingham data ranged from 3,685 dollars/LYG to 4,353 dollars/LYG, with over 97% of bootstrap-derived ICER estimates below 50,000 dollars/LYG. The ICERs based on Saskatchewan data were 2,929 dollars/LYG to 3,460 dollars/LYG, with over 98% of estimates below 50,000 dollars/LYG.
Platelet inhibition with clopidogrel loading before PCI followed by therapy for one year is highly cost effective.
Journal of the American College of Cardiology 10/2005; 46(5):761-9. · 14.16 Impact Factor
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ABSTRACT: Data are limited regarding the impact of acute coronary syndromes (ACSs) on the relative benefits of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI).
The SoS trial compared patients with multivessel disease who were randomly assigned to CABG (n = 500) or stent-assisted PCI (n = 488). The impact of treatment on 1-year outcomes was compared in ACS (n = 126, CABG; n = 116, PCI) and non-ACS (n = 374, CABG; n = 372, PCI) subgroups.
Baseline characteristics were similar between treatment groups within ACS and non-ACS groups, as was the 1-year composite incidence of mortality and myocardial infarction (ACS, 5.2% for PCI vs 5.6% for CABG, P = .89; non-ACS, 7.0% vs 8.3%, P = .50). The need for repeat revascularizations was higher after PCI versus CABG within each subgroup (ACS, 15.5% vs 7.1%, P = .04; non-ACS, 18.0% vs 3.2%, P < .001). At 6 and 12 months, scores on the Seattle Angina Questionnaire improved significantly in patients with and without ACS. In patients without ACS, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life at 6 and 12 months. In patients with ACS, there was only a nonsignificant slight trend toward greater improvement with CABG at 1 year. The total 1-year costs for PCI and CABG in patients without ACS were 5760 pound sterling and 8509 pound sterling (Delta = 2749 pound sterling, 95% CI 1890 pound sterling - 3409 pound sterling), and in patients with ACS, 8014 pound sterling and 10080 pound sterling (Delta = 2066 pound sterling, 95% CI -690 pound sterling to 3487 pound sterling).
In patients with and without ACS, CABG had similar clinical outcomes, less need for repeat revascularization and higher costs compared to PCI. The benefit of CABG relative to PCI in improving patients' health status tended to be greater in patients without ACS than in patients with ACS.
American heart journal 07/2005; 150(1):175-81. · 4.65 Impact Factor
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William S Weintraub, Zefeng Zhang,
Elizabeth M Mahoney,
Paul Kolm,
John A Spertus,
Jaime Caro,
Jack Ishak,
Robert Goldberg,
Joseph Tooley,
Richard Willke,
Bertram Pitt
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ABSTRACT: In the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), aldosterone blockade with eplerenone decreased mortality in patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction. The present study was performed to evaluate the cost-effectiveness of eplerenone compared with placebo in these patients.
A total of 6632 patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction were randomized to eplerenone or placebo and followed up for a mean of 16 months. The coprimary end points were all-cause mortality and the composite of cardiovascular mortality/cardiovascular hospitalization. The evaluation of resource use included hospitalizations, outpatient services, and medications. Eplerenone was priced at the average wholesale price, 3.60 dollars per day. Survival beyond the trial period was estimated from data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. The incremental cost-effectiveness of eplerenone in cost per life-year and quality-adjusted life-year gained compared with placebo was estimated. The number of life-years gained with eplerenone was 0.1014 based on Framingham (95% CI, 0.0306 to 0.1740), 0.0636 with Saskatchewan (95% CI, 0.0229 to 0.1038), and 0.1337 with Worcester (95% CI, 0.0438 to 0.2252) data. Cost was 1391 dollars higher over the trial period in the eplerenone arm (95% CI, 656 to 2165) because of drug cost. The incremental cost-effectiveness ratio was 13,718 dollars per life-year gained with Framingham (96.7% under 50,000 dollars per life-year gained), 21,876 dollars with Saskatchewan, and 10,402 dollars with Worcester.
Eplerenone compared with placebo in the treatment of heart failure after acute myocardial infarction is effective in reducing mortality and is cost-effective in increasing years of life by commonly used criteria.
Circulation 04/2005; 111(9):1106-13. · 14.74 Impact Factor
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ABSTRACT: OBJECTIVE: To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis. DESIGN: CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial. SETTING: 20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center. PATIENTS: 705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery. INTERVENTION: Cilostazol (100 mg twice daily) or placebo for 6 months. OUTCOME MEASURES: Costs: Primary endpoint, total direct medical costs at 6 months; secondary endpoints, initial hospital costs and follow-up costs. QOL: Health-related quality of life (QOL) will be assessed using the EQ-5D and the Seattle Angina Questionnaire at baseline and at 1, 3, and 6 months. Cost-effectiveness analysis: Preliminary data show that cilostazol is clinically superior to placebo and if the mean cost for the cilostazol arm is higher than that for placebo, cost-effectiveness analysis will be determined for the cost per episode of restenosis prevented, the cost per episode of major clinical and angiographic endpoints averted, and the cost per quality-adjusted life-years gained.
The Journal of invasive cardiology 06/2004; 16(5):257-9. · 1.84 Impact Factor
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ABSTRACT: Information on the relative benefit of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI) for improvement of cardiac-related health status in women and how it compares with men is limited. The Stent or Surgery trial compared randomly assigned CABG and stent-assisted PCI in 206 women and 782 men with multivessel disease. We examined longitudinal changes at 6 and 12 months from baseline by gender and treatment in 3 subscales of the Seattle Angina Questionnaire (SAQ): physical limitation, angina frequency, and quality of life. At the time of revascularization, women were older, more severely ill, and tended to have lower SAQ scores than men. At 6 months, SAQ scores after both procedures improved significantly in both genders, with greater improvement achieved with CABG. After adjustment for other factors, in men, CABG was associated with a 54.7% greater improvement in physical limitation compared with PCI, 31.3% greater improvement in angina frequency, and 18.3% greater improvement in quality of life. In women, these relative differences were 11.6%, 43.2%, and 39.3%, respectively. At 1 year, men continued to show greater improvement with CABG in all 3 dimensions (50.6%, 19.7%, and 15.3%, respectively), but in women the relative differences decreased substantially (1.6%, 11.1%, and 0.6%, respectively) due to a greater later improvement after PCI (p = 0.049 for the interaction among treatment, gender, and follow-up for the quality of life domain). Although CABG may be superior to PCI in men, in women, at 1 year after intervention, both procedures appear equally effective.
The American Journal of Cardiology 03/2004; 93(4):404-9. · 3.37 Impact Factor
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ABSTRACT: Functional status and quality of life are important outcomes in the evaluation of revascularization approaches for symptomatic coronary artery disease. Few data are available regarding the comparative improvement in disease-specific health status after CABG versus percutaneous coronary intervention (PCI) in the era of coronary stenting.
Cardiac-specific health status was evaluated at baseline and at 6 and 12 months after intervention with the Seattle Angina Questionnaire (SAQ) in patients randomized to stent-assisted PCI (n=488) versus CABG (n=500) in the Stent or Surgery trial. Scores for physical limitation, angina frequency, and quality of life improved significantly for both treatment groups at 6 months (range of improvement from 13.6 to 34.7 points) and 12 months (14.3 to 38.2 points; all P<0.001). CABG patients had greater improvement than those assigned to PCI, although the magnitude of the difference decreased over time (difference at 6 months, 4.03 to 6.48 points; 12 months, 2.05 to 2.93 points). A component of this reduction is accounted for by PCI-arm patients who required repeat intervention. Differences between treatment groups were greatest for the 6-month angina frequency scores (difference=6.48 points; 95% CI 3.96 to 8.99). Overall, treatment satisfaction was high and did not differ significantly between groups.
Both CABG and stent-assisted PCI dramatically improved cardiac-related health status in patients with multivessel disease at 6- and 12-month follow-up. During the first postprocedure year, patients' angina burden and physical limitations were alleviated to a greater extent with CABG.
Circulation 11/2003; 108(14):1694-700. · 14.74 Impact Factor
