Ronna H. Berezin

Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses Results From the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) Trial

Background—Recently, sirolimus-eluting stents (SESs) have been shown to dramatically reduce the risk of angiographic and clinical restenosis compared with bare metal stent (BMS) implantation. However, the overall cost-effectiveness of this strategy is unknown. Methods and Results—Between February and August 2001, 1058 patients with complex coronary stenoses were enrolled in the SIRIUS trial and randomized to percutaneous coronary revascularization with either a SES or BMS. Clinical outcomes, resource use, and costs were assessed prospectively for all patients over a 1-year follow-up period. Initial hospital costs were increased by

Percutaneous coronary revascularization in Elderly patients: Impact on functional status and quality of life

2881 per patient with SESs. Over the 1-year follow-up period, use of SESs led to substantial reductions in the need for repeat revascularization, including repeat percutaneous coronary intervention and bypass surgery. Although follow-up costs were reduced by

Economic Evaluation of Bivalirudin With or Without Glycoprotein IIb/IIIa Inhibition Versus Heparin With Routine Glycoprotein IIb/IIIa Inhibition for Early Invasive Management of Acute Coronary Syndromes

2571 per patient with SESs, aggregate 1-year costs remained

Impact of a practice guideline for patients with atrial fibrillation on medical resource utilization and costs

309 per patient higher. The incremental cost-effectiveness ratio for SES was

Costs and cost‐effectiveness of carotid stenting versus endarterectomy for patients at increased surgical risk: Results from the SAPPHIRE trial

1650 per repeat revascularization event avoided or

Cost-Effectiveness of Coronary Stenting and Abciximab for Patients With Acute Myocardial Infarction Results From the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) Trial

27 540 per quality-adjusted year of life gained, values that compare reasonably with other accepted medical interventions. Under updated treatment assumptions regarding available stent lengths and duration of antiplatelet therapy, use of SESs was projected to reduce total 1-year costs compared with BMSs. Conclusions—Although use of SESs was not cost-saving compared with BMS implantation, for patients undergoing percutaneous coronary intervention of complex coronary stenoses, their use appears to be reasonably cost-effective within the context of the US healthcare system.

Cost-Effectiveness of Gamma Radiation for Treatment of In-Stent Restenosis Results From the Gamma-1 Trial

Ischemic heart disease affects more than 25% of persons older than 65 years of age in the United States. Although elderly patients with coronary artery disease tend to be treated less aggressively than nonelderly patients, the use of percutaneous coronary intervention (PCI) in the elderly is increasing rapidly; it more than doubled between 1979 and 1986 (1). Previous studies have examined the risks for PCI-related complications among elderly patients and found that elderly patients have a higher risk for vascular complications and in-hospital death than younger patients (2). Nonetheless, little is known about the critical outcomes of these procedures from the patients perspective. Although short- and long-term mortality rates are important outcomes to consider, PCI is generally done to improve the patients quality of life by relieving the signs and symptoms of myocardial ischemia. Improvement in quality of life may be particularly germane to older patients, for whom competing risks tend to limit any potential gains in longevity (3). We examined changes in health-related quality of life among elderly patients after PCI and compared these changes with those in nonelderly patients. Methods Study Sample Patients in this study had PCI as part of two randomized multicenter clinical trials: the Balloon versus Optimal Atherectomy Trial (BOAT; n =989), which compared directional atherectomy with balloon angioplasty (4), and the Advanced Cardiovascular System Multi-Link-Stent System Trial (ASCENT; n =1040), which compared the ACS Multi-Link stent to the PalmazSchatz stent (5). Only patients enrolled in U.S. hospitals who completed a baseline health-related quality-of-life survey (n =1789) were eligible for our substudy. Inclusion and exclusion criteria for the trials were similar. All patients had symptomatic coronary artery disease that required percutaneous revascularization of a single native coronary artery. Patients with a myocardial infarction within 5 days of treatment, stroke within the preceding 3 months, bifurcation lesions, or severe proximal tortuosity were excluded. The institutional review boards of each institution approved the studies, and all patients provided informed consent before participation. Quality-of-Life Assessment Health-related quality of life was assessed by using the physical and mental health summary scales of the Medical Outcomes Study Short-Form Survey (SF-36) (6, 7). These summary scales are standardized such that the mean ( SD) for the U.S. population is 50 10. Higher scores indicate better health. Patients in ASCENT also completed the Seattle Angina Questionnaire (SAQ), a validated disease-specific instrument that measures five health-related quality-of-life domains specific for coronary artery disease (physical functioning, anginal stability, anginal frequency, disease perception, and treatment satisfaction) (8, 9). The SAQ scores range from 0 to 100, and higher scores indicate better levels of functioning (that is, less physical limitation and less frequent angina). Baseline health-related quality of life was assessed by using self-administered questionnaires that were completed immediately before the index revascularization procedure. Follow-up measurements were obtained by surveys mailed to participants 6 months and 1 year after initial treatment. Patients who did not respond to the mailed survey within 2 weeks were administered the same instrument by telephone when possible. Statistical Analysis Baseline patient characteristics of elderly ( 70 years of age) and nonelderly (<70 years of age) patients were compared by using t-tests and Wilcoxon rank-sum tests for continuous variables and Fisher exact tests for categorical variables. Logistic regression was used to determine whether the likelihood of substantial improvement in health-related quality of life after PCI differed between elderly and nonelderly patients (10). For each health-related quality-of-life scale, each patient was classified as improved or not improved according to the level of change at which patients in previous studies had reported substantial improvement. Previous studies involving the SF-36 have demonstrated that changes in the physical component score of 3.8 points or more and changes in the mental component score of 7.2 points or more were meaningful to patients (6). For the SAQ subscales, an improvement of 10 or more points has been found to correlate with clinically meaningful changes (9) and was used to classify patients as improved or not improved for our analysis. Each regression model adjusted for patient demographic characteristics (sex, marital status, education, race or ethnicity) and medical conditions (previous myocardial infarction, congestive heart failure, diabetes, chronic obstructive pulmonary disease, peripheral vascular disease, arthritis, vision problems, number of comorbid conditions, smoking status). Standardized predicted probabilities derived from these models were used to estimate the percentage of patients in each age group who were expected to demonstrate substantial improvement after PCI. We also calculated standardized risk differences and associated confidence intervals (11). The main results were not altered in analyses that adjusted for clustering (data not shown). All analyses were done by using Stata software, version 6.0 (Stata Corp., College Station, Texas). P values less than 0.05 were considered statistically significant. Significance tests were not adjusted for multiple comparisons. All data were collected and analyzed by an independent data coordinating center (Cardiovascular Data Analysis Center, Boston, Massachusetts), without direct input from the study sponsor. Twenty percent of the data were missing because of patient nonresponse at follow-up. To examine whether our results were sensitive to differences between respondents and nonrespondents, we imputed the change scores of nonrespondents by using multiple imputation techniques (12) and re-estimated the models for the full study sample. Because the results of these sensitivity analyses were similar to our primary results, we report only the primary results. Results Of the patients who completed the baseline survey, 1445 (80%) completed the 6-month follow-up survey. These patients made up our analytic cohort. Compared with nonrespondents, respondents were more likely to be nonwhite and unmarried and were less likely to have congestive heart failure. Among respondents, the median age of the nonelderly group was 57 years (range, 38 to 69 years) and the median age of the elderly group was 74 years (range, 70 to 89 years). Compared with nonelderly patients, elderly patients were more likely to be female, white, and unmarried and were less well-educated. Elderly patients were less likely to smoke cigarettes but were more likely to have hypertension and congestive heart failure and had more comorbid conditions (data not shown). Clinical Events During the initial hospitalization and 1-year follow-up period, the incidence of major adverse cardiac events, including myocardial infarction, bypass surgery, and repeated PCI, was low in both groups. However, during the initial hospitalization, older patients were more likely than younger patients to sustain a major vascular complication (3.7% compared with 1.7%; P =0.04). Effect of Percutaneous Coronary Intervention on Health-Related Quality of Life At baseline, both elderly and nonelderly patients had substantial impairments in physical health and modest impairments in mental health relative to the overall U.S. population (Table). The SAQ subscales also demonstrated substantial physical limitations and impaired quality of life due to angina in both age groups. At 6-month follow-up, both elderly and nonelderly patients demonstrated substantial improvement in each quality-of-life domain, and these gains persisted at 1 year (Table). At both 6 months and 1 year, approximately 60% of patients reported no angina. Table. Distribution of Health-Related Quality-of-Life Scores at Baseline, 6 Months, and 1 Year In adjusted analyses, the change in health-related quality of life associated with PCI did not significantly differ between elderly and nonelderly patients (Figure). At 6-month follow-up, physical health improved substantially for 51% of elderly patients and 58% of nonelderly patients (difference, 7 percentage points [95% CI, 15 to 1 percentage point]). Similarly, mental health improved substantially for 29% of elderly patients and 30% of nonelderly patients (difference, 1 percentage point [CI, 9 to 6 percentage points]). At 6-month follow-up, most patients demonstrated substantial improvement in all three aspects of disease-specific quality of life, with nearly identical benefits regardless of age. Physical limitations related to angina improved substantially for 58% of elderly patients and 54% of younger patients (difference, 4 percentage points [CI, 7 to 13 percentage points]). Elderly and nonelderly patients demonstrated similar rates of improvement in frequency of angina (75% compared with 74% [difference, 1 percentage point; CI, 6 to 10 percentage points]) and in disease burden (77% compared with 71% [difference, 6 percentage points; CI, 6 to 10 percentage points]). Only 4% to 13% of patients reported meaningful declines in cardiovascular-specific quality of life, and the proportion did not vary with age. Similar changes were observed at 1-year follow-up as well (data not shown). Figure. Standardized estimates of the percentage of patients expected to have improvements in health-related quality of life ( QOL ) 6 months after percutaneous coronary intervention, according to age. Discussion We found that PCI resulted in substantial population-level benefits for elderly patients with regard to both physical and mental health as well as reductions in physical limitations due to angina, frequency of angina, and the perceived burden of coronary artery disease. During 6- to 12-

In-hospital costs of self-expanding nitinol stent implantation versus balloon angioplasty in the femoropopliteal artery (the VascuCoil Trial).

OBJECTIVES The aim of this study was to determine the economic impact of several anticoagulation strategies for moderate- and high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients managed invasively. BACKGROUND The ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial demonstrated that bivalirudin monotherapy yields similar rates of ischemic complications and less bleeding than regimens incorporating glycoprotein IIb/IIIa receptor inhibitors (GPI) for moderate- and high-risk NSTE-ACS. METHODS In ACUITY, 7,851 U.S. patients were randomized to: 1) heparin (unfractionated or enoxaparin) + GPI; 2) bivalirudin + GPI; or 3) bivalirudin monotherapy. Patients assigned to GPI were also randomized to upstream GPI before catheterization or selective GPI only with percutaneous coronary intervention. Resource use data were collected prospectively through 30-day follow-up. Costs were estimated with standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule. RESULTS At 30 days, ischemic events were similar for all groups. Major bleeding was reduced with bivalirudin monotherapy compared with heparin + GPI or bivalirudin + GPI (p < 0.001). Length of stay was lowest with bivalirudin monotherapy or bivalirudin + catheterization laboratory GPI (p = 0.02). Despite higher drug costs, aggregate hospital stay costs were lowest with bivalirudin monotherapy (mean difference range:

Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention : Results from the REPLACE-2 trial

184 to

Cost-Effectiveness of Coronary Stenting in Acute Myocardial Infarction Results From the Stent Primary Angioplasty in Myocardial Infarction (Stent-PAMI) Trial

1,081, p < 0.001 for overall comparison) and at 30 days (mean difference range: