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  • Ovid Technologies (Wolters Kluwer Health)  (28)
  • 1
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 15, No. 10 ( 2022-10)
    Abstract: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR. Methods: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data. Results: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P 〈 0.001). Conclusions: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02287662.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2450801-9
    detail.hit.zdb_id: 2450797-0
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  • 2
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. 9 ( 2012-09), p. 2408-2416
    Abstract: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated similar rates of the primary composite end point between carotid artery stenting (CAS) and carotid endarterectomy (CEA), although the risk of stroke was higher with CAS, and the risk of myocardial infarction was higher with CEA. Given the large number of patients who are candidates for these procedures, an understanding of their relative cost and cost-effectiveness may have important implications for health care policy and treatment guidelines. Methods— We performed a formal economic evaluation alongside the CREST trial. Costs were estimated from all trial participants over the first year of follow-up using a combination of resource use data and hospital billing data. Patient-level health use scores were obtained using data from the SF-36. We then used a Markov disease-simulation model calibrated to the CREST results to project 10-year costs and quality-adjusted life expectancy for the 2 treatment groups. Results— Although initial procedural costs were $1025/patient higher with CAS, postprocedure costs and physician costs were lower such that total costs for the index hospitalization were similar for the CAS and CEA groups ($15 055 versus $14 816; mean difference, $239/patient; 95% CI for difference, −$297 to $775). Neither follow-up costs after discharge nor total 1-year costs differed significantly. For the CREST population, model-based projections over a 10-year time horizon demonstrated that CAS would result in a mean incremental cost of $524/patient and a reduction in quality-adjusted life expectancy of 0.008 years compared with CEA. Probabilistic sensitivity analysis demonstrated that CEA was economically attractive at an incremental cost-effectiveness threshold of $50 000/quality-adjusted life-year gained in 54% of samples, whereas CAS was economically attractive in 46%. Conclusions— Despite slightly lower in-trial costs and lower rates of stroke with CEA compared with CAS, projected 10-year outcomes from this controlled clinical trial demonstrate only trivial differences in overall healthcare costs and quality-adjusted life expectancy between the 2 strategies. If the CREST results can be replicated in clinical practice, these findings suggest that factors other than cost-effectiveness should be considered when deciding between treatment options for carotid artery stenosis in patients at standard risk for surgical complications. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique Identifier: NCT00004732.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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  • 3
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 130, No. 14 ( 2014-09-30), p. 1146-1157
    Abstract: The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, stroke, or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents (DES-PCI)). The long-term cost-effectiveness of these strategies is unknown. Methods and Results— Between 2005 and 2007, 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG (n=897) or DES-PCI (n=903). Costs were assessed from a US perspective, and health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs, life expectancy, and quality-adjusted life expectancy over a lifetime horizon. Although initial procedural costs were $3415 per patient lower with CABG, total hospitalization costs were $10 036 per patient higher. Over the next 5 years, follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations, revascularization procedures, and higher medication costs. Over a lifetime horizon, CABG remained more costly than DES-PCI, but the incremental cost-effectiveness ratio was favorable ($16 537 per quality-adjusted life-year gained) and remained 〈 $20 000 per quality-adjusted life-year in most bootstrap replicates. Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs. In patients with left main disease or a SYNTAX score ≤22, however, DES-PCI was economically dominant compared with CABG, although these findings were less certain. Conclusions— For most patients with 3-vessel or left main coronary artery disease, CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI. However, among patients with less complex disease, DES-PCI may be preferred on both clinical and economic grounds. Clinical Trial Registration— URL: www.clinicaltrials.gov . Unique identifier: NCT00114972.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1466401-X
    detail.hit.zdb_id: 80099-5
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  • 4
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 15, No. 7 ( 2022-07)
    Abstract: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) demonstrated in patients with left main coronary artery disease, no significant difference between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with everolimus-eluting stents for the composite end point of death, stroke, or myocardial infarction at 5 years. However, all-cause mortality at 5 years was higher with PCI. Long-term cost-effectiveness of these 2 strategies has heretofore not been evaluated. Methods: From 2010 to 2014, 1905 patients with left main coronary artery disease were randomized to CABG (n=957) or PCI (n=948). Costs ($2019) were assessed over 5 years using resource-based costing and Medicare reimbursement rates. Health utilities were assessed using the EuroQOL 5-dimension questionnaire. Five-year EXCEL data in combination with US lifetables were used to develop a Markov model to evaluate lifetime cost-effectiveness. An incremental cost-effectiveness ratio 〈 $50 000 per quality-adjusted life year (QALY) gained was considered highly cost-effective. Results: Index revascularization procedure costs were $4,850/patient higher with CABG, and total costs for the index hospitalization were $17 610/patient higher with CABG ($32 297 versus $19 687, P 〈 0.001). Cumulative 5-year costs were $20 449/patient higher with CABG. CABG was projected to increase lifetime costs by $21 551 while increasing quality-adjusted life expectancy by 0.49 QALYs, yielding an incremental cost-effectiveness ratio of $44 235/QALY. In a post hoc sensitivity analysis using mortality hazard ratios from a meta-analysis of all randomized CABG versus PCI in left main disease trials, the gain associated with CABG was 0.08 to 0.14 QALYs, resulting in an incremental cost-effectiveness ratio of $139 775 to $232 710/QALY gained. Conclusions: Based on data from the EXCEL trial, CABG is an economically attractive revascularization strategy compared with PCI over a lifetime horizon for patients with significant left main coronary artery disease. However, this conclusion is sensitive to the long-term mortality rates with the 2 strategies, and CABG is no longer highly cost-effective when substituting the pooled treatment effect from the 4 major PCI versus CABG trials for left main disease. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01205776.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2450801-9
    detail.hit.zdb_id: 2450797-0
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  • 5
    In: Circulation: Cardiovascular Quality and Outcomes, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 10 ( 2019-10)
    Abstract: In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared. Methods and Results: Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117–$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093–$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio 〈 $50 000/QALY or 〈 $150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy. Conclusions: With an incremental cost-effectiveness ratio 〉 $200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.
    Type of Medium: Online Resource
    ISSN: 1941-7713 , 1941-7705
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 2453882-6
    detail.hit.zdb_id: 2483197-9
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  • 6
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 139, No. 7 ( 2019-02-12), p. 877-888
    Abstract: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar rates of death or stroke at 2 years. Whether TAVR is cost-effective compared with SAVR for intermediate-risk patients remains uncertain. Methods: Between 2011 and 2014, 3110 intermediate-risk AS patients were treated with TAVR or SAVR in the PARTNER 2 trial (Placement of Aortic Transcatheter Valves 2). A total of 2032 patients were randomized to receive TAVR using the SAPIEN XT valve (XT-TAVR) or SAVR in the PARTNER 2A trial, whereas the PARTNER S3i registry included an additional 1078 patients treated with TAVR using the SAPIEN 3 valve (S3-TAVR), which offers a lower delivery profile and sealing skirt designed to reduce paravalvular regurgitation compared with XT-TAVR. Procedural costs were estimated using measured resource utilization. Other in-trial costs were assessed by linkage of trial data with Medicare claims (n=2333) or by linear regression models for unlinked patients (n=682). Health utilities were estimated using the EQ-5D at baseline and 1, 12, and 24 months. Using a Markov model informed by in-trial costs, utilities, and survival data, lifetime cost-effectiveness from the perspective of the US healthcare system was estimated in terms of cost per quality-adjusted life-year gained. Results: Although procedural costs were ≈$20 000 higher with TAVR than SAVR, total cost differences for the index hospitalization were only $2888 higher with XT-TAVR ( P =0.014) and were $4155 lower with S3-TAVR ( P 〈 0.001) owing to reductions in length of stay with TAVR. Follow-up costs were significantly lower with XT-TAVR (Δ=−$9304; P 〈 0.001) and S3-TAVR (Δ=−$11 377; P 〈 0.001) than with SAVR. Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years. XT-TAVR and S3-TAVR were found to be economically dominant compared with SAVR in 84% and 97% of bootstrap replicates, respectively. Conclusions: Among intermediate-risk AS patients, TAVR is projected to be economically dominant from the perspective of the US healthcare system by providing both greater quality-adjusted life expectancy and lower long-term costs than SAVR. If long-term data demonstrate comparable late mortality with TAVR and SAVR, these findings suggest that TAVR might be the preferred treatment strategy for intermediate-risk AS patients based on both clinical and economic considerations. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01314313.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 1466401-X
    detail.hit.zdb_id: 80099-5
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  • 7
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 127, No. 7 ( 2013-02-19), p. 820-831
    Abstract: Studies from the balloon angioplasty and bare metal stent eras have demonstrated that coronary artery bypass grafting (CABG) is cost-effective compared with percutaneous coronary intervention (PCI) for patients undergoing multivessel coronary revascularization—particularly among patients with complex coronary artery disease or diabetes mellitus. Whether these results apply in the drug-eluting stent (DES) era is unknown. Methods and Results— Between 2005 and 2010, 1900 patients with diabetes mellitus and multivessel coronary artery disease were randomized to PCI with DES (DES-PCI; n=953) or CABG (n=947). Costs were assessed from the perspective of the U.S. health care system. Health state utilities were assessed using the EuroQOL 5 dimension 3 level questionnaire. A patient-level microsimulation model based on U.S. life-tables and in-trial results was used to estimate lifetime cost-effectiveness. Although initial procedural costs were lower for CABG, total costs for the index hospitalization were $8622 higher per patient. Over the next 5 years, follow-up costs were higher with PCI, owing to more frequent repeat revascularization and higher outpatient medication costs. Nonetheless, cumulative 5-year costs remained $3641 higher per patient with CABG. Although there were only modest gains in survival with CABG during the trial period, when the in-trial results were extended to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with substantial gains in both life expectancy and quality-adjusted life expectancy and incremental cost-effectiveness ratios 〈 $10 000 per life-year or quality-adjusted life-year gained across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. Conclusions— Despite higher initial costs, CABG is a highly cost-effective revascularization strategy compared with DES-PCI for patients with diabetes mellitus and multivessel coronary artery disease. Clinical Trial Registration— URL: http://www.clinical-trials.gov . Unique identifier: NCT00086450.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
    detail.hit.zdb_id: 1466401-X
    detail.hit.zdb_id: 80099-5
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  • 8
    In: Circulation: Cardiovascular Quality and Outcomes, Ovid Technologies (Wolters Kluwer Health), Vol. 5, No. 3 ( 2012-05), p. 267-275
    Abstract: Patients with multivessel coronary disease treated with coronary artery bypass graft (CABG) have less angina than those treated with percutaneous coronary intervention (PCI); however, there is uncertainty as to the mechanism of greater angina relief with CABG and whether more frequent repeat revascularization in patients treated with PCI could account for this treatment difference. Methods and Results— In the Synergy between percutaneous coronary intervention (PCI) with TAXUS and Cardiac Surgery trial, 1800 patients with 3-vessel or left main coronary artery disease were randomized to CABG or PCI with paclitaxel-eluting stents. Health status was assessed at baseline, 1, 6, and 12 months, using the Seattle Angina Questionnaire and the Medical Outcomes Study Short Form General Health Survey, and the association between repeat revascularization and health status during follow-up was assessed using longitudinal models. In adjusted analyses, patients who underwent repeat revascularization had worse angina frequency scores than patients who did not in both treatment groups, with differences of 8.5 points at 6 months and 3.1 points at 12 months in patients treated with PCI and 19.8 points at 6 months and 11.2 points at 12 months in patients with patients treated with CABG. Among patients who did not require repeat revascularization, the adjusted effect of CABG versus PCI on 12-month angina frequency scores was nearly identical to the overall benefit in the intention-to-treat analysis. Conclusions— Among patients with multivessel coronary artery disease treated with PCI or CABG, the occurrence of repeat revascularization during follow-up did not fully explain the antianginal benefit of CABG in the overall population. The differential association between repeat revascularization and anginal status, according to the type of initial revascularization procedure, suggests that this end point should play a limited role in any direct comparison of the 2 treatment strategies. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00114972.
    Type of Medium: Online Resource
    ISSN: 1941-7713 , 1941-7705
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 2453882-6
    detail.hit.zdb_id: 2483197-9
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  • 9
    In: Circulation: Cardiovascular Quality and Outcomes, Ovid Technologies (Wolters Kluwer Health), Vol. 7, No. suppl_1 ( 2014-07)
    Abstract: BACKGROUND: Anticoagulation in AF patients involves consideration of the benefit of stroke risk reduction versus increased bleeding risk. The impact of bleeding events on health state utility has not been clearly understood. METHODS: We used prospectively-collected data from the ENGAGE AF-TIMI 48 Trial to estimate the impact of different bleeding events on utility scores derived from the EQ-5D. EQ-5D data were collected at randomization and 3 month intervals for up to 48 months; at least two EQ-5D assessments were available for 15,618 participants. Spontaneous bleeding events were identified prospectively and adjudicated according to prespecified criteria. Patients who experienced a bleed and provided at least one EQ-5D assessment before and after the event were included in the analysis. To maximize specificity, patients were excluded if they had more than 1 bleeding event or any other major cardiovascular events in addition to bleeding. Longitudinal growth curve models were used to estimate changes in utilities after the following mutually exclusive bleeding event categories: intracranial hemorrhage (ICH; n=25); major GI (n=294); major non-GI (n=236); clinically relevant non-major (CRNM) (n=1,414); and minor (n=783). RESULTS: There were reductions in EQ-5D utility after the event for all categories of bleeding that were in parallel with the severity of bleeding (Table). The estimated decrease in utility was greatest for ICH (-0.079), followed by major non-GI (–0.045), GI (–0.030) and CRNM (–0.009). In addition, a significant linear improvement over time was observed for major non-GI bleeds (and a similar albeit non significant improvement for major GI bleeds) such that EQ-5D scores returned to near pre-event levels one year after the bleeding event. No post-event improvement was observed for ICH, CRNM and minor bleeds, however. CONCLUSION: Spontaneous bleeding events are associated with a negative impact on health state utility, with greatest immediate impact for major bleeds. Health state utility remains low 1 year after an ICH, but gradually returns to baseline 1-year after other major bleeding events. Future cost-effectiveness analysis of strategies to prevent stroke in AF should consider both the economic and health status impact of bleeding events to inform health care decision making.
    Type of Medium: Online Resource
    ISSN: 1941-7713 , 1941-7705
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 2453882-6
    detail.hit.zdb_id: 2483197-9
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  • 10
    In: Circulation: Cardiovascular Quality and Outcomes, Ovid Technologies (Wolters Kluwer Health), Vol. 10, No. 5 ( 2017-05)
    Abstract: Ezetimibe, when added to simvastatin therapy, reduces cardiovascular events after recent acute coronary syndrome. However, the impact of ezetimibe on cardiovascular-related hospitalizations and associated costs is unknown. Methods and Results— We used patient-level data from the IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) to examine the impact of simvastatin–ezetimibe versus simvastatin–placebo on cardiovascular-related hospitalizations and related costs (excluding drug costs) over 7 years follow-up. Medicare Severity–Diagnosis Related Groups were assigned to all cardiovascular hospitalizations. Hospital costs were estimated using Medicare reimbursement rates for 2013. Associated physician costs were estimated as a percentage of hospital costs. The impact of treatment assignment on hospitalization rates and costs was estimated using Poisson and linear regression, respectively. There was a significantly lower cardiovascular hospitalization rate with ezetimibe compared with placebo (risk ratio, 0.95; 95% confidence interval, 0.90–0.99; P =0.031), mainly attributable to fewer hospitalizations for percutaneous coronary intervention, angina, and stroke. Consequently, cardiovascular-related hospitalization costs over 7 years were $453 per patient lower with ezetimibe (95% confidence interval, −$38 to −$869; P =0.030). Although all prespecified subgroups had lower cost with ezetimibe therapy, patients with diabetes mellitus, patients aged ≥75 years, and patients at higher predicted risk for recurrent ischemic events had even greater cost offsets. Conclusions— Addition of ezetimibe to statin therapy in patients with a recent acute coronary syndrome leads to reductions in cardiovascular-related hospitalizations and associated costs, with the greatest cost offsets in high-risk patients. These cost reductions may completely offset the cost of the drug once ezetimibe becomes generic, and may lead to cost savings from the perspective of the healthcare system, if treatment with ezetimibe is targeted to high-risk patients. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique Identifier: NCT00202878
    Type of Medium: Online Resource
    ISSN: 1941-7713 , 1941-7705
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 2453882-6
    detail.hit.zdb_id: 2483197-9
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