Clinical and Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients With Coronary Artery Disease and/or Peripheral Artery Disease.

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.

Continuation with apixaban treatment is associated with lower risk for hospitalization and medical costs among elderly patients.

Objective: To compare the risk of hospitalization and costs associated with major bleeding (MB) or stroke/systemic embolism (SE) among elderly patients with nonvalvular atrial fibrillation (NVAF) who initiated apixaban then switched to another oral anticoagulant (OAC) vs. those who continued with apixaban treatment. Methods: NVAF patients (≥65 years) initiating apixaban were identified from the Humana database (1 January 2013-30 September 2017) and grouped into switcher and continuer cohorts. For switchers, the earliest switch from apixaban to another OAC was defined as the index event/date. A random date during apixaban treatment was selected as the index date for continuers. Patients were followed from index date to health plan disenrollment or 31 December 2017, whichever was earlier. Multivariable regression analyses were used to examine the association of switchers vs. continuers with risk of MB-related or stroke/SE-related hospitalization and healthcare costs during follow-up. Results: Of 7858 elderly NVAF patients included in the study, 14% (N = 1110; mean age: 78 years) were switchers; 86% (N = 6748; mean age: 79 years) were continuers. Apixaban switchers vs. continuers had significantly greater risk of MB-related hospitalization (hazard ratio [HR]: 2.00; 95% CI: 1.52-2.64; p < .001) during follow-up; risk of stroke/SE hospitalization did not differ significantly (HR: 1.36, 95% CI: 0.89-2.06, p = .154). MB- and stroke/SE-related medical costs were higher for switchers vs. continuers, although total all-cause healthcare costs were similar. Conclusion: Elderly patients with NVAF in the US who continued with apixaban treatment had a lower risk of MB-related hospitalization and lower MB- and stroke/SE-related medical costs compared to patients who switched to another OAC.

Real-World Comparative Effectiveness, Safety, and Health Care Costs of Oral Anticoagulants in Nonvalvular Atrial Fibrillation Patients in the U.S. Department of Defense Population.

BACKGROUND: The ARISTOTLE trial demonstrated that apixaban had significantly lower rates of stroke/systemic embolism (SE) and major bleeding than warfarin; however, no direct clinical trials between apixaban and other direct oral anticoagulants (DOACs) are available. Few real-world studies comparing the effectiveness and safety between DOACs have been conducted. OBJECTIVE: To compare effectiveness, safety, and health care costs among oral anticoagulants (OACs) for nonvalvular atrial fibrillation (NVAF) patients in the U.S. Department of Defense (DoD) population. METHODS: Adult NVAF patients initiating warfarin or DOACs (apixaban, rivaroxaban, and dabigatran) were selected from U.S. DoD data from January 1, 2013, to September 30, 2015. The first OAC claim date was designated as the index date. Patients initiating another OAC were matched 1:1 to apixaban patients using propensity score matching to balance demographics and clinical characteristics. Cox proportional hazards models were used to estimate the risk of stroke/SE and major bleeding for each OAC versus apixaban. Generalized linear and two-part models with bootstrapping were used to compare all-cause health care costs and stroke/SE-related and major bleeding-related medical costs. RESULTS: Of the 41,001 eligible patients, 7,607 warfarin-apixaban, 4,129 dabigatran-apixaban, and 11,284 rivaroxaban-apixaban pairs were matched. Warfarin (HR = 1.84; 95% CI = 1.30-2.59; P < 0.001) and rivar-oxaban (HR = 1.46; 95% CI = 1.08-1.98; P = 0.015) were associated with a significantly higher risk of stroke/SE compared with apixaban. Dabigatran (HR = 1.17; 95% CI = 0.68-2.03; P = 0.573) was associated with a numerically higher risk of stroke/SE compared with apixaban. Warfarin (HR = 1.53; 95% CI = 1.24-1.89; P < 0.001), dabigatran (HR = 1.76; 95% CI = 1.27-2.43; P < 0.001), and rivaroxaban (HR = 1.59; 95% CI = 1.34-1.89; P < 0.001) were associated with higher risks of major bleeding compared with apixaban. Compared with apixaban, patients prescribed warfarin incurred numerically higher all-cause total health care costs per patient per month (PPPM) ($2,498 vs. $2,277; P = 0.148) and significantly higher stroke/SE-related ($118 vs. $46; P = 0.012) and major bleeding-related ($166 vs. $76; P = 0.003) medical costs. Dabigatran patients incurred numerically higher all-cause total health care PPPM costs ($2,372 vs. $2,143; P = 0.150) and stroke/SE-related medical costs ($61 vs. $32; P = 0.240) but significantly higher major bleeding-related costs ($114 vs. $58; P = 0.025). Rivaroxaban patients incurred significantly higher all-cause total health care costs ($2,546 vs. $2,200; P < 0.001) and major bleeding-related medical costs PPPM ($137 vs. $69; P < 0.001) but numerically higher stroke/SE-related medical costs PPPM ($58 vs. $38; P = 0.057). CONCLUSIONS: Among NVAF patients in the U.S. DoD population, warfarin and rivaroxaban were associated with a significantly higher risk of stroke/SE and major bleeding compared with apixaban. Dabigatran use was associated with a numerically higher risk of stroke/SE and a significantly higher risk of major bleeding compared with apixaban. Warfarin and dabigatran incurred numerically higher all-cause total health care costs compared with apixaban. Rivaroxaban was associated with significantly higher all-cause total health care costs compared with apixaban. DISCLOSURES This study was funded by Bristol-Myers Squibb and Pfizer, which were involved in the study design, as well as in the writing and revision of the manuscript. Keshishian and Zhang are paid employees of STATinMED Research, which was paid by Bristol-Myers Squibb and Pfizer to conduct this study and develop the manuscript. Gupta, Rosenblatt, Hede, and Nadkarni are paid employees of Bristol-Myers Squibb. Trocio, Dina, Mardekian, Liu, and Shank are paid employees of Pfizer.

Predictors for total hospital and cardiology cost claims among patients with atrial fibrillation initiating dabigatran or acenocoumarol in The Netherlands.

AIMS: The prevalence of atrial fibrillation (AF) has increased over the past years due to aging of the population, and healthcare costs associated with AF reflect a significant financial burden. The aim of this study was to explore predictors for the real-world AF-related in-hospital costs in patients that recently initiated anticoagulation with acenocoumarol or dabigatran. METHODS: Predictors for claimed total hospital care costs and cardiology costs in AF patients were explored by using hospital financial claims data from propensity score matched patient groups in a large Dutch community hospital. This study analyzed the total dataset (n = 766) and carried out a secondary analysis for all matched pairs of anticoagulation naïve AF patients (n = 590) by ordinal regression. RESULTS: Dabigatran was a predictor for significantly lower cardiology and total hospital care costs (Odds Ratio [OR] = 0.43, 95% confidence interval (CI) = 0.33-0.57; and OR = 0.60, 95% CI = 0.46-0.79, respectively). Female gender was a predictor for lower total hospital care costs. Predictors for an increase in total hospital care costs were the occurrence of stroke or systemic embolism, major bleeding, and minor bleeding. The costs predictors were comparable when limiting the analysis to patients that were anticoagulation naïve. Age and CHA2DS2-VASc were not predictors for either cardiology or total hospital care costs in both analyses. CONCLUSION: Dabigatran treatment was as a predictor for lower cardiology costs and lower total hospital care costs in AF patients that initiated oral anticoagulation.

Comparison of the cost-effectiveness of new oral anticoagulants for the prevention of stroke and systemic embolism in atrial fibrillation in a UK setting.

PURPOSE: Three new oral anticoagulants (NOACs) have recently become available in the United Kingdom as an alternative to warfarin in the prevention of stroke and systemic embolism in atrial fibrillation. This study examines the relative cost-effectiveness of dabigatran (BID dosing of 150 mg or 110 mg based on patient age), rivaroxaban, and apixaban from a UK payer perspective. METHODS: A previously published model that follows up patients through treatment of atrial fibrillation during a lifetime was adapted to allow comparison of the 3 NOACs and warfarin. Acute thromboembolic and bleeding events, as well as long-term consequences of stroke, intracranial hemorrhage, and acute myocardial infarction, were tracked. Relative efficacy was calculated from a formal indirect treatment comparison using data from the 3 key trials (Randomized Evaluation of Long-Term Anticoagulation Therapy, Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation, and Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation) of the NOACs. Data from the rivaroxaban trial were adjusted for the difference in international normalized ratio control among warfarin patients versus the other 2 trials. Model outputs included total costs, event rates, and quality-adjusted life-years. FINDINGS: Among the patients taking NOACs, those taking dabigatran had the highest total QALYs (7.68 QALYs), followed by apixaban (7.63 QALYs) and rivaroxaban (7.47 QALYs). Patients taking dabigatran had the lowest total lifetime costs (£23,342), followed by apixaban (£24,014) and rivaroxaban (£25,220). The differences between dabigatran and apixaban were modest but consistent in sensitivity analyses, with the directionality only changing at the limits of the CIs for the relative risks of ischemic stroke or intracranial hemorrhage or when assuming that both treatment discontinuation and post-event disability rates differ by drug. IMPLICATIONS: Dabigatran was found to be economically dominant over rivaroxaban and apixaban in the UK setting. These economic findings are based on relative clinical efficacy from an indirect treatment comparison and would benefit from any data of direct comparisons of the NOACs in the future.

Age-specific incidence, outcome, cost, and projected future burden of atrial fibrillation-related embolic vascular events: a population-based study.

BACKGROUND: Prevalence of atrial fibrillation (AF) is >10% at age ≥80 years, but the impact of population aging on rates of AF-related ischemic events is uncertain. METHODS AND RESULTS: We studied age-specific incidence, outcome, and cost of all AF-related incident strokes and systemic emboli from 2002 to 2012 in the Oxford Vascular Study (OXVASC). We determined time trends in incidence of AF-related stroke in comparison with a sister study in 1981 to 1986, extrapolated numbers to the UK population and projected future numbers. Of 3096 acute cerebral or peripheral vascular events in the 92 728 study population, 383 incident ischemic strokes and 71 systemic emboli were related to AF, of which 272 (59.9%) occurred at ≥80 years. Of 597 fatal or disabling incident ischemic strokes, 262 (43.9%) were AF-related. Numbers of AF-related ischemic strokes at age ≥80 years increased nearly 3-fold from 1981-1986 to 2002-2012 (extrapolated to the United Kingdom: 6621 to 18 176 per year), due partly to increased age-specific incidence (relative rate 1.52, 95% confidence interval 1.31-1.77, P=0.001), with potentially preventable AF-related events at age ≥80 years costing the United Kingdom £374 million per year. At current incidence rates, numbers of AF-related embolic events at age ≥80 years will treble again by 2050 (72 974/year), with 83.5% of all events occurring in this age group. CONCLUSIONS: Numbers of AF-related incident ischemic strokes at age ≥80 years have trebled over the last 25 years, despite the introduction of anticoagulants, and are projected to treble again by 2050, along with the numbers of systemic emboli. Improved prevention in older people with AF should be a major public health priority.

Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation in Taiwan.

BACKGROUND: Economic evaluation of dabigatran, a new anti-antithrombotic agent, is done mostly in Western countries. It remains to be seen whether dabigatran will be cost effective in a practice environment where warfarin is significantly underused and the costs of both warfarin and international normalized ration INR monitoring are cheap. METHODS: We performed a cost-effectiveness analysis with a Markov model to evaluate the value of dabigatran to prevent stroke and systemic embolism in patients with atrial fibrillation (AF) in Taiwan. Dabigatran was given through sequential dosing, where patients<80 years old received 150 mg of dabigatran twice a day and the dosage was reduced to 110 mgs for patients ≥ 80 years old. Dabigatran was compared with warfarin under two scenarios: the "real-world adjusted-dose warfarin" assuming all AF patients eligible for warfarin were given the medication and maintained at the INR observed in routine clinical practice in Taiwan, and the "real-world prescribing behaviour" similar to the treatment with antithrombotics in real-world practice in Taiwan, where eligible patients could receive warfarin, aspirin, or no treatment. RESULTS: The percentage of AF patients who received warfarin, aspirin or no treatment in Taiwan was 16%, 62% and 22%, respectively. The event rates of ischemic stroke per 100 patient-years were 4.5, 8.0, and 6.0 for sequential dabigatran, real-world prescribing behaviour and real-world warfarin use, respectively. The incremental cost-effectiveness ratio was $280 US per quality-adjusted-year (QALY) in the real-world prescribing scenario and $10,551 US/QALY in real-word warfarin use. CONCLUSIONS: Dabigatran was highly cost-effective in a clinical practice setting where warfarin has been significantly underused.

Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: A NICE single technology appraisal.

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dabigatran etexilate (Boehringer Ingelheim Ltd, UK) to submit evidence for the clinical and cost-effectiveness of this drug for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) as part of the NICE single technology appraisal process. The Centre for Reviews and Dissemination and the Centre for Health Economics at the University of York were commissioned to act as the evidence review group (ERG). This article presents a summary of the manufacturer's submission, the ERG report and the subsequent development of NICE guidance for the use of dabigatran within the UK National Health Service. Dabigatran was granted marketing authorisation by the European Medicines Agency for a sequential dosing regimen (DBG sequential), in which patients under 80 years are treated with dabigatran 150 mg twice daily (DBG150) and patients 80 years and over are given dabigatran 110 mg twice daily (DBG110). NICE decisions are bound by the marketing authorisation; therefore, the decision problem faced by the committee was whether the DBG sequential regimen was effective and cost-effective compared with warfarin or aspirin for patients with non-valvular AF and one or more risk factors. The RE-LY trial, a large multi-centre non-inferiority randomised clinical trial, was the primary source of clinical evidence. DBG150 was shown to be non-inferior, and subsequently superior to warfarin, for the primary outcome of all stroke/systemic embolism. DBG110 was found to be non-inferior to warfarin. Results were presented for a post hoc subgroup analysis for patients under and over 80 years of age, where DBG110 showed a statistically significant reduction of haemorrhagic stroke and intracranial haemorrhage in comparison to warfarin in patients over 80 years of age. This post hoc subgroup analysis by age was the basis for the licensed DBG sequential regimen. The economic evaluation compared the costs and outcomes of DBG110, DBG150 and DBG sequential against warfarin, aspirin, and aspirin plus clopidogrel. Across the three dosing regimens, dabigatran was associated with greater costs and better health outcomes than warfarin; however, DBG150 offered the most benefits and dominated DBG110 and DBG sequential (i.e. less costly and more effective). The cost-effectiveness of DBG150 was less favourable for patients well controlled on warfarin. In the first appraisal meeting, the committee issued a 'minded no' decision until additional analyses on the licensed DBG sequential regimen were presented by the manufacturer. These additional analyses indicated that the incremental cost-effectiveness ratio (ICER) of the DBG sequential regimen compared with warfarin ranged from £8,388 to £18,987 per quality-adjusted life year (QALY) gained depending on the level of monitoring costs assumed for warfarin. Patients on warfarin would need to be within therapeutic range 83-85 % of the time for the ICER to exceed £30,000 per additional QALY. Following consideration of the additional evidence and the responses from a large number of consultees and commentators, the committee recommended dabigatran as DBG sequential as an option for the prevention of stroke and systemic embolism in people with non-valvular AF with one or more risk factors for ischaemic stroke.

Análisis coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica en fibrilación auricular no valvular en España / Cost-effectiveness of dabigatran for stroke prevention in non-valvular atrial fibrillation in Spain

Introducción y objetivos. Análisis coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica por fibrilación auricular no valvular en España, según la perspectiva del Sistema Nacional de Salud. Métodos. Adaptación de un modelo de Markov secuencial que simula la historia natural de la enfermedad para una cohorte de 10.000 pacientes con fibrilación auricular no valvular a lo largo de su vida. Los comparadores son warfarina en un primer escenario y el patrón de prescripción habitual (el 60% con antagonistas de la vitamina K, el 30% con ácido acetilsalicílico y el 10% no tratados) en el segundo. Se realizaron análisis de sensibilidad determinístico y probabilístico. Resultados. En ambos escenarios dabigatrán disminuyó los eventos sufridos y consiguió ganancias en cantidad y calidad de vida. La razón coste-efectividad incremental de dabigatrán comparado con warfarina fue de 17.581 euros/año de vida ajustado por calidad ganado y de 14.118 euros/año de vida ajustado por calidad ganado respecto al patrón de prescripción habitual. Se demostró eficiencia en subgrupos. Incorporando los costes sociales al análisis, dabigatrán es una estrategia dominante (más efectiva y de menor coste). El modelo demostró ser robusto. Conclusiones. Desde la perspectiva del Sistema Nacional de Salud, dabigatrán resulta una estrategia eficiente para la prevención de ictus en pacientes con fibrilación auricular no valvular en comparación con warfarina y con el patrón de prescripción habitual; en ambas comparaciones realizadas, los valores de la razón coste-efectividad incremental estuvieron por debajo del umbral de 30.000 euros/año de vida ajustado por calidad. Desde la perspectiva de la sociedad, dabigatrán sería además una estrategia dominante que aporta más efectividad y menores costes que las dos alternativas (AU)

Introduction and objectives. Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System. Methods. Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10 000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed. Results. Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17581 euros/quality-adjusted life year gained and 14118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust. Conclusions. From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30 000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives (AU)

Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation.

OBJECTIVE: To assess the cost-effectiveness of dabigatran etexilate, a new oral anticoagulant, versus warfarin and other alternatives for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation (AF). METHODS: A Markov model estimated the cost-effectiveness of dabigatran etexilate versus warfarin, aspirin or no therapy. Two patient cohorts with AF (starting age of <80 and ≥80 years) were considered separately, in line with the UK labelled indication. Modelled outcomes over a lifetime horizon included clinical events, quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs). RESULTS: Patients treated with dabigatran etexilate experienced fewer ischaemic strokes (3.74 dabigatran etexilate vs 3.97 warfarin) and fewer combined intracranial haemorrhages and haemorrhagic strokes (0.43 dabigatran etexilate vs 0.99 warfarin) per 100 patient-years. Larger differences were observed comparing dabigatran etexilate with aspirin or no therapy. For patients initiating treatment at ages <80 and ≥80 years, the ICERs for dabigatran etexilate were £4831 and £7090/QALY gained versus warfarin with a probability of cost-effectiveness at £20 000/QALY gained of 98% and 63%, respectively. For the patient cohort starting treatment at ages <80 years, the ICER versus aspirin was £3457/QALY gained and dabigatran etexilate was dominant (ie, was less costly and more effective) compared with no therapy. These results were robust in sensitivity analyses. CONCLUSIONS: This economic evaluation suggests that the use of dabigatran etexilate as a first-line treatment for the prevention of stroke and systemic embolism is likely to be cost-effective in eligible UK patients with AF.

Do the benefits of anti-arrhythmic drugs outweigh the associated risks? A tale of treatment goals in atrial fibrillation.

Atrial fibrillation (AF) is the most common cardiac rhythm disorder and places a substantial burden on the US healthcare system. Unfortunately, there is no consensus as to whether patients should be treated with a primary rate- or rhythm-control strategy. The use of anti-arrhythmic drugs in the treatment of AF is discussed in the broader context of AF disease-management strategies with a focus on rhythm control. Outside of rhythm/ECG, AF treatment targets and cardiovascular outcomes are highlighted.

Clinical and economic outcomes of embolic complications and strategies for distal embolic protection during percutaneous coronary intervention in saphenous vein grafts.

BACKGROUND: Although distal embolic protection (DEP) is increasingly utilized in saphenous vein graft percutaneous coronary intervention (SVG PCI), the clinical and economic outcomes of different DEP strategies are unknown. METHODS: We compared 3 DEP strategies (no DEP, routine DEP, selective DEP in high-risk cases) in 126 consecutive cases of SVG PCI performed without DEP in a single catheterization laboratory over a 4-year period. No SVG PCI was excluded. High risk was defined using 2 multivariate predictors of embolic complication previously validated by NCDR (graft age greater than or equal to 8 years and or friable appearance with thrombus). Costs were determined by a ratio of cost-to-charges methodology and average cost of the two FDA-approved DEP devices ($1,350) with similar efficacy. RESULTS: Without DEP, the incidence of embolic complications was 17% (22/126), resulting in major adverse coronary events (MACE) in 3.2% (4/126) of all cases: 2 deaths, 1 myocardial infarction, and 1 emergency coronary artery bypass. Embolic complications significantly increased both procedure costs by $2,725 (p < .001) and total hospital costs approximately $2,800 (p < 0.05). Risk adjustment for selective DEP use correctly predicted 86% (19/22) of embolic complications, including all MACE, at an incremental cost of $684 per patient for selective DEP versus $1,150 per patient for routine DEP. Selective DEP would cost $43,127 per death prevented versus $72,461 using routine DEP during the index hospitalization. CONCLUSIONS: Embolic complications increase cost in excess of the cost of a DEP device. This risk adjustment model correctly predicted the majority of cases of embolic complication and all MACE, suggesting that selective DEP use may help reduce utilization of DEP by an almost 50% cost reduction compared to routine use.

The John Charnley Award: heritable thrombophilia and development of thromboembolic disease after total hip arthroplasty.

UNLABELLED: We retrospectively assessed whether heritable thrombophilia-hypofibrinolysis was more common in patients developing venous thromboembolism after total hip replacement than among control patients who did not develop venous thromboembolism, as an approach to better identify causes of venous thromboembolism after total hip arthroplasty. Twenty patients with proximal deep venous thrombosis after THA and 23 patients with symptomatic pulmonary embolism were compared with 43 control patients who did not have postoperative venous thromboembolism. Five of 42 patients with venous thromboembolism (12%) and 0 of 43 control patients (0%) had antithrombin III deficiency (< 75%). Nine of 42 patients with venous thromboembolism (21%) and 2 of 43 control patients (4.7%) had protein C deficiency (< 70%). Ten of 43 patients with venous thromboembolism (9 heterozygous, 1 homozygous; 23%) and 1 of 43 control patients (heterozygous; 2%) had the prothrombin gene mutation. Patients who had venous thromboembolism after total hip arthroplasty were more likely than matched control patients to have heritable thrombophilia with antithrombin III or protein C deficiency, or homo-heterozygosity for the prothrombin gene mutation. Screening for these three tests of heritable thrombophilia before total hip arthroplasty should improve the identification of patients with a reduced risk of venous thromboembolism who may need only mild thromboprophylaxis, and of those patients with heritable thrombophilia in whom prophylaxis should be more aggressive. LEVEL OF EVIDENCE: Prognostic study, Level II-1 (lesser-quality RCT). See the Guidelines for Authors for a complete description of levels of evidence.

Cost-effectiveness of distal embolic protection for patients undergoing percutaneous intervention of saphenous vein bypass grafts: results from the SAFER trial.

OBJECTIVES: The goal of this research was to determine the incremental cost and cost-effectiveness of embolic protection in patients undergoing percutaneous revascularization (PCI) of diseased saphenous vein bypass grafts (SVGs). BACKGROUND: Distal protection using the GuardWire balloon occlusion device has been shown to reduce major ischemic complications in patients undergoing SVG PCI, but the cost-effectiveness of this approach is unknown. METHODS: We prospectively measured medical resource utilization and cost for 801 patients undergoing SVG intervention who were randomized to distal protection using the GuardWire (n = 406) or conventional treatment (n = 395) in the Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial. Long-term survival and cost-effectiveness were projected based on observed 30-day outcomes and a validated survival model for postcoronary artery bypass graft patients. RESULTS: Compared with conventional treatment, distal protection increased initial procedural costs by approximately $1,600 ($6,326 vs. $4,779, p < 0.001). However, by reducing ischemic complications, distal protection reduced mean length of stay by 0.4 days and other hospital costs by nearly $1,000 ($6,846 vs. $7,811, p = 0.018). As a result, overall initial hospital costs were only $582 per patient higher with distal protection. Based on the observed 30-day cost and outcome differences in the trial, the incremental cost-effectiveness ratio for distal protection was $3,718 per year of life saved and remained <$40,000 per year of life saved in 97.3% of bootstrap simulations (95% confidence interval, $0 to $43,079). CONCLUSIONS: For patients undergoing PCI of diseased SVGs, distal protection using the GuardWire system is an attractive use of limited health care resources.