Healthcare costs before and after stroke in patients with non-valvular atrial fibrillation who initiated treatment with rivaroxaban or warfarin.

AIMS: Rivaroxaban reduces stroke compared with warfarin in patients with non-valvular atrial fibrillation (NVAF). This study compared healthcare costs before and after stroke in NVAF patients treated with rivaroxaban or warfarin. MATERIALS AND METHODS: Using de-identified IBM MarketScan Commercial and Medicare databases, this retrospective cohort study (from 2011 to 2019) included patients with NVAF who initiated rivaroxaban or warfarin within 30 days after initial NVAF diagnosis. Patients who developed stroke were identified, and stroke severity was determined by the National Institutes of Health Stroke Scale (NIHSS) score, imputed by a random forest method. Total all-cause per-patient per-year (PPPY) costs of care were determined for patients: (1) who developed stroke during the pre- and post-stroke periods and (2) who remained stroke-free during the follow-up period. Treatment groups were balanced using inverse probability of treatment weighting. RESULTS: A total of 13,599 patients initiated rivaroxaban and 39,861 initiated warfarin, of which 272 (2.0%) and 1,303 (3.3%), respectively, developed stroke during a mean follow-up of 28 months. Among patients who developed stroke, PPPY costs increased from the pre-stroke to post-stroke period, with greater increases in the warfarin cohort relative to the rivaroxaban cohort. Overall, the costs increased by 1.78-fold for rivaroxaban vs 3.07-fold for warfarin; for less severe strokes (NIHSS < 5), costs increased 0.88-fold and 1.05-fold, respectively. Cost increases for more severe strokes (NIHSS ≥ 5) among rivaroxaban patients were half those for warfarin patients (3.19-fold vs 6.37-fold, respectively). Among patients without stroke, costs were similar during the follow-up period between the two treatment groups. CONCLUSIONS: Total all-cause costs of care increased in the post-stroke period, and particularly in the patients treated with warfarin relative to those treated with rivaroxaban. The lower rate of stroke in the rivaroxaban cohort suggests that greater pre- to post-stroke cost increases result from more strokes occurring in the warfarin cohort.

Four-year incidence of major adverse cardiovascular events in patients with atherosclerosis and atrial fibrillation.

BACKGROUND: There is a paucity of contemporary data assessing the implications of atrial fibrillation (AF) on major adverse cardiovascular events (MACE) in patients with or at high-risk for atherosclerotic disease managed in routine practice. HYPOTHESIS: We sought to evaluate the 4-year incidence of MACE in patients with or at risk of atherosclerotic disease in the presence of AF. METHODS: Using US MarketScan data, we identified AF patients ≥45 years old with billing codes indicating established coronary artery disease, cerebrovascular disease, or peripheral artery disease or the presence of ≥3 risk factors for atherosclerotic disease from January 1, 2013 to December 31, 2013 with a minimum of 4-years of available follow-up. We calculated the 4-year incidence of MACE (cardiovascular death or hospitalization with a primary billing code for myocardial infarction or ischemic stroke). Patients were further stratified by CHA2 DS2 -VASc score and oral anticoagulation (OAC) use at baseline. RESULTS: We identified 625,951 patients with 4-years of follow-up, of which 77,752 (12.4%) had comorbid AF. The median (25%, 75% range) CHA2 DS2 -VASc score was 4 (3, 5) and 64% of patients received an OAC at baseline. The incidence of MACE increased as CHA2 DS2 -VASc scores increased (P-interaction<.0001 for all). AF patients receiving an OAC were less likely to experience MACE (8.9% vs 11.6%, P < .0001) including ischemic stroke (5.4% vs 6.7%, P < .0001). CONCLUSION: Comorbid AF carries a substantial risk of MACE in patients with or at risk of atherosclerotic disease. MACE risk increases with higher CHA2 DS2 -VASc scores and is more likely in patients without OAC.

Cost and inpatient burden of peripheral artery disease: Findings from the National Inpatient Sample.

BACKGROUND AND AIMS: We aimed to examine the prevalence, demographics, clinical outcomes and economic burden of hospitalizations for patients with PAD. METHODS: Using the National Inpatient Sample, we retrospectively evaluated patients hospitalized with PAD in 2014. Hospitalizations in patients with PAD were identified by the presence of an International Classification of Diseases-9th Revision (ICD-9) diagnosis code of 440.20-440.24. We calculated hospitalization rates/100,000 patients, the proportion of hospitalizations with a major adverse limb event (MALE), as well as minor amputation, mortality, median (interquartile range) length-of-stay (LOS) and treatment costs (in 2017 US$). A separate analysis of hospitalizations of patients with clinical limb ischemia defined as Fontaine class III or IV PAD (440.22, resting pain; 440.23-440.24, ulcers or gangrene) was also performed. RESULTS: We identified 286,160 hospitalizations for patients with PAD. The rate of hospitalizations for PAD was 89.5/100,000, with 137,050 (or 45%) of these having Fontaine class III-IV disease. The proportion of hospitalizations resulting in MALE, major or minor lower extremity amputation or in-hospital death was 45.8%, 8.9%, 8.2% and 3.1%, respectively. Median hospital LOS was 5 (3, 9) days and costs were $15,755 ($8972, $27,800), resulting in an annual cost burden for hospitalization of patients with PAD of ∼$6.31 billion. In hospitalizations of Fontaine class III-IV PAD, MALE, major and minor amputation and death occurred in 60.9%, 16.8%, 15.8% and 3.3% of cases, respectively. Median LOS and costs were 7 (4, 11) days and $18,984 ($10,913, $31,816). CONCLUSIONS: Hospitalizations of patients with PAD represent a substantial medical and financial burden for patients and the US healthcare system.

Evidence-Based Policy Making: Assessment of the American Heart Association's Strategic Policy Portfolio: A Policy Statement From the American Heart Association.

BACKGROUND: American Heart Association (AHA) public policy advocacy strategies are based on its Strategic Impact Goals. The writing group appraised the evidence behind AHA's policies to determine how well they address the association's 2020 cardiovascular health (CVH) metrics and cardiovascular disease (CVD) management indicators and identified research needed to fill gaps in policy and support further policy development. METHODS AND RESULTS: The AHA policy research department first identified current AHA policies specific to each CVH metric and CVD management indicator and the evidence underlying each policy. Writing group members then reviewed each policy and the related metrics and indicators. The results of each review were summarized, and topic-specific priorities and overarching themes for future policy research were proposed. There was generally close alignment between current AHA policies and the 2020 CVH metrics and CVD management indicators; however, certain specific policies still lack a robust evidence base. For CVH metrics, the distinction between policies for adults (age ≥20 years) and children (<20 years) was often not considered, although policy approaches may differ importantly by age. Inclusion of all those <20 years of age as a single group also ignores important differences in policy needs for infants, children, adolescents, and young adults. For CVD management indicators, specific quantitative targets analogous to criteria for ideal, intermediate, and poor CVH are lacking but needed to assess progress toward the 2020 goal to reduce deaths from CVDs and stroke. New research in support of current policies needs to focus on the evaluation of their translation and implementation through expanded application of implementation science. Focused basic, clinical, and population research is required to expand and strengthen the evidence base for the development of new policies. Evaluation of the impact of targeted improvements in population health through strengthened surveillance of CVD and stroke events, determination of the cost-effectiveness of policy interventions, and measurement of the extent to which vulnerable populations are reached must be assessed for all policies. Additional attention should be paid to the social determinants of health outcomes. CONCLUSIONS: AHA's public policies are generally robust and well aligned with its 2020 CVH metrics and CVD indicators. Areas for further policy development to fill gaps, overarching research strategies, and topic-specific priority areas are proposed.

Formation and function of acute stroke-ready hospitals within a stroke system of care recommendations from the brain attack coalition.

BACKGROUND AND PURPOSE: Many patients with an acute stroke live in areas without ready access to a Primary or Comprehensive Stroke Center. The formation of care facilities that meet the needs of these patients might improve their care and outcomes and guide them and emergency responders to such centers within a stroke system of care. METHODS: The Brain Attack Coalition conducted an electronic search of the English medical literature from January 2000 to December 2012 to identify care elements and processes shown to be beneficial for acute stroke care. We used evidence grading and consensus paradigms to synthesize recommendations for Acute Stroke-Ready Hospitals (ASRHs). RESULTS: Several key elements for an ASRH were identified, including acute stroke teams, written care protocols, involvement of emergency medical services and emergency department, and rapid laboratory and neuroimaging testing. Unique aspects include the use of telemedicine, hospital transfer protocols, and drip and ship therapies. Emergent therapies include the use of intravenous tissue-type plasminogen activator and the reversal of coagulopathies. Although many of the care elements are similar to those of a Primary Stroke Center, compliance rates of ≥67% are suggested in recognition of the staffing, logistical, and financial challenges faced by rural facilities. CONCLUSIONS: ASRHs will form the foundation for acute stroke care in many settings. Recommended elements of an ASRH build on those proven to improve care and outcomes at Primary Stroke Centers. The ASRH will be a key component for patient care within an evolving stroke system of care.

Prehospital triage to primary stroke centers and rate of stroke thrombolysis.

IMPORTANCE: Implementation of prehospital stroke triage is a public policy intervention that can have an immediate impact on acute stroke care in a region. OBJECTIVE To evaluate the impact that a citywide policy recommending prehospital triage of patients with suspected stroke to the nearest primary stroke center had on intravenous tissue plasminogen activator (tPA) use in Chicago, Illinois. DESIGN: Retrospective multicenter cohort study from September 1, 2010, to August 31, 2011 (6 months before and after intervention that began March 1, 2011). SETTING: Ten primary stroke center hospitals in Chicago. PATIENTS: All admitted patients with stroke and transient ischemic attack. INTERVENTION Prehospital triage policy of patients with stroke to primary stroke centers. MAIN OUTCOMES AND MEASURES: Intravenous tPA use (measured as a fraction of patients with ischemic strokes arriving through the emergency department). RESULTS There were 1075 stroke and transient ischemic attack admissions in the pretriage period and 1172 in the posttriage period. Patient demographic characteristics including age, sex, and risk factors were similar between the 2 periods (mean age, 65 years; 53% female). Compared with the pretriage period, use of emergency medical services increased from 30.2% to 38.1% (P < .001) and emergency medical services prenotification increased from 65.5% to 76.5% (P = .001) after implementation. Rates of intravenous tPA use were 3.8% and 10.1% (P < .001) and onset-to-treatment times decreased from 171.7 to 145.7 minutes (P = .03) in the pretriage and posttriage periods, respectively. Stroke unit admission, symptomatic intracranial hemorrhage rates, and in-hospital mortality were not significantly different between periods. Adjusting for mode of arrival, prehospital notification, and onset-to-arrival time, the posttriage period was independently associated with increased tPA use for patients with ischemic stroke presenting through the emergency department (adjusted odds ratio = 2.21; 95% CI, 1.34-3.64). CONCLUSIONS AND RELEVANCE: Implementation of a prehospital stroke triage policy in Chicago resulted in significant improvements in emergency medical services use and prenotification and more than doubled intravenous tPA use at primary stroke centers.

Attained educational level and incident atherothrombotic events in low- and middle-income compared with high-income countries.

BACKGROUND: Studies report a protective effect of higher attained educational level (AEL) on cardiovascular outcomes. However, most of these studies have been conducted in high-income countries (HICs) and lack representation from low- and middle-income countries (LMICs), which bear >80% of the global burden of cardiovascular disease. METHODS AND RESULTS: The Reduction of Atherothrombosis for Continued Health (REACH) Registry is a prospective study of 67 888 subjects with either established atherothrombotic (coronary, cerebrovascular, and/or peripheral arterial) disease or multiple atherothrombotic risk factors enrolled from 5587 physician practices in 44 countries. At baseline, AEL (0 to 8 years, 9 to 12 years, trade or technical school, and university) was self-reported for 61 332 subjects. Outcomes included the baseline prevalence of atherothrombotic risk factors and the rate of incident cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) through 23 months across AEL groups, stratified by sex and world region (LMICs or HICs). Educational attainment was inversely associated with age and diabetes mellitus and directly associated with hypercholesterolemia in all subjects. However, for other risk factors such as obesity, smoking, hypertension, and baseline burden of vascular disease, AEL was protective (inversely associated) in HICs but not protective in LMICs. The protective effect of greater AEL on incident cardiovascular events was strongest in men from HICs (P<0.0001), more modest in women from HICs (P=0.0026) and in men from LMICs (P=0.082), and essentially absent in women from LMICs (P=0.32). CONCLUSION: In contrast to HICs, higher AEL may not be protective against cardiovascular events in LMICs, particularly in women.

Consensus panel recommendation for incorporating lipoprotein-associated phospholipase A2 testing into cardiovascular disease risk assessment guidelines.

A consensus panel was formed to review the rapidly emerging literature on the vascular-specific inflammatory marker lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) and to update recommendations for the appropriate use of this novel biomarker in clinical practice. The recommendations of the panel build on guidelines of the Adult Treatment Panel III (ATP III) and the American Heart Association/Centers for Disease Control (AHA/CDC) for cardiovascular risk assessment. Consistent with the ATP III guideline recommendations for the use of inflammatory markers, Lp-PLA(2) is recommended as an adjunct to traditional risk assessment in patients at moderate and high 10-year risk. A simplified framework for traditional Framingham risk factor assessment is proposed. As a highly specific biomarker for vascular inflammation, elevated Lp-PLA(2) levels should prompt consideration of increasing the cardiovascular risk category from moderate to high or high to very high risk, respectively. Because intensification of lifestyle changes and low-density lipoprotein (LDL) cholesterol lowering is beneficial in high-risk patients, regardless of baseline LDL cholesterol levels, consideration should be given to lowering the LDL cholesterol target by 30 mg/dL (1 mg/dL = 0.02586 mmol/L) in patients with high levels of Lp-PLA(2). Lp-PLA(2) is recommended as a diagnostic test for vascular inflammation to better identify patients at high or very high risk who will benefit from intensification of lipid-modifying therapies. However, at this time Lp-PLA(2) cannot be recommended as a target of therapy.

One-year costs in patients with a history of or at risk for atherothrombosis in the United States.

BACKGROUND: Atherothrombosis is the underlying cause of cardiovascular, cerebrovascular, and peripheral arterial disease and is the leading cause of death in the industrialized world. The objectives of the present study are (1) to examine the annual costs associated with vascular events and interventions that require hospitalization, as well as long-term medication use for the management of associated risk factors, in a US population of outpatients with multiple atherothrombotic risk factors or a history of symptomatic disease and (2) to compare costs across patient subgroups defined according to specific arterial bed(s) affected and the number of affected arterial beds. METHODS AND RESULTS: The international REduction of Atherothrombosis for Continued Health (REACH) Registry enrolled outpatients > or =45 years of age who had established coronary artery, cerebrovascular, or peripheral artery disease or > or =3 atherothrombotic risk factors. Data on risk factors, associated medications, and vascular hospitalizations and interventions were collected. Of the total 68 236-patient REACH cohort, 25 763 were enrolled from US sites. Complete 1-year data were available for 23 974 (93%) of the US patients. Annualized medication costs ranged from $2401 to $3481. Mean annual hospitalization costs per patient were $1344, $2864, $4824, and $8155 for patients with 0 (n=6145), 1 (n=14 353), 2 (n=3106), and 3 (n=370) affected arterial beds at baseline (P<0.0001 for trend). Among patients with 1 affected arterial bed, mean hospitalization costs were $2999, $2010, and $3911 for patients with coronary artery disease (n=11 063), cerebrovascular disease (n=2613), and peripheral arterial disease (n=677), respectively. Annualized medication costs ranged from $2401 to $3481. CONCLUSIONS: These results reveal the high economic burden of atherothrombosis-related clinical events and procedures and the especially high economic burden associated with polyvascular disease.

An assessment of statin safety by neurologists.

The National Lipid Association's (NLA) Statin Safety Task Force charged the Neurology Expert Panel with the task of reviewing the scientific evidence related to adverse effects with statins and providing assessments and advice regarding the safety of statins. The evidence included key adverse reaction statin literature identified via a Medline search by the Task Force and Panel members and the commissioned reviews and research presented in this supplement. Panel members were asked to use this evidence to independently form explicit answers to a series of questions posed by the Task Force. Panelists were asked to grade the type of literature and the confidence they had in it in forming their answers using prescribed scales. Panelists were encouraged to seek the highest level of evidence available to answer their questions and to concentrate on literature involving humans. In addition, the Neurology Expert Panel was asked to propose recommendations to regulatory authorities, health professionals, patients, researchers, and the pharmaceutical industry to address statin safety issues.

Recommendations for improving the quality of care through stroke centers and systems: an examination of stroke center identification options: multidisciplinary consensus recommendations from the Advisory Working Group on Stroke Center Identification Options of the American Stroke Association.

BACKGROUND AND PURPOSE: The American Stroke Association (ASA) assembled a multidisciplinary group of experts to develop recommendations regarding the potential effectiveness of establishing an identification program for stroke centers and systems. "Identification" refers to the full spectrum of models for assessing and recognizing standards of quality care (self-assessment, verification, certification, and accreditation). A primary consideration is whether stroke center identification might improve patient outcomes. METHODS: In February 2001, ASA, with the support of the Stroke Council's Executive Committee, decided to embark on an evaluation of the potential impact of stroke center identification. HealthPolicy R&D was selected to prepare a comprehensive report. The investigators reported on models outside the area of stroke, ongoing initiatives within the stroke community (such as Operation Stroke), and state and federal activities designed to improve care for stroke patients. The investigators also conducted interviews with thought leaders in the stroke community, representing a diverse sampling of specialties and affiliations. In October 2001, the Advisory Working Group on Stroke Center Identification developed its consensus recommendations. This group included recognized experts in neurology, emergency medicine, emergency medical services, neurological surgery, neurointensive care, vascular disease, and stroke program planning. RESULTS: There are a variety of existing identification programs, generally falling within 1 of 4 categories (self-assessment, verification, certification, and accreditation) along a continuum with respect to intensity and scope of review and consumption of resources. Ten programs were evaluated, including Peer Review Organizations, trauma centers, and new efforts by the National Committee on Quality Assurance and the Joint Commission on the Accreditation of Healthcare Organizations to identify providers and disease management programs. The largest body of literature on clinical outcomes associated with identification programs involves trauma centers. Most studies support that trauma centers and systems lead to improved mortality rates and patient outcomes. The Advisory Working Group felt that comparison to the trauma model was most relevant given the need for urgent evaluation and treatment of stroke. The literature in other areas generally supports the positive impact of identification programs, although patient outcomes data have less often been published. In the leadership interviews, participants generally expressed strong support for pursuing some form of voluntary identification program, although concerns were raised that this effort could meet with some resistance. CONCLUSIONS: Identification of stroke centers and stroke systems competencies is in the best interest of stroke patients in the United States, and ASA should support the development and implementation of such processes. The purpose of a stroke center/systems identification program is to increase the capacity for all hospitals to treat stroke patients according to standards of care, recognizing that levels of involvement will vary according to the resources of hospitals and systems.