Effects of statin and antiplatelet therapy noncompliance and intolerance on patient outcomes following vascular surgery.

OBJECTIVE: Prior studies have evaluated the effects of statin and antiplatelet agent (APA) medications on patients with peripheral arterial disease. Although the benefits of statin and APA use are well-described, there is a paucity of research into the specific outcomes of patients who are not compliant or those who are unable to take the medication owing to intolerance. Here we examine the outcomes of patients intolerant to statin and APA and compare them with patients who are compliant or noncompliant with these therapies. METHODS: Patients treated from 2005 to 2018 in the Vascular Quality Initiative registry were included. Patients with missing data or deaths within 30 days of procedure were removed. Patients were considered noncompliant if they were previously prescribed a medication at discharge but were not taking it at 1-year follow-up or if the patient was reported to be noncompliant in the registry. Medication intolerance was defined if listed as "no, for medical reasons," and mortality data were ascertained using the Social Security Death Index, which is regularly cross-referenced to the Vascular Quality Initiative registry. RESULTS: We identified 105,628 patients who met our inclusion criteria. Statin intolerance was noted in 2.3% at discharge and 2.1% at the 1-year follow-up, with 0.7% listed as intolerant at all stages. Factors associated with increased risk of intolerance to statins included female gender (P = .001), discharge APA intolerance (P = .004), insurance status (non-U.S. insurance) (P < .001), discharge APA noncompliance (P = .019), and discharge angiotensin converting enzyme inhibitor noncompliance (P = .005). Patients who were compliant with statins showed a 91% survival at 5 years vs 87% survival in noncompliant patients and 87% in intolerant patients at 5 years (P < .001). Patients with statin intolerance have a similar survival curve as noncompliant patients across all registry cohorts. Noncompliance with statins was correlated with noncompliance with APA medications (R = 0.16, P < .001). Factors associated with increased risk of statin noncompliance included preoperative ambulatory status (requiring assistance) (P = .039), female sex (P < .001), peripheral vascular intervention (P < .001) or infrainguinal open bypass procedure surgery (P = .001), discharge status (to nursing home) (P = .006) and insurance (self-pay) (P < .001). CONCLUSIONS: Patients not taking statin and APA medications have a substantially decreased 5-year survival irrespective of the reason for not taking. Importantly, patients noted to be intolerant have a similar survival curve as noncompliant patients across all registry cohorts. Intolerant patients may benefit from attempts to alter statin dose, type (hydrophilic vs lipophilic), or from newer agents such as PCSK9 inhibitors.

Statin use improves limb salvage after intervention for peripheral arterial disease.

BACKGROUND: Statin use is recommended in all patients with peripheral arterial disease (PAD) owing to its morbidity and mortality benefits. However, the effect of statin use on limb salvage in patients with PAD after intervention is unclear. We examined the effect of statin use on limb salvage and survival among patients with PAD undergoing surgical or endovascular intervention. METHODS: A total of 488 patients with PAD were identified who underwent surgical (n = 297) or endovascular (n = 191) intervention between 2009 and 2010. Information was collected from electronic medical records and the Social Security Death Index. Predictors of ongoing statin use were identified first by univariate analysis and then via multivariable logistic regression. Survival and freedom from amputation were identified using Kaplan-Meier plots and adjusted hazard ratios by Cox regression. RESULTS: Of the 488 patients with PAD with intervention, 39% were non-whites, 44% were females, 41% received statins, 56% received antiplatelets, 26% received oral anticoagulants, 9% required a major amputation, and 11% died during follow-up of up to 88 months. Statin users were more often male (P = .03), white (P = .03), smokers (P < .01), and had higher comorbidities such as coronary artery disease (P < .01), hypertension (P < .01), and diabetes (P < .01). Antiplatelet use was not associated with limb salvage (P = .13), but did improve survival (P < .01). Dual antiplatelet therapy did not show any benefit over monotherapy for limb salvage (P = .4) or survival (P = .3). Statin use was associated with improved survival (P = .04), and improved limb salvage (hazard ratio, 0.3; 95% confidence interval, 0.1-0.7) after adjusting for severity of disease, traditional risk factors, and concurrent antiplatelet use. CONCLUSIONS: Statin use in patients with PAD with interventions was associated with improved limb salvage and survival. Despite existing guidelines, statin therapy was low in our PAD population, and efforts are ongoing to increase their use across the health care system.

Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing.

IMPORTANCE: In an effort to regulate physician conflicts of interest, some US academic medical centers (AMCs) enacted policies restricting pharmaceutical representative sales visits to physicians (known as detailing) between 2006 and 2012. Little is known about the effect of these policies on physician prescribing. OBJECTIVE: To analyze the association between detailing policies enacted at AMCs and physician prescribing of actively detailed and not detailed drugs. DESIGN, SETTING, AND PARTICIPANTS: The study used a difference-in-differences multivariable regression analysis to compare changes in prescribing by physicians before and after implementation of detailing policies at AMCs in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) that made up the intervention group with changes in prescribing by a matched control group of similar physicians not subject to a detailing policy. EXPOSURES: Academic medical center implementation of policies regulating pharmaceutical salesperson visits to attending physicians. MAIN OUTCOMES AND MEASURES: The monthly within-drug class market share of prescriptions written by an individual physician for detailed and nondetailed drugs in 8 drug classes (lipid-lowering drugs, gastroesophageal reflux disease drugs, diabetes drugs, antihypertensive drugs, hypnotic drugs approved for the treatment of insomnia [sleep aids], attention-deficit/hyperactivity disorder drugs, antidepressant drugs, and antipsychotic drugs) comparing the 10- to 36-month period before implementation of the detailing policies with the 12- to 36-month period after implementation, depending on data availability. RESULTS: The analysis included 16 121 483 prescriptions written between January 2006 and June 2012 by 2126 attending physicians at the 19 intervention group AMCs and by 24 593 matched control group physicians. The sample mean market share at the physician-drug-month level for detailed and nondetailed drugs prior to enactment of policies was 19.3% and 14.2%, respectively. Exposure to an AMC detailing policy was associated with a decrease in the market share of detailed drugs of 1.67 percentage points (95% CI, -2.18 to -1.18 percentage points; P < .001) and an increase in the market share of nondetailed drugs of 0.84 percentage points (95% CI, 0.54 to 1.14 percentage points; P < .001). Associations were statistically significant for 6 of 8 study drug classes for detailed drugs (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressant drugs) and for 9 of the 19 AMCs that implemented policies. Eleven of the 19 AMCs regulated salesperson gifts to physicians, restricted salesperson access to facilities, and incorporated explicit enforcement mechanisms. For 8 of these 11 AMCs, there was a significant change in prescribing. In contrast, there was a significant change at only 1 of 8 AMCs that did not enact policies in all 3 areas. CONCLUSIONS AND RELEVANCE: Implementation of policies at AMCs that restricted pharmaceutical detailing between 2006 and 2012 was associated with modest but significant reductions in prescribing of detailed drugs across 6 of 8 major drug classes; however, changes were not seen in all of the AMCs that enacted policies.

Costs Associated With Access Site and Same-Day Discharge Among Medicare Beneficiaries Undergoing Percutaneous Coronary Intervention: An Evaluation of the Current Percutaneous Coronary Intervention Care Pathways in the United States.

OBJECTIVES: The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs. BACKGROUND: PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown. METHODS: In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed. RESULTS: Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval [CI]: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p < 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually. CONCLUSIONS: Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.

Reforming research assessment.

It is time for the research community to rethink how the outputs of scientific research are evaluated and, as the San Francisco Declaration on Research Assessment makes clear, this should involve replacing the journal impact factor with a broad range of more meaningful approaches.

Risk scoring system to predict 3-year survival in patients treated for asymptomatic carotid stenosis.

OBJECTIVE: To identify risk factors and stratify their effect of compromising 3-year survival in patients treated for asymptomatic carotid disease based upon recently updated guidelines from the Society for Vascular Surgery. METHODS: Outcomes of 506 patients who underwent carotid intervention for asymptomatic carotid disease (1999-2008) were analyzed. Hospital computerized medical records were reviewed. When local records were sparse, Social Security Death Index was queried to confirm mortality. Following multivariable Cox regression analysis, a score was assigned based on the calculated hazard ratio (HR) in the following fashion: HR 1.5-1.9 = 1 point; HR 2.0-3.0 = 2 points; and HR >3 = 3 points. The sum of those points comprised the final score for each patient. Kaplan-Meier analyses were then performed to delineate survival differences. RESULTS: Seventy patients (13.83%) did not survive beyond 3 years after the procedure. Age >80 years (HR, 1.79; P = .05; score 1), diabetes mellitus (HR, 1.99; P < .05; score 1), coronary artery intervention (HR, 2.03; P < .01; score 2), severe chronic kidney disease defined as glomerular filtration rate <30 and not on dialysis (HR, 2.46; P = .03; score 2), dialysis patients (HR, 5.67; P = .001; score 3), and chronic obstructive pulmonary disease (HR, 3.53; P < .001; score 3) negatively influenced 3-year survival. Patients with score ≤2 experienced 3-year mortality of 6.0%, whereas score >2 was associated with 31.6% 3-year mortality (HR, 6.10; P < .001). The score value was not associated with the stroke rate at any time point. The resultant score was validated in a separate population of patients with symptomatic carotid disease. CONCLUSIONS: This easy predictive score underscores the association of medical risk factors with decreased 3-year survival. This finding may impact future clinical decisions for management of asymptomatic carotid disease.

Associations between prescription copayment levels and ß-blocker medication adherence in commercially insured heart failure patients 50 years and older.

BACKGROUND: High prescription copayments may create barriers to care, resulting in medication nonadherence. Although many studies have examined these associations in commercially insured patients with chronic disease, few have examined ß-blocker effects in heart failure patients. OBJECTIVE: Associations between ß-blocker prescription copayment levels and medication nonadherence were examined within commercially insured beneficiaries with a diagnosis of heart failure. METHODS: Heart failure patients were identified as those with at least 1 inpatient claim or 2 outpatient claims with an associated International Classification of Diagnosis, 9th Edition (ICD-9) code of 428.x, in addition to those with at least 2 ß-blocker claims. Copayment levels were defined in using $5.00 (USD) interval categories, and adherence was defined using the medication possession ratio (MPR). Ordinary least squares (OLS), fixed effects (FE), and random effect (RE) models were used to estimate associations between copayment level and MPR. Logistic regression was used to estimate the probability of nonadherence (MPR < 0.80) conditional upon copayment level. Regressions controlled for patient demographics, health status, prior hospitalizations, and concomitant medication use. RESULTS: The highest ß-blocker copayment level ($26+) had an average MPR that was 0.07 (95% CI, -0.11 to -0.03), 0.08 (95% CI, -0.12 to -0.04), and 0.09 (95% CI, -0.17 to -0.02) units lower than ß-blocker copayment level ($0 to $1) in the OLS, RE, and FE models, respectively. Copayment levels $21-$25 and $26+ were significantly associated with an increased risk of medication nonadherence (OR = 1.64; 95% CI, 1.1-2.4; and OR = 2.5; 95%, CI 1.6-4, respectively). CONCLUSIONS: Commercially insured heart failure patients aged ≥50 years who are prescribed higher costing ß-blockers may have up to an average 9% decrease in annual ß-blocker medication supply as well as an increased risk of nonadherence (MPR <0.80). Results need to be interpreted with caution given the potential of selection bias due to selective prescribing. Associations between copayment levels and nonadherence need to be further explored given the adverse health consequences of nonadherence to ß-blockers.

Process of care performance measures and long-term outcomes in patients hospitalized with heart failure.

BACKGROUND: Recent efforts to improve care for patients hospitalized with heart failure have focused on process-based performance measures. Data supporting the link between current process measures and patient outcomes are sparse. OBJECTIVE: To examine the relationship between adherence to hospital-level process measures and long-term patient-level mortality and readmission. RESEARCH DESIGN: Analysis of data from a national clinical registry linked to outcome data from the Centers for Medicare and Medicaid Services (CMS). SUBJECTS: A total of 22,750 Medicare fee-for-service beneficiaries enrolled in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure between March 2003 and December 2004. MEASURES: Mortality at 1 year; cardiovascular readmission at 1 year; and adherence to hospital-level process measures, including discharge instructions, assessment of left ventricular function, prescription of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker at discharge, prescription of beta-blockers at discharge, and smoking cessation counseling for eligible patients. RESULTS: Hospital conformity rates ranged from 52% to 86% across the 5 process measures. Unadjusted overall 1-year mortality and cardiovascular readmission rates were 33% and 40%, respectively. In covariate-adjusted analyses, the CMS composite score was not associated with 1-year mortality (hazard ratio, 1.00; 95% confidence interval, 0.98-1.03; P = 0.91) or readmission (hazard ratio, 1.01; 95% confidence interval, 0.99-1.04; P = 0.37). Current CMS process measures were not independently associated with mortality, though prescription of beta-blockers at discharge was independently associated with lower mortality (hazard ratio, 0.94; 95% confidence interval, 0.90-098; P = 0.004). CONCLUSION: Hospital process performance for heart failure as judged by current CMS measures is not associated with patient outcomes within 1 year of discharge, calling into question whether existing CMS metrics can accurately discriminate hospital quality of care for heart failure.

Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation.

BACKGROUND: The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial revealed no significant differences among 1587 symptomatic heart failure patients randomized to warfarin, clopidogrel, or aspirin in time to all-cause death, nonfatal myocardial infarction, or nonfatal stroke. We compared within-trial medical resource use and costs between treatments. METHODS AND RESULTS: We assigned country-specific costs to medical resources incurred during follow-up. Annualized rates of hospitalizations, inpatient and outpatient procedures, and emergency department visits did not differ significantly between groups. Annualized total costs averaged $5901 (95% confidence interval [CI], $4776-$7520) for the aspirin group, $5646 (95% CI, $4903-$6584) for the clopidogrel group, and $5830 (95% CI, $4838-$7400) for the warfarin group. CONCLUSIONS: Consistent with clinical findings, our analyses did not identify significant cost differences between treatments.

Comparison of magnetically navigated and conventional wire percutaneous coronary intervention of a single discrete stenosis.

OBJECTIVE: The objective of this study is to compare magnetic guidewire navigation in percutaneous coronary intervention (MPCI) to conventional percutaneous coronary intervention (CPCI) for the elective treatment of a single discrete stenosis. BACKGROUND: Magnetic navigation actively steers an angioplasty wire-tip and may improve PCI procedures, but it is not known whether the intricacy and increased preparation necessary for using the system negatively influences the performance of simple procedures in terms of time and contrast use. METHODS: The procedures of 44 patients (mean age 65 +/- 10 year) undergoing elective single vessel MPCI of a single discrete stenosis were matched for age, gender, and lesion location with 44 concurrent patients (mean age 65 +/- 10 year) undergoing CPCI. The major endpoint was procedural time. RESULTS: Technical success was defined as an intraluminal wire position distal to the stenosis. Procedural outcome, contrast use, and costs were evaluated. Clinical demographics and angiographic characteristics of the two groups were similar, except for a higher incidence of previous MI and class III angina pectoris in the conventional group. The technical success rate was high and identical in both groups (97.7%). Procedural and fluoroscopy times were not significantly different for MPCI compared to CPCI (21.0 +/- 14.5 min vs. 24.7 +/- 14.0 min; 4.9 +/- 4.8 min vs. 7.3 +/- 10.3 min, P = NS). There was a significant reduction in median contrast use [60 ml/patient (41-100) vs. 100 ml/patient (64-130); P = 0.006]. CONCLUSION: Magnetic navigation does not increase procedural time, irradiation, equipment use, or cost compared to conventional PCI of a single discrete stenosis. It proved feasible, yielding high rates of procedural success with less contrast use.

Magnetically navigated percutaneous coronary intervention in distal and/or complex lesions may improve procedural outcome and material consumption.

AIMS: Comparison of magnetic guidewire navigation in percutaneous coronary intervention (magnetic PCI) across distal and/or complex lesions versus conventional navigation (conventional PCI). METHODS AND RESULTS: Forty-seven consecutive patients (age 61 +/- 10 yr) undergoing elective single vessel magnetic PCI for distal and/or complex lesions were matched by age and lesion location with 45 patients undergoing conventional PCI (age 63 +/- 10 yr). Technical success rate was defined as an intraluminal wire position distal to the stenosis. Procedural outcome and costs were evaluated. Baseline demographics and angiographic characteristics of the two groups were similar. The technical success rate did not differ between magnetic and conventional PCI (95.7 vs 97.8%; p = 1.00). Significantly shorter procedural and fluoroscopy time were observed for magnetic compared to conventional PCI (29.9 +/- 17.6 vs 41.1 +/- 21 min, p = 0.007; 7.5 +/- 7.3 vs 16.1 +/- 22.4 min, p = 0.02 respectively). Less contrast was used in the magnetic PCI group (58 ml/patient; P = 0.02). These advantages resulted in a mean estimated saving of 1400 euro per patient (P < 0.001). Advantages of procedural outcome were even more pronounced in the ACC/AHA lesion class C subgroup. CONCLUSIONS: Magnetic compared to conventional PCI is an attractive novel technique that proved to be feasible and safe and might be faster in distal and especially complex lesions.

Psychological distress as a barrier to preventive care in community-dwelling elderly in the United States.

OBJECTIVE: The presence of psychologic distress in older adults may be associated with decreased adherence to recommended preventive-care services. This analysis aimed to measure the association between psychologic distress and adherence to United States Preventive Services Task Force (USPSTF)-recommended preventive-care services among older adults in the United States. DESIGN: We undertook a cross-sectional analysis of 3655 U.S. community-dwelling elderly from the 2001 Medical Expenditure Panel (MEPS) survey. MEASUREMENTS: The presence of psychologic distress was captured by the Mental Component Survey (MCS) of the SF-12. The receipt of 9 preventive care services were captured using MEPS: hypertension screening, influenza vaccination, fecal occult blood testing or sigmoidoscopy, mammography, clinical breast examination, cholesterol screening, prostate-specific antigen test, routine check-up, and dental checkup. RESULTS: Elderly reporting psychologic distress were 30% less likely than nondistressed elderly to receive influenza vaccination (OR = 0.70, 95% CI = 0.55-0.88) and 23% less likely to receive annual dental check-ups (OR= 0.77, 95% CI = 0.61-0.97). Women with psychologic distress were 27% less likely to receive a clinical breast examination (OR = 0.73, 95% CI = 0.57-0.94). Psychologic distress was not significantly associated with screening for hypertension, colon cancer, high cholesterol, or prostrate cancer, mammography, or routine check-ups. CONCLUSIONS: Elderly reporting psychologic distress were less likely to adhere to some, but not all, recommended preventive care guidelines. These results suggest that adherence to recommended preventive care guidelines may be improved, indirectly, by improving recognition and treatment of emotional health problems in the elderly.

Ruptured abdominal aortic aneurysm: a retrospective assessment of open versus endovascular repair.

Aortic stent graft repair has recently been applied as an alternative therapy for infrarenal ruptured abdominal aortic aneurysms (rAAAs). We retrospectively assessed outcome in a continuous series at a single institution (an academic tertiary referral center) of patients with infrarenal rAAAs treated by either open or endovascular repair. Between October 1999 and July 2004, 24 patients were treated at the University of Alabama Hospital for infrarenal rAAA. They were treated by either open procedure (n = 15) or endovascular stent graft repair (n = 9). Outcome parameters included mortality, morbidity, procedure time, blood loss, and length of stay. Endovascular aneurysm repair (EVAR) was performed whenever the anatomy was deemed suitable and experienced personnel were available. Age (mean 70.8 years for EVAR vs. 72.2 years for open), gender (men 71% vs. women 75%), AAA size (mean 6.7 vs. 6.4 cm), early mortality (22% vs. 26%), and major morbidity (56% vs. 53%) were similar in both groups. Blood loss difference between the two groups was statistically significant (p = 0.0001). Our series supports the feasibility and short-term viability of EVAR for infrarenal rAAA when anatomy is suitable and patient and facility conditions are favorable.