Search

Purpose: Platinum based chemotherapy is widely used for bladder cancer but is associated with vascular toxicity, especially thromboembolism. We evaluated the short-term (less than 1 year) and intermediate-term (2 to 5 years) vascular toxicity of platinum agents in older patients with bladder cancer., Materials and Methods: We identified Medicare beneficiaries 66 to 94 years old diagnosed with stage II-III bladder cancer from 1998 to 2007 in the SEER-Medicare database. We measured the association between platinum based chemotherapy and vascular events (thromboembolic and nonthromboembolic) using Cox proportional hazard regression models., Results: The sample included 5,057 patients, of whom 21.3% received platinum based chemotherapy. Patients receiving platinum based chemotherapy were more likely to be younger and male with less comorbidity than those not receiving any chemotherapy. During the first year after diagnosis the patients who received platinum based chemotherapy had a higher risk of a thromboembolic event (19.8% vs 11.6%, AHR 1.43, 95% CI 1.17-1.75) compared to those who did not receive chemotherapy. The likelihood of having a thromboembolic outcome was similar whether platinum chemotherapy was cisplatin based (21.1%, AHR 1.56, 95% CI 1.22-2.00) or carboplatin based (18.9%, AHR 1.35, 95% CI 1.07-1.71). During years 2 to 5 after diagnosis there was no significant association between platinum chemotherapy and the risk of thromboembolic events. The risk of nonthromboembolic vascular events was not increased with platinum chemotherapy in either period., Conclusions: Patients receiving platinum based chemotherapy were at higher risk for thromboembolism but not other vascular events, particularly in the first year after diagnosis. This risk of thromboembolism is similar for cisplatin and carboplatin., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Stroke is a common and important adverse event after acute myocardial infarction (AMI) in the elderly. It is unclear whether the risk of stroke after AMI has changed with improvements in treatments and outcomes for AMI in the last decade., Methods: To assess trends in risk of stroke after AMI, we used a national sample of Medicare data to identify Fee-for-Service patients (n = 2,305,441) aged ≥65 years who were discharged alive after hospitalization for AMI from 1999 to 2010., Results: We identified 57,848 subsequent hospitalizations for ischemic stroke and 4,412 hospitalizations for hemorrhagic stroke within 1 year after AMI. The 1-year rate of ischemic stroke decreased from 3.4% (95% CI 3.3%-3.4%) to 2.6% (2.5%-2.7%; P < .001). The risk-adjusted annual decline was 3% (hazard ratio, 0.97; [0.97-0.98]) and was similar across all age and sex-race groups. The rate of hemorrhagic stroke remained stable at 0.2% and did not differ by subgroups. The 30-day mortality for patients admitted with ischemic stroke after AMI decreased from 19.9% (18.8%-20.9%) to 18.3% (17.1%-19.6%) and from 48.3% (43.0%-53.6%) to 45.7% (40.3%-51.2%) for those admitted with hemorrhagic stroke. We observed a decrease in 1-year mortality from 37.8% (36.5%-39.1%) to 35.3% (33.8%-36.8%) for ischemic stroke and from 66.6% (61.4%-71.5%) to 60.6% (55.1%-65.9%) for hemorrhagic stroke., Conclusions: From 1999 to 2010, the 1-year risk for ischemic stroke after AMI declined, whereas the risk of hemorrhagic stroke remained unchanged. However, 30-day and 1-year mortality continued to be high., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: CHARISMA was a landmark randomized clinical trial that failed to demonstrate a benefit of dual antiplatelet therapy (DAPT) over aspirin alone for preventing cardiovascular events. However, subgroup analyses of the trial found fewer major adverse cardiovascular events (MACEs) for patients with established cardiovascular disease but more MACEs for patients with multiple risk factors without established cardiovascular disease. Our objective was to examine DAPT use in contemporary clinical practice after publication of CHARISMA results., Study Design: Retrospective analysis of a large clinical registry of outpatient cardiovascular visits to over 1000 physicians that collected data on patient clinical history, symptoms, vital signs, and medications., Methods: Clinical characteristics and prescription rates of aspirin and clopidogrel were compared for patients with established cardiovascular disease and for patients with only multiple cardiovascular risk factors. Prescription of DAPT by calendar quarter was evaluated from 2008 to 2011 using multivariable Poisson regression models., Results: Of 167,839 patients with established cardiovascular disease, 20.5% were prescribed both aspirin and clopidogrel. Of 20,478 patients with multiple risk factors but no known cardiovascular disease, 3.5% were prescribed both aspirin and clopidogrel. Across 14 calendar quarters, prescription rates of DAPT did not change significantly for patients with established CVD but decreased for patients with multiple risk factors with an incidence rate ratio of 0.77., Conclusions: Use of DAPT is modest in patients with established cardiovascular disease, for whom the CHARISMA trial suggested decreased MACEs, and prescription rates have remained stable over time. Use of DAPT in patients with multiple risk factors only, for whom CHARISMA suggested that DAPT may lead to increased MACE, was low and decreased over time.

To evaluate how often trastuzumab therapy is ended early (i.e., early discontinuation) and how cardiovascular events and early discontinuation affect survival among older women with breast cancer. A population-based cohort of female Medicare beneficiaries with stage I-III breast cancer in 2005-2009 who received trastuzumab was assembled and followed through 2011. Completed trastuzumab treatment was defined as ≥11 months of continuous trastuzumab treatments with no delay between trastuzumab treatments >45 days. We identified trastuzumab-associated cardiovascular events as those occurring within 45 days before or after the last trastuzumab treatment. Using Cox proportional hazard models, we examined the association between early discontinuation of trastuzumab and cardiovascular events on all-cause mortality. Our cohort consisted of 585 women (mean age: 71.6 years). Approximately 41 % of women discontinued trastuzumab therapy early. Patients with early discontinuation of trastuzumab were more likely to have heart failure /cardiomyopathy, atrial fibrillation, and other cardiovascular events than women who completed trastuzumab. Cardiovascular events were strongly associated with an increased risk of all-cause mortality [adjusted hazard ratio (AHR) 3.54; 95 % confidence interval (CI) 1.87 to 6.68]. Women with early discontinuation of trastuzumab had a non-significant increase in risk of all-cause mortality (AHR: 1.74; 95 % CI 0.94 to 3.23), compared to women who completed trastuzumab. Early trastuzumab discontinuation was common among older patients, and often associated with adverse cardiovascular events. Development of cardiovascular events was associated with a higher mortality risk than early trastuzumab discontinuation, implying that reducing cardiovascular complications from trastuzumab therapy could likely have a substantive impact on overall survival in this population.

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

The American College of Cardiology Foundation along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical presentations for stable ischemic heart disease (SIHD) to consider use of stress testing and anatomic diagnostic procedures. This document reflects an updating of the prior Appropriate Use Criteria (AUC) published for radionuclide imaging (RNI), stress echocardiography (Echo), calcium scoring, coronary computed tomography angiography (CCTA), stress cardiac magnetic resonance (CMR), and invasive coronary angiography for SIHD. This is in keeping with the commitment to revise and refine the AUC on a frequent basis. A major innovation in this document is the rating of tests side by side for the same indication. The side-by-side rating removes any concerns about differences in indication or interpretation stemming from prior use of separate documents for each test. However, the ratings were explicitly not competitive rankings due to the limited availability of comparative evidence, patient variability, and range of capabilities available in any given local setting. The indications for this review are limited to the detection and risk assessment of SIHD and were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Eighty clinical scenarios were developed by a writing committee and scored by a separate rating panel on a scale of 1-9, to designate Appropriate, May Be Appropriate, or Rarely Appropriate use following a modified Delphi process following the recently updated AUC development methodology. The use of some modalities of testing in the initial evaluation of patients with symptoms representing ischemic equivalents, newly diagnosed heart failure, arrhythmias, and syncope was generally found to be Appropriate or May Be Appropriate, except in cases where low pre-test probability or low risk limited the benefit of most testing except exercise electrocardiogram (ECG). Testing for the evaluation of new or worsening symptoms following a prior test or procedure was found to be Appropriate. In addition, testing was found to be Appropriate or May Be Appropriate for patients within 90 days of an abnormal or uncertain prior result. Pre-operative testing was rated Appropriate or May Be Appropriate only for patients who had poor functional capacity and were undergoing vascular or intermediate risk surgery with 1 or more clinical risk factors or an organ transplant. The exercise ECG was suggested as an Appropriate test for cardiac rehabilitation clearance or for exercise prescription purposes. Testing in asymptomatic patients was generally found to be Rarely Appropriate, except for calcium scoring and exercise testing in intermediate and high-risk individuals and either stress or anatomic imaging in higher-risk individuals, which were all rated as May Be Appropriate. All modalities of follow-up testing after a prior test or percutaneous coronary intervention (PCI) within 2 years and within 5 years after coronary artery bypass graft (CABG) in the absence of new symptoms were rated Rarely Appropriate. Pre-operative testing for patients with good functional capacity, prior normal testing within 1 year, or prior to low-risk surgery also were found to be Rarely Appropriate. Imaging for an exercise prescription or prior to the initiation of cardiac rehabilitation was Rarely Appropriate except for cardiac rehabilitation clearance for heart failure patients.

Objectives: Identifying the distributions and determinants of fluoroscopy time for invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI)., Background: ICA and PCI are significant contributors to radiation exposure from medical imaging in the US. Fluoroscopy time is a potentially modifiable determinant of radiation exposure for these procedures, but has not been well characterized in contemporary practice., Methods: We evaluated the distribution of fluoroscopy time in patients undergoing ICA and/or PCI in the CathPCI Registry(®) , stratifying patients by numerous clinical scenarios. Hierarchical models were used to determine patient, procedure, operator and hospital-level factors associated with fluoroscopy time for these procedures., Results: Our study included a total of 3,295,348 ICA and PCI procedures performed by 9,600 operators from January 2005 through June 2009. There was wide variation in fluoroscopy times for these procedures with median [IQR] fluoroscopy times of 2.6 [1.7-4.5] minutes for ICA, 6.7 [4.2-10.8] minutes for ICA in patients with prior coronary artery bypass grafting (CABG), 10.1 [6.0-17.4] minutes for PCI, 10.7 [7.0-16.9] minutes for PCI with ICA, and 16.0 [10.6-24.0] minutes for PCI and ICA in patients with prior CABG. Prolonged fluoroscopy times (>30 minutes) were rare for ICA, but occurred in 6.7% of PCIs and 14.7% of PCIs in patients with prior CABG. After accounting for patient characteristics and procedure complexity, operator and hospital-level factors explained nearly 20% of the variation in fluoroscopy time., Conclusions: Fluoroscopy times vary widely during ICA and PCI with operator and hospital-level factors contributing substantially to these differences. A better understanding of potentially modifiable sources of this variation will elucidate opportunities for enhancing the radiation safety of these procedures., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: The Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial found a statistically significant reduction in cardiovascular events when clopidogrel was added to aspirin in a prespecified subgroup of patients with established cardiovascular disease. However, the economic implications of such a strategy for the Canadian health care system are unknown., Methods: For each patient in the CHARISMA trial with established cardiovascular disease, costs were estimated by multiplying resource utilization by unit costs derived from populations of Canadian patients in 2008 dollars. Changes in life expectancy due to nonfatal events were estimated with parametric regression models based on the Saskatchewan Health database., Results: For patients with established cardiovascular disease, a strategy of clopidogrel plus aspirin for median duration of 28 months was associated with a 12.5% relative reduction in cardiovascular death, myocardial infarction, or stroke compared with aspirin alone (6.9% vs 7.9%, P =.048). Mean cost per patient was CAD$1,488 higher for clopidogrel plus aspirin, and life expectancy increased by 0.057 years. The resulting incremental cost-effectiveness ratio for adding clopidogrel was CAD$25,969 per life-year gained or CAD$21,549 per quality-adjusted life-year. These results were sensitive to the cost of clopidogrel but relatively insensitive to plausible variations in discount rate, costs other than clopidogrel, and the prognostic impact of nonfatal events., Conclusion: Among the subgroup of patients with established cardiovascular disease in the CHARISMA trial, adding clopidogrel to aspirin increases life expectancy at a cost generally considered acceptable in Canada., (Copyright © 2011. Published by Elsevier Inc.)

Objective: To determine the incremental cost-effectiveness of clopidogrel plus aspirin (C + A) compared with aspirin (A) alone during the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial from a US payer perspective., Background: Although the CHARISMA trial did not find a benefit of adding clopidogrel to aspirin in its overall study cohort, a benefit was suggested in a prespecified subgroup of patients with established cardiovascular (CV) disease. The cost-effectiveness of dual antiplatelet therapy in this population is unknown., Methods: Medical resource utilization was assessed prospectively, and costs for hospitalizations, physician services, outpatient care, and medications were assigned using 2007 US dollars. Life expectancy was estimated contingent on fatal and nonfatal CV events using statistical models of long-term survival from the Saskatchewan Health database., Results: C + A was associated with a 12.5% relative reduction in CV death, myocardial infarction, or stroke compared with A alone (6.9% vs. 7.9%, P = 0.048) over a median 28 months of follow-up. Severe or moderate bleeding events were higher in patients receiving C + A versus A alone (3.6% vs. 2.5%, P < 0.001). Mean cost/patient was $2607 higher for C + A, while projected life expectancy increased by an average of 0.072 years due to fewer in-trial events. The resulting incremental cost-effectiveness ratio (ICER) for C + A was $36,343/year of life gained. Findings were insensitive to discount rate, life expectancy projections, post-event costs, and indirect costs from lost productivity; the ICER was most sensitive to the cost of clopidogrel. Bootstrap analysis demonstrated that the ICER for C + A remained <$50,000/life-year gained in 70.6% of bootstrap replicates and <$100,000/life-year gained in 87.4%., Conclusions: Among patients with established CV disease, adding clopidogrel to aspirin appears to increase life expectancy modestly at a cost generally considered acceptable within the US health-care system.

Background: Patients and purchasers prefer board-certified physicians, but whether these physicians provide better quality of care and outcomes for hospitalized patients is unclear., Objective: We evaluated whether care by board-certified physicians after acute myocardial infarction (AMI) was associated with higher use of clinical guideline recommended therapies and lower 30-day mortality., Subjects and Methods: We examined 101,251 Medicare patients hospitalized for AMI in the United States and compared use of aspirin, beta-blockers, and 30-day mortality according to the attending physicians' board certification in family practice, internal medicine, or cardiology., Results: Board-certified family practitioners had slightly higher use of aspirin (admission: 51.1% vs 46.0%; discharge: 72.2% vs 63.9%) and beta-blockers (admission: 44.1% vs 37.1%; discharge: 46.2% vs 38.7%) than nonboard-certified family practitioners. There was a similar pattern in board-certified Internists for aspirin (admission: 53.7% vs 49.6%; discharge: 78.2% vs 68.8%) and beta-blockers (admission: 48.9% vs 44.1%; discharge: 51.2% vs 47.1). Board-certified cardiologists had higher use of aspirin compared with cardiologists certified in internal medicine only or without any board certification (admission: 61.3% vs 53.1% vs 52.1%; discharge: 82.2% vs 71.8% vs 71.5%) and beta-blockers (admission: 52.9% vs 49.6% vs 41.5%; discharge: 54.7% vs 50.6% vs 42.5%). In multivariate regression analyses, board certification was not associated with differences in 30-day mortality., Conclusions: Treatment by a board-certified physician was associated with modestly higher quality of care for AMI, but not differences in mortality. Regardless of board certification, all physicians had opportunities to improve quality of care for AMI.

Background: The association between low blood pressure and prognosis in the general population has been controversial, with some reports suggesting an increased mortality for patients with the lowest blood pressures. Whereas many standard heart failure therapies decrease blood pressure, the relationship between mortality and blood pressure in patients with heart failure has not been previously evaluated., Methods: We used the Digitalis Investigation Group trial database to evaluate retrospectively the relationship among systolic blood pressure (SBP), diastolic blood pressure (DBP), and survival among 5747 patients with New York Heart Association class II or III heart failure and left ventricular ejection fraction < or = 0.45. Cox proportional hazards models were used to identify covariates predictive of long-term mortality., Results: The adjusted all-cause mortality rate during the entire study period for patients in the lowest SBP group (< 100 mm Hg) was 50% and was significantly higher than that of the reference group of patients with SBP of 130 to 139 mm Hg, which had a mortality rate of 32% (hazard ratio 1.65, 95% CI 1.25-2.17, P < .001). The relationship between SBP and mortality was significant (P < .001) and nonlinear (P = .009). The relationship between DBP and mortality was significant (P < .001), with the highest mortality seen in patients with DBP < 60 mm Hg., Conclusions: In patients with systolic dysfunction (left ventricular ejection fraction < or = 0.45) and New York Heart Association classes II and III symptoms, lower SBPs and DBPs were associated with greater mortality.

Background: Previous studies have reported that myocardial infarction (MI) treatment in New England differs from that of other regions of the United States. We sought to determine whether regional differences in MI treatment were independent of regional differences in patient, hospital, or physician characteristics, and whether the New England region's practice pattern was associated with better outcomes than those of patients in other regions., Methods: We evaluated 167,180 patients aged > or =65 years who were hospitalized with MI between 1994 to 1996 to assess regional variations in quality of care. Patients were evaluated for the use of reperfusion therapy, aspirin, and beta-blockers on admission and 30-day mortality rate. Hierarchical logistic regression models were used to determine whether practice patterns specific to New England were independent of regional variations in patient, physician, hospital, or other geographic characteristics., Results: New England had the highest use of beta-blockers (72% vs 52% other regions, P <.001), and aspirin (80% vs 76% other regions, P <.001), a lower use of reperfusion therapy (61% vs 67% other regions, P <.001), and the lowest risk-standardized 30-day mortality rate (15% vs 19% other regions, P <.001). These differences persisted after adjusting for patient, physician, and hospital characteristics., Conclusions: Patients with MI in New England have higher rates of medical therapy use and lower 30-day mortality rates than patients in other US regions. This pattern is independent of patient or provider characteristics, suggesting other factors likely contribute to better short-term outcomes in New England.