Publications by authors named "Timothy P Murphy"

105 Publications

Should Annular Closure Devices Be Utilized to Reduce the Risk of Recurrent Lumbar Disk Herniation?

Clin Spine Surg 2020 Oct 23. Epub 2020 Oct 23.

Department of Orthopaedic Surgery, Walter Reed National Military Medical Center, Bethesda, MD.

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http://dx.doi.org/10.1097/BSD.0000000000001104DOI Listing
October 2020

Content versus Label Claims in Cannabidiol (CBD)-Containing Products Obtained from Commercial Outlets in the State of Mississippi.

J Diet Suppl 2020 20;17(5):599-607. Epub 2020 May 20.

School of Pharmacy, National Center for Natural Products Research University of Mississippi, University, MS, USA.

Products containing cannabidiol (CBD) are now available throughout the United States, but their quality is oftentimes questionable. The CBD and Δ-tetrahydrocannabinol (THC) content of 25 commercially available hemp oil products, obtained throughout the state of Mississippi, was determined gas chromatography/flame ionization detection (GC/FID). These products were also analyzed for the presence of synthetic cannabinoids using full scan gas chromatography/mass spectrometry (GC/MS). Analytical findings were compared to label claims for CBD content. Product label claims for CBD ranged from no claim to 500mg per serving; however, marked variability was observed between actual CBD content and claimed quantities. Of the 25 products, only three were within ±20% of label claim. Fifteen were well below the stated claim for CBD; two exceed claims in excess of 50%; and 5 made no claims. In addition, THC content for three products exceeded the 0.3% legal limit. Furthermore, four products-primarily marketed for vaping-were adulterated with synthetic cannabinoids. From this small, but diverse, sampling of hemp-derived merchandise, it appears that most product label claims do not accurately reflect actual CBD content and are fraudulent in that regard. Moreover, products that exceed legal THC levels may jeopardize a consumer's employment status (i.e. failed "drug test"), while those adulterated with synthetic cannabinoids may subject them to serious adverse health effects. These findings argue strongly for further development of current good manufacturing practices for CBD-containing products and their stringent enforcement.
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http://dx.doi.org/10.1080/19390211.2020.1766634DOI Listing
May 2020

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.

J Vasc Interv Radiol 2020 Feb 8;31(2):221-230.e3. Epub 2019 Nov 8.

Department of Vascular Surgery, UNC Rex Hospital, NC Heart and Vascular Research, Raleigh, North Carolina.

Purpose: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE).

Materials And Methods: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years.

Results: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms.

Conclusions: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.
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http://dx.doi.org/10.1016/j.jvir.2019.08.036DOI Listing
February 2020

Early Rapid Decline in Kidney Function in Medically Managed Patients With Atherosclerotic Renal Artery Stenosis.

J Am Heart Assoc 2019 06 1;8(11):e012366. Epub 2019 Jun 1.

Joan C. Edwards School of Medicine Marshall University Huntington WV.

Background Early rapid declines of kidney function may occur in patients with atherosclerotic renal artery stenosis with institution of medical therapy. The causes and consequences are not well understood. Methods and Results Patients enrolled in the medical therapy-only arm of the CORAL (Cardiovascular Outcomes With Renal Artery Lesions) study were assessed for a rapid decline (RD) in estimated glomerular filtration rate (eGFR), defined as a ≥30% decrease from baseline to either 3 months, 6 months, or both. In the medical therapy-only cohort, eGFR was available in 359 subjects at all time points, the subjects were followed for a median of 4.72 years, and 66 of 359 (18%) subjects experienced an early RD. Baseline log cystatin C (odds ratio, 1.78 [1.11-2.85]; P=0.02), age (odds ratio, 1.04 [1.00-1.07]; P<0.05), and Chronic Kidney Disease Epidemiology Collaboration creatinine eGFR (odds ratio, 1.86 [1.15-3.0]; P=0.01) were associated with an early RD. Despite continued medical therapy only, the RD group had an improvement in eGFR at 1 year (6.9%; P=0.04). The RD and nondecline groups were not significantly different for clinical events and all-cause mortality (P=0.78 and P=0.76, respectively). Similarly, renal replacement therapy occurred in 1 of 66 (1.5%) of the RD patients and in 6 of 294 (2%) of the nondecline patients. The regression to the mean of improvement in eGFR at 1 year in the RD group was estimated at 5.8±7.1%. Conclusions Early rapid declines in kidney function may occur in patients with renal artery stenosis when medical therapy is initiated, and their clinical outcomes are comparable to those without such a decline, when medical therapy only is continued.
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http://dx.doi.org/10.1161/JAHA.119.012366DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585374PMC
June 2019

Prediction of cardiovascular outcomes with machine learning techniques: application to the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study.

Int J Nephrol Renovasc Dis 2019 21;12:49-58. Epub 2019 Mar 21.

Marshall University, Huntington, WV, USA,

Background: Data derived from the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study were analyzed in an effort to employ machine learning methods to predict the composite endpoint described in the original study.

Methods: We identified 573 CORAL subjects with complete baseline data and the presence or absence of a composite endpoint for the study. These data were subjected to several models including a generalized linear (logistic-linear) model, support vector machine, decision tree, feed-forward neural network, and random forest, in an effort to attempt to predict the composite endpoint. The subjects were arbitrarily divided into training and testing subsets according to an 80%:20% distribution with various seeds. Prediction models were optimized within the CARET package of R.

Results: The best performance of the different machine learning techniques was that of the random forest method which yielded a receiver operator curve (ROC) area of 68.1%±4.2% (mean ± SD) on the testing subset with ten different seed values used to separate training and testing subsets. The four most important variables in the random forest method were SBP, serum creatinine, glycosylated hemoglobin, and DBP. Each of these variables was also important in at least some of the other methods. The treatment assignment group was not consistently an important determinant in any of the models.

Conclusion: Prediction of a composite cardiovascular outcome was difficult in the CORAL population, even when employing machine learning methods. Assignment to either the stenting or best medical therapy group did not serve as an important predictor of composite outcome.

Clinical Trial Registration: ClinicalTrials.gov, NCT00081731.
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http://dx.doi.org/10.2147/IJNRD.S194727DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6433104PMC
March 2019

Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial.

Thromb Haemost 2019 Apr 30;119(4):633-644. Epub 2019 Jan 30.

Department of Radiology, Washington University in St. Louis, St. Louis, Missouri, United States.

Background And Objectives:  The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins).

Patients And Methods:  Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months.

Results:  From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale ≥ 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale ≥ 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life ( > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none ( = 0.06) and any bleeding occurred in eight versus two ( = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients ( = 0.24).

Conclusion:  In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335).
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http://dx.doi.org/10.1055/s-0039-1677795DOI Listing
April 2019

Relationship of mildly increased albuminuria and coronary artery revascularization outcomes in patients with diabetes.

Catheter Cardiovasc Interv 2019 03 23;93(4):E217-E224. Epub 2018 Nov 23.

Department of Medicine, University of Toledo, Toledo, Ohio, United States.

Background: The aim of this study was to examine the relationship of albuminuria to cardiovascular disease outcomes in diabetic patients undergoing treatment for stable coronary artery disease.

Methods And Results: We analyzed data from 2176 participants of the Bypass Angioplasty Revascularization Investigation in type-2 diabetes (BARI-2D) trial, a randomized clinical trial comparing Percutaneous coronary intervention/Coronary artery bypass grafting (PCI/CABG) to medical therapy for people with diabetes. The population was stratified by baseline spot urine albumin-creatinine ratio (uACR) into normal (uACR <10 mg/g), mildly (uACR ≥10 mg/g < 30 mg/g), moderately (uACR ≥30 mg/g < 300 mg/g) and severely increased (uACR ≥300 mg/g) groups, and outcomes compared between groups. Death, myocardial infarction (MI) and/or stroke were experienced by 489 patients at a mean follow-up of 4.3 ± 1.5 years. Compared with normal uACR, mildly increased uACR was associated with a 1.4 times (P = 0.042) increase in all-cause mortality. Additionally, nonwhites with type-II diabetes and stable coronary artery disease who had mildly increased albuminuria had a Hazard ratio (HR) of 3.3 times (P = 0.028) for cardiovascular death, 3.1 times for (P = 0.002) all-cause mortality, and two times for (P = 0.015) MI during follow-up.

Conclusions: Mildly increased albuminuria is a significant predictor of all-cause mortality in those with type-II diabetes mellitus and stable coronary artery disease, as well as for cardiovascular events those who are nonwhites.
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http://dx.doi.org/10.1002/ccd.27890DOI Listing
March 2019

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter.

J Vasc Interv Radiol 2018 10 1;29(10):1350-1361.e4. Epub 2018 Sep 1.

Department of Vascular Surgery, UNC Rex Hospital, NC Heart and Vascular Research, Raleigh, North Carolina.

Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE).

Materials And Methods: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months.

Results: Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%-99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%-100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months.

Conclusions: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 12 months of imaging-intense follow-up.
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http://dx.doi.org/10.1016/j.jvir.2018.05.009DOI Listing
October 2018

Interaction between Albuminuria and Treatment Group Outcomes for Patients with Renal Artery Stenosis: The NITER Study.

J Vasc Interv Radiol 2018 07 26;29(7):966-970. Epub 2018 May 26.

Unit of Nephrology and Dialysis, "Guglielmo da Saliceto" AUSL Piacenza Hospital, Piacenza, Italy.

Purpose: To perform a post-hoc analysis of the Nephropathy Ischemic Therapy (NITER) trial, which enrolled patients with atherosclerotic renal artery stenosis, to evaluate whether medical therapy plus stent placement is superior to medical therapy alone in patients without elevated albuminuria.

Materials And Methods: Data from 51 patients were analyzed and stratified into 2 cohorts by median urinary albumin (UAlb) levels: cohort 1 ("low albuminuria," UAlb ≤0.04 g/24h) and cohort 2 ("high albuminuria," UAlb >0.04g/24h). Interaction effect between treatment arms and UAlb cohorts was calculated using Cox regression analysis. Survival analysis was followed by test for effect size, power analysis, and construction of a Kaplan-Meier survival table.

Results: At study completion, 13 patients had an outcome event: 6 (23%) from cohort 1 and 7 (28%) from cohort 2. Patients in cohort 1 had event-free survival of 83% at 3.9 ± 0.3 years from the primary endpoints of all-cause mortality, dialysis, and cardiovascular events when treated with interventional therapy, compared to 45% when treated with medical therapy alone (P = .501), which showed a 62% treatment effect for stent placement. In cohort 2, event-free survival rates were 64% for medical therapy versus 52% for medical plus interventional therapy (P = .64). Using Cox regression analysis, the interaction effect between treatment arms and UAlb cohorts was not significant (P = .32). The power of the study to detect an interaction effect, if one existed, was only 15%.

Conclusions: Inference cannot be drawn for similar populations because of inadequate sample size, but, in this sample, patients treated with stent placement who had low albuminuria had better outcomes than patients treated with medical therapy alone.
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http://dx.doi.org/10.1016/j.jvir.2018.03.003DOI Listing
July 2018

Racial Heterogeneity in Treatment Effects in Peripheral Artery Disease: Insights From the CLEVER Trial (Claudication: Exercise Versus Endoluminal Revascularization).

Circ Cardiovasc Qual Outcomes 2018 04;11(4):e004157

Department of Medicine, University of Missouri-Kansas City (Y.P., G.G., D.C., J.A.S., K.S.). Department of Cardiovascular Research, Saint Luke's Mid America Heart Institute, Kansas City, Missouri (Y.P., P.G.J., G.G., D.C., J.A.S., K.S.). School of Medicine, University of Kansas, Wichita (T.C.). Department of Medicine, Center for Women's Health Research, University of Colorado School of Medicine, Denver (J.G.R.). Alpert Medical School of Brown University, Rhode Island Hospital, Providence (T.P.M.).

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http://dx.doi.org/10.1161/CIRCOUTCOMES.117.004157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5901766PMC
April 2018

Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis.

N Engl J Med 2017 12;377(23):2240-2252

From the Washington University School of Medicine, St. Louis (S.V., L.L., J.R.D., P.N., M.C.D., N.S., M.B.); Brigham and Women's Hospital, Harvard Medical School (S.Z.G.), and Massachusetts General Hospital, Harvard Medical School (M.R.J.) - all in Boston; McMaster University, Hamilton, ON (J.A.J., M.F., C.-S.G., C.K.), and McGill University, Jewish General Hospital, Montreal (S.R.K.) - all in Canada; the University of Missouri, St. Luke's Mid America Heart Institute, Kansas City (D.J.C., E.M.); St. Joseph's Vascular Institute, Orange (M.K.R.), and University of California, Los Angeles, Los Angeles (S.K.) - both in California; University of Michigan, Ann Arbor (A.J.C.); Cleveland Clinic Heart and Vascular Institute, Cleveland (H.L.G.); Rhode Island Hospital, Brown University, Providence (T.P.M.); Central DuPage Hospital, Winfield, IL (J.S.); University of North Carolina, Chapel Hill (S.M.); Reading Hospital, Reading, PA (D.S.); Henry Ford Hospital, Detroit (J.L.); Holy Name Hospital, Teaneck, NJ (J.R.); Christiana Care Hospital, Newark, DE (M.G.); St. Elizabeth's Regional Medical Center, Lincoln, NE (R.R., E.V.); and Pepin Heart Center, Tampa, FL (V.M.).

Background: The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome.

Methods: We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up.

Results: Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups.

Conclusions: Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).
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http://dx.doi.org/10.1056/NEJMoa1615066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5763501PMC
December 2017

Cigarette smoking and cardio-renal events in patients with atherosclerotic renal artery stenosis.

PLoS One 2017 17;12(3):e0173562. Epub 2017 Mar 17.

Department of Medicine, University of Toledo College of Medicine and Life Sciences, Toledo, OH, United States of America.

Cigarette smoking causes cardiovascular disease and is associated with poor kidney function in individuals with diabetes mellitus and primary kidney diseases. However, the association of smoking on patients with atherosclerotic renal artery stenosis has not been studied. The current study utilized data from the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL, NCT00081731) clinical trial to evaluate the effects of smoking on the risk of cardio-renal events and kidney function in this population. Baseline data showed that smokers (n = 277 out of 931) were significantly younger at enrollment than non-smokers (63.3±9.1 years vs 72.4±7.8 years; p<0.001). In addition, patients who smoke were also more likely to have bilateral renal artery stenoses and peripheral vascular disease (PVD). Longitudinal analysis showed that smokers experienced composite endpoint events (defined as first occurrence of: stroke; cardiovascular or renal death; myocardial infarction; hospitalization for congestive heart failure; permanent renal replacement; and progressive renal insufficiency defined as 30% reduction of GFR from baseline sustained for ≥ 60 days) at a substantially younger age compared to non-smokers (67.1±9.0 versus 76.1±7.9, p<0.001). Using linear regression and generalized linear modeling analysis controlled by age, sex, and ethnicity, smokers had significantly higher cystatin C levels (1.3±0.7 vs 1.2±0.9, p<0.01) whereas creatinine and estimated glomerular filtration rate (eGFR) were not different from non-smokers. From these data we conclude that smoking has a significant association with deleterious cardio-renal outcomes in patients with renovascular hypertension.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0173562PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5357000PMC
September 2017

Stating the Obvious, for What It's Worth.

Authors:
Timothy P Murphy

J Vasc Interv Radiol 2016 11;27(11):1663-1664

Vascular Disease Research Center, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903; Department of Diagnostic Imaging, The Warren Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address:

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http://dx.doi.org/10.1016/j.jvir.2016.06.022DOI Listing
November 2016

Relationship of Albuminuria and Renal Artery Stent Outcomes: Results From the CORAL Randomized Clinical Trial (Cardiovascular Outcomes With Renal Artery Lesions).

Hypertension 2016 11 19;68(5):1145-1152. Epub 2016 Sep 19.

From the Departments of Diagnostic Imaging (T.P.M.) and Medicine (L.D.D.), Rhode Island Hospital, Providence; Alpert Medical School of Brown University, Providence, RI (T.P.M., L.D.D.); Department of Medicine, University of Toledo, OH (C.J.C.); Departments of Statistics (K.M.P., R.B.D, J.M.M.), Medicine (D.E.C.), and Biostatistics (Q.G.), Harvard Clinical Research Institute, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (D.E.C.); Department of Mathematics and Statistics, Boston University, MA (R.B.D.); Department of Medicine, University of Michigan, Ann Arbor (K.J.); Department of Radiology, University of Virginia, Charlottesville (A.H.M.); Department of Medicine, University of Texas Health Science Center, San Antonio (W.H.); Department of Medicine, Marshall University, Huntington, WV (J.I.S.); Department of Medicine, Providence Health Care and University of Washington School of Medicine, Spokane (K.R.T.); Department of Medicine, St. Luke's Hospital, Kansas City, MO (D.J.C.); Departments of Pathology (M.S.) and Medicine (A.H.), The University of Minnesota Medical School, Minneapolis; Department of Medicine, Wellmont-Holston Valley Medical Center, Kingsport, TN (D.C.M.); Department of Medicine, Asheville Cardiology Associates, NC (W.B.A.); Department of Medicine, Mayo Clinic, Rochester, MN (S.C.T.); Department of Radiology, Lancaster General Hospital, PA (J.B.); and Department of Medicine, Sunnybrook Research Institute (S.T.), Toronto, Ontario, Canada.

Randomized clinical trials have not shown an additional clinical benefit of renal artery stent placement over optimal medical therapy alone. However, studies of renal artery stent placement have not examined the relationship of albuminuria and treatment group outcomes. The CORAL study (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) is a prospective clinical trial of 947 participants with atherosclerotic renal artery stenosis randomized to optimal medical therapy with or without renal artery stent which showed no treatment differences (3(5.8% and 35.1% event rate at mean 43-month follow-up). In a post hoc analysis, the study population was stratified by the median baseline urine albumin/creatinine ratio (n=826) and analyzed for the 5-year incidence of the primary end point (myocardial infarction, hospitalization for congestive heart failure, stroke, renal replacement therapy, progressive renal insufficiency, or cardiovascular disease- or kidney disease-related death), for each component of the primary end point, and overall survival. When baseline urine albumin/creatinine ratio was ≤ median (22.5 mg/g, n=413), renal artery stenting was associated with significantly better event-free survival from the primary composite end point (73% versus 59% at 5 years; P=0.02), cardiovascular disease-related death (93% versus 85%; P≤ 0.01), progressive renal insufficiency (91% versus 77%; P=0.03), and overall survival (89% versus 76%; P≤0.01), but not when baseline urine albumin/creatinine ratio was greater than median (n=413). These data suggest that low albuminuria may indicate a potentially large subgroup of those with renal artery stenosis that could experience improved event-free and overall-survival after renal artery stent placement plus optimal medical therapy compared with optimal medical therapy alone. Further research is needed to confirm these preliminary observations.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00081731.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.116.07744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5634521PMC
November 2016

Effects of Stenting for Atherosclerotic Renal Artery Stenosis on eGFR and Predictors of Clinical Events in the CORAL Trial.

Clin J Am Soc Nephrol 2016 07 25;11(7):1180-8. Epub 2016 May 25.

University of Toledo, Toledo, Ohio.

Background And Objectives: Atherosclerotic renal artery stenosis may cause kidney function loss, but effects of stenting on eGFR and clinical events associated with CKD are uncertain. Our study objectives were to determine effects of stenting on eGFR and predictors of clinical events.

Design, Setting, Participants, & Measurements: Participants (n=931) in the Cardiovascular Outcomes in Renal Artery Stenosis Trial (from May of 2005 to September of 2012) had >60% atherosclerotic renal artery stenosis and systolic hypertension on two or more antihypertensive drugs and/or stage ≥3 CKD. The intervention was stenting versus no stenting on a background of risk factor management: renin-angiotensin system inhibition, statin, antiplatelet therapy, and smoking cessation education. The effect of stenting on eGFR by the serum creatinine-cystatin C Chronic Kidney Disease Epidemiology Collaboration equation was the prespecified analysis of kidney function. Predictors of eGFR and CKD outcomes (≥30% eGFR loss, ESRD, and death) and cardiovascular disease outcomes (stroke, myocardial infarction, heart failure, and death) controlling for eGFR and albuminuria were also determined.

Results: eGFR was 59±24 ml/min per 1.73 m(2) (mean±SD) at baseline. Over 3 years, eGFR change, assessed by generalized estimating equations, was -1.5±7.0 ml/min per 1.73 m(2) per year in the stent group versus -2.3±6.3 ml/min per 1.73 m(2) per year in the medical therapy only group (P=0.18). eGFR predictors (multiple variable generalized estimating equations) were age, albuminuria, systolic BP, and diabetes (inverse associations) as well as men, total cholesterol, and HDL cholesterol (positive associations). CKD outcomes events occurred in 19% (175 of 931), and predictors (Cox proportional hazards models) included albuminuria (positive association), systolic BP (positive association), and HDL cholesterol (inverse association). Cardiovascular disease outcomes events occurred in 22% (207 of 931), and predictors included age, albuminuria, total cholesterol, prior cardiovascular disease, and bilateral atherosclerotic renal artery stenosis (positive associations).

Conclusions: Stenting did not influence eGFR in participants with atherosclerotic renal artery stenosis receiving renin-angiotensin system inhibition-based therapy. Predictors of clinical events were traditional risk factors for CKD and cardiovascular disease.
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http://dx.doi.org/10.2215/CJN.10491015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4934844PMC
July 2016

Acute Lower Gastrointestinal Bleeding: Temporal Factors Associated With Positive Findings on Catheter Angiography After (99m)Tc-Labeled RBC Scanning.

AJR Am J Roentgenol 2016 Jul 21;207(1):170-6. Epub 2016 Apr 21.

2 Department of Diagnostic Imaging, Warren Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI.

Objective: The objective of the study was to determine if time to positive (TTP), defined as the time from the start of (99m)Tc-labeled RBC scanning to the appearance of a radionuclide blush (considered to be a positive finding for acute lower gastrointestinal bleeding [LGIB]), and lag time (LT), defined as the time from the appearance of a radionuclide blush to the start of catheter angiography (CA), affected the yield of CA for the detection of acute LGIB.

Materials And Methods: TTP and LT were retrospectively evaluated in 120 patients who had positive findings for acute LGIB on (99m)Tc-labeled RBC scanning and subsequently underwent CA for the diagnosis and localization of gastrointestinal bleeding. Two nuclear medicine fellowship-trained radiologists independently reviewed the (99m)Tc-labeled RBC scans. Two fellowship-trained interventional radiologists independently reviewed the angiograms. All data were analyzed using SAS software.

Results: When a TTP threshold of ≤ 9 minutes was used, the sensitivity, specificity, positive predictive value, and negative predictive value for a positive CA study were 92%, 35%, 27%, and 94%, respectively. In addition, the odds of detecting bleeding on CA increased 6.1-fold with a TTP of ≤ 9 minutes relative to a TTP of > 9 minutes (p = 0.020). A significant inverse relationship was found between LT and a positive CA study (p = 0.041).

Conclusion: TTP and LT impact the rate of positive CA studies. A TTP threshold of ≤ 9 minutes allows the detection of almost all patients who would benefit from CA for treatment and allows a reduction in unnecessary negative CA studies. The likelihood of positive findings on CA decreases with a delay in the performance of CA.
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http://dx.doi.org/10.2214/AJR.15.15380DOI Listing
July 2016

A Behavioral Assay for Mechanosensation of MARCM-based Clones in Drosophila melanogaster.

J Vis Exp 2015 Dec 30(106):e53537. Epub 2015 Dec 30.

Department of Biology, College of the Holy Cross;

Because of the structural and functional homology to the hair cells of the mammalian inner ear, the neurons that innervate the Drosophila external sense organs provide an excellent model system for the study of mechanosensation. This protocol describes a simple touch behavior in fruit flies which can be used to identify mutations that interfere with mechanosensation. The tactile stimulation of a macrochaete bristle on the thorax of flies elicits a grooming reflex from either the first or third leg. Mutations that interfere with mechanotransduction (such as NOMPC), or with other aspects of the reflex arc, can inhibit the grooming response. A traditional screen of adult behaviors would have missed mutants that have essential roles during development. Instead, this protocol combines the touch screen with mosaic analysis with a repressible cell marker (MARCM) to allow for only limited regions of homozygous mutant cells to be generated and marked by the expression of green fluorescent protein (GFP). By testing MARCM clones for abnormal behavioral responses, it is possible to screen a collection of lethal p-element mutations to search for new genes involved in mechanosensation that would have been missed by more traditional methods.
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http://dx.doi.org/10.3791/53537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4780906PMC
December 2015

Renal Artery Stent Outcomes: Effect of Baseline Blood Pressure, Stenosis Severity, and Translesion Pressure Gradient.

J Am Coll Cardiol 2015 Dec;66(22):2487-94

Rhode Island Hospital, Providence, Rhode Island; Alpert Medical School of Brown University, Providence, Rhode Island.

Background: Multiple randomized clinical trials comparing renal artery stent placement plus medical therapy with medical therapy alone have not shown any benefit of stent placement. However, debate continues whether patients with extreme pressure gradients, stenosis severity, or baseline blood pressure benefit from stent revascularization.

Objectives: The study sought to test the hypothesis that pressure gradients, stenosis severity, and/or baseline blood pressure affects outcomes after renal artery stent placement.

Methods: Using data from 947 patients with a history of hypertension or chronic kidney disease from the largest randomized trial of renal artery stent placement, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, we performed exploratory analyses to determine if subsets of patients experienced better outcomes after stent placement than the overall cohort. We examined baseline stenosis severity, systolic blood pressure, and translesion pressure gradient (peak systolic and mean) and performed interaction tests and Cox proportional hazards analyses for the occurrence of the primary endpoint through all follow-up, to examine the effect of these variables on outcomes by treatment group.

Results: There were no statistically significant differences in outcomes based on the examined variables nor were there any consistent nonsignificant trends.

Conclusions: Based on data from the CORAL randomized trial, there is no evidence of a significant treatment effect of the renal artery stent procedure compared with medical therapy alone based on stenosis severity, level of systolic blood pressure elevation, or according to the magnitude of the trans-stenotic pressure gradient. (Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions [CORAL]; NCT00081731).
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http://dx.doi.org/10.1016/j.jacc.2015.09.073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4819253PMC
December 2015

The effect of gender on outcomes of aortoiliac artery interventions for claudication.

Clin Imaging 2016 Jan-Feb;40(1):96-100. Epub 2015 Sep 4.

Clinical Investigations, Harvard Clinical Research Institute, 930 Commonwealth Avenue, Boston, MA, USA. Electronic address:

Objective: To explore the relationship between gender, native artery diameters, and outcomes of stent revascularization (ST) in the "Claudication: Exercise versus Endoluminal Revascularization" trial.

Methods: A comparative analysis was performed of the impact of gender, age, weight, height, body mass index, and body surface area on revascularization outcomes at baseline and 6months in 55 arterial segments of aorta, common iliac artery, and external iliac artery (EIA).

Results: Women demonstrated smaller diameter of the EIA. However, the clinical outcomes of revascularization were not negatively affected by the gender-based differences.

Conclusion: Gender-based differences are unlikely to significantly impact outcome of ST.
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http://dx.doi.org/10.1016/j.clinimag.2015.09.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4688129PMC
August 2016

Regional and physician specialty-associated variations in the medical management of atherosclerotic renal-artery stenosis.

J Am Soc Hypertens 2015 Jun 28;9(6):443-52. Epub 2015 Mar 28.

Department of Medicine, University of Toledo College of Medicine and Life Sciences, Toledo, OH, USA.

For people enrolled in Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL), we sought to examine whether variation exists in the baseline medical therapy of different geographic regions and if any variations in prescribing patterns were associated with physician specialty. Patients were grouped by location within the United States (US) and outside the US (OUS), which includes Canada, South America, Europe, South Africa, New Zealand, and Australia. When comparing US to OUS, participants in the US took fewer anti-hypertensive medications (1.9 ± 1.5 vs. 2.4 ± 1.4; P < .001) and were less likely to be treated with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (46% vs. 62%; P < .001), calcium channel antagonist (37% vs. 58%; P < .001), and statin (64% vs. 75%; P < .05). In CORAL, the identification of variations in baseline medical therapy suggests that substantial opportunities exist to improve the medical management of patients with atherosclerotic renal-artery stenosis.
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http://dx.doi.org/10.1016/j.jash.2015.03.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4460564PMC
June 2015

LC-MS-MS Analysis of N,α-Diethylphenethylamine (N,α-ETH) and Its Positional Isomer N,β-Diethylphenethylamine (N,β-ETH) in Dietary Supplements.

J Anal Toxicol 2015 Jun 19;39(5):387-406. Epub 2015 Mar 19.

ElSohly Laboratories, Inc. (ELI), 5 Industrial Park Drive, Oxford, MS 38655, USA Phytochemical Services, Incorporated (PSI), 5 Industrial Park Drive, Oxford, MS 38655, USA National Center for Natural Products Research, The University of Mississippi, University, MS 38677, USA.

In a previous publication, we reported on the analysis of several dietary supplement/exercise formulas and the quantitation of N,α-diethylphenethylamine (N,α-ETH, 3: ). In this article we report on the reanalysis of these products using LC-MS-MS and GC-MS methods capable of clearly separating the N,α-isomer ( 3: ) from its N,β-isomer (N,β-ETH, 4: ). The reanalysis, by both methods, showed that all samples previously reported as containing N,α-ETH ( 3: ) do contain only that isomer with no detectable concentrations of the N,β-ETH ( 4: ).
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http://dx.doi.org/10.1093/jat/bkv022DOI Listing
June 2015

Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study.

J Am Coll Cardiol 2015 Mar;65(10):999-1009

Lillehei Heart Institute, Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota.

Background: Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known.

Objectives: The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC).

Methods: Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life.

Results: Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC.

Conclusions: Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment.
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http://dx.doi.org/10.1016/j.jacc.2014.12.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278564PMC
March 2015

Fenoldopam for the prevention of contrast-induced nephropathy (CIN)-do we need more trials? A meta-analysis.

Clin Imaging 2015 Sep-Oct;39(5):759-64. Epub 2015 Feb 12.

Vascular Disease Research Center, Division of Vascular and Interventional Radiology, Department of Diagnostic Imaging, Rhode Island Hospital, Warren Alpert Medical School of Brown University, Providence, RI.

We conducted a pooled analysis of clinical trials comparing intravenous Fenoldopam (FP) with Saline/Placebo/N-acetyl cysteine (NAC) for the prevention of contrast-induced nephropathy (CIN). Five studies were eligible. Quantitative analyses were done with Review Manager (RevMan version 5.2.). A total of 85 out of 353 patients in Fenoldopam group while 73 among 366 in the control group were affected due to CIN. The risk ratio for the development of CIN in the Fenoldopam group was 1.19 compared to the control group. This was not statistically significant. Fenoldopam is no better than Placebo/Saline or NAC in preventing CIN, but more studies are required.
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http://dx.doi.org/10.1016/j.clinimag.2015.02.003DOI Listing
April 2016

Outcomes of preimplantation genetic diagnosis in neurofibromatosis type 1.

Fertil Steril 2015 Mar 31;103(3):761-8.e1. Epub 2014 Dec 31.

Department of Neurology and Cancer Center, Massachusetts General Hospital, Boston, Massachusetts. Electronic address:

Objective: To examine the effect of patient and facility level factors on the success of preimplantation genetic diagnosis (PGD) in patients with neurofibromatosis 1 (NF1).

Design: Retrospective review.

Setting: Large PGD reference laboratory.

Patient(s): All patients with NF1 referred from June 2004 to May 2013.

Intervention(s): None.

Main Outcome Measure(s): Embryos' NF1 mutation status and live birth rates.

Result(s): Seventy-seven couples underwent 156 PGD cycles during the study period. The average maternal age at the time of embryo biopsy was 33.2 years. The majority of embryos had a day 3 single blastomere biopsy without aneuploidy screening. A diagnosis was obtained for 80% of biopsied embryos; 20% of biopsies were nondiagnostic due to technical failures. Diagnosis was more often obtained for embryos of parents with familial disease and for embryos biopsied at centers that referred multiple NF1 cases. Among diagnosed embryos, 483/1,060 (46%) were unaffected by the parental NF1 mutation. Twenty-two (14%) of the 156 cycles had a confirmed live birth; if the observed success rate is applied to cycles with unknown outcomes, 33/156 (21%) cycles are expected to have resulted in live birth. In multivariate logistic regression, having a live birth was significantly associated with having more unaffected embryos available for transfer (odds ratio 1.33 per additional embryo, 95% confidence interval 1.02-1.72).

Conclusion(s): Advances in biopsy and diagnostic techniques which increase the number of unaffected embryos identified may improve live birth rates for patients with NF1. Clinicians should counsel patients about their fertility and reproductive options early, with the use of disease-specific data, to set appropriate expectations for the PGD process.
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http://dx.doi.org/10.1016/j.fertnstert.2014.11.021DOI Listing
March 2015

Cost-effectiveness of supervised exercise, stenting, and optimal medical care for claudication: results from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial.

J Am Heart Assoc 2014 Nov 11;3(6):e001233. Epub 2014 Nov 11.

Saint-Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, MO (D.J.C.).

Background: Both supervised exercise (SE) and stenting (ST) improve functional status, symptoms, and quality of life compared with optimal medical care (OMC) in patients with claudication. The relative cost-effectiveness of these strategies is not well defined.

Methods And Results: The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program, to ST, or to OMC. Participants who completed 6-month follow-up (n=98) were included in a health economic analysis through 18 months. Costs were assessed using resource-based methods and hospital billing data. Quality-adjusted life-years were estimated using the EQ-5D. Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life. Through 18 months, mean healthcare costs were $5178, $9804, and $14 590 per patient for OMC, SE, and ST, respectively. Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20. In our base case analysis, which assumed that observed differences in quality of life would dissipate after 5 years, the incremental cost-effectiveness ratios were $24 070 per quality-adjusted life-year gained for SE versus OMC, $41 376 for ST versus OMC, and $122 600 for ST versus SE. If the treatment effect of ST was assumed to be more durable than that of SE, the incremental cost-effectiveness ratio for ST versus SE became more favorable.

Conclusions: Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease. ST is more expensive than SE, with uncertain incremental benefit.

Clinical Trial Registration Url: www.clinicaltrials.gov, Unique identifier: NCT00132743.
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http://dx.doi.org/10.1161/JAHA.114.001233DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338709PMC
November 2014

Methylhexanamine is not detectable in Pelargonium or Geranium species and their essential oils: A multi-centre investigation.

Drug Test Anal 2015 Jul 23;7(7):645-54. Epub 2014 Oct 23.

School of Pharmacy, Second Military Medical University, Shanghai, China.

In an earlier study, we developed two sensitive and reliable procedures for gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis of methylhexaneamine (MHA) in P. graveolens plant materials and volatile oils. None of the analyzed plant materials or oils showed any detectable levels of MHA which was further substantiated by high resolution liquid chromatography-quantum time of flight-mass spectrometry (LC-QTOF-MS) analysis with a limit of detection of 10 ppb. However, other laboratories (two studies) reported the presence of MHA in some samples of P. graveolens and pelargonium oil acquired by the investigators from China. Because of the controversy of whether Pelargonium species or pelargonium oil contains MHA, it was recommended that splits of multiple samples be analyzed by different laboratories. In this investigation, multiple plant materials and oil samples were collected from around the world. These samples were submitted to four different sites for analysis. All sites adopted a similar extraction method. All the analysis sites used LC-MS/MS or LC-QTOF-MS and detection limit was set close to the 10 ng/mL as previously reported. A total of 18 plant samples belonging to 6 different Pelargonium species and 9 oils from different locations around the world were split among 4 different analytical laboratories for analysis (each lab received the same samples). None of the laboratories detected MHA in any of the samples at or around the 10 ppb detection level of the procedure used.
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http://dx.doi.org/10.1002/dta.1726DOI Listing
July 2015

Is fibromuscular dysplasia underdiagnosed? A comparison of the prevalence of FMD seen in CORAL trial participants versus a single institution population of renal donor candidates.

Vasc Med 2014 Oct 31;19(5):363-7. Epub 2014 Jul 31.

Beth Israel Deaconess Medical Center, Boston, MA, USA.

Renal artery fibromuscular dysplasia (FMD) may be underdiagnosed. We evaluated the prevalence of FMD in CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) renal artery stent trial participants, in which FMD was an exclusion criterion for inclusion. We also evaluated the prevalence of FMD in a relatively healthy population of patients undergoing computed tomographic angiographic (CTA) screening for renal donor evaluation. All renal donor CTAs performed at our institution from January 2003 through November 2011 were retrospectively reviewed for the presence of FMD along with patient sex and age. These results were compared to angiographic core lab (ACL) findings for the CORAL trial. The CORAL ACL database contained 997 patients (mean age 69.3 years; 50% female). Fifty-eight (5.8%) CORAL trial patients (mean age 71.8 years; 75.9% female) demonstrated incidental FMD. The renal donor cohort included 220 patients (mean age 40.5 years; 64.5% female). Five (2.3%) demonstrated FMD (mean age 48.6 years; all female). The odds of FMD in the CORAL cohort were 2.65 times that seen in the renal donor cohort (95% CI: 1.12, 7.57). In C: onclusion, the 5.8% prevalence of renal artery FMD in the CORAL trial population, the presence of which was biased against, suggests underdiagnosis.
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http://dx.doi.org/10.1177/1358863X14544715DOI Listing
October 2014

Use of renin-angiotensin inhibitors in people with renal artery stenosis.

Clin J Am Soc Nephrol 2014 Jul 5;9(7):1199-206. Epub 2014 Jun 5.

Department of Medicine, University of Toledo College of Medicine, Toledo, Ohio;

Background And Objectives: People with atherosclerotic renal artery stenosis may benefit from renin-angiotensin inhibitors, angiotensin-converting enzyme inhibitors, and angiotensin-receptor blockers, but little is known about the factors associated with their use.

Design, Setting, Participants, & Measurements: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions study (ClinicalTrials.gov identified: NCT00081731) is a prospective, international, multicenter clinical trial that randomly assigned participants with atherosclerotic renal artery stenosis who received optimal medical therapy to stenting versus no stenting from May 2005 through January 2010. At baseline, medication information was available from 853 of 931 randomly assigned participants. Kidney function was measured by serum creatinine-based eGFR at a core laboratory.

Results: Before randomization, renin-angiotensin inhibitors were used in 419 (49%) of the 853 participants. Renin-angiotensin inhibitor use was lower in those with CKD (eGFR<60 ml/min per 1.73 m(2)) (58% versus 68%; P=0.004) and higher in individuals with diabetes (41% versus 27%; P<0.001). Presence of bilateral renal artery stenosis or congestive heart failure was not associated with renin-angiotensin inhibitor use. Although therapy with renin-angiotensin inhibitors varied by study site, differences in rates of use were not related to the characteristics of the site participants. Participants receiving a renin-angiotensin inhibitor had lower systolic BP (mean ± SD, 148 ± 23 versus 152 ± 23 mmHg; P=0.003) and more often had BP at goal (30% versus 22%; P=0.01).

Conclusions: Kidney function and diabetes were associated with renin-angiotensin inhibitor use. However, these or other clinical characteristics did not explain variability among study sites. Patients with renal artery stenosis who received renin-angiotensin inhibitor treatment had lower BP and were more likely to be at treatment goal.
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http://dx.doi.org/10.2215/CJN.11611113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078968PMC
July 2014