Rationale & Objective: Although renal artery stenosis (RAS) and heart failure (HF) have been linked, the incidence and predictors of HF among patients with RAS are not well described. Study Design: Post hoc analysis of the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) multicenter, open-label, randomized controlled trial (RCT). Settings and Participants: Patients with atherosclerotic RAS and elevated blood pressure, chronic kidney disease, or both, and without a history of HF at enrollment. Intervention: Medical therapy alone versus medical therapy plus renal artery stenting. Outcomes: Incident HF events. Results: This analysis included 808 participants enrolled in the CORAL trial without evidence of baseline HF. During a median follow-up of 4.8 years, 54 participants (6.7%) developed incident HF. HF incidence rates did not differ by randomized intervention (HR, 0.84; 95% confidence interval [CI], 0.49-1.43 for stent arm with medical arm as reference). Baseline diabetes (subdistribution hazard ratio (sHR), 2.07; 95% CI, 1.20-3.58), albuminuria (sHR, 1.12 per doubling of urinary albumin-creatinine ratio, 95% CI, 1.02-1.24), lower eGFR (sHR, 0.78 per 10 mL/min/1.73 m2 estimated glomerular fi ltration rate calculated with cystatin C and creatinine, 95% CI, 0.69-0.88), and peripheral vascular disease (PVD) (sHR, 2.18, 95% CI, 1.213.91) were independent predictors of incident HF. Participants who experienced incident HF had greater kidney function decline before HF events. Limitations: This is a post hoc analysis of a RCT. The number of HF events is small. Conclusions: In patients with RAS, rates of incident HF did not differ between participants randomized to optimal medical therapy alone versus optimal medical therapy plus renal artery stenting. The presence of diabetes, PVD, and worse kidney health at baseline were associated with future HF events.

Objective: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial with 947 patients, concluded that there was no benefit of renal artery stenting (RAS) over medical therapy. However, patients with chronic kidney disease (CKD) were not analyzed separately in the CORAL trial. CKD is a risk factor for cardiovascular and renal morbidity. We hypothesized that improved renal function after RAS would be associated with increased long-term survival and a lower risk of cardiovascular and renal events in patients with CKD. Methods: This post hoc analysis of the CORAL trial included 842 patients with CKD stages 2 to 4 at baseline who were randomized to optimal medical therapy alone (OMT; n = 432) or RAS plus OMT (RAS + OMT; n = 410). Patients were categorized as responders or nonresponders based on the change in the estimated glomerular filtration rate (eGFR) from baseline to last follow-up (median, 3.6 years; interquartile range, 2.6-4.6 years). Responders were defined by a 20% or greater increase in eGFR from baseline; all others were designated as nonresponders. Event-free survival was defined as freedom from death and multiple cardiovascular and renal complications. Event-free survival was analyzed using the Kaplan-Meier method and log-rank test. Multivariable Cox proportional hazards regression analysis was used to identify independent predictors of event-free survival. Results: The RAS + OMT group had a higher proportion of patients with improved renal function (>= 20% increase in eGFR over baseline), compared with the OMT group (25.6% vs 17.1%; P = .003). However, event-free survival was no different for the two cohorts (P = .18 by the log-rank test). Multivariable Cox proportional hazards regression analysis identified four variables that independently correlated with event-free survival for the stented cohort. Higher preoperative eGFR (hazard ratio, 0.98; 95% confidence interval [CI], 0.96-0.99; P = .002) and being a responder to stenting (hazard ratio, 0.49; 95% CI, 0.26-0.95; P = .033) increased event-free survival, whereas a history of congestive heart failure (hazard ratio, 2.52; 95% CI, 1.46-4.35; P < .001) and a higher preoperative systolic BP (hazard ratio, 1.02; 95% CI, 1.01-1.03; P = .002) decreased event-free survival. Within the stented group, 105 of 410 patients (25.6%) were responders. Event-free survival was superior for responders, compared with nonresponders (P = .009 by log-rank test). The only independent preoperative negative predictor of improved renal function after stenting was diabetes (odds ratio, 0.37; 95% CI, 0.16-0.84; P = .017), which decreased the probability of improved renal function after RAS + OMT. A subset of patients (23.4%) after RAS had worsened renal function, but OMT alone produced an equivalent incidence of worsened renal function. An increased urine albumin/creatinine ratio was an independent predictor of worsened renal function after RAS. Conclusions: CORAL participants who demonstrated improved kidney function after RAS + OMT demonstrated improved event-free survival. This finding reinforces the need for predictors of outcome to guide patient selection for RAS.

•Trauma care is expensive, and although it provides value and saves lives for critically injured patients, the cost of primary overtriage (minimally injured patients taken from the scene to the emergency department with involvement of the trauma team in the emergency department) is unknown.•This study demonstrated that hospital costs increased from $12 080 to $16 611 and that hospital charges increased from $52 142 to $78 323 when the trauma service was involved in the care of the minimally injured patient.•There was no difference in complications or hospital length of stay in matched cohorts of minimally injured patients whether the trauma service was involved or not. Identifying better means of triage to avoid trauma service care in those who do not need it may improve value.

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.

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 (p > 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 (p = 0.06) and any bleeding occurred in eight versus two (p = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients (p = 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).

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.

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.

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.

HomeCirculation: Cardiovascular Quality and OutcomesVol. 11, No. 4Racial Heterogeneity in Treatment Effects in Peripheral Artery Disease Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBRacial Heterogeneity in Treatment Effects in Peripheral Artery DiseaseInsights From the CLEVER Trial (Claudication: Exercise Versus Endoluminal Revascularization) Yashashwi Pokharel, MD, MSCR, Philip G. Jones, MS, Garth Graham, MD, Tracie Collins, MD, MPH, Judith G. Regensteiner, PhD, Timothy P. Murphy, MD, David Cohen, MD, MSc, John A. Spertus, MD, MPH and Kim Smolderen, PhD Yashashwi PokharelYashashwi Pokharel 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.). , Philip G. JonesPhilip G. Jones 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.). , Garth GrahamGarth Graham 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.). , Tracie CollinsTracie Collins 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.). , Judith G. RegensteinerJudith G. Regensteiner 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.). , Timothy P. MurphyTimothy P. Murphy 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.). , David CohenDavid Cohen 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.). , John A. SpertusJohn A. Spertus 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.). and Kim SmolderenKim Smolderen 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.). Originally published11 Apr 2018https://doi.org/10.1161/CIRCOUTCOMES.117.004157Circulation: Cardiovascular Quality and Outcomes. 2018;11:e004157IntroductionImproving symptoms, functions, and quality-of-life (ie, health status) is one of the important goals in treatment of patients with peripheral artery disease (PAD).1 However, it is unknown whether health status responses differ by race (black versus white) with alternative PAD treatment modalities. Such differences may exist given the disproportionate burden of PAD in minority populations, and rapid disease progression as compared with white,2 as well as differences in psychosocial and economic factors and possibly differences in exercise level, which is known to improve outcomes in patients with PAD.3,4 Understanding whether black and white respond differently to treatments can help us better support targeted therapy to improve quality of care. This is relevant because until now, supervised exercise (SE) programs for PAD were not available in the United States, and recently, the Centers for Medicare and Medicaid Services agreed to reimburse for SE therapy.5 If there is heterogeneity in response to SE, knowing this difference is important to provide patient-centered care and to get maximum treatment benefit for each unique patient population.The CLEVER trial (Claudication: Exercise Versus Endoluminal Revascularization) randomized patients with claudication from aortoiliac disease to SE, stent therapy (ST), or optimal medical care (OMC). Short-term results indicated superior treadmill walking performance (ie, peak walking time and claudication onset time) with SE than either ST or OMC. Conversely, benefit in PAD-specific health status (Peripheral Artery Questionnaire [PAQ] summary score)6 was more favorable for ST than either SE or OMC.3 Similarly, general quality-of-life benefit as assessed with Short Form-12 Physical Component Summary (SF-12 PCS)7 was similar for ST and SE when compared with OMC.3 Long-term results, however, showed similar and sustained benefits for both ST and SE over OMC in treadmill walking performance, but PAQ summary score was more favorable for ST when compared with SE or OMC.4 Improvement in SF-12 PCS was seen only with SE.4 The purpose of this study is to understand whether there is heterogeneity in response to alternative treatment modalities, such as SE, ST, or OMC, by race (black versus white) and whether any difference in treatment varies over time, using data from the CLEVER trial.Methods and ResultsDetails about the CLEVER trial have been reported before.3,4 Briefly, it examined the benefits of ST, SE, or OMC on both walking outcomes and quality-of-life measures in 119 patients with moderate-to-severe intermittent claudication and hemodynamically significant aortoiliac arterial stenosis from 22 sites in the United States and Canada. For the current analysis, data were accessed through National Heart, Lung, and Blood Institute data repository (https://biolincc.nhlbi.nih.gov/studies/clever/?q=clever) with Institutional Review Board approval from Saint Luke’s Hospital, Kansas City, MO. Our primary outcomes of interest were changes in PAQ and SF-12 PCS scores from baseline at 6 and 18 months after randomization. Higher change scores represent greater health status improvements. We also examined changes in treadmill walking performance (peak walking time and claudication onset time) and Walking Impairment Questionnaire (WIQ). We did not assess other outcomes that did not vary by treatment in the CLEVER study.3 We excluded 7 patients of races other than black or white. Change from baseline was analyzed using linear mixed-effects models, including treatment groups, race, and follow-up time in months as fixed effects. We examined all 2- and 3-way interaction terms to test for differences in treatment response over time between race groups and used an unstructured covariance matrix to account for repeated measurements. The models were adjusted for baseline health status and baseline characteristics that differed within races or by treatment within races (age, sex, hypertension, smoking status, diabetes mellitus, arthritis/musculoskeletal disorders, stroke, myocardial infarction, and percutaneous coronary intervention).Among 104 eligible patients, 41, 43, and 20 patients were randomized to SE, ST, and OMC, respectively. The mean age was 64.2 years, and 37.5% were women. Seventy-five patients were white (OMC, 14; SE, 25; ST, 36) and 29 were black (OMC, 6; SE, 16; ST, 7). Follow-up at 18 months was similar for white versus black (86.7% versus 89.7%, respectively) with no intervening death. At baseline, there were no significant racial differences in resting ankle–brachial index, use of antiplatelet, statin or cilostazol therapy, PAQ summary scores, SF-12 PCS, peak walking time, claudication onset time, or WIQ. However, compared with white participants, black participants were more likely to be women (55.2% versus 30.7%), current smokers (58.6% versus 52.0%), have diabetes mellitus (40.7% versus 18.7%), and arthritis/other musculoskeletal disorder (44.8% versus 22.5%). Within each racial group, there were no significant baseline differences by treatment groups in resting ankle–brachial index, PAQ summary scores, SF-12 PCS, peak walking time, claudication onset time, or WIQ.There was a significant race–treatment interaction for PAQ summary scores (P=0.035); in white, PAQ scores increased only with ST, whereas in black, they increased with both ST and SE, compared with OMC (Figure, top). Interestingly, in the OMC group, PAQ score decreased over time in black but not in white. Model-estimated mean changes (95% confidence interval) in PAQ summary scores in SE and ST compared with OMC were 2.9 (−10.0 to 15.8) and 26.6 (14.6 to 38.6) in white, and 28.2 (8.7 to 47.7) and 31.8 (10.4 to 53.2) in black, respectively, which was unchanged at 6 and 18 months (P=0.22 for race–month interaction and P=0.38 for race–treatment–month interaction). A significant race–treatment interaction was also found for SF-12 PCS (P=0.005), which increased only with ST in white and only with SE in black, compared with OMC (Figure, bottom). Model-estimated mean changes in SF-12 PCS scores in SE and ST compared with OMC were 3.9 (−0.6 to 8.4) and 6.7 (2.5 to 10.9) in white and 15.9 (7.0 to 24.8) and 5.8 (−2.4 to 14.1) in black, respectively, which were unchanged at 6 and 18 months (P=0.28 for race–month interaction and P=0.64 for race–treatment–month interaction). Similarly, model-estimated changes in PAQ scores were −23.7 (−34.4 to −13.0) and −3.6 (−21.2 to 14.0) in SE compared with ST in white and black, respectively, and for SF-12, the scores were −2.8 (−6.8 to 1.2) and 10.0 (3.1 to 17.0), respectively. The race–treatment, race–month, and race–treatment–month interactions were not significant for other outcomes (all P>0.05).Download figureDownload PowerPointFigure. Unadjusted Peripheral Artery Questionnaire (PAQ) summary (top) and Short Form (SF)-12 physical component (bottom) scores means by race and treatment. OMC indicates optimal medical care; SE, supervised exercise; and ST, stent therapy.CommentWe found that although PAD-specific health status scores were greater with both SE and ST compared with OMC in black, such difference was seen only with ST in white. Furthermore, compared with ST, PAQ summary scores were lower with SE in white but were not different in black. Compared with OMC, general health status scores were greater only with SE in black and only with ST in white. However, when compared with ST, SF-12 PCS scores were greater with SE in black but were not different in white. No significant differences were noted for treadmill walking performance or WIQ.Although the smaller sample size reduces statistical power, the observed significant racial differences in health status may suggest racial heterogeneity in treatment responses. Should these findings be replicated in larger studies, we need to understand why SE may be more beneficial in black as compared with white. Identifying whether these differences in treatment response are mediated by psychosocial stress, economic factors, adherence, baseline exercise level, or other unknown factors could help identify opportunities to tailor PAD treatment strategies to specific racial groups or other patient-centered factors that would benefit the most. Black may have a more compromised starting situation, such as socioeconomic, mental health, or risk factor control, as seen in this study. Engaging in exercise could provide greater overall benefit in black.A difference of 8 points in PAQ and >5 points in SF-12 is considered clinically important.3 The observed changes in health status are clinically significant. If substantiated later, additional studies should corroborate these improvements with other clinical measures to improve interpretability. Furthermore, the Centers for Medicare and Medicaid Services recently agreed to reimburse SE programs,5 and targeting such therapy to right patient population will be the most impactful.The CLEVER trial enrolled selected patients with aortoiliac disease irrespective of femoropopliteal PAD. Therefore, our findings may not extend to patients with isolated femoropopliteal lesions or patients not meeting trial eligibility criteria. Despite 3 randomization arms (SE, ST, and OMC), OMC was provided in all patients, and the primary interest of the trial was to compare the effect of SE with ST.3 So, our results require careful interpretation when considering OMC as a control.Although some overlap between PAQ and SF-12 PCS is expected, PAQ provides PAD-specific information that SF-12 does not. We did not find significant interactions for mobility-based outcomes, like WIQ and treadmill-based measures. Although WIQ provides information on PAD-specific mobility, it does not provide other quality-of-life information.8 Whether this explains the disparate findings requires further study.This hypothesis-generating post hoc analysis of the CLEVER trial demonstrates differential quality-of-life benefits by race with alternative PAD treatment modalities. These findings warrant further examination to confirm the veracity of these observations and to understand the mechanisms responsible for observed treatment responses so that treatment approaches can be optimized to fit patients’ needs, preferences, and potential benefits.Sources of FundingThe CLEVER study (Claudication: Exercise Versus Endoluminal Revascularization) was sponsored mostly by the National Heart, Lung, and Blood Institute (grant numbers HL77221 and HL081656) and received financial support from Cordis/Johnson & Johnson (Warren, NJ), eV3 (Plymouth, MN), and Boston Scientific (Natick, MA). Otsuka America, Inc, (San Francisco, CA) donated cilostazol for all study participants throughout the study. Omron Healthcare, Inc, Lake Forest, IL, donated pedometers. Krames Staywell, San Bruno, CA, donated print materials for study participants on exercise and diet. Dr Pokharel is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number T32HL110837.DisclosuresDr Collins serves as a consultant for ViroMed. Dr Cohen has received research grant support from Medtronic, Abbott Vascular, and Boston Scientific and serves as a consultant for Medtronic and Cardinal Health. Dr Spertus owns the copyright to the Peripheral Artery Questionnaire. Dr Smolderen has received research grant support from Merck and Boston Scientific. The other authors report no conflicts.FootnotesThe content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.http://circoutcomes.ahajournals.orgThis article was handled by Philip Goodney, MD, as a Guest Editor. The editors had no role in the evaluation of the manuscript or in the decision about its acceptance.Yashashwi Pokharel, MD, MSCR, Department of Cardiovascular Research, Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, 4401 Wornall Rd, Cardiovascular Research, 9th Floor, Kansas City, MO 64111. E-mail [email protected]References1. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2011; 58:2020–2045. doi: 10.1016/j.jacc.2011.08.023.MedlineGoogle Scholar2. Allison MA, Ho E, Denenberg JO, Langer RD, Newman AB, Fabsitz RR, Criqui MH. Ethnic-specific prevalence of peripheral arterial disease in the United States.Am J Prev Med. 2007; 32:328–333. doi: 10.1016/j.amepre.2006.12.010.CrossrefMedlineGoogle Scholar3. Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study.Circulation. 2012; 125:130–139. doi: 10.1161/CIRCULATIONAHA.111.075770.LinkGoogle Scholar4. Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Jaff MR, Comerota AJ, Steffes MW, Abrahamsen IH, Goldberg S, Hirsch AT. Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study.J Am Coll Cardiol. 2015; 65:999–1009. doi: 10.1016/j.jacc.2014.12.043.CrossrefMedlineGoogle Scholar5. The Centers for Medicare and Medicaid Services: Proposed Decision Memo for Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease. https://www.cms.gov/medicare-coverage-database/shared/handlers/highwire.ashx?url=https://www.cms.gov/medicare-coverage-database/details/[email protected]@@NCAId$$$287&session=1cin1p45wtawuf3p0uukf4fn&kq=873007742. Accessed July 5, 2017.Google Scholar6. Spertus J, Jones P, Poler S, Rocha-Singh K. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease.Am Heart J. 2004; 147:301–308. doi: 10.1016/j.ahj.2003.08.001.CrossrefMedlineGoogle Scholar7. Ware J, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity.Med Care. 1996; 34:220–233.CrossrefMedlineGoogle Scholar8. Poku E, Duncan R, Keetharuth A, Essat M, Phillips P, Woods HB, Palfreyman S, Jones G, Kaltenthaler E, Michaels J. Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties.Health Qual Life Outcomes. 2016; 14:161. doi: 10.1186/s12955-016-0563-y.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited BySmolderen K, Alabi O, Collins T, Dennis B, Goodney P, Mena-Hurtado C, Spertus J and Decker C (2022) Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment: A Scientific Statement From the American Heart Association, Circulation, 146:20, (e286-e297), Online publication date: 15-Nov-2022. Bronas U and Regensteiner J (2022) Connecting the past to the present: A historical review of exercise training for peripheral artery disease, Vascular Medicine, 10.1177/1358863X211073620, 27:2, (174-185), Online publication date: 1-Apr-2022. Hackler E, Hamburg N and White Solaru K (2021) Racial and Ethnic Disparities in Peripheral Artery Disease, Circulation Research, 128:12, (1913-1926), Online publication date: 11-Jun-2021. April 2018Vol 11, Issue 4 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCOUTCOMES.117.004157PMID: 29643064 Manuscript receivedJuly 31, 2017Manuscript acceptedMarch 14, 2018Originally publishedApril 11, 2018 Keywordshumansgoalsexercisecontinental population groupswalkingPDF download Advertisement SubjectsHealth Services

Improving symptoms, functions, and quality-of-life (ie, health status) is one of the important goals in treatment of patients with peripheral artery disease (PAD).1 However, it is unknown whether health status responses differ by race (black versus white) with alternative PAD treatment modalities. Such differences may exist given the disproportionate burden of PAD in minority populations, and rapid disease progression as compared with white,2 as well as differences in psychosocial and economic factors and possibly differences in exercise level, which is known to improve outcomes in patients with PAD.3,4 Understanding whether black and white respond differently to treatments can help us better support targeted therapy to improve quality of care. This is relevant because until now, supervised exercise (SE) programs for PAD were not available in the United States, and recently, the Centers for Medicare and Medicaid Services agreed to reimburse for SE therapy.5 If there is heterogeneity in response to SE, knowing this difference is important to provide patient-centered care and to get maximum treatment benefit for each unique patient population. The CLEVER trial (Claudication: Exercise Versus Endoluminal Revascularization) randomized patients with claudication from aortoiliac disease to SE, stent therapy (ST), or optimal medical care (OMC). Short-term results indicated superior treadmill walking performance (ie, peak walking time and claudication onset time) with SE than either ST or OMC. Conversely, benefit in PAD-specific health status (Peripheral Artery Questionnaire [PAQ] summary score)6 was more favorable for ST than either SE or OMC.3 Similarly, general quality-of-life benefit as assessed with Short Form-12 Physical Component Summary (SF-12 PCS)7 was similar for ST and SE when compared with OMC.3 Long-term results, however, showed similar and sustained benefits for both ST and SE over OMC in treadmill walking performance, but PAQ summary score was more favorable …

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 .).

In May of 2017, the Society for Interventional Radiology (SIR) and its Women in Interventional Radiology section issued an official position statement outlining recommended policies for parental leave. This statement encourages institutions and practices to support interventional radiologists who choose to become parents. The websites of the 119 American medical specialty societies recognized by the American Medical Association's House of Delegates were searched for keywords "parental leave," "maternity leave," and "paternity leave." To ensure completeness, a second search of the society name plus the same keywords were performed in the search engine Google©. Position statements were analyzed based on their recommendations in nine categories. Seven out of the 119 specialty societies (5.9%) had publicly available parental leave statements. The oldest was from 1989 and the most recent was from the SIR. All statements recommended that parental leave policies be explicitly stated in employment contracts. The responsibility of the physician to notify practices of planned pregnancies was stated in 71.4%. Prenatal schedule flexibility was advised in 85.7%. Four of the seven set six-weeks minimums for leave, and only the American College of Surgeons (ACS) increased this to 8 weeks for cesarean. Three extended this minimum to paternity leave. The American Academy of Family Physicians was the only to recommend that parents should have make-up call coverage; the rest recommended against. Three recommend a minimum of six weeks of pay, and three did not make recommendations regarding pay. The ACS stated that pay should be negotiated by practices. Two were explicitly directed at residents, one to both residents and practicing physicians, and the rest did not include residents. Four included adopting and fostering parents. Few professional societies have issued parental leave statements. The parental leave position statement issued by the SIR is one of the most comprehensive and inclusive parental leave statements. To improve its inclusiveness, clarification on the positions applicability to residents and fellows could be amended.

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 (UA1b) levels: cohort 1 ("low albuminuria," UA1b <= 0.04 g/24h) and cohort 2 ("high albuminuria," UA1b >0.04g/24h). Interaction effect between treatment arms and UA1b 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 UA1b 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.

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.

In digital X-ray imaging, a crucial factor determining image resolution of all indirect detection systems is the spread of light in the X-ray scintillator. Currently deployed clinical x-ray detectors, with a resolution between 75 and 300 microns, are affected by such spread of light. This work demonstrates the significantly improved the resolution of an indirect X-ray scintillation detector using a new structuring approach The new structured scintillator consists of three main components: a high optical quality ‘channel plate’, a reflective material within the capillaries of the channel plate, and a polymer-based scintillating material that is incorporated in the capillaries. Channel plates, which are utilized for a variety of optical applications, are produced from bundles of hollow drawn borosilicate glass fibers, with repeated bundling and drawing reducing the diameter of the core and capillary pores down to values as low as 5 microns. These bundles are then cut to make high quality plates (‘channel plates’) with a thickness around 1 mm. Channel plates contain geometrically ordered capillary channels (about 5 million channels per square cm). The channel walls were coated with a 70 nm thick coating of Al2O3:W using atomic layer deposition (ALD) to optically confine the photoemission within the channel. The optical channel plates were infiltrated with a new bismuth-based scintillating polymer developed at Lawrence Livermore National Laboratory, with a photon yield of > 30,600 photons/keV for X-ray energies of 20-30 keV, a range of interest for mammography. The new scintillator plate was used to experimentally demonstrate an X-ray resolution of 10 microns (or 50 linepairs/ mm), an approximately 7 times improvement over existing scintillating detectors. A structured scintillator plate, coupled with a digital detection system may be used to improve the spatial resolution in applications such as mammography, radiography, and computed tomography.

The CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial failed to demonstrate a benefit of renal artery stenting (RAS) over medical therapy. Clinical experience suggests that there are patients who benefit from RAS, so multiple studies have sought to identify preoperative markers that portend a higher probability of benefit from RAS. A recent retrospective, single-center study reported three preoperative predictors of blood pressure (BP) response to RAS: (1) requirement for four or more antihypertensive medications (MEDS); (2) preoperative diastolic BP >90 mm Hg; and (3) preoperative clonidine use. The aim of the current study was to validate these predictors using data from the CORAL Trial, which is the largest prospectively collected database on renovascular disease. This post hoc analysis of the CORAL Trial included 436 patients who were randomized to RAS. A modification of American Heart Association guidelines was used to categorize patients as BP “responders” or “nonresponders.” BP responders were defined by a postoperative BP <160/90 on a reduced number of antihypertensive MEDS or a reduction in diastolic BP to <90 mm Hg on the same MEDS after RAS. Patients with stable or worsened BP were labeled nonresponders. Predictors of BP response were identified by multivariate analysis. The median age was 70 years (interquartile range [IQR], 63-76 years). The median systolic and diastolic BPs of the stented cohort at baseline were 149 mm Hg (IQR, 132-164 mm Hg) and 78 mm Hg (IQR, 70-87 mm Hg), respectively. A positive BP response occurred in 284 of 436 (65.1%) of stented patients. Multivariate analysis identified three independent predictors of a positive BP response: (1) requirement for four or more MEDS (odds ratio [OR], 5.9; P < .001); (2) preoperative diastolic BP >90 mm Hg (OR, 13.9; P < .001); and (3) preoperative clonidine use (OR, 4.52; P = .008). The percentage of patients with a positive BP response increased incrementally as the number of predictors per patient increased (P < .0001; Fig). The current study independently validates the three previously described clinical predictors of BP response to RAS using data from the CORAL trial. For patients who have failed medical therapy and stenting iontemplated, these clinical predictors may assist clinicians in patient selection and provide more concrete data for counseling patients on the probability of BP improvement.

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.

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 pharmaco-mechanical 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.

Takahashi et al ( 1 Takahashi E.A. McKusick M.A. Bjarnason H. Piryani A. Harmsen W.S. Misra S. Treatment of in-stent restenosis in patients with renal artery stenosis. J Vasc Interv Radiol. 2016; 27: 1657-1662 Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar ) report a series of 1,090 renal artery stent procedures done in 1,052 patients between 1996 and 2009. The patients were followed on average for 5.1 years. The authors observed in-stent restenosis (ISR) in 101 stents in 79 patients and noted that patients treated for ISR with bare metal stents (BMS) had a 6.89 times higher rate of repeat ISR than patients treated with percutaneous transluminal angioplasty (PTA). Treatment of In-Stent Restenosis in Patients with Renal Artery StenosisJournal of Vascular and Interventional RadiologyVol. 27Issue 11PreviewTo determine clinical outcomes of patients treated for renal artery in-stent restenosis (ISR) with atherosclerotic renal artery stenosis. Full-Text PDF Re: Stating the Obvious, for What It’s WorthJournal of Vascular and Interventional RadiologyVol. 28Issue 2PreviewWe read Dr. Murphy’s commentary (1) with interest and acknowledge several points that were raised. Our study (2) retrospectively reviewed 101 renal artery stents treated for in-stent restenosis (ISR). Patients in our study were treated with percutaneous transluminal angioplasty (PTA) or repeat stent implantation. The patients who presented earlier in the study period were generally treated with PTA. Patients who presented later tended to be treated with bare metal stents (BMSs). Only six patients were treated with drug-eluting stents (DESs) toward the end of the study period as the technology became available. Full-Text PDF

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.