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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ERevascularization with stenting added to optimal medical therapy did not prevent clinical events in patients with atherosclerotic renal artery stenosis in the prospective, randomized, open-label, international, multicenter Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study. This article details the results.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Artery Obstruction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Coronary Artery Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Artery Obstruction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENephrology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECoronary Artery Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ERevascularization with stenting added to optimal medical therapy (OMT) did not prevent clinical events in patients with atherosclerotic renal artery stenosis (ARAS) in the prospective, randomized, open-label, international, multicenter Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study [Cooper CJ et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThe most common justifications to intervene in ARAS are resistant hypertension, declining or impaired renal function to prevent progression to end-stage renal disease, and recurrent congestive heart failure (CHF). However, there is little evidence that revascularization and stenting improve outcomes, stated Lance D. Dworkin, MD, Rhode Island Hospital, Providence, Rhode Island, USA. CORAL was conducted to evaluate OMT plus stent revascularization vs OMT alone in a study that was designed to address concerns regarding prior trials in ARAS, including possible selection bias, imprecise definition of renal artery stenosis (RAS), inadequate or unspecified medical regimen, surrogate end points, and crossovers between treatment groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EIn CORAL, patients with hypertension requiring \u2265 2 antihypertensive medications or \u2265 stage 3 chronic kidney disease (CKD) plus ARAS were randomized to OMT (n = 472) or OMT plus stent revascularization (stent group; n = 459). OMT consisted of candesartan (16 to 32 mg daily) \u00b1 hydrochlorothiazide (12.5 to 50 mg daily), a fixed-dose tablet of atorvastatin plus amlodipine (10\u201380\/2.5\u201310 mg daily), and antiplatelet therapy. The only crossovers were from OMT to stenting, and the primary reason was experiencing a primary outcome event.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EIn most patients, stenosis (\u2265 60% and \u2264 100%) was defined angiographically but with prior approval was defined noninvasively by duplex ultrasonography (systolic velocity \u0026gt; 300 cm\/s), magnetic resonance angiography, or computed tomographic angiography. The baseline angiographic and clinical characteristics were similar in both groups (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15296\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15296\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15296\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EBaseline Characteristics in the CORAL Study\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EThe composite primary outcome was cardiovascular or renal death, stroke, myocardial infarction, heart failure hospitalization, progressive renal insufficiency, and permanent renal replacement therapy and was adjudicated by a blinded clinical events committee. At 3 years, 35.8% and 35.1% of the OMT and stent groups, respectively, had a primary outcome event (HR, 0.94; 95% CI, 0.76 to 1.17; \u003Cem\u003EP\u003C\/em\u003E = .58). No differences were seen between groups for any of the components of the primary outcome or among the subgroups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EA significant reduction in the degree of stenosis was achieved with stenting, from a mean 67.94% to 16.25% (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001), with a mean 1.04 stents per vessel. An embolic protection device was used in 124 of 543 (22.8%) patients. A small (2.3 mm Hg) but significant reduction in systolic blood pressure (SBP) was found with stenting vs OMT (\u003Cem\u003EP\u003C\/em\u003E = .03).\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThe small decline in the estimated glomerular filtration rate (eGFR) over time was not different between groups. A CKD event occurred in 175 (19%) participants. The baseline predictors of eGFR and CKD events were age, SBP, log albumin\/creatinine ratio, and lower levels of total and high-density lipoprotein cholesterol; stenting and bilateral RAS were not predictive.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ETREATMENT OF ARAS AFTER CORAL\u003C\/h2\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EMedical therapy is the preferred treatment of ARAS in patients with hypertension taking antihypertensive agents or with stage 3 CKD, based on the CORAL results, including patients with a creatinine \u2265 or \u0026lt; 1.6 mg\/dL, with or without global cardiac ischemia, SBP \u2265 or \u0026lt; 160 mm Hg, or stenosis \u2265 or \u0026lt; 80%, stated Christopher J. Cooper, MD, University of Toledo College of Medicine, Toledo, Ohio, USA. When the need for revascularization is uncertain, medical therapy is preferred, based on the ASTRAL results [The ASTRAL Investigators. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2009].\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EFurther, he stated that the data, including the CORAL results, do not support the recommendations for the appropriate use of renal artery stenting in the expert consensus statement by the Society for Cardiac Angiography and Interventions (SCAI) [Parikh SA et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E. 2014].\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EThe CORAL study employed a rigorous vetting of the study sites that included an evaluation of the quality of renal artery stenting during the roll-in phase to ensure quality. Of the 115 sites evaluated, 12 (10%) did not qualify for the randomization phase, and 15 of the 239 cases were not interpretable [Murphy TP et al. \u003Cem\u003EJ Vasc Interv Radiol\u003C\/em\u003E. 2014]. The roll-in phase and feedback to the study sites resulted in better-quality procedures during the study, with a lower rate of complications (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E). Revascularization was clinically safe, with no patient requiring dialysis within 30 days of randomization and only 1 patient in the stent group needing dialysis between days 30 and 90 [Cooper CJ et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014]. There was 1 stroke leading to death in the OMT group. Although the risk was low with this procedure, Dr Cooper noted that it was not without risk.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15297\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15297\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15297\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003EAngiographic Complications During the Roll-in and Randomized Phases\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EPatient selection did not affect the CORAL results. Neither the initial subgroup analysis nor a more in-depth retrospective subgroup analysis by quartiles of degree of stenosis, baseline SBP, and translesional pressure gradients identified a group of patients who would benefit from revascularization. CORAL included a representative sample of stenosis severity, similar to that in the Food and Drug Administration (FDA) approval studies (ranging from 62% to 68%).\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EThe reduction in SBP in CORAL did not translate into a difference in clinical events. Although the FDA approval study for a new renal stent found a reduction in SBP, it was similar to the reduction obtained with OMT in CORAL. Thus, stenting to reduce SBP in patients with ARAS is not supported.\u003C\/p\u003E\n         \u003Cp id=\u0022p-20\u0022\u003EIn contrast to the SCAI recommendations for revascularization and based on the CORAL results, OMT is preferred in patients with resistant hypertension, ischemic nephropathy, and CHF. The SCAI recommendation for revascularization in CHF was based on observational studies with a small number of patients, and Dr Cooper and colleagues are preparing to publish data showing that these patients have similar outcomes with OMT. Revascularization should not be performed in patients with unilateral stenosis and an eGFR \u0026lt; 45 until OMT has clearly failed or in patients with anatomically challenging or high-risk lesions.\u003C\/p\u003E\n         \u003Cp id=\u0022p-21\u0022\u003ERenal artery revascularization is rarely indicated in ARAS. Although it may have a role in patients with stage 4 to 5 CKD, Dr Cooper stressed that this is based only on expert opinion, not evidence.\u003C\/p\u003E\n         \u003Cp id=\u0022p-22\u0022\u003EOMT and risk factor management as practiced in the CORAL study provide decisive support of medical management as the initial approach for patients with ARAS, reinforced Kenneth A. Jamerson, MD, University of Michigan Health System, Ann Arbor, Michigan, USA.\u003C\/p\u003E\n         \u003Cp id=\u0022p-23\u0022\u003EA number of features of the study design\u2014including vetting of the study sites, a survey to determine the willingness of investigators to randomize patients with ARAS to revascularization, monitoring of risk factor management via report cards to investigators, and targeting an SBP \u0026lt; 140 mm Hg\u2014contributed to the outcomes achieved in CORAL and likely do not reflect medical management in usual clinical practice.\u003C\/p\u003E\n         \u003Cp id=\u0022p-24\u0022\u003ENotably, the study patients did not have refractory hypertension at baseline, and more likely were under-treated. Regardless of the baseline SBP levels, there was an early reduction in SBP in both groups, and patients benefited from treatment and achieved target SBP levels.\u003C\/p\u003E\n         \u003Cp id=\u0022p-25\u0022\u003EContemporary studies have lower event rates because of the improvements in medical care over the decades that have led to optimal treatment of patients within the studies, making it difficult to show incremental improvements with additional treatment strategies, explained Dr Jamerson. Yet, the primary strategy to treat patients with ARAS is optimizing medical therapy and risk factor management.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/49\/20.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlu9d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzlu9d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}