Vascular Medicine (London, England)最新文献

{"title":"Effect of sodium-glucose co-transporter-2 inhibitors on arterial stiffness: A systematic review and meta-analysis of randomized controlled trials.","authors":"Dimitrios Patoulias,&nbsp;Christodoulos Papadopoulos,&nbsp;George Kassimis,&nbsp;Nikolaos Fragakis,&nbsp;Vassilios Vassilikos,&nbsp;Asterios Karagiannis,&nbsp;Michael Doumas","doi":"10.1177/1358863X221101653","DOIUrl":"https://doi.org/10.1177/1358863X221101653","url":null,"abstract":"<p><strong>Background: </strong>Arterial stiffness represents an established cardiovascular risk marker. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors have significant cardio-protective effects. Herein we sought to determine the effect of SGLT-2 inhibitors on pulse wave velocity (PWV).</p><p><strong>Methods: </strong>We searched PubMed, Cochrane Library, and grey literature from inception to 7^th February 2022 for randomized controlled trials (RCTs) enrolling adult subjects with or without type 2 diabetes mellitus (T2DM), assigned to a SGLT-2 inhibitor versus control and addressing their effect on PWV. We set as primary efficacy outcome the change in PWV with SGLT-2 inhibitors versus placebo or control.</p><p><strong>Results: </strong>We pooled data from six trials in a total of 452 enrolled participants assigned either to SGLT-2 inhibitor or control. Overall, SGLT-2 inhibitor treatment compared to control resulted in a nonsignificant decrease in PWV. Exclusion of a trial utilizing cardiac magnetic resonance imaging for the assessment of PWV demonstrated that SGLT-2 inhibitors induce a significant reduction in PWV by 0.21 m/s. When we restricted our analysis to RCTs enrolling subjects with T2DM, we observed that SGLT-2 inhibitor compared to control resulted in a significant decrease in PWV by 0.17 m/s.</p><p><strong>Conclusion: </strong>SGLT-2 inhibitors do not decrease PWV in patients with established cardiovascular disease or cardiovascular risk factors. However, we have shown that SGLT-2 inhibitors lead to a slight, but significant decrease in PWV in patients with T2DM. The latter finding is of great value, based on the significant correlation between PWV and micro- and macro-vascular complications of T2DM.</p>","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"433-439"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40400597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort.","authors":"Herman Schroë,&nbsp;Ravish Sachar,&nbsp;Koen Keirse,&nbsp;Yoshimitsu Soga,&nbsp;Marianne Brodmann,&nbsp;Vikram Rao,&nbsp;Martin Werner,&nbsp;Andrew Holden,&nbsp;Louis Lopez,&nbsp;Prakash Krishnan,&nbsp;Juan Diaz-Cartelle","doi":"10.1177/1358863X221097164","DOIUrl":"https://doi.org/10.1177/1358863X221097164","url":null,"abstract":"<p><strong>Background: </strong>The objective of the RANGER II SFA long lesion cohort analysis was to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) in patients with lesion lengths greater than 100 mm.</p><p><strong>Methods: </strong>Patients from the RANGER II SFA randomized controlled trial and long balloon sub-study were included in the long lesion cohort if their baseline lesion measurement was > 100 mm and if they had been treated with a RANGER DCB. Patients had symptomatic lower limb peripheral artery disease and Rutherford classification 2-4 symptomatology. The endpoints of interest included the 12-month target lesion primary patency and freedom from major adverse events (MAEs).Additional patient outcomes including changes in Rutherford classification were also evaluated.</p><p><strong>Results: </strong>A total of 129 patients met the inclusion criteria and were included in the long lesion cohort. Mean lesion length was 144.5 ± 31.7 mm. Seventy-five lesions had Peripheral Arterial Calcium Scoring System (PACSS) grades 3 (33.3%, 43/129) and 4 (24.8%, 32/129). The Kaplan-Meier estimate of the primary patency rate at 12 months was 88.0%. The rate of freedom from MAEs at 12 months was 95.1% (117/123; 95% CI: 89.7%, 98.2%); all MAEs were clinically driven target lesion revascularization (4.9%, 6/123). The 12-month mortality rate was 2.4% (3/125).</p><p><strong>Conclusions: </strong>Patients with lesions > 100 mm treated with Ranger DCBs demonstrated excellent 1-year safety and efficacy results, comparable to those of the overall RANGER II SFA randomized clinical trial. This suggests that the Ranger DCB can provide consistent results regardless of lesion length. <b>(ClinicalTrials.gov Identifier: NCT03064126)</b>.</p>","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"457-465"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4f/8f/10.1177_1358863X221097164.PMC9551318.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40613029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of D-dimer with short-term risk of venous thromboembolism in acutely ill medical patients: A systematic review and meta-analysis.","authors":"Gerald Chi,&nbsp;Jane J Lee,&nbsp;Sahar Memar Montazerin,&nbsp;Jolanta Marszalek","doi":"10.1177/1358863X221109855","DOIUrl":"https://doi.org/10.1177/1358863X221109855","url":null,"abstract":"<p><strong>Background: </strong>D-dimer, a marker of ongoing procoagulant activity, has been widely used for the diagnosis of venous thromboembolism (VTE). The prognostic significance of D-dimer in stratifying VTE risk for acutely ill medical patients has not been well-established.</p><p><strong>Methods: </strong>A literature search was performed to collect studies that compared the incidence of short-term VTE between acutely ill medical patients with elevated or nonelevated D-dimer levels. The cutoff of D-dimer was 0.5 μg/mL or otherwise defined by included studies. The study endpoint was any occurrence of VTE (inclusive of deep vein thrombosis [DVT], pulmonary embolism, or VTE-related death) within 90 days of hospital presentation. A meta-analytic approach was employed to estimate the odds ratio (OR) with 95% CI by fitting random-effects models using the generic inverse variance weighted approach.</p><p><strong>Results: </strong>A total of 10 studies representing 31,119 acutely ill medical patients were included. Compared to those with nonelevated D-dimer levels, patients with elevated D-dimer had approximately threefold greater odds for short-term VTE within 90 days (OR, 3.28; 95% CI, 2.44 to 4.40; <i>p</i> < 0.0001). The association of elevated D-dimer with VTE composite (OR, 3.33; 95% CI, 2.20 to 5.02) and with DVT (OR, 3.26; 95% CI, 2.32 to 4.58) was comparable. The association was significant among patients who presented various acute medical illness (OR, 2.68; 95% CI, 2.01 to 3.58) and those who presented with acute stroke (OR, 3.25; 95% CI, 2.31 to 4.58).</p><p><strong>Conclusion: </strong>Elevation of D-dimer was predictive of the occurrence of VTE within 90 days among acutely ill medical patients.</p>","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"478-486"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40662689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Images in Vascular Medicine: Clinical and radiological features of Maffucci syndrome.","authors":"Yuchen Shen,&nbsp;Lixin Su,&nbsp;Xindong Fan,&nbsp;Deming Wang","doi":"10.1177/1358863X221101654","DOIUrl":"https://doi.org/10.1177/1358863X221101654","url":null,"abstract":"A 26-year-old woman presented with extensive bluish violet nodules on both hands and feet. She reported gradual asymmetric growth on the whole body over the last 20 years, which seriously affected her daily life. Informed consent was obtained, and the patient agreed to publish the case details and images. Maffucci syndrome is a very rare congenital disease caused by somatic mutations in isocitrate dehydrogenase 1 (IDH1) or IDH2. Typical manifestations include venous malformations, spindle-cell hemangiomas, and multiple enchondromas (benign overgrowths of cartilage).1 The same mutations in IDH1 and IDH2 are found in a related disorder, Ollier disease, which can be distinguished from Maffucci symptoms by a lack of venous malformations.2 In contrast to the soft and compressible nature of common venous malformations,3 the venous lesions of Maffucci syndrome typically present with hard and nodular masses in the skin (Panels A-1, B-2, C-2). The morphological abnormalities of veins give rise to blood flow stasis and thrombosis, eventually forming ‘phleboliths’ by calcification, which result in dotted opaque images on plain film X-rays (Panels A–C, white arrows).4 Localized intravascular coagulation (LIC) may be seen in the extensive venous malformations3; however, patients with Maffucci syndrome usually do not present with generalized coagulation dysfunction. Among the cutaneous and subcutaneous venous lesions, spindle-cell hemangiomas may also be found in pathological examinations.5 The enchondromas occur in multiple sites, most often in the metaphysis or epiphysis of the long bone (Panels A–C, black stars), giving rise to dysplasia of the affected bone. In radiological examination, underdevelopment is accompanied by irregular ‘frosted glass’ sign at the end of long bones, indicating the existence of an enchondroma. The unilateral enchondroma presented in this case resulted in severe hypoplasia of the patient’s affected side (Panels A-2, B-1, C-1) in contrast with the healthy side (Panels A-3, B-3, C-3). Notably, enchondromas have the potential for malignant transformation. The frequency of transition to chondrosarcoma is related to the number of enchondromas present and is estimated to occur in 15–40% of patients.2 Images in Vascular Medicine: Clinical and radiological features of Maffucci syndrome","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"515-517"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40654666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Carotid siphon calcifications are associated with all-cause mortality: Results from the Atahualpa Project.","authors":"Oscar H Del Brutto,&nbsp;Robertino M Mera","doi":"10.1177/1358863X221111821","DOIUrl":"https://doi.org/10.1177/1358863X221111821","url":null,"abstract":"The carotid siphon is the intracranial arterial segment most susceptible to develop atherosclerotic lesions.1 These lesions typically present as calcium deposits in the tunica media and represent a reliable biomarker of intracranial atherosclerotic disease.2 Therefore, carotid siphon calcifications (CSC) may be related to premature mortality. However, studies assessing CSC-related mortality are limited. This cohort study, embedded within the populationbased Atahualpa Project,3 aimed to assess differences in mortality risk according to CSC severity. The Atahualpa Project is a population-based prospective cohort study designed to determine risk factors associated with the increasing burden of noncommunicable neurological and cardiovascular diseases in individuals of Amerindian ancestry living in rural Ecuador.4 For the purposes of the present study, community-dwellers aged ⩾ 40 years (mean age 54.9 ± 12.6 years; 55% women) who received baseline head computed tomography (CT) and clinical interviews were prospectively followed. According to Woodcock et al.,5 CSC Grade 1 were defined as the absence or nearabsence of calcification, Grade 2 as tiny, scattered calcifications, Grade 3 as thick interrupted or thin confluent calcifications, and Grade 4 as thick contiguous calcifications. For simplicity in analyses and based on our previous work,6 individuals were further classified into those with low (Grades 1 and 2) and high (Grades 3 and 4) calcium content in carotid siphons. Cox-proportional hazards models were adjusted for demographics, cardiovascular risk factors (smoking status, body mass index, physical activity, diet, blood pressure, fasting glucose, and total cholesterol blood levels), the presence of strokes at baseline and follow-up, and the regular use of statins over the study years. Cardiovascular risk factors were stratified according to the American Heart Association’s proposed criteria.7 This model was fitted to estimate the mortality hazard ratio (HR) according to CSC severity. All participants signed a comprehensive informed consent at enrolment, and the study was approved by the Ethics Committee of our institution. Medical students continuously visited households where participants live to identify cases with a suspected overt stroke, which was confirmed by a neurologist with the aid of a magnetic resonance image (MRI). In the event of death, certificates were reviewed and verbal autopsies were obtained to ascertain the date and probable cause of death. The last administrative censoring date was set as March 1, 2022. Participants who declined consent and those who emigrated were censored at the last annual survey when the individuals were interviewed, and those who died were censored at the time of death. All these individuals contributed to the total time of follow-up. Of 933 individuals identified during door-to-door surveys, 778 (83%) received a head CT and baseline clinical interviews, and were eligible for this study. The total fol","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"487-489"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40510026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vascular Disease Patient Information Page: Giant cell (temporal) arteritis.","authors":"Samip Sheth,&nbsp;Alexandra Solomon,&nbsp;Brendan Antiochos,&nbsp;Natalie Evans,&nbsp;Elizabeth V Ratchford","doi":"10.1177/1358863X221112187","DOIUrl":"https://doi.org/10.1177/1358863X221112187","url":null,"abstract":"each side of the forehead near the ears. 3 The temporal arteries enlarge, swell, or thicken in many patients with GCA. Although GCA and temporal arteritis are synonymous, GCA can also simulta-neously affect multiple arteries, even smaller arteries in the head and neck, including the ophthalmic, occipital, vertebral, posterior ciliary, or proximal vertebral arteries. Blindness, the most serious complication of GCA, is caused by damage to the posterior ciliary branch of the ophthalmic artery. Inflammation in larger arteries can cause both aneurysm (dilation) or stenosis (narrowing) of the vessel. HLA-DRB1*04 and other genetic mutations.","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"521-524"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40648846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vascular response to stress: Protective action of the bisphosphonate alendronate.","authors":"Pablo H Cutini,&nbsp;Adrián E Campelo,&nbsp;Virginia L Massheimer","doi":"10.1177/1358863X221112168","DOIUrl":"https://doi.org/10.1177/1358863X221112168","url":null,"abstract":"<p><strong>Background: </strong>Since several additional actions of bone bisphosphonates have been proposed, we studied the effect of the bisphosphonate alendronate (ALN) on the vascular response to environmental stress.</p><p><strong>Methods: </strong>Primary cultures of endothelial cells (EC) and vascular smooth muscle cells (VSMC) exposed to strained conditions were employed for experimental evaluation. After ALN treatment, cell migration, proliferation, and angiogenesis assays were performed. The participation of signal transduction pathways in the biochemical action of ALN was also assessed.</p><p><strong>Results: </strong>In VSMC cultures, ALN counteracted the stimulation of cellular migration elicited by the proinflammatory agent lipopolysaccharide (LPS) or by high levels of calcium and phosphorus (osteogenic medium). Indeed, ALN reduced the increase of VSMC proliferation evoked by the stressors. When LPS and osteogenic medium were added simultaneously, the enhancement of cell proliferation dropped to control values in the presence of ALN. The mechanism of action of ALN involved the participation of nitric oxide synthase, mitogen-activated protein kinase (MAPK), and protein kinase C (PKC) signaling pathways. The study revealed that ALN exhibits a proangiogenic action. On EC, ALN enhanced vascular endothelial growth factor (VEGF) synthesis, and induced capillary-like tube formation in a VEGF-dependent manner. The presence of vascular stress conditions (LPS or osteogenic medium) did not modify the proangiogenic action elicited by ALN.</p><p><strong>Conclusion: </strong>The findings presented suggest an extra-bone biological action of ALN, which could contribute to the maintenance of vascular homeostasis avoiding cellular damage elicited by environmental stress.</p>","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"425-432"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40648847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Images in Vascular Medicine Pectoralis minor syndrome - A forgotten vascular compression syndrome.","authors":"Randy K Ramcharitar,&nbsp;Omar Elghawy,&nbsp;Louise Man,&nbsp;Aditya M Sharma,&nbsp;Aditya Peruri,&nbsp;Auh Whan Park,&nbsp;Patrick Norton,&nbsp;Minhaj Khaja,&nbsp;Ramesh Tripathi","doi":"10.1177/1358863X221110925","DOIUrl":"https://doi.org/10.1177/1358863X221110925","url":null,"abstract":"Patient A is a 38-year-old male with left arm pain, swelling, and discoloration for 6 months. Exam was notable for prominent superficial venous collaterals over the left upper arm and shoulder extending into his chest (Urschel’s sign; Panel A, arrows). Symptoms worsened with an elevated arm stress test (EAST) maneuver. Duplex displayed a dampened respirophasic waveform in the left subclavian vein. Venography showed axillary vein obstruction in adducted (Panel B-1, blue arrow) and neutral positions with collateral flow (Panel B-2, blue and yellow arrows). With abduction, axillary vein obstruction was released with improved flow (Panel B-3, green arrow). Patient B is a 36-year-old male with progressive bilateral arm erythema and claudication for 1 year. Arm elevation elicited a left subclavian bruit and improved bilateral blanching arm erythema. The EAST maneuver elicited pain in both arms. The wrist–brachial index (WBI) showed dampened waveforms with both arms in 180 degrees and military positions compared to baseline (Panel C-1). Duplex showed continuous waveforms in subclavian and axillary","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"518-520"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40648848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine learning-based classification of arterial spectral waveforms for the diagnosis of peripheral artery disease in the context of diabetes: A proof-of-concept study.","authors":"Pasha Normahani,&nbsp;Viknesh Sounderajah,&nbsp;Danilo Mandic,&nbsp;Usman Jaffer","doi":"10.1177/1358863X221105113","DOIUrl":"https://doi.org/10.1177/1358863X221105113","url":null,"abstract":"Background: Point-of-care duplex ultrasound has emerged as a promising test for the diagnosis of peripheral artery disease (PAD). However, the interpretation of morphologically diverse Doppler arterial spectral waveforms is challenging and associated with wide inter-observer variation. The aim of this study is to evaluate the utility of machine learning techniques for the diagnosis of PAD from Doppler arterial spectral waveforms sampled at the level of the ankle in patients with diabetes. Methods: In two centres, 590 Doppler arterial spectral waveform images (PAD 369, no-PAD 221) from 305 patients were prospectively collected. Doppler arterial spectral waveform signals were reconstructed. Blinded full lower-limb reference duplex ultrasound results were used to label waveform according to PAD status (i.e., PAD, no-PAD). Statistical metrics and multiscale wavelet variance were extracted as discriminatory features. A long short-term memory (LSTM) network was used for the classification of raw signals, and logistic regression (LR) and support vector machines (SVM) were used for classification of extracted features. Signals and feature vectors were randomly divided into training (80%) and testing (20%) sets. Results: The highest overall accuracy was achieved using a logistic regression model with a combination of statistical and multiscale wavelet variance features, with 88% accuracy, 92% sensitivity, and 82% specificity. The area under the receiver operating characteristics curve (AUC) was 0.93. Conclusion: We have constructed a machine learning algorithm with high discriminatory ability for the diagnosis of PAD using Doppler arterial spectral waveforms sampled at the ankle vessels.","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"450-456"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40240371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The safety and efficacy of 'going long'.","authors":"Andrew Jp Klein","doi":"10.1177/1358863X221110924","DOIUrl":"https://doi.org/10.1177/1358863X221110924","url":null,"abstract":"In this issue of Vascular Medicine, Schroë and colleagues present the 12-month results of the long lesion cohort from the RANGER II Superficial Femoral Artery (SFA) Trial (ClinicalTrials.gov identifier: NCT03064126).1 This cohort is composed of patients who were in the original RANGER II SFA randomized controlled trial (RCT) plus the long balloon substudy, had a baseline lesion measurement &gt; 100 mm, and were treated with a Ranger drug-coated balloon (DCB; Boston Scientific, Natick, MA, USA). This cohort contained symptomatic patients with Rutherford classification 2–4 disease. The major endpoints of the study included target lesion primary patency and freedom from major adverse events (MAEs) at 12 months. A secondary endpoint included changes in Rutherford classification. These are standard outcomes and are comparable to other studies in the field. Though small compared to many coronary interventional trials, a total of 129 patients met criteria for this cohort, which is comparable to many contemporary peripheral DCB trials.1 The mean lesion length was 144.5 ± 31.7 mm, which is more ‘real-world’ given that most RCTs in this vascular bed (SFA) limit lesion length to 80 mm.1 There were an impressive 32.6% total occlusions included, and calcification as graded by the Peripheral Arterial Calcium Scoring System (PACSS) was significant in 58.1% of the patients (grades 3 or 4), which is again illustrative of more ‘real-world’ contemporary SFA lesions. It is in the outcomes of this study where things diverge from other similar studies. Schroë and colleagues report a rather impressive primary patency in this study of 88% at 12 months with a very low adverse event rate of 4.9%, which was entirely accounted for by clinically driven target lesion revascularization (CD-TLR).1 To the interventionalist, outside of mortality, CD-TLR is the most important endpoint, as it reports how many patients needed to come back for repeat procedures – the bane of our existence in this vascular bed. A CD-TLR rate this low, as reported in this study, is unique given the length of lesions included. The most important outcome to report in any DCB trial in today’s climate is mortality, which in this study was very low at 2.4% (3/125) at 12 months.1 This is consistent with the 2019 study by Secemsky et al.2 and underscores the safety of this class of devices, though one might argue this is only 1-year data. In any DCB trial published after 2018, we must first focus on the safety profile of these devices. Most practicing in this field are aware of a controversial 2018 systematic review and meta-analysis performed by Katsanos et al.3 This analysis included 28 RCTs (total of 4663 patients) and identified an increased risk of death at 2 and 5 years posttreatment in patients treated with paclitaxel balloons and/or stents compared to the control arm.3 This study prompted the U.S. Food & Drug Administration (FDA) to release the following statement4: Based on the FDA’s review of available","PeriodicalId":151049,"journal":{"name":"Vascular Medicine (London, England)","volume":" ","pages":"466-468"},"PeriodicalIF":3.5,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40596590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}