Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction

Erin Murphy, Kathleen Gibson, Marc Sapoval, David J Dexter, Raghu Kolluri, Mahmood Razavi, Stephen Black, Erin Murphy, Kathleen Gibson, Marc Sapoval, David J Dexter, Raghu Kolluri, Mahmood Razavi, Stephen Black

Abstract

Background: Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction.

Methods: The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) is a single-arm, multicenter, prospective study that included 200 subjects from 24 global sites. The primary end points were 12-month primary patency and major adverse events within 30 days. Secondary end points included lesion and procedure success, primary-assisted and secondary patency, major adverse events, stent migration, stent fracture, and quality of life changes. End point-related adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively.

Results: Venous obstruction cause was classified as acute deep vein thrombosis (16.5%, 33/200), post-thrombotic syndrome (47.5%, 95/200), or nonthrombotic iliac vein lesion (36.0%, 72/200). The common iliac and external iliac veins were stented in 96.0% (192/200), 80.5% (161/200) of subjects, respectively. Stent implant into the common femoral vein was required in 44.0% (88/200). Primary patency at 12 months was 88.0% (162/184). Four (2.0%) major adverse events occurred within 30 days. Twelve-month primary-assisted and secondary patency were 91.8% (169/184) and 92.9% (171/184), respectively. No stent fractures or migrations were reported. Mean target limb Villalta score decreased from 11.2±5.6 at baseline to 4.1±4.8 at 12 months, and the mean target limb revised Venous Clinical Severity Score decreased from 8.8±4.7 at baseline to 4.3±3.6 at 12 months. Clinically meaningful improvements in quality of life and venous functional assessment scores from baseline were demonstrated through 12 months in all measures.

Conclusions: Symptomatic iliofemoral venous obstruction can be successfully treated with an Abre venous stent. Study outcomes demonstrated a high patency rate with a good safety profile. Patients demonstrated a significant reduction in clinical symptoms and improvement in quality of life that was maintained through 12-month follow-up. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03038438.

Keywords: iliac vein; quality of life; stent; thromboembolism; thrombosis.

Figures

Figure 1.
Figure 1.
Abre venous stent design. The width and thickness of the struts on the Abre venous stent were altered for each stent diameter to achieve strength uniformity of all stent sizes, and the strut radii were opened selectively to achieve maximal fracture resistance. The stent has connection points that spiral down the stent (A, green circles). The stent cells are connected at 3 points around the circumference for maximum flexibility and kink resistance (A, blue squares). The Abre venous stent is easily seen under fluoroscopy (B, C) with 3 radiopaque markers on the cranial and caudal stent ends (see arrows on A, B, and C).
Figure 2.
Figure 2.
Subject compliance flowchart. The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) included 200 subjects with 191 (95.5%) subjects completing the 12-mo follow-up.
Figure 3.
Figure 3.
Kaplan-Meier estimates of patency.A, Primary patency rates through 12 mo across subgroups. B, Patency estimates by Kaplan-Meir estimate through 12 mo. aDVT indicates acute deep vein thrombosis; NIVL, nonthrombotic iliac vein lesion; PAP, primary assisted patency; PP, primary patency; PTS, post-thrombotic syndrome; and SP, secondary patency.
Figure 4.
Figure 4.
Summary of quality of life and functional assessments. Quality of life and functional assessments were taken at baseline (0 d), 6 mo, and 12 mo. Sustained and clinically meaningful improvement were demonstrated for all measures at 12 mo compared with baseline, despite a high proportion of stents crossing the inguinal ligament. A, Venous Insufficiency Epidemiological and Economics Study Quality of Life (VEINES-QoL). B, VEINES-Symptoms. C, Villalta score. D, Revised Venous Clinical Severity Score (VCSS). E, EuroQoL Five Dimensions (EQ-5D). aDVT indicates acute deep vein thrombosis; NIVL, nonthrombotic iliac vein lesion; and PTS, post-thrombotic syndrome.

References

    1. Mahnken AH, Thomson K, de Haan M, O’Sullivan GJ. CIRSE standards of practice guidelines on iliocaval stenting. Cardiovasc Intervent Radiol. 2014;37:889–897. doi: 10.1007/s00270-014-0875-4
    1. Esposito A, Charisis N, Kantarovsky A, Uhl JF, Labropoulos N. A comprehensive review of the pathophysiology and clinical importance of iliac vein obstruction. Eur J Vasc Endovasc Surg. 2020;60:118–125. doi: 10.1016/j.ejvs.2020.03.020
    1. Neglén P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg. 2007;46:979–990. doi: 10.1016/j.jvs.2007.06.046
    1. Raju S, Darcey R, Neglén P. Unexpected major role for venous stenting in deep reflux disease. J Vasc Surg. 2010;51:401–8. discussion 408. doi: 10.1016/j.jvs.2009.08.032
    1. Rossi FH, Kambara AM, Izukawa NM, Rodrigues TO, Rossi CB, Sousa AG, Metzger PB, Thorpe PE. Randomized double-blinded study comparing medical treatment versus iliac vein stenting in chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2018;6:183–191. doi: 10.1016/j.jvsv.2017.11.003
    1. Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, et al. ; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014;130:1636–1661. doi: 10.1161/CIR.0000000000000130
    1. Liu D, Peterson E, Dooner J, Baerlocher M, Zypchen L, Gagnon J, Delorme M, Sing CK, Wong J, Guzman R, et al. ; Interdisciplinary Expert Panel on Iliofemoral Deep Vein Thrombosis (InterEPID). Diagnosis and management of iliofemoral deep vein thrombosis: clinical practice guideline. CMAJ. 2015;187:1288–1296. doi: 10.1503/cmaj.141614
    1. Meissner MH, Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Lohr JM, McLafferty RB, Murad MH, Padberg F, et al. ; Society for Vascular Surgery; American Venous Forum. Early thrombus removal strategies for acute deep venous thrombosis: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2012;55:1449–1462. doi: 10.1016/j.jvs.2011.12.081
    1. Badesha AS, Bains PRS, Bains BRS, Khan T. A systematic review and meta-analysis of the treatment of obstructive chronic deep venous disease using dedicated venous stents. J Vasc Surg Venous Lymphat Disord. 2022;10:267–282.e4. doi: 10.1016/j.jvsv.2021.04.014
    1. Dabir D, Feisst A, Thomas D, Luetkens JA, Meyer C, Kardulovic A, Menne M, Steinseifer U, Schild HH, Kuetting DLR. Physical properties of venous stents: an experimental comparison. Cardiovasc Intervent Radiol. 2018;41:942–950. doi: 10.1007/s00270-018-1916-1
    1. Taha MAH, Busuttil A, Bootun R, Thabet BAH, Badawy AEH, Hassan HA, Shalhoub J, Davies AH. A clinical guide to deep venous stenting for chronic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2022;10:258–266.e1. doi: 10.1016/j.jvsv.2020.12.087
    1. Robertson SW, Launey M, Shelley O, Ong I, Vien L, Senthilnathan K, Saffari P, Schlegel S, Pelton AR. A statistical approach to understand the role of inclusions on the fatigue resistance of superelastic Nitinol wire and tubing. J Mech Behav Biomed Mater. 2015;51:119–131. doi: 10.1016/j.jmbbm.2015.07.003
    1. Vogel JH, Noffke P, Zhang Z, Inventors; Covidien LP, Assignee. Stent with varying radius of curvature between struts. US Patent 10,022,253. 2018.
    1. Alhalbouni S, Hingorani A, Shiferson A, Gopal K, Jung D, Novak D, Marks N, Ascher E. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012;26:185–189. doi: 10.1016/j.avsg.2011.05.033
    1. de Wolf MA, de Graaf R, Kurstjens RL, Penninx S, Jalaie H, Wittens CH. Short-term clinical experience with a dedicated venous nitinol stent: initial results with the sinus-venous stent. Eur J Vasc Endovasc Surg. 2015;50:518–526. doi: 10.1016/j.ejvs.2015.05.011
    1. Ganelin A, Hingorani A, Ascher E, Kheyson B, Iadgarova E, Marks N, Ostrozhynskyy Y. Complications with office-based venoplasties and stenting and their clinical correlation. J Vasc Surg Venous Lymphat Disord. 2015;3:376–379. doi: 10.1016/j.jvsv.2015.03.007
    1. Hartung O, Barthelemy P, Arnoux D, Boufi M, Alimi YS. Management of pregnancy in women with previous left ilio-caval stenting. J Vasc Surg. 2009;50:355–359. doi: 10.1016/j.jvs.2009.01.034
    1. Kölbel T, Lindh M, Akesson M, Wassèlius J, Gottsäter A, Ivancev K. Chronic iliac vein occlusion: midterm results of endovascular recanalization. J Endovasc Ther. 2009;16:483–491. doi: 10.1583/09-2719.1
    1. Kurklinsky AK, Bjarnason H, Friese JL, Wysokinski WE, McBane RD, Misselt A, Moller SM, Gloviczki P. Outcomes of venoplasty with stent placement for chronic thrombosis of the iliac and femoral veins: single-center experience. J Vasc Interv Radiol. 2012;23:1009–1015. doi: 10.1016/j.jvir.2012.04.019
    1. Park JY, Ahn JH, Jeon YS, Cho SG, Kim JY, Hong KC. Iliac vein stenting as a durable option for residual stenosis after catheter-directed thrombolysis and angioplasty of iliofemoral deep vein thrombosis secondary to May-Thurner syndrome. Phlebology. 2014;29:461–470. doi: 10.1177/0268355513491724
    1. Park SI, Lee M, Lee MS, Kim MD, Won JY, Lee DY. Single-session aspiration thrombectomy of lower extremity deep vein thrombosis using large-size catheter without pharmacologic thrombolysis. Cardiovasc Intervent Radiol. 2014;37:412–419. doi: 10.1007/s00270-013-0676-1
    1. Raju S, Ward M, Jr, Kirk O. A modification of iliac vein stent technique. Ann Vasc Surg. 2014;28:1485–1492. doi: 10.1016/j.avsg.2014.02.026
    1. Sang H, Li X, Qian A, Meng Q. Outcome of endovascular treatment in postthrombotic syndrome. Ann Vasc Surg. 2014;28:1493–1500. doi: 10.1016/j.avsg.2014.03.031
    1. Sarici IS, Yanar F, Agcaoglu O, Ucar A, Poyanli A, Cakir S, Aksoy SM, Kurtoglu M. Our early experience with iliofemoral vein stenting in patients with post-thrombotic syndrome. Phlebology. 2014;29:298–303. doi: 10.1177/0268355513477641
    1. Shi WY, Gu JP, Liu CJ, He X, Lou WS. Endovascular treatment for iliac vein compression syndrome with or without lower extremity deep vein thrombosis: a retrospective study on mid-term in-stent patency from a single center. Eur J Radiol. 2016;85:7–14. doi: 10.1016/j.ejrad.2015.10.021
    1. Xue GH, Huang XZ, Ye M, Liang W, Zhang H, Zhang JW, Zhang BG. Catheter-directed thrombolysis and stenting in the treatment of iliac vein compression syndrome with acute iliofemoral deep vein thrombosis: outcome and follow-up. Ann Vasc Surg. 2014;28:957–963. doi: 10.1016/j.avsg.2013.11.012
    1. Ye K, Lu X, Jiang M, Yang X, Li W, Huang Y, Huang X, Lu M. Technical details and clinical outcomes of transpopliteal venous stent placement for postthrombotic chronic total occlusion of the iliofemoral vein. J Vasc Interv Radiol. 2014;25:925–932. doi: 10.1016/j.jvir.2014.02.031
    1. Ye K, Lu X, Li W, Huang Y, Huang X, Lu M, Jiang M. Long-term outcomes of stent placement for symptomatic nonthrombotic iliac vein compression lesions in chronic venous disease. J Vasc Interv Radiol. 2012;23:497–502. doi: 10.1016/j.jvir.2011.12.021
    1. Yin M, Shi H, Ye K, Lu X, Li W, Huang X, Lu M, Jiang M. Clinical assessment of endovascular stenting compared with compression therapy alone in post-thrombotic patients with iliofemoral obstruction. Eur J Vasc Endovasc Surg. 2015;50:101–107. doi: 10.1016/j.ejvs.2015.03.029
    1. Bland JM, Dumville JC, Ashby RL, Gabe R, Stubbs N, Adderley U, Kang’ombe AR, Cullum NA. Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial. BMC Cardiovasc Disord. 2015;15:85. doi: 10.1186/s12872-015-0080-7
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–1736. doi: 10.1007/s11136-011-9903-x
    1. Kahn SR, Lamping DL, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, et al. ; VETO Study. Investigators. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol. 2006;59:1049–1056. doi: 10.1016/j.jclinepi.2005.10.016
    1. Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003;37:410–419. doi: 10.1067/mva.2003.152
    1. Strijkers RH, Wittens CH, Kahn SR. Villalta scale: goals and limitations. Phlebology. 2012;27(Suppl 1):130–135. doi: 10.1258/phleb.2011.012s02
    1. Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working group. J Vasc Surg. 2010;52:1387–1396. doi: 10.1016/j.jvs.2010.06.161
    1. Lichtenberg M, Breuckmann F, Stahlhoff WF, Neglén P, Rick G. Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions - short-term safety, patency, and clinical outcomes. Vasa. 2018;47:475–481. doi: 10.1024/0301-1526/a000731
    1. Lichtenberg M, de Graaf R, Stahlhoff WF, Özkapi A, Simon M, Breuckmann F. Patency rates, safety and clinical results of the sinus-Obliquus venous stent in the treatment of chronic ilio-femoral venous outflow obstruction - data from the Arnsberg venous registry. Vasa. 2019;48:270–275. doi: 10.1024/0301-1526/a000772
    1. Razavi MK, Black S, Gagne P, Chiacchierini R, Nicolini P, Marston W; VIRTUS Investigators. Pivotal study of endovenous stent placement for symptomatic iliofemoral venous obstruction. Circ Cardiovasc Interv. 2019;12:e008268. doi: 10.1161/CIRCINTERVENTIONS.119.008268
    1. Dake M, O'Sullivan G. A prospective, multicenter evaluation of the Venovo self-expanding vascular stent used to treat obstructive lesions of the iliac and femoral veins: 12-month results from the VERNACULAR trial. J Vasc Interv Radiol. 2019;30:3.
    1. Guillen K, Falvo N, Nakai M, Chevallier O, Aho-Glélé S, Galland C, Demaistre E, Pescatori L, Samson M, Audia S, et al. . Endovascular stenting for chronic femoro-iliac venous obstructive disease: clinical efficacy and short-term outcomes. Diagn Interv Imaging. 2020;101:15–23. doi: 10.1016/j.diii.2019.03.014
    1. Murphy EH. Surveying the 2019 venous stent landscape. Endovasc Today. 2019;18:53–64. .
    1. Moeri L, Lichtenberg M, Gnanapiragasam S, Barco S, Sebastian T. Braided or laser-cut self-expanding nitinol stents for the common femoral vein in patients with post-thrombotic syndrome. J Vasc Surg Venous Lymphat Disord. 2021;9:760–769. doi: 10.1016/j.jvsv.2020.08.027

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