Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia

Stefanos Giannopoulos, Eric A Secemsky, Jihad A Mustapha, George Adams, Robert E Beasley, George Pliagas, Ehrin J Armstrong, Stefanos Giannopoulos, Eric A Secemsky, Jihad A Mustapha, George Adams, Robert E Beasley, George Pliagas, Ehrin J Armstrong

Abstract

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

Keywords: amputation; balloon angioplasty; critical limb ischemia; endovascular treatment/therapy; femoropopliteal segment; infrapopliteal arteries; mortality; orbital atherectomy; peripheral artery disease; stent.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Eric A. Secemsky reports grants and modest consulting fees given by Medtronic. Jihad A. Mustapha is a consultant to Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc (CSI), Medtronic, Spectranetics, and Terumo. George Pliagas is a consultant to Cook, Philips, CSI, and Medtronic. Ehrin J. Armstrong is a consultant to Abbott Vascular, Boston Scientific, CSI, Medtronic, Philips, and PQ Bypass.

Figures

Figure 1.
Figure 1.
Kaplan-Meier estimates of freedom from (A) major adverse events (MAEs), (B) all-cause death, (C) major amputation, and (D) target vessel/limb revascularization (TVR/TLR). CLTI, chronic limb-threatening ischemia.

References

    1. Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011;124:17–23.
    1. Fowkes FG, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382:1329–1340.
    1. Hirsch AT, Duval S. The global pandemic of peripheral artery disease. Lancet. 2013;382:1312–1314.
    1. Subherwal S, Patel MR, Kober L, et al. Peripheral artery disease is a coronary heart disease risk equivalent among both men and women: results from a nationwide study. Eur J Prev Cardiol. 2015;22:317–325.
    1. McDermott MM, Hahn EA, Greenland P, et al. Atherosclerotic risk factor reduction in peripheral arterial disease: results of a national physician survey. J Gen Intern Med. 2002;17: 895–904.
    1. Chen DC, Singh GD, Armstrong EJ, et al. Long-term comparative outcomes of patients with peripheral artery disease with and without concomitant coronary artery disease. Am J Cardiol. 2017;119:1146–1152.
    1. Shammas AN, Jeon-Slaughter H, Tsai S, et al. Major limb outcomes following lower extremity endovascular revascularization in patients with and without diabetes mellitus. J Endovasc Ther. 2017;24:376–382.
    1. Thiruvoipati T, Kielhorn CE, Armstrong EJ. Peripheral artery disease in patients with diabetes: epidemiology, mechanisms, and outcomes. World J Diabetes. 2015;6:961–969.
    1. Armstrong EJ, Chen DC, Westin GG, et al. Adherence to guideline-recommended therapy is associated with decreased major adverse cardiovascular events and major adverse limb events among patients with peripheral arterial disease. J Am Heart Assoc. 2014;3:e000697.
    1. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517–538.
    1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–S67.
    1. Levin SR, Arinze N, Siracuse JJ. Lower extremity critical limb ischemia: a review of clinical features and management. Trends Cardiovasc Med. 2020;30:125–130.
    1. Becker F, Robert-Ebadi H, Ricco JB, et al. Chapter I: Definitions, epidemiology, clinical presentation and prognosis. Eur J Vasc Endovasc Surg. 2011;42(suppl 2):S4–S12.
    1. Conte SM, Vale PR. Peripheral arterial disease. Heart Lung Circ. 2018;27:427–432.
    1. Hiatt WR. Medical treatment of peripheral arterial disease and claudication. N Engl J Med. 2001;344:1608–1621.
    1. TASC Steering Committee, Jaff MR, White CJ, et al. An update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Endovasc Ther. 2015;22:663–677.
    1. Tendera M, Aboyans V, Bartelink ML, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–2906.
    1. Peacock JM, Keo HH, Duval S, et al. The incidence and health economic burden of ischemic amputation in Minnesota, 2005-2008. Prev Chronic Dis. 2011;8:A141.
    1. Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg. 2010;51:230–241.
    1. Allie DE, Hebert CJ, Lirtzman MD, et al. Critical limb ischemia: a global epidemic. A critical analysis of current treatment unmasks the clinical and economic costs of CLTI. EuroIntervention. 2005;1:75–84.
    1. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;69:1465–1508.
    1. Jones WS, Dolor RJ, Hasselblad V, et al. Comparative effectiveness of endovascular and surgical revascularization for patients with peripheral artery disease and critical limb ischemia: systematic review of revascularization in critical limb ischemia. Am Heart J. 2014;167:489–498.e7.
    1. Utsunomiya M, Takahara M, Iida O, et al. Limb-based patency after surgical vs endovascular revascularization in patients with chronic limb-threatening ischemia [published online May 20, 2020]. J Endovasc Ther. doi:10.1177/1526602820923388
    1. Swaminathan A, Vemulapalli S, Patel MR, et al. Lower extremity amputation in peripheral artery disease: improving patient outcomes. Vasc Health Risk Manag. 2014;10: 417–424.
    1. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86:64–70.
    1. Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37:898–907.
    1. Bishop PD, Feiten LE, Ouriel K, et al. Arterial calcification increases in distal arteries in patients with peripheral arterial disease. Ann Vasc Surg. 2008;22:799–805.
    1. Halwani DO, Anderson PG, Brott BC, et al. The role of vascular calcification in inducing fatigue and fracture of coronary stents. J Biomed Mater Res B Appl Biomater. 2012;100:292–304.
    1. Schillinger M, Minar E. Percutaneous treatment of peripheral artery disease: novel techniques. Circulation. 2012;126:2433–2440.
    1. Adlakha S, Sheikh M, Wu J, et al. Stent fracture in the coronary and peripheral arteries. J Interv Cardiol. 2010;23:411–419.
    1. Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012;19:480–488.
    1. Mattesini A, Di Mario C. Calcium: a predictor of interventional treatment failure across all fields of cardiovascular medicine. Int J Cardiol. 2017;231:97–98.
    1. Lee MS, Beasley R, Adams GL. Impact of advanced age on procedural and acute angiographic outcomes in patients treated for peripheral artery disease with orbital atherectomy: a CONFIRM Registries subanalysis. J Invasive Cardiol. 2015;27:381–386.
    1. Adams GL, Das T, Lee MS, et al. Subanalysis of the CONFIRM Registries: acute procedural outcomes in claudicant and critical limb ischemia patients with varying levels of calcification treated for peripheral arterial disease with orbital atherectomy. J Invasive Cardiol. 2015;27:516–520.
    1. Abedin M, Tintut Y, Demer LL. Vascular calcification: mechanisms and clinical ramifications. Arterioscler Thromb Vasc Biol. 2004;24:1161–1170.
    1. Erbel R, Schmermund A. Clinical significance of coronary calcification. Arterioscler Thromb Vasc Biol. 2004;24:e172.
    1. Kim TI, Schneider PA. New innovations and devices in the management of chronic limb-threatening ischemia. J Endovasc Ther. 2020;27(4):524–539.
    1. Armstrong EJ, Alam S, Henao S, et al. Multidisciplinary care for critical limb ischemia: current gaps and opportunities for improvement. J Endovasc Ther. 2019;26:199–212.
    1. Armstrong EJ, Shishehbor MH. Commentary: Contemporary outcomes of endovascular interventions for peripheral artery disease: the LIBERTY to determine optimal treatment strategies. J Endovasc Ther. 2019;26:155–157.
    1. Topfer LA, Spry C. New technologies for the treatment of peripheral artery disease. 2018 Apr 1. In: CADTH Issues in Emerging Health Technologies. Canadian Agency for Drugs and Technologies in Health; 2016, p172 Accessed June 1, 2020
    1. Foley TR, Cotter RP, Kokkinidis DG, et al. Mid-term outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of femoropopliteal disease. Catheter Cardiovasc Interv. 2017;89:1078–1085.
    1. Li F, McDermott MM, Li D, et al. The association of lesion eccentricity with plaque morphology and components in the superficial femoral artery: a high-spatial-resolution, multi-contrast weighted CMR study. J Cardiovasc Magn Reson. 2010;12:37.
    1. Adams GL, Khanna PK, Staniloae CS, et al. Optimal techniques with the Diamondback 360 degrees system achieve effective results for the treatment of peripheral arterial disease. J Cardiovasc Transl Res. 2011;4:220–229.
    1. Heuser RR. Treatment of lower extremity vascular disease: the Diamondback 360 degrees orbital atherectomy system. Expert Rev Med Devices. 2008;5:279–286.
    1. Safian RD, Niazi K, Runyon JP, et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial. Catheter Cardiovasc Interv. 2009;73:406–412.
    1. Korabathina R, Mody KP, Yu J, et al. Orbital atherectomy for symptomatic lower extremity disease. Catheter Cardiovasc Interv. 2010;76:326–332.
    1. Makam P. Use of orbital atherectomy treatment in a high-volume clinical practice modifies non-compliant plaque to deliver durable long-term results. J Invasive Cardiol. 2013;25:85–88.
    1. Kokkinidis DG, Jawaid O, Cantu D, et al. Two-year outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of heavily calcified femoropopliteal lesions. J Endovasc Ther. 2020;27:492–501.
    1. Mustapha J, Gray W, Martinsen BJ, et al. One-year results of the LIBERTY 360 study: evaluation of acute and midterm clinical outcomes of peripheral endovascular device interventions. J Endovasc Ther. 2019;26:143–154.
    1. Adams GL, Mustapha J, Gray W, et al. The LIBERTY study: design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease. Am Heart J. 2016;174:14–21.
    1. Antoniou GA, Georgiadis GS, Antoniou SA, et al. Bypass surgery for chronic lower limb ischaemia. Cochrane Database Syst Rev. 2017;4:cd002000.
    1. Goksel OS, Karpuzoglu E, Issever H, et al. Midterm results with drug-coated balloons for SFA lesions in patients with CLTI: comparison with conventional bypass surgery. Int Angiol. 2018;37:365–369.
    1. Goodney PP, Beck AW, Nagle J, et al. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009;50:54–60.
    1. Hallett JW, Jr, Byrne J, Gayari MM, et al. Impact of arterial surgery and balloon angioplasty on amputation: a population-based study of 1155 procedures between 1973 and 1992. J Vasc Surg. 1997;25:29–38.
    1. Nehler MR, Coll JR, Hiatt WR, et al. Functional outcome in a contemporary series of major lower extremity amputations. J Vasc Surg. 2003;38:7–14.
    1. Writing Committee M, Gerhard-Herman MD, Gornik HL, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary. Vasc Med. 2017;22:NP1–NP43.
    1. Katsanos K, Kitrou P, Spiliopoulos S, et al. Comparative effectiveness of plain balloon angioplasty, bare metal stents, drug-coated balloons, and drug-eluting stents for the treatment of infrapopliteal artery disease: systematic review and Bayesian network meta-analysis of randomized controlled trials. J Endovasc Ther. 2016;23:851–863.
    1. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–1888.
    1. Shammas NW, Dippel EJ, Coiner D, et al. Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry. J Endovasc Ther. 2008;15:270–276.
    1. Lee MS, Heikali D, Mustapha J, et al. Acute procedural outcomes of orbital atherectomy for the treatment of common femoral artery disease: sub-analysis of the CONFIRM Registries. Vasc Med. 2017;22:301–306.
    1. Lee MS, Canan T, Rha SW, et al. Pooled analysis of the CONFIRM Registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease. J Endovasc Ther. 2015;22:57–62.
    1. Das T, Mustapha J, Indes J, et al. Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry. Catheter Cardiovasc Interv. 2014;83:115–122.
    1. Thukkani AK, Kinlay S. Endovascular intervention for peripheral artery disease. Circ Res. 2015;116:1599–1613.

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