Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study

References

• 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(1):17–23. doi:10.1161/CIRCULATIONAHA.110.003954
   PubMed Web of Science ®Google Scholar
• 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(9901):1329–1340. doi:10.1016/S0140-6736(13)61249-0
   PubMed Web of Science ®Google Scholar
• 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(3):317–325. doi:10.1177/2047487313519344
   PubMed Web of Science ®Google Scholar
• 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(12):895–904. doi:10.1046/j.1525-1497.2002.20307.x
   PubMed Web of Science ®Google Scholar
• Chen DC, Singh GD, Armstrong EJ, Waldo SW, Laird JR, Amsterdam EA. Long-term comparative outcomes of patients with peripheral artery disease with and without concomitant coronary artery disease. Am J Cardiol. 2017;119(8):1146–1152. doi:10.1016/j.amjcard.2016.12.023
   PubMed Web of Science ®Google Scholar
• Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–S67. doi:10.1016/j.jvs.2006.12.037
   PubMed Web of Science ®Google Scholar
• Levin SR, Arinze N, Siracuse JJ. Lower extremity critical limb ischemia: a review of clinical features and management. Trends Cardiovasc Med. 2019.
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/S1078-5884(11)60009-9
   PubMedGoogle Scholar
• Jaff MR, White CJ, Hiatt WR, 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): the TASC steering committee. Ann Vasc Dis. 2015;8(4):343–357. doi:10.3400/avd.tasc.15-01000
   PubMedGoogle Scholar
• 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(22):2851–2906. doi:10.1093/eurheartj/ehr211
   PubMed Web of Science ®Google Scholar
• 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(6):A141.
   PubMed Web of Science ®Google Scholar
• Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg. 2010;51(1):230–241. doi:10.1016/j.jvs.2009.08.073
   PubMed Web of Science ®Google Scholar
• 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 CLI. EuroIntervention. 2005;1(1):75–84.
   PubMedGoogle Scholar
• Sachs T, Pomposelli F, Hamdan A, Wyers M, Schermerhorn M. Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft. J Vasc Surg. 2011;54(4):1021–1031.e1021. doi:10.1016/j.jvs.2011.03.281
   PubMed Web of Science ®Google Scholar
• Rudofker EW, Hogan SE, Armstrong EJ. Preventing major amputations in patients with critical limb ischemia. Curr Cardiol Rep. 2018;20(9):74. doi:10.1007/s11886-018-1019-2
   PubMed Web of Science ®Google Scholar
• 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(11):1465–1508. doi:10.1016/j.jacc.2016.11.008
   PubMed Web of Science ®Google Scholar
• 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(4):489–498.e487. doi:10.1016/j.ahj.2013.12.012
   PubMed Web of Science ®Google Scholar
• Jones WS, Schmit KM, Vemulapalli S, et al. AHRQ Comparative Effectiveness Reviews. In: Treatment Strategies for Patients with Peripheral Artery Disease. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 May. Report No.: 13-EHC090-EF.
   Google Scholar
• Swaminathan A, Vemulapalli S, Patel MR, Jones WS. Lower extremity amputation in peripheral artery disease: improving patient outcomes. Vasc Health Risk Manag. 2014;10:417–424. doi:10.2147/VHRM.S50588
   PubMedGoogle Scholar
• 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(2):143–154. doi:10.1177/1526602819827295
   PubMed Web of Science ®Google Scholar
• Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak RM. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009;50(1):54–60. doi:10.1016/j.jvs.2009.01.035
   PubMed Web of Science ®Google Scholar
• Gerhard-Herman M, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary. Vasc Med. 2017;22(3):NP1–NP43. doi:10.1177/1358863X17701592
   PubMed Web of Science ®Google Scholar
• Katsanos K, Kitrou P, Spiliopoulos S, Diamantopoulos A, Karnabatidis D. 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(6):851–863. doi:10.1177/1526602816671740
   PubMed Web of Science ®Google Scholar
• 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(18):1879–1888. doi:10.1056/NEJMoa051303
   PubMed Web of Science ®Google Scholar
• Bunte MC, House JA, Spertus JA, Cohen DJ, Marso SP, Safley DM. Association between health status and long-term mortality after percutaneous revascularization of peripheral artery disease. Catheter Cardiovasc Interv. 2016;87(6):1149–1155. doi:10.1002/ccd.26442
   PubMed Web of Science ®Google Scholar
• Jones WS, Patel MR, Tsai TT, et al. Anatomic runoff score predicts cardiovascular outcomes in patients with lower extremity peripheral artery disease undergoing revascularization. Am Heart J. 2015;170(2):400–408. doi:10.1016/j.ahj.2015.04.026
   PubMed Web of Science ®Google Scholar
• Chang SH, Tsai YJ, Chou HH, et al. Clinical predictors of long-term outcomes in patients with critical limb ischemia who have undergone endovascular therapy. Angiology. 2014;65(4):315–322. doi:10.1177/0003319713515544
   PubMed Web of Science ®Google Scholar
• O’Brien-Irr MS, Dosluoglu HH, Harris LM, Dryjski ML. Outcomes after endovascular intervention for chronic critical limb ischemia. J Vasc Surg. 2011;53(6):1575–1581. doi:10.1016/j.jvs.2011.01.068
   PubMed Web of Science ®Google Scholar
• Krishnamurthy V, Munir K, Rectenwald JE, et al. Contemporary outcomes with percutaneous vascular interventions for peripheral critical limb ischemia in those with and without poly-vascular disease. Vasc Med. 2014;19(6):491–499. doi:10.1177/1358863X14552013
   PubMed Web of Science ®Google Scholar
• Meltzer AJ, Shrikhande G, Gallagher KA, et al. Heart failure is associated with reduced patency after endovascular intervention for symptomatic peripheral arterial disease. J Vasc Surg. 2012;55(2):353–362. doi:10.1016/j.jvs.2011.08.016
   PubMed Web of Science ®Google Scholar
• Chen DC, Armstrong EJ, Singh GD, Amsterdam EA, Laird JR. Adherence to guideline-recommended therapies among patients with diverse manifestations of vascular disease. Vasc Health Risk Manag. 2015;11:185–192. doi:10.2147/VHRM.S76651
   PubMed Web of Science ®Google Scholar
• Ortmann J, Nuesch E, Cajori G, et al. Benefit of immediate revascularization in women with critical limb ischemia in an intention-to-treat analysis. J Vasc Surg. 2011;54(6):1668–1678. doi:10.1016/j.jvs.2011.06.110
   PubMed Web of Science ®Google Scholar
• McCoach CE, Armstrong EJ, Singh S, et al. Gender-related variation in the clinical presentation and outcomes of critical limb ischemia. Vasc Med. 2013;18(1):19–26. doi:10.1177/1358863X13475836
   PubMed Web of Science ®Google Scholar
• Hirsch AT, Allison MA, Gomes AS, et al. A call to action: women and peripheral artery disease: a scientific statement from the American Heart Association. Circulation. 2012;125(11):1449–1472. doi:10.1161/CIR.0b013e31824c39ba
   PubMed Web of Science ®Google Scholar
• Egorova N, Vouyouka AG, Quin J, et al. Analysis of gender-related differences in lower extremity peripheral arterial disease. J Vasc Surg. 2010;51(2):372–378.e371;discussion 378–379. doi:10.1016/j.jvs.2009.09.006
   Web of Science ®Google Scholar
• Pulli R, Dorigo W, Pratesi G, Fargion A, Angiletta D, Pratesi C. Gender-related outcomes in the endovascular treatment of infrainguinal arterial obstructive disease. J Vasc Surg. 2012;55(1):105–112. doi:10.1016/j.jvs.2011.07.050
   PubMed Web of Science ®Google Scholar
• Soga Y, Iida O, Takahara M, et al. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014;7(12):1444–1449. doi:10.1016/j.jcin.2014.06.018
   PubMed Web of Science ®Google Scholar
• Armstrong EJ, Wu J, Singh GD, et al. Smoking cessation is associated with decreased mortality and improved amputation-free survival among patients with symptomatic peripheral artery disease. J Vasc Surg. 2014;60(6):1565–1571. doi:10.1016/j.jvs.2014.08.064
   PubMed Web of Science ®Google Scholar
• Armstrong EJ, Chen DC, Singh GD, Amsterdam EA, Laird JR. Angiotensin-converting enzyme inhibitor or angiotensin receptor blocker use is associated with reduced major adverse cardiovascular events among patients with critical limb ischemia. Vasc Med. 2015;20(3):237–244. doi:10.1177/1358863X15574321
   PubMed Web of Science ®Google Scholar
• Westin GG, Armstrong EJ, Bang H, et al. Association between statin medications and mortality, major adverse cardiovascular event, and amputation-free survival in patients with critical limb ischemia. J Am Coll Cardiol. 2014;63(7):682–690. doi:10.1016/j.jacc.2013.09.073
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/j.ahj.2015.12.013
   PubMed Web of Science ®Google Scholar
• Vogel TR, Dombrovskiy VY, Carson JL, Graham AM. In-hospital and 30-day outcomes after tibioperoneal interventions in the US Medicare population with critical limb ischemia. J Vasc Surg. 2011;54(1):109–115. doi:10.1016/j.jvs.2010.12.055
   PubMed Web of Science ®Google Scholar
• Iida O, Soga Y, Hirano K, et al. Midterm outcomes and risk stratification after endovascular therapy for patients with critical limb ischaemia due to isolated below-the-knee lesions. Eur J Vasc Endovasc Surg. 2012;43(3):313–321. doi:10.1016/j.ejvs.2011.11.025
   PubMed Web of Science ®Google Scholar
• Khaira KB, Brinza E, Singh GD, et al. Long-term outcomes in patients with critical limb ischemia and heart failure with preserved or reduced ejection fraction. Vasc Med. 2017;22(4):307–315. doi:10.1177/1358863X17714153
   PubMed Web of Science ®Google Scholar
• Singh GD, Armstrong EJ, Waldo SW, et al. Non-compressible ABIs are associated with an increased risk of major amputation and major adverse cardiovascular events in patients with critical limb ischemia. Vasc Med. 2017;22(3):210–217. doi:10.1177/1358863X16689831
   PubMed Web of Science ®Google Scholar
• Lansky AJ, Ng VG, Maehara A, et al. Gender and the extent of coronary atherosclerosis, plaque composition, and clinical outcomes in acute coronary syndromes. JACC Cardiovasc Imaging. 2012;5(3 Suppl):S62–S72. doi:10.1016/j.jcmg.2012.02.003
   PubMed Web of Science ®Google Scholar
• Forster A, Gass A, Kern R, et al. Gender differences in acute ischemic stroke: etiology, stroke patterns and response to thrombolysis. Stroke. 2009;40(7):2428–2432. doi:10.1161/STROKEAHA.109.548750
   PubMed Web of Science ®Google Scholar
• Norris CM, Johnson NL, Hardwicke-Brown E, McEwan M, Pelletier R, Pilote L. The contribution of gender to apparent sex differences in health status among patients with coronary artery disease. J Womens Health (Larchmt). 2017;26(1):50–57. doi:10.1089/jwh.2016.5744
   PubMed Web of Science ®Google Scholar
• Shishehbor MH, White CJ, Gray BH, et al. Critical limb ischemia: an expert statement. J Am Coll Cardiol. 2016;68(18):2002–2015. doi:10.1016/j.jacc.2016.04.071
   PubMed Web of Science ®Google Scholar
• Suckow BD, Goodney PP, Nolan BW, et al. Domains that determine quality of life in vascular amputees. Ann Vasc Surg. 2015;29(4):722–730. doi:10.1016/j.avsg.2014.12.005
   PubMed Web of Science ®Google Scholar
• Ramkumar N, Suckow BD, Brown JR, et al. Role of sex in determining treatment type for patients undergoing endovascular lower extremity revascularization. J Am Heart Assoc. 2019;8(17):e013088. doi:10.1161/JAHA.119.013088
   PubMed Web of Science ®Google Scholar
• Eugster T, Gurke L, Obeid T, Stierli P. Infrainguinal arterial reconstruction: female gender as risk factor for outcome. Eur J Vasc Endovasc Surg. 2002;24(3):245–248. doi:10.1053/ejvs.2002.1712
   PubMed Web of Science ®Google Scholar
• Vouyouka AG, Egorova NN, Salloum A, et al. Lessons learned from the analysis of gender effect on risk factors and procedural outcomes of lower extremity arterial disease. J Vasc Surg. 2010;52(5):1196–1202. doi:10.1016/j.jvs.2010.05.106
   PubMed Web of Science ®Google Scholar
• Magnant JG, Cronenwett JL, Walsh DB, Schneider JR, Besso SR, Zwolak RM. Surgical treatment of infrainguinal arterial occlusive disease in women. J Vasc Surg. 1993;17(1):67–76; discussion 76–68. doi:10.1016/0741-5214(93)90010-J
   PubMed Web of Science ®Google Scholar
• Choi KH, Park TK, Kim J, et al. Sex differences in outcomes following endovascular treatment for symptomatic peripheral artery disease: an analysis from the K- VIS ELLA registry. J Am Heart Assoc. 2019;8(2):e010849. doi:10.1161/JAHA.118.010849
   PubMed Web of Science ®Google Scholar
• Schaumeier MJ, Hawkins AT, Hevelone ND, Sethi RKV, Nguyen LL. Association of treatment for critical limb ischemia with gender and hospital volume. Am Surg. 2018;84(6):1069–1078.
   PubMed Web of Science ®Google Scholar
• Miller SM, Sumpio BJ, Miller MS, Erben Y, Cordova AC, Sumpio BE. Higher inpatient mortality for women after intervention for lifestyle limiting claudication. Ann Vasc Surg. 2019;58:54–62. doi:10.1016/j.avsg.2019.01.006
   PubMed Web of Science ®Google Scholar
• Ferranti KM, Osler TM, Duffy RP, Stanley AC, Bertges DJ. Association between gender and outcomes of lower extremity peripheral vascular interventions. J Vasc Surg. 2015;62(4):990–997. doi:10.1016/j.jvs.2015.03.066
   PubMed Web of Science ®Google Scholar
• Fernandez N, McEnaney R, Marone LK, et al. Multilevel versus isolated endovascular tibial interventions for critical limb ischemia. J Vasc Surg. 2011;54(3):722–729. doi:10.1016/j.jvs.2011.03.232
   PubMed Web of Science ®Google Scholar
• Ortmann J, Nuesch E, Traupe T, Diehm N, Baumgartner I. Gender is an independent risk factor for distribution pattern and lesion morphology in chronic critical limb ischemia. J Vasc Surg. 2012;55(1):98–104. doi:10.1016/j.jvs.2011.07.074
   PubMed Web of Science ®Google Scholar
• Kumakura H, Kanai H, Araki Y, et al. Sex-related differences in Japanese patients with peripheral arterial disease. Atherosclerosis. 2011;219(2):846–850. doi:10.1016/j.atherosclerosis.2011.08.037
   PubMed Web of Science ®Google Scholar
• Diehm N, Shang A, Silvestro A, et al. Association of cardiovascular risk factors with pattern of lower limb atherosclerosis in 2659 patients undergoing angioplasty. Eur J Vasc Endovasc Surg. 2006;31(1):59–63. doi:10.1016/j.ejvs.2005.09.006
   PubMed Web of Science ®Google Scholar