Performance of stenting in femoropopliteal disease: a systematic literature review and meta-analysis of proportions
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: To evaluate the performance of four stent types (BMS, bare metal stents; Eluvia, a polymer-based paclitaxel-eluting stent; Viabahn, a covered stent; and Zilver PTX, a polymer-free paclitaxel-coated stent) in femoropopliteal lesions at 12 and 24 months using a meta-analysis of proportions. Materials & methods: This systematic review (PROSPERO CRD42024528559) used PubMed to identify relevant single-arm and comparative studies (with ≥50 patients/study) published between 1 January 2009 and 1 July 2024. Data on patient/lesion characteristics and outcomes were extracted. Subgroup analyses were based on lesion length (<150 mm vs ≥150 mm) and study quality. A random-intercept logistic regression model was used to pool the data. The 95% CI around the pooled effect was calculated using Knapp–Hartung adjustments. Results: Data were extracted from 141 of the 870 screened studies, corresponding to 35,897 patients. The mean patient age was 70.9 (range: 63.3–80.0) years; 69.6% were male. The overall mean lesion length was 153.1 (range: 37–330) mm. Although all stent types performed well in the main analysis, Eluvia exhibited consistently high primary patency and low target lesion revascularization rates at both timepoints and across lesion lengths. Mortality rates for all stent types were stable for short lesions but more variable for long lesions. Conclusion: All stents used in short lesions performed well; however, Eluvia also demonstrated reliable performance in long lesions.
Plain language summary: How well do stents work for blocked arteries between the hip & the knee: an overview of published evidence
What is this article about?
Stenting is one of the treatments available for narrowed or blocked leg arteries. This study focused on four different stent types that are used in the artery that runs between the hip and the knee. We reviewed the available scientific literature on these stents and then combined the results from different studies to find out how often stenting is successful at keeping the artery open for 1 year and for 2 years. We also looked at the success of stents used in long or short sections of closed off artery.
What were the results?
We combined the results from 141 studies that looked at 35,897 patients overall. The average performance and a range where 95% of the results would fall (the 95% CI) was calculated. Although all stents performed well, one stent infused with a drug had a range that did not overlap with the other stents, this could mean that this stent has a better performance.
Why is this important?
The results of this analysis provide a summary of the performance of the different stent types which can help physicians understand the options available to them.
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References
Papers of special note have been highlighted as: • of interest
1.
Aronow WS. Peripheral arterial disease of the lower extremities. Arch. Med. Sci. 8(2), 375–388 (2012).
2.
Jones WS, Patel MR, Dai D et al. High mortality risks after major lower extremity amputation in Medicare patients with peripheral artery disease. Am. Heart J. 165(5), 809–815; 815.e1 (2013).
3.
Gerhard-Herman MD, Gornik HL, Barrett C et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 135(12), e726–e779 (2017).
4.
Johnson AP, Swaminathan RV, Minc SD, Gutierrez JA. Femoropopliteal interventions for peripheral artery disease: a review of current evidence and future directions. Int. Cardiol. Clin. 14(2), 243–256 (2025).
5.
Debing E, Aerden D, Vanhulle A, Gallala S, von Kemp K. Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: the Belgian diabetic IN.PACT Trial. J. Cardiovasc. Surg. 58(4), 528–534 (2017).
6.
Mosarla RC, Armstrong E, Bitton-Faiwiszewski Y, Schneider PA, Secemsky EA. State-of-the-art endovascular therapies for the femoropopliteal segment: are we there yet? J. Soc. Cardiovasc. Angiogr. Interv. 1(5), 100439 (2022).
7.
Tepe G, Brodmann M, Micari A et al. 5-year outcomes of drug-coated balloons for peripheral artery in-stent restenosis, long lesions, and CTOs. JACC Cardiovasc. Interv. 16(9), 1065–1078 (2023).
8.
Gouëffic Y, Brodmann M, Deloose K, Dubosq-Lebaz M, Nordanstig J. Drug-eluting devices for lower limb peripheral arterial disease. EuroIntervention 20(18), e1136–e1153 (2024).
9.
Katsanos K, Spiliopoulos S, Karunanithy N, Krokidis M, Sabharwal T, Taylor P. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J. Vasc. Surg. 59(4), 1123–1133.e8 (2014).
10.
Zhou Y, Shu C, Zhang Z, Wang T, He H, Li Q. Optimal endovascular strategy for femoropopliteal claudication and infrapopliteal CLTI: a network meta-analysis stratified by lesion length. Cardiovasc. Interv. Ther. 41(1), 123–140 (2026).
11.
Gray WA, Keirse K, Soga Y et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet 392(10157), 1541–1551 (2018).
• This is a randomized, single-blinded study that compares the efficacy and safety of Zilver PTX and Eluvia. It is a multicentre study, that includes 465 patients. The study demonstrates noninferiority at 12 months.
12.
Gouëffic Y, Torsello G, Zeller T et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: primary results of the EMINENT randomized trial. Circulation 146(21), 1564–1576 (2022).
• This is a multicentre randomized controlled trial, that compares drug-eluting stents to bare metal stents. It includes 775 patients overall and reports primary patency, target lesion revascularization, primary sustained clinical improvement and health-related quality of life measures.
13.
Gouëffic Y, Sauguet A, Desgranges P et al. A polymer-free paclitaxel-eluting stent versus a bare-metal stent for de novo femoropopliteal lesions: the BATTLE trial. JACC Cardiovasc. Interv. 13(4), 447–457 (2020).
14.
Page MJ, McKenzie JE, Bossuyt PM et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 372, n71 (2021).
15.
Viechtbauer W. Conducting meta-analyses in R with the metafor package. J. Stat. Soft. 36(3), 1–48. (2010).
16.
Balduzzi S, Rücker G, Schwarzer G. How to perform a meta-analysis with R: a practical tutorial. Evid. Based Ment. Health 22(4), 153–160 (2019).
17.
Knol MJ, Pestman WR, Grobbee DE. The (mis)use of overlap of confidence intervals to assess effect modification. Eur. J. Epidemiol. 26(4), 253–254 (2011).
18.
Cho J, Seo DM, Uh Y. Clinical application of overlapping confidence intervals for monitoring changes in serial clinical chemistry test results. Ann. Lab. Med. 40(3), 201–208 (2020).
19.
Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J. Epidemiol. Commun. Health 52(6), 377–384 (1998).
20.
Abi-Khalil J, Astarci P, Elens M. Comparison of interwoven nitinol and drug-eluting stents for endovascular treatment of femoropopliteal artery disease. Surg. Tech. Int. 40, sti40/1532 (2022).
21.
AbuRahma AF, Beasley M, AbuRahma ZT et al. Clinical outcome of drug-eluted stenting (Zilver PTX) in patients with femoropopliteal occlusive disease a single center experience. J. Endovasc. Ther. 29(3), 350–360 (2022).
22.
Armstrong EJ, Saeed H, Alvandi B et al. Nitinol self-expanding stents vs. balloon angioplasty for very long femoropopliteal lesions. J. Endovasc. Ther. 21(1), 34–43 (2014).
23.
Armstrong EJ, Jeon-Slaughter H, Kahlon RS, Niazi KA, Shammas NW, Banerjee S. Comparative outcomes of supera interwoven nitinol vs bare nitinol stents for the treatment of femoropopliteal disease: insights from the XLPAD Registry. J. Endovasc. Ther. 27(1), 60–65 (2020).
24.
Astarcıoglu MA, Kılıt C, Sen T et al. One-year results of primary stenting for TASC II D lesions of the superficial femoral and popliteal arteries. Acta Cardiol. 72(1), 36–40 (2017).
25.
Bausback Y, Wittig T, Schmidt A et al. Drug-eluting stent versus drug-coated balloon revascularization in patients with femoropopliteal arterial disease. J. Am. Coll. Cardiol. 73(6), 667–679 (2019).
26.
Bertges DJ, Eldrup-Jorgensen J, Robbins S et al. Vascular quality initiative surveillance of femoropopliteal artery paclitaxel devices. JACC Cardiovasc. Interv. 14(23), 2598–2609 (2021).
27.
Bianchini Massoni C, Strozzi F, Epifani E et al. Real-world outcomes of Cook Zilver PTX in femoro-popliteal district from multicenter experience. Int. Angiol. 42(1), 9–18 (2023).
28.
Bisdas T, Beropoulis E, Argyriou A, Torsello G, Stavroulakis K. 1-year all-comers analysis of the Eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC Cardiovasc. Interv. 11(10), 957–966 (2018).
29.
Bosiers M, Torsello G, Gissler H-M et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J. Endovasc. Ther. 16(3), 261–269 (2009).
30.
Bosiers M, Deloose K, Callaert J et al. Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions. J. Vasc. Surg. 54(4), 1042–1050 (2011).
31.
Bosiers M, Deloose K, Callaert J et al. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J. Endovasc. Ther. 22(1), 1–10 (2015).
32.
Bosiers M, Donato G, Torsello G et al. ZILVERPASS Study: ZILVER PTX stent vs. bypass surgery in femoropopliteal lesions, 3 year results and economic analysis. J. Cardiovasc. Surg. 64(4), 413–421 (2023).
33.
Bunte MC, Cohen DJ, Jaff MR et al. Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study. Catheter Cardiovasc. Interv. 92(1), 106–114 (2018).
34.
Chan YC, Cheng SW, Cheung GC. Predictors of restenosis in the use of helical interwoven nitinol stents to treat femoropopliteal occlusive disease. J. Vasc. Surg. 62(5), 1201–1209 (2015).
35.
Cheban AV, Osipova OS, Ignatenko PV et al. One-year results of long femoropopliteal lesions stenting with fasciotomy lamina vastoadductoria. Ann. Vasc. Surg. 88, 100–107 (2023).
36.
Dake MD, Ansel GM, Jaff MR et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J. Am. Coll. Cardiol. 61(24), 2417–2427 (2013).
37.
Dake MD, Ansel GM, Jaff MR et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation 133(15), 1472–1483; discussion 1483 (2016).
38.
Davaine J-M, Azéma L, Guyomarch B et al. One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions (the STELLA “STEnting Long de L'Artère fémorale superficielle” cohort). Eur. J. Vasc. Endovasc. Surg. 44(4), 432–441 (2012).
39.
Davaine JM, Quérat J, Guyomarch B et al. Incidence and the clinical impact of stent fractures after primary stenting for TASC C and D femoropopliteal lesions at 1 year. Eur. J. Vasc. Endovasc. Surg. 46(2), 201–212 (2013).
40.
Dearing DD, Patel KR, Compoginis JM, Kamel MA, Weaver FA, Katz SG. Primary stenting of the superficial femoral and popliteal artery. J. Vasc. Surg. 50(3), 542–547 (2009).
41.
Dick P, Wallner H, Sabeti S et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc. Interv. 74(7), 1090–1095 (2009).
42.
Elmahdy MF, Buonamici P, Trapani M et al. Long-term primary patency rate after nitinol self-expandable stents implantation in long, totally occluded femoropopliteal (TASC II C & D) lesions. Heart Lung Circ. 26(6), 604–611 (2017).
43.
Falkowski A, Bogacki H, Szemitko M. Assessment of mortality and factors affecting outcome of use of paclitaxel-coated stents and bare metal stents in femoropopliteal PAD. JCM 9(7), 2221 (2020).
44.
Fujihara M, Utsunomiya M, Higashimori A, Yokoi Y, Nakamura M. Outcomes of Zilver PTX stent implantation for the treatment of complex femoropopliteal artery disease. Heart Vessels 31(2), 152–157 (2016).
45.
Fujihara M, Takahara M, Iida O et al. Endovascular therapy with interwoven nitinol stent placement after predilation for heavily calcified femoropopliteal artery disease: results of the BURDOCK study. J. Vasc. Interv. Radiol. 34(11), 1929–1937 (2023).
46.
Gabrielli R, Rosati MS, Chiappa R et al. First clinical experience with the Innova versus the Protege EverFlex self-expanding bare metal stents in superficial femoral artery occlusions. Thorac. Cardiovasc. Surg. 63(2), 158–163 (2015).
47.
Garcia L, Jaff MR, Metzger C et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: twelve-month results of the SUPERB trial. Circ. Cardiovasc. Interv. 8(5), e000937 (2015).
48.
Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J. Vasc. Surg. 58(2), 386–95.e4 (2013).
49.
Golzar J, Soga Y, Babaev A et al. Effectiveness and safety of a paclitaxel-eluting stent for superficial femoral artery lesions up to 190 mm: one-year outcomes of the single-arm IMPERIAL long lesion substudy of the Eluvia drug-eluting stent. J. Endovasc. Ther. 27(2), 296–303 (2020).
50.
Gostev AA, Osipova OS, Saaya SB et al. Bypass versus interwoven nitinol stents for long femoro-popliteal occlusions: a propensity matched analysis. Cardiovasc. Interv. Radiol. 45(7), 929–938 (2022).
51.
Gostev AA, Osipova OO, Cheban AV et al. Treatment of long femoropopliteal occlusive lesions with self-expanding interwoven nitinol stent: 24 month outcomes of the STELLA-SUPERA-SIBERIA register trial. J. Endovasc. Ther. 32(1), 192–198 (2025).
52.
Gray WA, Cardenas J, Teigen CL. Evaluation of safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System (OPEN study). Catheter Cardiovasc. Interv. 100(6), 1078–1087 (2022).
53.
Guo X, Xue G, Huang X et al. Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study. BMC Cardiovasc. Disord. 15, 44 (2015).
54.
Guzzardi G, Spinazzola A, Cangiano G et al. Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study. J. Public Health Res. 11(1), 2360 (2021).
55.
Haine A, Schmid MJ, Schindewolf M et al. Comparison between interwoven nitinol and drug eluting stents for endovascular treatment of femoropopliteal artery disease. Eur. J. Vasc. Endovasc. Surg. 58(6), 865–873 (2019).
56.
Hendriks JM, Dubois M, Lauwers P et al. Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry. J. Cardiovasc. Surg. 61(1), 84–92 (2020).
57.
Horie K, Takahara M, Nakama T et al. Retrospective multicenter comparison between Viabahn covered stent-grafts and Supera Interwoven Nitinol Stents for endovascular treatment in severely calcified femoropopliteal artery disease: the ARMADILLO study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns). J. Endovasc. Ther. 31(3), 400–409 (2024).
58.
Horie K, Takahara M, Nakama T et al. Multicenter registry of common femoral artery disease treated with endovascular revascularization using interwoven nitinol stents: an observational retrospective study. J. Endovasc. Ther. 32(6), 2039–2049 (2025).
59.
Hu H, Zhang H, He Y et al. Endovascular nitinol stenting for long occlusive disease of the superficial femoral artery in critical limb ischemia: a single-center, mid-term result. Ann. Vasc. Surg. 25(2), 210–216 (2011).
60.
Ichihashi S, Shibata T, Fujimura N et al. Vessel calcification as a risk factor for in-stent restenosis in complex femoropopliteal lesions after Zilver PTX paclitaxel-coated stent placement. J. Endovasc. Ther. 26(5), 613–620 (2019).
61.
Ichihashi S, Takahara M, Yamaoka T et al. Drug eluting versus covered stent for femoropopliteal artery lesions: results of the ULTIMATE study. Eur. J. Vasc. Endovasc. Surg. 64(4), 359–366 (2022).
• This is a multicentre retrospective study that compares a drug eluting stents and a covered stent. This is an important direct comparison, and it indicated a higher patency for drug-eluting stents.
62.
Iida O, Nanto S, Uematsu M et al. Long-term results of endovascular therapy with nitinol stent implantation for TASC II A/B femoro-popliteal artery lesions: 4 years' experience. Circ. J. 73(11), 2143–2147 (2009).
63.
Iida O, Soga Y, Hirano K et al. Long-term outcomes and risk stratification of patency following nitinol stenting in the femoropopliteal segment: retrospective multicenter analysis. J. Endovasc. Ther. 18(6), 753–761 (2011).
64.
Iida O, Uematsu M, Soga Y et al. Timing of the restenosis following nitinol stenting in the superficial femoral artery and the factors associated with early and late restenoses. Catheter. Cardiovasc. Interv. 78(4), 611–617 (2011).
65.
Iida O, Takahara M, Soga Y et al. 1-year results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): predictors of restenosis. JACC Cardiovasc. Interv. 8(8), 1105–1112 (2015).
66.
Iida O, Urasawa K, Komura Y et al. Self-expanding nitinol stent vs percutaneous transluminal angioplasty in the treatment of femoropopliteal lesions: 3-year data from the SM-01 trial. J. Endovasc. Ther. 26(2), 158–167 (2019).
67.
Iida O, Takahara M, Soga Y et al. Three-year clinical course after fluoropolymer-based drug-eluting stent implantation for femoropopliteal lesions. Vasc. Med. 29(2), 182–188 (2024).
• This is a multicentre, prospective, observational study with a large population. It includes 1204 limbs that had implantation of a drug-eluting stent. This study also includes 3-year follow-up data.
68.
Ito R, Ishii H, Oshima S et al. Long-term clinical outcomes after self-expandable bare nitinol stent implantation for femoropopliteal occlusive disease in hemodialysis patients. Catheter. Cardiovasc. Interv. 97(2), 318–324 (2021).
69.
Ito N, Takahara M, Soga Y et al. Lumen loss at 1 year after bare nitinol stent implantation in the superficial femoral artery. J. Endovasc. Ther. 28(1), 132–138 (2021).
70.
Jeon-Slaughter H, Khalili H, Tsai S et al. Comparative effectiveness study of drug-eluting and bare-metal peripheral artery stents in endovascular femoropopliteal artery revascularization. J. Invasive Cardiol. 30(10), 373–379 (2018).
71.
Kang WY, Campia U, Didier RJ et al. A single center experience of Zilver PTX for femoro-popliteal lesions. Cardiovasc. Revasc. Med. 17(6), 399–403 (2016).
72.
Karashima E, Takahara M, Hozawa K et al. Three-year clinical outcomes of the Innova™ self-expanding nitinol stent for the treatment of femoropopliteal lesions. Cardiovasc. Interv. Radiol. 44(11), 1722–1727 (2021).
73.
Karpenko AA, Rabtsun AA, Popova IV et al. Influence of lamina vastoadductoria dissection on the outcomes of femoral artery extensive lesion stenting: a pilot randomised investigation. J. Biomech. 136, 111053 (2022).
74.
Katsuki T, Takahara M, Soga Y et al. Mortality risk following application of a paclitaxel-coated stent in femoropopliteal lesions. J. Endovasc. Ther. 26(5), 593–599 (2019).
75.
Katsuki T, Tomoi Y, Yamaji K et al. Combination therapy of heparin-bonded covered stent and bare-nitinol stent assessed by intravascular ultrasound. Heart Vessels 35(11), 1502–1509 (2020).
76.
Kawamura Y, Ishii H, Aoyama T et al. Nitinol stenting improves primary patency of the superficial femoral artery after percutaneous transluminal angioplasty in hemodialysis patients: a propensity-matched analysis. J. Vasc. Surg. 50(5), 1057–1062 (2009).
77.
Kichikawa K, Ichihashi S, Yokoi H et al. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 2-year results. Cardiovasc. Interv. Radiol. 42(3), 358–364 (2019).
• This is a large prospective, multicentre study that includes 905 patients. This study reports two-year data on the safety and effectiveness of Zilver PTX.
78.
Kim J, Ko Y-G, Lee S-J et al. Korean Multicenter Registry of ELUVIA stent for femoropopliteal artery disease: K-ELUVIA Registry. Korean Circ. J. 54(9), 565–576 (2024).
79.
Ko Y-G, Ahn C-M, Rha S-W et al. Comparison of spot versus long stenting for femoropopliteal artery disease. Ann. Vasc. Surg. 58, 101–107 (2019).
80.
Kum S, Ipema J, Huizing E et al. Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia. Vasc. Med. 26(3), 267–272 (2021).
81.
Labed P, Gonzalez F, Jayet J, Javerliat I, Coggia M, Coscas R. Endovascular treatment of long femoropopliteal lesions with contiguous bare metal stents. Ann. Vasc. Surg. 76, 276–284 (2021).
82.
Laird JR, Katzen BT, Scheinert D et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J. Endovasc. Ther. 19(1), 1–9 (2012).
83.
Laird JR, Jain A, Zeller T et al. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J. Endovasc. Ther. 21(2), 202–212 (2014).
84.
Laird JR, Zeller T, Loewe C et al. Novel nitinol stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries: 24-month results from the TIGRIS randomized trial. J. Endovasc. Ther. 25(1), 68–78 (2018).
85.
Lammer J, Zeller T, Hausegger KA et al. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface VIA versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J. Am. Coll. Cardiol. 62(15), 1320–1327 (2013).
86.
Lammer J, Zeller T, Hausegger KA et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc. Interv. Radiol. 38(1), 25–32 (2015).
87.
Lee Y-J, Kook H, Ko Y-G et al. Drug eluting stent vs. drug coated balloon for native femoropopliteal artery disease: a two centre experience. Eur. J. Vasc. Endovasc. Surg. 61(2), 287–295 (2021).
88.
Leopardi M, Houbballah R, Becquemin JP. Effectiveness of Zilver PTX eluting stent in TASC C/D lesions and restenosis. J. Cardiovasc. Surg. 55(2), 229–234 (2014).
89.
Lichtenberg M, Kolks O, Hailer B et al. PEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions. J. Endovasc. Ther. 21(3), 373–380 (2014).
90.
Lichtenberg M, Breuckmann F, Kramer V et al. Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions – the BIOFLEX PEACE All-Comers Registry. VASA Zeitschrift fur Gefasskrankheiten 48(5), 425–432 (2019).
91.
Liistro F, Angioli P, Porto I et al. Drug-eluting balloon versus drug-eluting stent for complex femoropopliteal arterial lesions: the DRASTICO study. J. Am. Coll. Cardiol. 74(2), 205–215 (2019).
92.
Loureiro L, Pinelo A, Veterano C, Rocha H, Castro J, Machado R. Navigating complexity: the Supera's triumph in femoropopliteal lesions. Vascular 33(6), 1274–1281 (2025).
93.
Low J, Shih T, Lu E, Derubertis BG, Baril DT. Midterm results of the Supera stent for the treatment of femoropopliteal occlusive disease. Ann. Vasc. Surg. 86, 177–183 (2022).
94.
Ma H, Zhang X, Li J et al. Mid-term Efficacy and safety of drug-coated balloon versus nitinol bare metal stent for primary lesions in femoropopliteal artery disease. Ann. Vasc. Surg. 81, 316–323 (2022).
95.
Marples R, Binks M, Spina R, Wright M, Huilgol R. Prophylactic paclitaxel-eluting stent placement does not improve covered femoropopliteal stent patency. Surgery Open Sci. 7, 18–21 (2022).
96.
Matsumi J, Ochiai T, Tobita K et al. Long-term outcomes of self-expandable nitinol stent implantation with intraluminal angioplasty to treat chronic total occlusion in the superficial femoral artery (TransAtlantic Inter-Society Consensus Type D Lesions). J. Invasive Cardiol. 28(2), 58–64 (2016).
97.
Matsumi J, Takada T, Moriyama N et al. Long-term risks for patency loss in patients with hemodialysis after bare self-expandable nitinol stent implantation to femoropopliteal artery occlusive lesions. Int. J. Cardiol. 223, 268–275 (2016).
98.
Matsumura JS, Yamanouchi D, Goldstein JA et al. The United States StuDy for EvalUating EndovasculaR TreAtments of lesions in the superficial femoral artery and proximal popliteal by using the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). J. Vasc. Surg. 58(1), 73–83.e1 (2013).
99.
McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J. Vasc. Surg. 52(3), 584–590; discussion 590–591, 591.e1–591.e7 (2010).
100.
Meng F-C, Chen P-L, Lee C-Y, Shih C-C, Chen I-M. Real-world comparison of drug-eluting and bare-metal stents in superficial femoral artery occlusive disease with Trans-Atlantic Intersociety Consensus B Lesions: a 2-year, single-institute study. Acta Cardiologica Sinica 34(2), 130–136 (2018).
101.
Miura T, Miyashita Y, Soga Y et al. Drug-eluting versus bare-metal stent implantation with or without cilostazol in the treatment of the superficial femoral artery. Circ. Cardiovasc. Interv. 11(8), e006564 (2018).
102.
Montero-Baker M, Ziomek GJ, Leon L et al. Analysis of endovascular therapy for femoropopliteal disease with the Supera stent. J. Vasc. Surg. 64(4), 1002–1008 (2016).
103.
Mori S, Hirano K, Yamauchi Y et al. Penetration rate of the placement of a drug-eluting stent for the treatment of superficial femoral artery lesions in Japan. Heart Vessels 32(9), 1093–1098 (2017).
104.
Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J. Twelve-month results from the MAJESTIC trial of the eluvia paclitaxel-eluting stent for treatment of obstructive femoropopliteal disease. J. Endovasc. Ther. 23(5), 701–707 (2016).
105.
Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J. Long-term results from the majestic trial of the eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc. Interv. Radiol. 40(12), 1832–1838 (2017).
106.
Myint M, Schouten O, Bourke V, Thomas SD, Lennox AF, Varcoe RL. A real-world experience with the Supera interwoven nitinol stent in femoropopliteal arteries: midterm patency results and failure analysis. J. Endovasc. Ther. 23(3), 433–441 (2016).
107.
Nakamura M, Jaff MR, Settlage RA, Kichikawa K. Nitinol self-expanding stents for the treatment of obstructive superficial femoral artery disease: three-year results of the RELIABLE Japanese multicenter study. Ann. Vasc. Dis. 11(3), 324–334 (2018).
108.
Nakao S, Iida O, Takahara M et al. Impact of procedural techniques on midterm patency of fluoropolymer-based drug-eluting stent placed in the femoropopliteal artery. J. Vasc. Interv. Radiol. 35(2), 259–268 (2024).
109.
Nanto K, Iida O, Takahara M et al. Effect of cilostazol following endovascular intervention for peripheral artery disease. Angiology 66(8), 774–778 (2015).
110.
Oberto S, Cetta F, Trabattoni P et al. Comparison of SFA lesion treatment with Zilver PTX in diabetics vs. non-diabetics: 2-year clinical and functional results. J. Cardiovasc. Surg. 58(4), 565–573 (2017).
111.
Okuno S, Iida O, Iida T et al. Comparison of clinical outcomes between endovascular therapy with self-expandable nitinol stent and femoral-popliteal bypass for Trans-Atlantic Inter-Society Consensus II C and D femoropopliteal lesions. Ann. Vasc. Surg. 57, 137–143 (2019).
112.
Palena LM, Isernia G, Parlani G et al. A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study. Catheter Cardiovasc. Interv. 103(6), 963–971 (2024).
113.
Park J-I, Ko Y-G, Lee Y-J et al. Long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: PARADE II study. Front. Cardiovasc. Med. 9, 1022071 (2022).
114.
Phair J, Carnevale M, Lipsitz EC, Shariff S, Scher L, Garg K. Amputation-free survival in patients with critical limb ischemia treated with paclitaxel-eluting stents and paclitaxel-coated balloons. Ann. Vasc. Surg. 62, 8–14 (2020).
115.
Phair J, Carnevale M, Lipsitz EC, Shariff S, Scher L, Garg K. Primary patency of long-segment femoropopliteal artery lesions in patients with peripheral arterial occlusive disease treated with paclitaxel-eluting technology. Ann. Vasc. Surg. 66, 595–600 (2020).
116.
Phillips JA, Falls A, Kolluri R et al. Full drug-eluting stent jacket: two-year results of a single-center experience with Zilver PTX stenting for long lesions in the femoropopliteal arteries. J. Endovasc. Ther. 25(3), 295–301 (2018).
117.
Powell RJ, Jaff MR, Schroë H, Benko A, Diaz-Cartelle J, Müller-Hülsbeck S. Stent placement in the superficial femoral and proximal popliteal arteries with the innova self-expanding bare metal stent system. Catheter Cardiovasc. Interv. 89(6), 1069–1077 (2017).
118.
Rammos C, Zeller T, Piorkowski M et al. The BioMimics 3D helical centreline nitinol stent in chronic limb threatening ischaemia and complex lesions: three year outcomes of the MIMICS-3D Registry. Eur. J. Vasc. Endovasc. Surg. 67(6), 923–932 (2024).
119.
Rastan A, Krankenberg H, Baumgartner I et al. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation 127(25), 2535–2541 (2013).
120.
Salamaga S, Stępak H, Żołyński M et al. Three-year real-world outcomes of interwoven nitinol Supera stent implantation in long and complex femoropopliteal lesions. JCM 12(14), 4869 (2023).
121.
Saratzis A, Rudarakanchana N, Patel S et al. Interwoven nitinol stents versus drug eluting stents in the femoro-popliteal segment: a propensity matched analysis. Eur. J. Vasc. Endovasc. Surg. 58(5), 719–727 (2019).
122.
Saxon RR, Chervu A, Jones PA et al. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial. J. Vasc. Interv. Radiol. 24(2), 165–73; quiz 174 (2013).
123.
Scheinert D, Grummt L, Piorkowski M et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J. Endovasc. Ther. 18(6), 745–752 (2011).
124.
Scheinert D, Werner M, Scheinert S et al. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc. Interv. 6(1), 65–71 (2013).
125.
Schulte K-L, Kralj I, Gissler HM et al. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J. Endovasc. Ther. 19(6), 774–784 (2012).
126.
Shehada Y, Bisdas T, Argyriou A et al. Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease. Vascular 32(1), 102–109 (2024).
127.
Shibata T, Iba Y, Shingaki M et al. One year outcomes of Zilver PTX versus Eluvia for femoropopliteal disease in real-world practice: REALDES study. J. Endovasc. Ther. 32(2), 490–497 (2025).
128.
Soga Y, Iida O, Hirano K, Yokoi H, Nanto S, Nobuyoshi M. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J. Vasc. Surg. 52(3), 608–615 (2010).
129.
Soga Y, Iida O, Hirano K et al. Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery. J. Vasc. Surg. 54(4), 1058–1066 (2011).
130.
Stavroulakis K, Torsello G, Manal A et al. Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years. J. Vasc. Surg. 64(6), 1696–1702 (2016).
131.
Stavroulakis K, Torsello G, Bosiers MJ, Argyriou A, Tsilimparis N, Bisdas T. 2-year outcomes of the eluvia drug-eluting stent for the treatment of complex femoropopliteal lesions. JACC Cardiovasc. Interv. 14(6), 692–701 (2021).
132.
Steiner S, Schmidt A, Bausback Y et al. Midterm patency after femoropopliteal interventions: a comparison of standard and interwoven nitinol stents and drug-coated balloons in a single-center, propensity score-matched analysis. J. Endovasc. Ther. 23(2), 347–355 (2016).
133.
Stern JR, Tran K, Chandra V, Harris EJ, Lee JT. Paclitaxel exposure and long-term mortality of patients treated with the Zilver PTX drug-eluting stent. Vascular 29(4), 567–573 (2021).
134.
Sullivan TM, Zeller T, Nakamura M, Gaines PA. Treatment of femoropopliteal lesions with the BioMimics 3D vascular stent system: two-year results from the MIMICS-2 trial. J. Endovasc. Ther. 28(2), 236–245 (2021).
135.
Suzuki K, Takahara M, Shintani Y et al. Retrospective multicenter comparison of S.M.A.R.T. CONTROL and MISAGO stents in treatment of femoropopliteal lesions. J. Vasc. Interv. Radiol. 27(11), 1642–1649 (2016).
• This is a large multicentre, retrospective study with a large population, a total of 1505 cases. This study includes 2-year data on the performance of the two different stent types.
136.
Tan M, Urasawa K, Haraguchi T et al. Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease. Cardiovasc. Interv. Ther. 37(1), 136–144 (2022).
137.
Tan M, Takahara M, Soga Y et al. Three-year clinical outcomes following implantation of LifeStent self-expanding nitinol stents in patients with femoropopliteal artery lesions. Angiology 73(3), 244–251 (2022).
138.
Teymen B, Akturk S, Akturk U, Tdjani M. Comparison of drug-eluting balloon angioplasty with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Vascular 26(1), 54–61 (2018).
139.
Torsello GF, Stavroulakis K, Bisdas T, Cardona Y, Wichmann K, Torsello GB. Treatment of femoropopliteal artery disease with polymer-coated drug-eluting stent: 5-year results of a prospective, non-randomized study including the halo phenomenon. Cardiovasc. Interv. Radiol. 47(2), 177–185 (2024).
140.
Treitl KM, Woerner B, Schinner R et al. Evolution of patency rates of self-expandable bare metal stents for endovascular treatment of femoro-popliteal arterial occlusive disease: does stent design matter? Eur. Radiol. 27(9), 3947–3955 (2017).
141.
Tsujimura T, Takahara M, Iida O et al. Clinical outcomes of polymer-free, paclitaxel-coated stents vs stent grafts in peripheral arterial disease patients with femoropopliteal artery lesions. J. Vasc. Surg. 73(6), 1998–2008.e1 (2021).
142.
van Meirvenne E, Reyntjens P, Tielemans Y. Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System®. Acta Chirurgica Belgica 123(5), 463–472 (2023).
143.
Vartanian SM, Johnston PC, Walker JP et al. Clinical consequence of bare metal stent and stent graft failure in femoropopliteal occlusive disease. J. Vasc. Surg. 58(6), 1525–1531 (2013).
144.
Vent P-A, Kaladji A, Davaine J-M et al. Bare metal versus paclitaxel-eluting stents for long femoropopliteal lesions: prospective cohorts comparison using a propensity score-matched analysis. Ann. Vasc. Surg. 43, 166–175 (2017).
145.
Watanabe Y, Hozawa K, Hiroyoshi K, Naganuma T, Ishiguro H, Nakamura S. The importance of patency of tibial run off arteries on clinical outcomes after stenting for chronic total occlusions in the superficial femoro-popliteal artery. Eur. J. Vasc. Endovasc. Surg. 56(6), 857–863 (2018).
146.
Werner M, Piorkowski M, Thieme M et al. SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment. J. Endovasc. Ther. 20(6), 759–766 (2013).
147.
Werner M, Paetzold A, Banning-Eichenseer U et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry. Euro Intervention 10(7), 861–868 (2014).
148.
Wittig T, Schmidt A, Fuß T et al. Randomized trial comparing a stent-avoiding with a stent-preferred strategy in complex femoropopliteal lesions. JACC Cardiovasc. Interv. 17(9), 1134–1144 (2024).
149.
Yang M, Shi B, Ma L et al. Treatment of atherosclerotic femoropopliteal artery disease with supera interwoven nitinol stent: a real-world study in China. Ann. Vasc. Surg. 85, 183–189 (2022).
150.
Ye W, Böhme T, Fu W et al. First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study. Front. Cardiovasc. Med. 9, 877578 (2022).
151.
Ye M, Ni Q, Zhu Y et al. Stent graft vs drug-coated balloon in endovascular treatment of complex femoropopliteal artery lesions: a 2-center experience. J. Endovasc. Ther. 32(4), 1038–1046 (2025).
152.
Yokoi H, Ohki T, Kichikawa K et al. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 12-month results. JACC Cardiovasc. Interv. 9(3), 271–277 (2016).
153.
Yoshioka N, Tokuda T, Koyama A et al. Two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease. Heart Vessels 38(3), 429–437 (2023).
154.
Zamani N, Sharath SE, Browder RC et al. Outcomes after endovascular stent placement for long-segment superficial femoral artery lesions. Ann. Vasc. Surg. 71, 298–307 (2021).
155.
Zeller T, Rastan A, Macharzina R et al. Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions. J. Endovasc. Ther. 21(3), 359–368 (2014).
156.
Zeller T, Gaines PA, Ansel GM, Caro CG. Helical centerline stent improves patency: two-year results from the randomized Mimics trial. Circ. Cardiovasc. Interv. 9(6), e002930 (2016).
157.
Zhao H, Ma B, Chen J et al. Drug-coated balloon versus bare nitinol stent in femoropopliteal artery: 12 months outcome from a single center in China. Ann. Vasc. Surg. 74, 367–381 (2021).
158.
Bosiers MJ, Donato G, Torsello G et al. ZILVERPASS Study: ZILVER PTX stent versus prosthetic above-the-knee bypass surgery in femoropopliteal lesions, 5-year results. Cardiovasc. Interv. Radiol. 46(10), 1348–1358 (2023).
159.
Maleckis K, Anttila E, Aylward P et al. Nitinol stents in the femoropopliteal artery: a mechanical perspective on material, design, and performance. Ann. Biomed. Eng. 46(5), 684–704 (2018).
160.
Nasr B, Gouailler F, Marret O et al. Treatment of long femoropopliteal lesions with self-expanding interwoven nitinol stent: 24 month outcomes of the STELLA-SUPERA trial. J. Endovasc. Ther. 30(1), 98–105 (2023).
161.
Müller-Hülsbeck S, Hopf-Jensen S, Keirse K et al. Eluvia drug-eluting vascular stent system for the treatment of symptomatic femoropopliteal lesions. Future Cardiol. 14(3), 207–213 (2018).
162.
Edwards CT, Schneider PA, Huynh C. Paclitaxel exposure and dosage of drug-coated devices for the treatment of femoropopliteal peripheral artery disease. Vasc. Endovasc. Rev. 4, e05 (2021).
163.
Palena LM, Diaz-Sandoval LJ, Sultato E et al. Feasibility and 1-year outcomes of subintimal revascularization with supera® stenting of long femoropopliteal occlusions in critical limb ischemia: the “Supersub” study. Catheter Cardiovasc. Interv. 89(5), 910–920 (2017).
164.
Tepe G, Brodmann M, Werner M et al. Intravascular lithotripsy for peripheral artery calcification: 30-day outcomes from the randomized disrupt PAD III trial. JACC Cardiovasc. Interv. 14(12), 1352–1361 (2021).
165.
Korosoglou G, Schmidt A, Lichtenberg M et al. Global algorithm for the endovascular treatment of chronic femoropopliteal lesions: an interdisciplinary expert opinion statement. JACC Cardiovasc. Interv. 18(5), 545–557 (2025).
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Received: 19 September 2025
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Published online: 10 March 2026
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Performance of stenting in femoropopliteal disease: a systematic literature review and meta-analysis of proportions. (2026) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2025-0152
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