Purpose: To evaluate the effect of vessel calcification on in-stent restenosis (ISR) after drug-coated stent (DCS) placement in the femoropopliteal segment. Materials and Methods: A retrospective multicenter study was undertaken involving 220 consecutive symptomatic patients (mean age 73.1±8.3 years; 175 men) with femoropopliteal lesions in 230 limbs treated with the Zilver PTX DCS and having duplex surveillance after the endovascular procedures. Mean lesion length was 16.4±9.8 cm (range 2–40); there were 104 (45.2%) total occlusions and 68 (29.6%) in-stent restenoses (ISR). Twenty (8.7%) vessels had no runoff. The majority of lesions (148, 64.3%) were calcified according to the peripheral arterial calcium scoring system (PACSS). Primary patency was evaluated by duplex. Lesions were classified as either PACSS 0–2 (none or unilateral wall calcification) or PACSS 3 and 4 (bilateral wall calcification). Multivariate analysis was performed to identify variables associated with ISR; the results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 1-, 2-, and 5-year primary patency and freedom from clinically-driven target lesion revascularization estimates were 75.9%, 63.6%, and 45.0%, and 84.7%, 73.7%, and 54.2%, respectively. Major amputations were performed on 4 limbs during follow-up. In multivariate analysis, vessel calcification (adjusted HR 1.718, 95% CI 1.035 to 2.851, p=0.036) was significantly correlated with the occurrence of ISR, along with lesion length (adjusted HR 1.041, 95% CI 1.013 to 1.070, p=0.003), and cilostazol administration (adjusted HR 0.476, 95% CI 0.259 to 0.876, p=0.017). Conclusion: This study suggested that bilateral vessel wall calcification was an independent risk factor for ISR in complex femoropopliteal lesions after Zilver PTX DCS placement, along with lesion length; cilostazol administration had a protective effect.
AboyansVRiccoJBBartelinkMEL, et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018;55:305–368.
2.
SogaYIidaOHiranoK, 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. 2011;54:1058–1066.
3.
SogaYIidaOHiranoK, et al. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010;52:608–615.
4.
BecqueminJPFavreJPMarzelleJ, et al. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg. 2003;37:487–494.
5.
DakeMDAnselGMJaffMR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.
6.
DakeMDAnselGMJaffMR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133:1472–1483.
FanelliFCannavaleAGazzettiM, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37:898–907.
9.
AnselGMJaffMRPopmaJJ, et al. A quantitative angiographic comparison of restenotic tissue following placement of drug-eluting stents and bare metal stents in symptomatic patients with femoropopliteal disease. J Endovasc Ther. 2017;24:499–503.
10.
IidaOTakaharaMSogaY, et al. The characteristics of in-stent restenosis after drug-eluting stent implantation in femoropopliteal lesions and 1-year prognosis after repeat endovascular therapy for these lesions. JACC Cardiovasc Interv. 2016;9:828–834.
11.
BosiersMPeetersPTessarekJ, et al. The Zilver® PTX® single arm study: 12-month results from the TASC C/D lesion subgroup. J Cardiovasc Surg (Torino). 2013;54:115–122.
12.
IidaOTakaharaMSogaY, 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. 2015;8:1105–1112.
13.
YokoiHOhkiTKichikawaK, 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. 2016;9:271–277.
14.
PhillipsJAFallsAKolluriR, 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. 2018;25:295–301.
15.
LeopardiMHoubballahRBecqueminJP.Effectiveness of Zilver PTX eluting stent in TASC C/D lesions and restenosis. J Cardiovasc Surg (Torino). 2014;55:229–234.
16.
DavaineJMQueratJKaladjiA, et al. Treatment of TASC C and D femoropopliteal lesions with paclitaxel eluting stents: 12 month results of the STELLA-PTX registry. Eur J Vasc Endovasc Surg. 2015;50:631–637.
17.
ScheinertDScheinertSSaxJ, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–315.
18.
SuzukiKIidaOSogaY, et al. Long-term results of the S.M.A.R.T. Control™ stent for superficial femoral artery lesions, J-SMART registry. Circ J. 2011;75:939–944.
19.
TzafririARGarcia-PoliteFZaniB, et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release. 2017;264:203–210.
20.
ZellerTLanghoffRRocha-SinghKJ, et al. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency: twelve-month results of the DEFINITIVE AR study. Circ Cardiovasc Interv. 2017;10:e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
21.
ZellerTLopezLPigottJP.Acute outcomes with a novel plaque modification system in real-world femoropopliteal lesions. J Endovasc Ther. 2019;26:333–341.
22.
JangJSJinHYSeoJS, et al. A meta-analysis of randomized controlled trials appraising the efficacy and safety of cilostazol after coronary artery stent implantation. Cardiology. 2012;122:133–143.
23.
IidaOYokoiHSogaY, et al. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the sufficient treatment of peripheral intervention by cilostazol study. Circulation. 2013;127:2307–2315.
24.
MiuraTMiyashitaYSogaY, et al. Drug-eluting versus bare-metal stent implantation with or without cilostazol in the treatment of the superficial femoral artery. Circ Cardiovasc Interv. 2018;11:e006564.
25.
ZenKTakaharaMIidaO, et al. Drug-eluting stenting for femoropopliteal lesions, followed by cilostazol treatment, reduces stent restenosis in patients with symptomatic peripheral artery disease. J Vasc Surg. 2017;65:720–725.
26.
KimuraTYokoiHNakagawaY, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996;334:561–566.
27.
LammerJZellerTHauseggerKA, 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. 2013;62:1320–1327.
28.
IidaOUematsuMSogaY, 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. 2011;78:611–617.
29.
CipollariSYokoiHOhkiT, et al. Long-term effectiveness of the Zilver PTX drug-eluting stent for femoropopliteal peripheral artery disease in patients with no patent tibial runoff vessels—results from the Zilver PTX Japan post-market surveillance study. J Vasc Interv Radiol. 2018;29:9–17.e1.
30.
OgawaYYokoiHOhkiT, et al. Impact of chronic renal failure on safety and effectiveness of paclitaxel-eluting stents for femoropopliteal artery disease: subgroup analysis from Zilver PTX post-market surveillance study in Japan. Cardiovasc Intervent Radiol. 2017;40:1669–1677.
31.
FanelliFDi PrimoMBoattaE, et al. Drug-eluting nitinol stent treatment of the superficial femoral artery and above-the-knee popliteal artery (the Zilver PTX single-arm clinical study): a comparison between diabetic and nondiabetic patients. Cardiovasc Intervent Radiol. 2013;36:1232–1240.
32.
ZellerTDakeMDTepeG, et al. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013;6:274–281.
33.
IshiharaTTakaharaMIidaO, et al. Comparable 2-year restenosis rates following subintimal and intraluminal drug-eluting stent implantation for femoropopliteal chronic total occlusion. J Endovasc Ther. 2016;23:889–895.
34.
PatelMRConteMSCutlipDE, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015;65:931–941.
35.
DattiloRHimmelsteinSICuffRF.The COMPLIANCE 360 Degrees Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014;26:355–360.
