To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR).
Materials and Methods:
The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI).
Results:
Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively.
Conclusion:
JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.
BosiersMDelooseKCallaertJ, 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. 2015;22:1–10.
2.
DickPSabetiSMlekuschW, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology. 2008;248:297–302.
3.
LiistroFAngioliPPortoI, et al. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014;21:1–8.
4.
KrankenbergHTüblerTIngwersenM, et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized Femoral Artery In-Stent Restenosis (FAIR) trial. Circulation. 2015;132:2230–2236.
5.
DippelEJMakamPKovachR, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015;8(1Pt A):92–101.
6.
ShammasNWShammasGAHelouTJ, et al. Safety and 1-year revascularization outcome of SilverHawk atherectomy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center. Cardiovasc Revasc Med. 2012;13:224–227.
7.
ShammasNWShammasGAHafezA, et al. Safety and one-year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center. Cardiovasc Revasc Med. 2012;13:341–344.
8.
LairdJRYeoKKRocha-SinghK.Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study. Catheter Cardiovasc Interv. 2012;80:852–859.
9.
BrodmannMRiefPFroehlichH, et al. Neointimal hyperplasia after SilverHawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial. Cardiovasc Intervent Radiol. 2013;36:69–74.
10.
BeschornerUKrankenbergHScheinertD, et al. Rotational and aspiration atherectomy for infrainguinal in-stent restenosis. Vasa. 2013;42:127–133.
11.
TrentmannJCharalambousNDjawanscherM, et al. Safety and efficacy of directional atherectomy for the treatment of in-stent restenosis of the femoropopliteal artery. J Cardiovasc Surg (Torino). 2010;51:551–560.
12.
SchmidtAZellerTSievertH, et al. Photoablation using the turbo-booster and excimer laser for in-stent restenosis treatment: twelve-month results from the PATENT study. J Endovasc Ther. 2014;21:52–60.
13.
WissgottCKamusellaPAndresenR.Treatment of in-stent reocclusions of femoropopliteal arteries with mechanical rotational catheters. Rofo. 2011;183:939–944.
14.
ShammasNWChandraPBrodmannM, et al; EX-PAD-03 Investigators. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-Laser, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: results of the EX-PAD-03 Trial. Cardiovasc Revasc Med. 2020;21:86–92.
15.
ShammasNWAasenNBaileyL, et al. Two blades-up runs using the JetStream Navitus atherectomy device achieve optimal tissue debulking of nonocclusive in-stent restenosis: observations from a porcine stent/balloon injury model. J Endovasc Ther. 2015;22:518–524
16.
ShammasNWShammasGAJones-MillerS, et al. Long-term outcomes with JetStream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: a single center experience (JET-SCE). Cardiovasc Revasc Med. 2018;19(7pt A):771–777.
17.
GrayWAGarciaLAAminA, et al; JET Registry Investigators. JetStream Atherectomy System treatment of femoropopliteal arteries: results of the post-market JET Registry. Cardiovasc Revasc Med. 2018;19(5pt A):506–511.
18.
ShammasNWShammasGABanerjeeS, et al. JetStream rotational and aspiration atherectomy in treating in-stent restenosis of the femoropopliteal arteries: results of the JETSTREAM-ISR feasibility study. J Endovasc Ther. 2016;23:339–346.
19.
ShammasNWJones-MillerSLemkeJ.Meta-analysis-derived benchmarks of patency and target lesion revascularization of percutaneous balloon angioplasty from prospective clinical trials of symptomatic femoropopliteal in-stent restenosis. J Vasc Interv Radiol. 2016;27:1195–1203.
20.
ShammasNW.Restenosis in lower extremity interventions: current status and future directions. J Endovasc Ther. 2009;16(suppl I):I170–I182.
21.
TosakaASogaYIidaO, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59:16–23.
22.
WissgottCKamusellaPAndresenR.Treatment of in-stent reocclusions of femoropopliteal arteries with mechanical rotational catheters. Rofo. 2011;183:939–944.
23.
ShammasNWJones-MillerSShammasGA, et al. CRT-200.14 JetStream atherectomy in treating femoropopliteal in-stent restenosis: meta-analysis of the JETSTREAM-ISR and JET-ISR trials [abstract]. JACC Cardiovasc Interv. 2020;13(4 suppl):S30. doi:10.1016/j.jcin.2020.01.089
24.
TepeGSchnorrBAlbrechtT, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015;8(1pt A):102–108.
25.
WerkMLangnerSReinkensmeierB, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118:1358–1365.
26.
LiistroFGrottiSPortoI, et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013;6:1295–1302.
27.
KatsanosKSpiliopoulosSKitrouP, et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018;7(24):e011245.
28.
ZellerTMicariAScheinertD, et al; IN.PACT DEEP Trial Investigators. The IN.PACT DEEP clinical drug-coated balloon trial: 5-year outcomes. JACC Cardiovasc Interv. 2020;13:431–443.
29.
SchneiderPALairdJRDorosG, et al. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol. 2019;73:2550–2563.
30.
GrayWAJaffMRParikhSA, et al. Mortality assessment of paclitaxel-coated balloons: patient-level meta-analysis of the ILLUMENATE clinical program at 3 years. Circulation. 2019;140:1145–1155.
31.
van den BergJCPedrottiMCanevasciniR, et al. In-stent restenosis: mid-term results of debulking using excimer laser and drug-eluting balloons: sustained benefit?J Invasive Cardiol. 2014;26:333–337.
32.
KokkinidisDGBehanSJawaidO, et al. Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-year outcomes. Catheter Cardiovasc Interv. 2020;95:439–446.
33.
GiannopoulosSKokkinidisDGJawaidO, et al. Turbo-power™ laser atherectomy combined with drug-coated balloon angioplasty is associated with improved one-year outcomes for the treatment of Tosaka II and III femoropopliteal in-stent restenosis [published online October 18, 2019]. Cardiovasc Revasc Med. doi:10.1016/j.carrev.2019.10.006
34.
KokkinidisDGHossainPJawaidO, et al. Laser atherectomy combined with drug-coated balloon angioplasty is associated with improved 1-year outcomes for treatment of femoropopliteal in-stent restenosis. J Endovasc Ther. 2018; 25:81–88.
35.
SixtSCarpio CancinoOGTreszlA, et al. Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries. J Vasc Surg. 2013;58:682–686.
36.
GandiniRDel GiudiceCMerollaS, et al. Treatment of chronic SFA in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study. J Endovasc Ther. 2013;20:805–814.
37.
ShammasNWCoinerDShammasGA, et al. Distal embolic event protection using excimer laser ablation in peripheral vascular interventions: results of the DEEP EMBOLI registry. J Endovasc Ther. 2009;16:197–202.
38.
SiablisDKarnabatidisDKatsanosK, et al. Outflow protection filters during percutaneous recanalization of lower extremities’ arterial occlusions: a pilot study. Eur J Radiol. 2005;55:243–249.
39.
SuriRWholeyMHPostoakD, et al. Distal embolic protection during femoropopliteal atherectomy. Catheter Cardiovasc Interv. 2006;67:417–422.
40.
RobertsDNiaziKMillerW, et alfor the DEFINITIVE Ca++ Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca++ trial. Catheter Cardiovasc Interv. 2014; 84:236–244.
41.
ShammasNWWeissmanNJCoinerD, et al. Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study. Cardiovasc Revasc Med. 2012;13:211–214.
42.
ShammasNWWeissmanNJCoinerD, et al. Dethrombosis of lower extremity thrombus by local delivery of thrombolysis using ClearWay transcatheter balloon irrigation: a feasibility study. Cardiovasc Revasc Med. 2011;12:350–354.
43.
ShammasNWCoinerDShammasGA, et al. Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus SilverHawk atherectomy and adjunctive balloon angioplasty: randomized trial. J Vasc Interv Radiol. 2011;22:1223–1228.
44.
ShammasNWPucilloAJenkinsJS, et al. WIRION embolic protection system in lower extremity arterial interventions: results of the pivotal WISE LE trial. JACC Cardiovasc Interv. 2018;11:1995–2003.
45.
ShammasNWAasenNBaileyL, et al. Two blades-up runs using the JetStream Navitus atherectomy device achieve optimal tissue debulking of nonocclusive in-stent restenosis: observations from a porcine stent/balloon injury model. J Endovasc Ther. 2015;22:518–524.
