Jetstream Rotational Atherectomy and Drug Coated Balloon Angioplasty with In Stent Re-stenosis and Occlusions. A Two Centre Study

Atherectomy can reduce the need for bailout stenting with de novo femoropopliteal lesions,1Wu Z. Huang Q. Pu H. Qin J. Wang X. Ye K. et al.Atherectomy combined with balloon angioplasty versus balloon angioplasty alone for de novo femoropopliteal arterial diseases: a systematic review and meta-analysis of randomised controlled trials.Eur J Vasc Endovasc Surg. 2021; 62: 65-73Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar which currently occur in > 50% of such cases and may lead to in stent re-stenosis (ISR) in the long term.2Korosoglou G. Giusca S. Langhoff R. Lichtenberg M. Lawall H. Schellong S. et al.Safety and effectiveness of endovascular therapy for the treatment of peripheral artery disease in patients with and without diabetes mellitus. Data from the RECording Courses of vascular Diseases (RECCORD) registry in 2123 patients.Angiology. 2022; 73 (956–6)PubMed Google Scholar Recent studies have demonstrated the efficacy of Jetstream atherectomy (Boston Scientific, Marlborough, MA, USA) for ISR treatment,3Shammas N.W. Jones-Miller S. Shammas G.A. Shammas W.J. Jetstream atherectomy in treating femoropopliteal in-stent restenosis: meta-analysis of the JETSTREAM-ISR and JET-ISR trials.J Invasive Cardiol. 2020; 32: 289-294PubMed Google Scholar but atherectomy was not routinely combined with drug coated balloon angioplasty (DCB). Between January 2017 and November 2020 symptomatic patients with ISR or occlusion were enrolled in this dual centre, prospective study after obtaining ethical approval (S-100/2017) and written informed consent. Demographic data and Rutherford categories (RC) were registered. All procedures were performed by experienced operators. Two catheter cutters XC 2.4/3.4 (for vessels between 3.0 and 5.0 mm) and XC 2.1/3.0 (for vessels ≥ 5.0 mm) were used for atherectomy, followed by DCB treatment and if necessary, bailout stenting. Closure devices were used in all cases. The Transatlantic Intersociety Consensus (TASC) classification was used for determining the lesion complexity, localisation, and calcification, together with the Tosaka classification for ISR. Clinical standardised follow up was conducted after six and 12 months, including wound examination, ankle brachial index (ABI) measures and duplex ultrasound. Safety endpoints included perforation and embolisation. Clinical endpoints included freedom from clinically driven target lesion revascularisation (TLR) and improvement of ≥ 2 RC. One hundred and thirteen patients were studied, including 47 (41.6%) with claudication (RC3), 44 (38.9%) with RC4, and 22 (19.5%) with ischaemic ulceration (RC5) (Table 1). TASC C/D and Tosaka class II/III lesions were present in 62 (55%) and 51 (45%) and in 27 (24%) and 86 (76%) patients, respectively. Mean lesion length was 24.9 ± 5.7 cm, and 86 (76%) patients had full length occlusions. Treatment was performed using the 2.1 mm atherectomy device in 47 (42%) and the 2.4 mm device in 66 (58%) cases. Adjunctive treatment with DCB was performed in all cases (67; 59%); using the Ranger, (Boston Scientific, Marlborough, MA, USA) in 46 (41%), and the Lutonix DCB (Bard, Wangs, St. Gallen, Switzerland). In 15 (13%) patients bailout stenting was necessary. No perforations occurred. Peripheral embolisation occurred in 24 (21%) patients, including one (3%) patient with vs. 23 (29%) without distal filter protection (p = .003). All distal embolisations were managed by catheter aspiration but in four (3.5%) cases additional short duration local lysis (4 – 6 hours) was necessary. Pseudoaneurysms in the groin were observed in three (3%) cases.Table 1Baseline, demographic, lesion, and procedural characteristics in 113 consecutive patients with claudication or critical limb threatening ischaemia (CLTI), treated with the Jetstream rotational atherectomy device for in stent restenosis or occlusionsAll patients (n = 113)Patients with claudication (n = 47)Patients with CLTI (n = 66)pDemographics Age – y72.4 ± 5.871.0 ± 6.573.5 ± 5.0.026 Male gender63 (56)26 (55)37 (56).93 Diabetes mellitus63 (56)27 (57)36 (55).76 History of CAD67 (59)30 (64)37 (56).68 History of heart failure42 (37)12 (26)30 (45).030 GFR < 30 mL/min/1.73 m233 (29)14 (30)19 (29).90Lesion characteristics Mean lesion length – cm24.9 ± 5.724.7 ± 6.824.9 ± 4.7.84 Patients with total occlusions86 (76)31 (66)55 (83).034 Mean occlusion length – cm19.4 ± 6.2∗Considering only chronic total occlusions.19.6 ± 7.3∗Considering only chronic total occlusions.19.3 ± 5.5∗Considering only chronic total occlusions..82 Total number of pre-implanted stents2.2 ± 0.72.1 ± 0.82.2 ± 0.7.38 Total length of pre-implanted stents11.9 ± 4.612.4 ± 5.511.5 ± 3.8.33 Number of distal runoff vessels1.62 ± 0.731.97 ± 0.811.39 ± 0.58<.001 TASC C61 (54)31 (66)30 (45).032 TASC D51 (45)15 (32)36 (55).018Atherectomy procedure Reference diameter of vessel – mm5.9 ± 0.35.9 ± 0.35.9 ± 0.2.45 Treatment with the 2.1/3.0 mm device47 (42)19 (40)28 (42).83 Treatment with the 2.4/3.4 mm device66 (58)28 (60)38 (58).83Adjunctive treatment Treatment with drug coated balloon113 (100)47 (100)66 (100)NARanger67 (59)35 (74)32 (48).006Lutonix46 (41)12 (25)34 (52).006 Bailout stent15 (13)4 (9)11 (17).21Intra-operative complications Perforation0 (0)0 (0)0 (0)NA Peripheral embolisation24 (21)7 (15)17 (26).17 Use of distal embolic protection device33 (29)20 (43)13 (20).008Data are presented as n (%) or mean ± standard deviation. CAD = coronary artery disease; GFR = glomerular filtration rate; TASC = Transatlantic Intersociety Consensus; NA = not applicable.∗ Considering only chronic total occlusions. Open table in a new tab Data are presented as n (%) or mean ± standard deviation. CAD = coronary artery disease; GFR = glomerular filtration rate; TASC = Transatlantic Intersociety Consensus; NA = not applicable. Follow up data (at 12.5 ± 2.7 months) including duplex sonography and ABI measures were complete. Three (2.7%) patients with critical limb threatening ischaemia (CLTI) died, one due to sepsis and two due to cancer, while three (3%) minor amputations were performed in CLTI patients. No procedure related deaths or major amputations occurred. ABI improved from 0.32 ± 0.15 to 0.96 ± 0.19 at discharge and measured 0.80 ± 0.18 at 12 months (p < .050 for both). Patency rates by duplex sonography were 100% and 88% at 30 days and 12 months of follow up, respectively (binary stenosis in 0 and 14 (12%) patients, respectively). Freedom from TLR at 12 months was 97% in patients with claudication and 90% in CLTI patients (p = .21 by log rank test). TLR rates were similar in patients treated with Ranger vs. Lutonix (p = .99). RC improvement was present in 94.6% patients (mean RCbaseline = 3.8 [95% confidence interval {CI} 3.6 – 3.9] vs. RCfollow up = 1.0 [95% CI 1.0 – 1.2], p < .001). This study has demonstrated the efficacy of Jetstream atherectomy in combination with DCB at 12 months for the treatment of ISR and occlusions. The rate of perforations was zero, but peripheral embolisation was high without the use of protection systems, so that filters need to be considered in patients with ISR. The combination of atherectomy and DCB results in high patency and clinically acceptable TLR rates (freedom from TLR of 100% and 93% at six and 12 months) compared with earlier studies.3Shammas N.W. Jones-Miller S. Shammas G.A. Shammas W.J. Jetstream atherectomy in treating femoropopliteal in-stent restenosis: meta-analysis of the JETSTREAM-ISR and JET-ISR trials.J Invasive Cardiol. 2020; 32: 289-294PubMed Google Scholar ISR remains a major problem after stent implantation, ranging between 50% and 60% after two to three years but also after drug eluting stent implantation (25% at two years and 35% at five years).4Laird J.R. Hong M. Drug-Eluting stents in the superficial femoral artery: the long and winding road.Circulation. 2016; 133: 1435-1437Crossref PubMed Scopus (8) Google Scholar Plain old balloon angioplasty (POBA) nor DCB, which was proposed as an effective alternative5Brodmann M Keirse K. Scheinert D. Spak L. Jaff M.R. Schmahl R. et al.Drug-coated balloon treatment for femoropopliteal artery disease: the IN.PACT global study de novo in-stent restenosis imaging cohort.JACC Cardiovasc Interv. 2017; 10: 2113-2123Crossref PubMed Scopus (54) Google Scholar are durable solutions to treat ISR, since the incidence of recurrent ISR increases to 36% two years after DCB. With Jetstream atherectomy and POBA, TLR rates rose significantly after one year, being markedly higher than in the present study. In earlier studies, encouraging results were obtained when Jetstream atherectomy was combined with DCB in de novo lesions.6Shammas N.W. Shammas G.A. Jones-Miller S. Shammas W.J. Bou-Dargham B. Shammas A.N. 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: 771-777Crossref PubMed Scopus (25) Google Scholar A single arm study is presented. Information on type of the pre-implanted stents, duration of the occlusion, time since the initial implantation, previous interventions, and information about clinical presentation at the time of initial stent placement as well as long term follow up data were not available. Furthermore, two different types of DCBs with different concentrations were used, which may have influenced outcomes, but TLR rates were similar. Absence of intravascular ultrasound for quality check and detection of atherothrombotic debris is another limitation. Finally, the rate of embolisation was high, which may be attributed partially to plaque destabilisation during the atherectomy procedure and not routinely using embolic protection devices. Future studies are necessary to further assess this safety signal. In conclusion, Jetstream atherectomy combined with DCB exhibits RC improvement, acceptable vessel patency, and low TLR rates at one year in patients with symptomatic ISR and occlusions. Peripheral embolisation was noted in 20%, so that distal embolic protection should be considered in these lesions. No conflicts of interest. M.A. and G.K. received an institutional research grant and speaker honoraria from Boston Scientific.