Midterm outcomes of rotational atherectomy-assisted endovascular treatment of severe peripheral arterial disease.

OBJECTIVE: We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. METHODS: We conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. RESULTS: In a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. CONCLUSIONS: The use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.

Outcomes of endovascular intervention for atherosclerotic lesions confined to the popliteal artery.

OBJECTIVE: Most surgeons employ an endovascular-first approach to the treatment of peripheral arterial disease (PAD), but controversy remains regarding the ideal interventions for the management of isolated popliteal artery disease (IPAD). Indeed, there are a paucity of data that compare outcomes of popliteal stents vs other peripheral vascular interventions (PVIs). The goal of this study was to evaluate outcomes of PVIs in IPAD. METHODS: The Vascular Study Group of New England database was queried for all IPAD PVIs performed for atherosclerotic occlusive disease from 2010 to 2021. Those with at least 1 year of follow-up data available were included for analysis. The primary endpoint was 1-year freedom from a composite target lesion (TL) treatment failure that included restenosis >50% on duplex, reintervention, or ipsilateral major amputation. RESULTS: We included 689 procedures performed on 634 patients. Of these, 250 (36.3%) were treated with plain balloons (POBA), 215 (31.2%) had stents, 170 (24.7%) had special balloons (drug-coated, cutting, or lithotripsy), and 54 (7.8%) atherectomies were performed. Stent placement was associated with lower freedom from TL treatment failure (72.6%) than special balloon (81.2%; P = .048) and atherectomy (88.9%; P = .012), but not POBA (76.8%; P = .293). On multivariable logistic regression, stents (odds ratio, 0.637; P = .021) and preoperative P2Y12 inhibitor therapy (odds ratio, 0.683; P = .048) were both associated with lower freedom from intervention failure. CONCLUSIONS: Popliteal stent placement is associated with a higher rate of TL treatment failure at 1 year when compared with other PVIs including special balloon angioplasty and atherectomy, but not POBA, and should therefore be avoided in favor of special balloons or atherectomy whenever feasible.

Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Comparison of mid-outcome among bare metal stent, atherectomy with or without drug-coated balloon angioplasty for femoropopliteal arterial occlusion.

This study evaluated the outcomes of a bare metal stent (BMS), DCB alone, atherectomy plus a drug-coated balloon (AT + DCB) and AT alone for the treatment of femoropopliteal artery occlusion. Four groups were included in this retrospective cohort study: 119 patients underwent the BMS procedure, 89 patients underwent DCB alone, 52 patients underwent AT + DCB, and 61 patients underwent AT alone. Patients were followed-up at 1, 6, 12 and 24 months after the procedure, the clinical outcomes and complications were assessed, and the primary outcomes were primary patency and restenosis. AT + DCB showed a lower bailout stent, and BMS displayed a higher retrograde puncture, flow-limiting dissection and postdilation (p < 0.05). For all procedures, the walking distance, ABI and pain score post-procedure were significantly improved compared with the pre-procedure values (p < 0.001). The restenosis rate was higher in BMS (21.0%) and AT alone (24.6%) than in DCB (10.1%) alone and AT + DCB (11.5%) (p = 0.04); there was no difference in amputation or clinically driven target lesion revascularization among procedures. The primary patency rates were 77.7%, 89.4%, 88.0% and 73.7% in the BMS, DCB alone, AT + DCB and AT alone groups at 24 months, respectively (p = 0.03), while the secondary patency and main adverse events (stroke, MI and death) were similar. Proximal concavity, proximal target vessel diameter ≥ 5 mm, runoff number ≥ 2 and DCB use were protective factors for primary patency. Our results suggested that AT + DCB and DCB alone were associated with higher primary patency, and DCB devices (combined with/without AT) should be the preferred choice for FP lesions.

Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial.

BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.