ABSTRACT
OBJECTIVE: Paclitaxel drug-coated balloon (PDCB) angioplasty has been shown to be an effective treatment of in-stent restenosis (ISR) at the femoropopliteal (FP) arteries. Long-term studies, however, have shown a progressive decrease in the patency rates following PDCB. The aim of this study was to determine the predictors of stenosis recurrence after PDCB treatment of FP-ISR, and its immediate and mid-term outcomes. METHODS: This prospective, non-randomized study included all chronic lower extremity ischemia patients of Rutherford class 3-6 who underwent PDCB angioplasty to treat >50% FP-ISR between June 2017 and December 2019. The primary endpoint was primary patency, defined as freedom from binary restenosis and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints included 12-months freedom from CD-TLR and major adverse events (MAEs). RESULTS: A total of 73 symptomatic chronic limb ischemia patients (73 limbs including 63 with limb threatening ischemia) underwent PDCB angioplasty of FP-ISR lesions (13.7% Tosaka class I, 54.8% class II, and 31.5% class III). The mean ISR lesion length was 121.8 ± 52.7 mm. Technical success was achieved in 70 (95.9%) patients. Kaplan-Meier estimate of the 12-months rates of primary patency and freedom from CD-TLR was 76.1% and 87.4%, respectively. At one year, MAEs occurred in eight patients (11.0%) including two deaths (2.7%), one major amputation (1.4%), and six (8.2%) surgical revascularizations. Multivariable analysis showed that Tosaka class III ISR (HR 4.51, CI: 1.31-15.53, p < 0.001) and reference vessel diameter (HR 0.38, 95% CI: 0.18-080, p = 0.01) were independently associated with recurrent ISR. CONCLUSIONS: PDCB is safe and effective treatment of FP-ISR lesions. Occlusive ISR lesions and reference vessel diameter were independently associated with recurrent ISR stenosis after PDCB treatment.
ABSTRACT
OBJECTIVE: Recanalization of flush ostial superficial femoral artery (SFA) occlusion is a very challenging procedure. Using the ipsilateral antegrade approach in such lesions has some difficulties. This study aimed to assess the feasibility, efficacy, and outcomes of duplex-guided ipsilateral antegrade access for endovascular treatment of atherosclerotic flush occlusion of the SFA. METHODS: This is a prospective two-center study that included chronic lower extremity ischemia patients with flush occlusion of SFA who underwent duplex-guided ipsilateral antegrade endovascular revascularization due to unfeasible contralateral femoral approach. Flush occlusions were preoperatively documented by duplex ultrasound and computed tomography angiography in all patients. The outcome measures were technical success, patency rates, perioperative morbidity and mortality, limb salvage, and amputation free survival rates. RESULTS: Between April 2019 and March 2021, 49 patients were enrolled in the current study with a mean age of 63.7 ± 5.7 years. Diabetes was the most common risk factor and was found in 40 (81.6%) patients. Associated popliteal lesions were found in seven (14.3%) patients, while 10 (20.4%) patients had combined tibial disease. Selective stenting was done in nine (18.4%) patients. Technical success was achieved in 43 (87.8%) patients. All failures were due to inability to cross the lesion rather than failure to access the common femoral artery. All complications were minor and occurred in seven (14.3%) patients. Primary, assisted primary, and secondary patency rates were 63.9% ± 7.1%, 82.8% ± 5.6%, and 93.5% ± 3.7% at 12 months, respectively. The overall 12-month limb salvage and amputation free survival rates were 91.8% and 83.3% ± 5.4%, respectively. CONCLUSION: Duplex-guided ipsilateral antegrade femoral access is a feasible, safe, and effective endovascular treatment option for flush SFA occlusion when contralateral femoral access is not possible.
