Rotational Atherectomy Plus Drug-Coated Balloon Angioplasty for the Treatment of Total In-Stent Occlusions in Iliac and Infrainguinal Arteries

Abstract

Purpose: To analyze the long-term outcomes of a hybrid treatment method combining rotational atherectomy with drug-coated balloon (DCB) angioplasty in patients with total in-stent occlusion in the iliac and/or infrainguinal arteries. Materials and Methods: Between April 2014 and June 2017, 74 consecutive patients (mean age 66.7±9.7 years; 49 men) with total occlusion of a previously implanted stent underwent endovascular recanalization using the Rotarex system and DCB angioplasty. Half (37, 50%) of the patients had critical limb ischemia (CLI), and 30 (41%) of the procedures were performed in emergency. Mean lesion length was 22±15 cm. Results: Overall procedure success was achieved in 73 (98.6%) patients. Six (8.1%) CLI patients developed distal embolism that responded to thrombolysis. Three (4.1%) dissections did not require treatment, while 1 (1.4%) perforation necessitated stent-graft implantation. In all, 33 (44.6%) patients had an additional stent implanted, mainly due to a suboptimal outcome (n=28) or complications (n=5 including the stent-graft). The restenosis rate assessed by duplex ultrasound at 12 months was 20.5% (15/73); 4 (5.5%) patients underwent target lesion revascularization. Recurrent restenosis was more frequent in patients with Rutherford category 5 ischemia (p=0.005), in emergency procedures (p=0.021), after extensive procedures involving 3 independent vessel segments (p=0.016), and if a complication arose during the procedure (p<0.001). In multivariate analysis, only occurrence of a procedural complication was an independent predictor of recurrent restenosis at 1 year (OR 63.3, 95% CI 5.7 to 701.5). Conclusion: These findings imply that rotational atherectomy and DCB angioplasty may provide satisfactory outcomes in the treatment of total in-stent occlusion, with a satisfactory recurrent restenosis rate at 12 months.

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

“…However, our bail‐out stenting rates were still higher compared to rates reported by RCTs of DCBs for FP ISR . This can be explained by their shorter average lesion length and lower rate of Tosaka III lesions . Most of the studies that examined DCBs with or without LA for the treatment of FP‐ISR are also limited to 1‐year outcomes.…”

“…The study compared DCB versus BA only and found a superiority for the DCB arm which started as early as at 6‐month follow‐up (Freedom from TLR rates: 100% vs. 79%; p = .004) and persisted up to 2‐years (81% vs. 50%, p = .007). Similar to the DEBATE ISR study, ISAR‐PEBIS included shorted lesions (average 140 mm), with almost 30% Tosaka I lesions, while the percentage of Tosaka III in the whole population was less than 35% (vs. 70% in our study) and the studied population consisted almost entirely of claudicants (only one CLI patient in each arm) …”

“…33 This can be explained by their shorter average lesion length and lower rate of Tosaka III lesions. 13,[34][35][36] Most of the studies that examined DCBs with or without LA for the treatment of FP-ISR are also limited to There is a relative paucity of data in term of the use of LA for the treatment of FP-ISR. 32 Apart from our group, LA in combination with DCB has been studied also in a single-center RCT by Gandini et al 36 LA helps debulk the neointimal tissue from the restenosed stent and therefore decreases recoil before balloon inflation.…”

Percutaneous Rotational Mechanical Atherectomy Plus Thrombectomy Using Rotarex S Device in Patients With Acute and Subacute Lower Limb Ischemia: A Review of Safety, Efficacy, and Outcomes

“…Main data regarding the utility of MATH using the Rotarex S device in the management of acute and subacute lower limb occlusive disease and its potential contribution in prolonging the durability of endovascular revascularization are coming mainly from retrospective studies ( Table 1) (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). Looking at the literature, we identified 16 clinical studies, which evaluated MATH using the Rotarex S device as a primary treatment during revascularization interventions in patients with peripheral arterial occlusive disease in iliac, femoral, and/or popliteal arteries.…”

“…Three retrospective studies assessed the use of Rotarex S MATH with or without adjunctive therapy (e.g., PTA, DCB, stenting) in the treatment of femoro-popliteal in-stent restenosis or occlusion in a population of 234 patients and showed very encouraging technical success rates ranging from 96.9 to 98.6% (6,20,21).…”