Drug-coated balloons in below-the-knee arteries.

Background: The search for an optimal interventional treatment strategy in infrapopliteal peripheral artery disease remains in the focus of interest. Whether drug-coated balloons (DCB) might enhance interventional outcomes after crural interventions is a matter of debate, as studies yielded conflicting results on DCB safety and efficacy. Patients and methods: We analyzed a retrospective cohort of 75 infrapopliteal DCB interventions performed at our institution in 68 patients with peripheral artery disease in Rutherford category 3 to 6. Results: Despite a high rate of long complex lesions and multi-vessel disease, freedom from clinically driven target lesions revascularization (TLR) after 365 days was 68%. After six months, healing or significant improvement of the ischemic ulcer was observed in 78% of cases. Accordingly, freedom from major amputation and death after 365 days was 82%. Freedom from major amputation and death was 76.2% of cases in patients with diabetes mellitus as opposed to 91.5% in patients without diabetes mellitus (p=0.049). Conclusions: With this real-world analysis we would like to contribute to the ongoing discussion on the benefit and safety of DCB treatment in below-the-knee interventions.

Safety and effectiveness of Phoenix atherectomy for endovascular treatment in calcified common femoral artery lesions.

Background: Traditionally endarterectomy has been considered as the gold standard technique for the treatment of common femoral artery (CFA) lesions. The aim of this study is to investigate the procedural safety and mid-term outcomes of minimal invasive Phoenix atherectomy for the treatment of CFA lesions. Patients and methods: Phoenix atherectomy was used for treatment of 61 consecutive, moderately to heavily calcified CFA lesions in 56 patients. Lesions were classified based on the CFA occlusive disease classification (Type I, II&III lesions). Primary endpoints were technical, procedural, and clinical success rate. Safety endpoints (vessel perforation, peripheral embolization) and clinically driven target lesion revascularization (TLR) were also assessed. Results: Of 61 CFA lesions, 58 (95%) exhibited at least moderate/severe calcification (PACSS3 in 38 (62%) and PACSS4 in 20 (33%) cases). Type III lesions were present in 30 (49%), type I/II lesions in 31 (51%) cases. Technical and procedural success was achieved in 30 (49%) and all 61 (100%) lesions, respectively with low complication rates (0% perforation, 2% embolization). Adjunctive treatment after atherectomy was performed using drug-coated balloon (DCB) in 35 (57%) and bail-out stenting in 6 (10%) cases. Target lesion revascularization (TLR) occurred in 4 (7%) cases during a mean follow-up duration of 11±7months. All patients exhibited clinical improvement at follow-up, showing mean Rutherford category reduction from 3.7±1.1 to 1.5±1.1 (p<0.001). Conclusions: The Phoenix device can be used for the effective endovascular treatment of CFA lesions, due to its reasonable safety profile and mid-term results.

Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial.

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants (P < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants (P = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7; P = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%; P = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03; P = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14; P = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020 Online supplemental material in available for this article.

Comparison of ante-versus retrograde access for the endovascular treatment of long and calcified, de novo femoropopliteal occlusive lesions.

To compare antegrade versus retrograde recanalization, in terms of procedural time, radiation and contrast agent exposure, number and total length of implanted stents and procedural complications, in long and calcified, de novo femoropopliteal occlusions. We performed retrospective matching of prospectively acquired data by lesion length, occlusion length and lesion calcification by the peripheral arterial calcium scoring system (PACSS) score in patients who were referred for endovascular treatment due to symptomatic peripheral artery disease (PAD). Forty-two consecutive patients with antegrade and 23 patients with retrograde after failed antegrade recanalization were identified (mean lesion length = 32.1 ± 6.9 cm; mean occlusion length = 24.6 ± 7.7 cm; PACSS score = 3.25 ± 0.91). 23% of the patients had intermittent claudication, whereas 77% exhibited critical limb ischemia (CLI). Patients who underwent retrograde versus antegrade recanalization required a significantly lower number of stents (0.9 ± 1.0 versus 1.8 ± 1.4, p = 0.01) and a lower total stent length (6.8 ± 8.5 cm versus 11.7 ± 9.9 cm, p < 0.05) in the interest of more extensive coverage of the lesions using drug coated balloons (DCB) (28.5 ± 12.0 cm versus 18.2 ± 16.0 cm, p = 0.01). No re-entry device was required with the retrograde versus 9 of 42 (21%) with the antegrade recanalization group (p = 0.02). The rate of complications due to retrograde puncture was low (one patient with hematoma and one with distal pseudoaneurysm, both managed conservatively). In long and calcified femoropopliteal occlusions, the retrograde approach is associated with a lower number of re-entry devices and stents and with more extensive lesion coverage with DCB, in the interest of costs and possibly long-term patency.German Clinical Trials Register: DRKS00015277.

Early clinical outcomes for treatment of post-thrombotic syndrome and common iliac vein compression with a hybrid Oblique self-expanding nitinol stent - the TOPOS study.

Background: Physical attributes of conventional stents used in the ilio-caval territory are often unfavorable in the presence of external compression close to the bifurcation. A hybrid oblique stent was developed for the treatment of common iliac vein compression without compromising the contralateral iliac vein inflow. Patients and methods: The ongoing international monitored TOPOS study enrolled 60 patients with post-thrombotic syndrome (PTS) treated with the sinus-Obliquus stent (optimed) and provisional distal stent extension. At 3-month follow-up, patency rates were obtained from duplex ultrasound, and clinical outcomes were assessed by the Villalta score, revised venous severity score (rVCSS), pain intensity score and chronic venous disease quality of life questionnaire (CIVIQ-20). Results: Mean age was 46.6 ± 14.9 years (68.3 % women). Mean number of implanted stents was 1.9 ± 0.6; 12 (20 %) patients received the hybrid oblique stent only. Forty-eight (80 %) patients had distal stent extension, and 42 (70 %) had stents below the inguinal ligament. Four (7 %) patients (all with stent extension) developed stent thrombosis. Primary and secondary patency rates at 3 months were 93.1 % (95 %CI 83.3-98.1 %), and 100 % (95 %CI 93.8-100 %), respectively. Improvement in Villalta, rVCSS, CIVIQ-20, and pain intensity score from baseline to 3-month follow-up was 6.9 ± 1.4 points (95 %CI 4.1-9.8; p < 0.0001), 3.4 ± 1.0 points (95 %CI 1.3-5.4 points; p < 0.01), 13.6 ± 2.7 points (95 %CI 8.2-19.0 points; p < 0.0001), and 2.4 ± 0.5 (95 %CI 1.4-3.3; p < 0.0001), respectively. At follow-up, 38 (63 %) patients were free from the PTS and none developed contralateral deep vein thrombosis. Conclusions: In patients with PTS and common iliac vein compression, treatment with the hybrid oblique stent with provisional stent extension resulted in high patency rates and improvement in PTS severity and quality of life at 3-month. Two-year results of TOPOS will assess the durability of this treatment.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).