Evaluation of acute and midterm outcomes after complex combined antegrade/retrograde recanalization for occlusions of the femoropopliteal and infrapopliteal arteries.

BACKGROUND: When antegrade recanalization of femoropopliteal and/or infrapopliteal occlusions fails, retrograde access has become an established option. To evaluate the results of combined antegrade and retrograde recanalization of femoropopliteal and infrapopliteal occlusions, patients undergoing secondary retrograde recanalization attempts were analyzed retrospectively. METHODS: The primary end point was the success of the procedure (successful occlusion crossing using the antegrade/retrograde technique). Secondary end points include complication rate, primary patency and target lesion revascularization (TLR) rate, amputation rate, changes in ankle-brachial index, and Rutherford-Becker class. Predictors for procedure failure and TLR were analyzed. RESULTS: We included 888 patients: 362 with femoropopliteal (group 1), 353 with infrapopliteal (group 2), and 173 with multilevel (group 3) recanalization. Critical limb-threatening ischemia was present in group 1, 2, and 3 in 36%, 62%, and 76% of patients, respectively. The intervention was successful in 92.5%, 93.8%, and 90.8% of the respective cases (P = .455). The overall peri-interventional complication rate was 7.2%. At 6, 12, and 24 months, primary patency was highest in group 1 (63.9%, 45.8%, and 33.3%), followed by group 3 (59.8%, 46.1%, and 33.3%), and group 2 (58.5%, 43.1%, and 30.4%; P = .537). The risk of undergoing repeated TLR within 24 months was 31.4% for group 1, 39.1% for group 2, and 45.7% for group 3. At 24 months, the survival rates in groups 1, 2, and 3 were 93.8%, 79.4%, and 87.5%, respectively. Over 24 months, 75 patients (8.4%) had to undergo amputation. Significant improvements in both ankle-brachial index and Rutherford-Becker class were present at discharge as well as at 6, 12, and 24 months (P < .001). Dialysis dependency was a predictor of unsuccessful antegrade/retrograde recanalization (P = .048). Lesion length (P = .0043), dialysis (P = .033), and recanalization level (P = .013) increase the risk of TLR. CONCLUSIONS: Using a combined antegrade/retrograde access, recanalization of occluded femoropopliteal and/or infrapopliteal arteries can be achieved in a large number of cases. Owing to the high rate of repeated TLR across all lesion localizations, the indication for antegrade and retrograde recanalization may be limited to patients with critical limb-threatening ischemia.

Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.

PURPOSE: Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions. METHODS: This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed. RESULTS: A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039). CONCLUSION: Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects. CLINICAL IMPACT: Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

BACKGROUND: The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. PURPOSE: To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. METHODS: A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. RESULTS: Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. CONCLUSION: In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. CLINICAL TRIAL REGISTRATION: German Clinical Trials Register: DRKS00031245. CLINICAL IMPACT: The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Clinical outcomes in patients with critical limb-threatening ischemia and infected ulcers following endovascular therapy are pathogen dependent: A single-center experience from 2012 to 2021.

BACKGROUND: Patients with critical limb-threatening ischemia (CLTI) and infected leg ulcers are at risk of amputation and postinterventional sepsis. METHODS: This retrospective, single-center study included patients with CLTI and infected leg ulcers who underwent endovascular treatment (EVT) between 2012 and 2021. RESULTS: The study included 712 patients, 286 (40.2%) of whom underwent amputation (minor, n = 212; major, n = 74). Gram-negative bacteria (GNB) were significantly more prevalent in amputees (36.4% vs 30.9%, p < 0.05). Patients with gram-positive bacteria (GPB) had a 4-year freedom from any amputation rate of 72% (95% CI 64-81%) compared to 52% (95% CI 42-66%) in patients with GNB identification (p < 0.05). Cox proportional regression analysis showed that GNB, male sex, mean Wound, Ischemia, and foot Infection (WIfI) score, diabetes mellitus, and end-stage renal disease were independently and positively associated with amputation (p < 0.05). The mean WIfI score and end-stage renal disease were independently and positively associated with death from any cause (p < 0.05). Staphylococcus aureus or GNB, end-stage renal disease, and diabetes mellitus were independent risk factors for sepsis after EVT (p < 0.05). Inpatient-administered antibiotic regimes had significantly higher microbiological activity in cases of GPB identification compared to GNB identification (28% vs 9%, p < 0.05). CONCLUSION: Although the isolation of both GNB and S. aureus is a risk factor for sepsis following EVT, the isolation of GNB is independently associated with higher rates of amputation, demonstrating the importance of identifying pathogens to recognize patients at high risk.

Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.

BACKGROUND: The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM). METHODS: Patients with claudication or ischemic rest pain (Rutherford class 2-4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. RESULTS: A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96). CONCLUSIONS: This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months. CLINICAL IMPACT: This substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.

Combined treatment of dysfunctional dialysis access with cutting balloon and paclitaxel-coated balloon in real world.

Background: Dysfunction in arteriovenous (AV) access is a common reason for subsequent intervention. To evaluate the results of endovascular treatment of AV access lesions using cutting balloon (CB) and drug-coated balloon (DCB) angioplasty compared to standard treatment using plain-old balloon angioplasty (POBA). Patients and methods: Patients who retrospectively were selected from a prospectively maintained database. Primary endpoint was primary patency rate at the target lesion up to 12 months after index procedure. Secondary endpoints were the acute treatment success, the "bail out" stent rate, primary patency at 6 months, freedom from target lesion revascularization (TLR), AV access replacement and surgical revision during a follow-up period up to 12 months, and all-cause mortality rate stratified to patients treated with and without DCB. Results: One hundred and eighty-four patients met the inclusion criteria. POBA as stand alone or combined with DCB angioplasty was performed in 71 patients (38.6%), CB in 54 patients (29.3%), and in 59 patients (32.1%), both CB and DCB were used. Primary patency rate at 12 months was 31.6% for the POBA/DCB-group, 52.3% for the CB-group, and 64.8% for the CB/DCB-group, respectively. In total, 80 patients (51.6%) had a TLR including endovascular or surgical revision, or a shunt replacement. All-cause mortality at 12 months was 7.2% in the DCB group and 9.1% in the group of patients treated without a DCB (p=0.747). Conclusions: The use of CB seems to be crucial for a better outcome. The combination of CB and DCB achieves the best patency results at mid-term.

Mortality Following Treatment With and Without Paclitaxel-Coated Devices in Dialysis Patients.

OBJECTIVES: To evaluate the mortality after treatment with a paclitaxel (PTX)-coated device and with uncoated devices of iliac, femoropopliteal, and below-the-knee lesions in dialysis patients. METHODS: Retrospective mortality analysis of dialysis patients with peripheral artery disease who underwent treatment of iliac, femoropopliteal, and/or infrapopliteal lesions with PTX-coated or uncoated devices. RESULTS: Between 2010 and 2018, 1125 dialysis patients were treated with iliac and/or femoropopliteal and/or infrapopliteal lesions. In all, 359 patients were selected for this retrospective analysis. Of those, 122 patients were treated with uncoated devices without crossover to a PTX-coated device during follow-up and 237 patients were treated with a PTX-coated device. Mean follow-up time was 27.38±24.76 months (range=0-103). For the entire cohort, the overall mortality was 95.1% after uncoated treatment and 75.9% after PTX treatment (p<0.001). After propensity score matching (n=119), overall mortality was 95.0% after uncoated treatment and 78.2% after PTX treatment (p<0.001). For the entire cohort, multivariate logistic regression analysis revealed age (p=0.002) and critical limb ischemia (p<0.001) as independent predictors for mortality. PTX treatment was a protective factor for mortality (p<0.001). CONCLUSION: Mortality in dialysis patients is in general high and higher after use of uncoated devices compared with PTX-coated devices. Mortality predictors were risk factors and disease severity but not PTX treatment. CLINICAL IMPACT: After the publication of Katsanos's metaanalyses, the uncertainty regarding PTX device safety in peripheral interventions in patients mainly without end-stage renal insufficiency was initially considerable. The present study for the first time investigates the potential long-term mortality risk of dialysis patients following PTX device treatment of PAD. In contrast to a recent meta-analysis, this real-world study could show a better survival after PTX treatment in comparison to uncoated devices.

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.

PURPOSE: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. MATERIALS AND METHODS: This prospective, multicenter, single-arm trial (ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. RESULTS: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. CONCLUSION: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.

Mortality Following Treatment with Paclitaxel-Coated Devices in Real World Utilization: Correlation to Total Lifetime Dosage?

PURPOSE: To evaluate the all-cause mortality after treatment with paclitaxel-coated devices depending on paclitaxel exposure in real-world practice. MATERIALS AND METHODS: A retrospective analysis of mortality of patients with at least a 3-year follow-up was performed. Patients were categorized into terciles according to the paclitaxel dosage received during the index procedure and every subsequent intervention. The incidence of mortality of these patients was compared with that of a paclitaxel-naïve control group. RESULTS: In total, 2,376 patients were treated with drug-coated devices and 980 patients with uncoated devices. The overall all-cause mortality rate at a mean follow-up of 46.27 months ± 24.71 was 29.2% (n = 696) for the paclitaxel group and 49.4% (n = 484) for the paclitaxel-naive control group. The mortality rate between the groups according to the initial paclitaxel exposure was not significantly different (P = .205). In comparison to the group of surviving patients, the total lifetime paclitaxel dosage was lower in the group of patients who died (P < .001). CONCLUSIONS: In this real-world retrospective analysis, long-term mortality was not correlated with the paclitaxel exposure during the index procedure. Regarding the total paclitaxel exposure, lower mortality was observed in the highest tercile of paclitaxel exposure.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC).

Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience.

Background: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. Patients and methods: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. Results: Overall 624 patients with femoropopliteal lesions were included in this study. Of those, 197 patients were treated with POBA without crossover to a paclitaxel coated device during follow-up and 427 patients with DCB angioplasty. Mean follow-up time was 33.3 ± 25.4 months. Mortality incidence was 81.7% (95% confidence interval [95% CI]: 76.1-86.8) after POBA and 59.0% (95% CI: 54.6-63.9) after DCB (p < 0.001). Multivariate logistic regression analysis revealed type of treatment (POBA vs. DCB, (hazard ratio [HR]: 0.332, 95% CI: 0.215-0.514, p < 0.001), age per year (HR: 1.065, 95% CI: 1.046-1.087, p < 0.001), coronary heart disease (HR: 1.969, 95% CI: 1.323-2.930, p = 0.001), renal insufficiency (HR: 1.583, 95% CI: 1.079-2.323, p = 0.019), stroke (HR: 2.505, 95% CI: 1.431-4.384, p = 0.001) as predictors for all-cause mortality. In the subgroup excluding octogenarians, mortality predictors were type of treatment (HR: 0.463, 95% CI: 0.269-0.796, p = 0.005), age per year (HR: 1.035, 95% CI: 1.002-1.069, p = 0.038), coronary heart disease (HR: 2.082, 95% CI: 1.274-3.400, p = 0.003), stroke (HR: 2.203, 95% CI: 1.156-4.197, p = 0.016) and renal insufficiency (HR: 2.201, 95% CI: 1.357-3.571, p < 0.001). Conclusions: This monocentric retrospective analysis showed no survival disadvantage for patients in Rutherford-Becker stage 5 after treatment with paclitaxel-coated balloons.

Evaluation of mortality following paclitaxel drug-coated stent angioplasty of femoropopliteal lesions in real world.

OBJECTIVES: To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice. BACKGROUND: A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices. METHODS: Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who underwent DES angioplasty or uncoated balloon or stent angioplasty of femoropopliteal lesions with a follow-up of 3-7 years. RESULTS: From 2010 to 2016 8,377 patients were treated with femoropopliteal lesions. This analysis included 599 patients. Three-hundred-three patients were treated with an uncoated device and 296 patients with a DES. The mean follow-up period was 51.80 ± 23.40 months (range 0-84). For the entire cohort mortality incidence was 32.3% after uncoated treatment and 22.6% after DES (p < .033). For the entire cohort multivariate logistic regression analysis revealed age (p < .001), diabetes mellitus (p = .010), renal insufficiency (p = .001) and RBC 4 (p < .001) as independent predictors for mortality. After propensity score matching mortality incidence was 32.5% after uncoated treatment and 24.1% after DES (p = .264). After propensity score matching, independent mortality predictors were age (p < .001), hyperlipidemia (p = .035), diabetes mellitus (p = .018) and RBC 4 (p < .001). Kaplan-Meier analysis showed that higher paclitaxel dosage was associated with lower mortality. CONCLUSION: In real world, long-term mortality rate was lower after DES angioplasty than after treatment with uncoated devices. Mortality predictors were co-morbidities, risk factors, and disease severity.

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.

Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting.

OBJECTIVE: To evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions. BACKGROUND: The benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions. METHODS: This retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI). RESULTS: One hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172). After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline. Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months. CONCLUSION: After one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory.