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 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.

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.

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.

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.

[Endovascular therapy for peripheral arterial disease]. / Interventionelle Therapie der peripheren arteriellen Verschlusskrankheit.

In addition to conservative therapy with intensive walking training, endovascular revascularisation and open vascular surgical revascularisation are of high importance in the treatment of peripheral arterial disease. Over the past decades, endovascular therapy has developed considerably and is now the treatment of choice for most vascular segments. The use of different devices has been shown to be beneficial for different vessel segments. Primary stent angioplasty has been shown to be superior to balloon angioplasty with secondary stent implantation for the treatment of iliac lesions. Femoropopliteal, the use of paclitaxel-eluting balloon angioplasty is recommended. A mortality signal shown in a meta-analysis was not confirmed. With directional atherectomy and intravascular lithotripsy, different options for plaque modification are available. The cytostatic drug sirolimus as another antirestenotic substance still has to be investigated in large, randomised trials. A final assessment of the effectiveness and safety is not yet possible. Infrapopliteal balloon angioplasty remains the standard treatment. After interventional therapy, regular follow-up is recommended.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

OBJECTIVES: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. METHODS: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 µg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). RESULTS: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. CONCLUSION: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Effect of Paclitaxel Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions on Mortality.

BACKGROUND: Meta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice. METHODS: A retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed. RESULTS: Overall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups. CONCLUSION: In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions.

The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions.

Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel wall. Besides the drug, the SELUTION SLR™ drug-eluting balloon system consists of a coating formulation of four excipients. The first excipient is a biodegradable polymer (poly(lactic-co-glycolic acid)) that is intermixed with the sirolimus to form micro-reservoirs and regulates drug release via matrix degradation. This review summarizes the existing pre-clinical and clinical literature on treatment of femoropopliteal artery lesions with the SELUTION SLR DCB.

Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World.

OBJECTIVES: This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice. BACKGROUND: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices. 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, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007). CONCLUSIONS: In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.