The efficacy of paclitaxel drug-eluting balloon angioplasty versus standard balloon angioplasty in stenosis of native hemodialysis arteriovenous fistulas

Background End stage renal disease is on increasing trend and haemodialysis is the main dialysis modality among these patients. Thus, a functioning dialysis vascular access is critical to the delivery of life-saving haemodialysis treatment to these patients. Conventional angioplasty is the first line of treatment; with a 50% of permeability rate (6 months). For this reason, new alternatives are necessary to maintain the access permeability.Hypothesis: Paclitaxel coated balloon is superior to conventional plain balloon angioplasty with decreased re-stenosis of target lesion, improved access circuit and target lesion patency, and decreased number of interventions needed to maintain patency. Methods A total of 39 patients were randomized to receive a paclitaxel-coated balloon (n=15) or plain angioplasty balloon (n=24) after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 3, 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival. Results We recruited 39 patients with dysfunctional vascular accesses; 24 were assigned to the conventional balloon angioplasty group and 15 drug-eluting balloon angioplasty (paclitaxel). With demographic characteristics in Table I. In group A, all were autologous acces. Group B 16% (4) of the accesses were prosthetic and 84% (20) autologous. In relation to the type and length of stenosis, group A was more frequent at the level and longer, whereas in group B it predominated in the central type and less than 20 mm.In our study, we also observed a high rate of total occlusions, frequently in central vessels in group B, while in group A, where peripheral vessels were predominant, total occlusion was less frequent. Table II. We had no complications in either group, and dialysis was immediate at the end of the procedure. Group A did not present restenosis. Table III. Table III shows DEB group (15p) with 100% of permeability according to follow-up and only one (1/15) of patients died due to myocardial infarction and cerebrovascular accident and this patient kept lasted 9 months without restenosis In Table IV. Group B had 2 (8%) patients with restenosis so it was necessary to reoperate using a drug eluting balloon and until now there is no restenosis. From this group we do not have mortality. One patient 1 (24%) had a recovered infarction. Conclusions Paclitaxel-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 12 meses. Both arms show equivalent complications and similar mortality FUNDunding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Enrique Garcés Hospital

Drug-eluting balloon catheters in the treatment of left main coronary artery bifurcation lesions: 4-years follow-up

Aim To evaluate the long-term results of the use of drug-eluting balloon catheters in patients with Left Main (LM) bifurcation stenosis. Methods The analysis involved 142 patients with true bifurcations of the Left Main. Randomization in 2 main groups: Group I (n=52) included patients, who received kissing- dilatation with traditional NC balloon catheters and Group II (n=52), who had a kissing-dilatation of the main bifurcation artery with a traditional NC balloon catheters, and a side branch - with drug-eluting balloon catheters. In retrospectively, the third (III) control group (n=38) was formed, where the two-stent technique was performed. All patients from main groups had previously performed “Provisional T” stenting and final “kissing balloons” dilation technique. Coronary angiography and OCT were performed to evaluate the results of all patients. Inclusion criteria: true LM bifurcation stenoses according to QCA and OCT; SYNTAX score <32. Primary endpoints: incidence of MACE - death, MI, re-interventions. Secondary endpoints: the incidence of restenosis and late stent thrombosis. Results The long-term results after 4-years were observe in 46 patients from Group I and 48 patients from Group II. Restenosis of the side branch of more than 50% according to QCA was detected in 12 patients (26.0%) from Group I and in 5 patients (10.4%) from Group II (p<0.05). In-stent restenosis of the main vessel of more than 50% according to QCA was detected in 4 patients (8.6%) from Group I and in 1 patients (2.1%) from Group II (p<0.05). In patients from group I, the average MLA in the side branch after 4-years compared with data after PCI was 5.58±1.34 and 4.12±1.21 mm2, respectively (p<0.05), in the main branch – 6.34±1.56 and 5.88±1.14 mm2, respectively (p>0.05). In patients from Group II, the average MLA were, respectively, 5.38±1.24 and 5.01±1.14 mm2 in side branch (p>0.05) and 6.68±1.75 and 6.36±1.22 mm2 in main branch (p>0.05). When comparing the data of MLA in the side branch in groups I and II, there was a significant difference (4.12±1.21 vs. 5.01±1.14 mm2; p<0.05).The repeat revascularization, in connection with the detected ischemia was performed in 7 patients (15.2%) from Group I and in 1 patients (2.1%) from Group II (p<0.05). In the Group I was observed non-fatal myocardial infarction in 2 patients (4.3%). The total incidence of MACE were 19.5 vs. 2.1% in groups I and II respectively (χ2=7.321; p<0.001). The survival without MACE was 97.9 and 80.5%, respectively (p=0.0219). Conclusions The use of dug-eluting balloon catheters for the “Provisional T” stenting in patients with true LM bifurcation stenosis, associated with good prognosis and demonstrated significantly lower frequency of MACE and side branch restenosis, according to OCT data, compared with patients who used traditional NC balloon catheters for “kissing-dilatation” and two-stent technique strategy. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Russian academic excellence project 5-100

Efficacy and safety of paclitaxel drug-eluting balloons in femoropopliteal artery disease: a prospective observational study

Background: The femoropopliteal artery is most frequently involved artery in peripheral artery disease. To treat femoropopliteal artery disease (FPAD), various revascularization approaches have been available such as simple balloon angioplasty, debulking techniques, stent implantation, and recently the drug-eluting balloon (DEBs). Nowadays, the paclitaxel DEBs have been emerged to treat FPAD with promising outcomes. We therefore evaluate the efficacy and safety of paclitaxel DEBs in patients with lower limb FPAD.Methods: In total, 25 patients with FPAD were enrolled in the study. All patients underwent peripheral angioplasty using paclitaxel DEBs via antegrade femoral approach or contralateral femoral artery using crossover sheath. Demographics, risk factors, clinical characteristics, and pre- and post-procedure VascuQol-6 score were noted.Results: Out of 25 patients, the majority of patients (52%) were in the 6th decades of life. The incidence of FPAD was most common in patients with an O +ve blood group. The common risk factors of FPAD, include smoking (88%), diabetes (68%), dyslipidemia (68%), and hypertension (64%). Rest pain (64%) and ulcer (32%) were the most frequent clinical symptoms of FPAD. The percent stenosis was 100% in 17 patients, and 70-99% in 32 patients. A statistically significant difference was found in VascuQol-6 score between pre and post peripheral angioplasty (p<0.001).Conclusions: We have concluded that the paclitaxel DEBs are safe and efficacious in treating FPAD. Authors recommend that clinician should educate FPAD patients pertaining to modification of controllable risk factors such as cessation of smoking, unhealthy diet, sedentary lifestyle, high blood pressure, and high blood sugar.

Intrastent hematoma after treatment with a drug eluting balloon for in-stent restenosis: a case report

Back ground Intrastent hematoma after dilatation of in-stent restenosis is rarely reported and the optimal treatment for this condition remains unclear. Case summary We present the case of an 87-year-old man with in-stent subtotal occlusion of left circumflex (LCX). He experienced chest pain after drug eluting balloon (DEB) was released in the stent. Intravascular ultrasound (IVUS) revealed intrastent hematoma, which was not relieved with a cutting balloon but completely sealed by an Endeavor Resolute stent. Discussion Intrastent hematoma after dilatation of in-stent restenosis is rare. Reimplantation of stent seems the best method to solve this problem. IVUS imaging may provide insight into the cause of in-stent restenosis and guide the treatment.