Drug-coated Balloon Group Research Articles

Clinical outcomes and predictors of restenosis in patients with femoropopliteal artery disease treated using polymer-coated paclitaxel-eluting stents or drug-coated balloons.

Both polymer-coated paclitaxel-eluting stents (PC-PESs) and drug-coated balloons (DCBs) are used in conjunction with endovascular therapy (EVT) for the treatment of peripheral artery disease (PAD). We aimed to identify the risk factors for the loss of patency following the use of PC-PES and DCB in a real clinical setting. We assessed the multi-center registry data of 151 lesions from 151 patients who underwent EVT for symptomatic PAD in the superficial femoral and proximal popliteal arteries using PC-PES or DCB. One-year primary patency (PP) and clinically driven target lesion revascularization (CD-TLR) were evaluated using Kaplan-Meier analysis. The predictive risk factors for 1-year outcomes were analyzed using the random survival forest method. PC-PES and DCB were used in 65 (43.0%) and 86 (57.0%) cases, respectively. There were no significant differences in 1-year PP or freedom from CD-TLR between PC-PES and DCB. PP occurred in 85.4% and 80.2% of cases in the PC-PES and DCB groups, respectively (log-rank p = 0.65), while freedom from CD-TLR was noted in 92.7% and 94.1% of cases in the PC-PES and DCB groups, respectively (log-rank p = 0.73). In order of importance, a Clinical Frailty Scale score ≥ 6, female sex, lower proximal vessel diameter, lower body mass index, and younger and older age were identified as predictive risk factors of restenosis in the PC-PES group. Peripheral artery calcification scoring system grade of ≥ 2, post-dissection pattern ≥ D, lower proximal and distal vessel diameter, and lesion length ≥ 100mm were identified as predictive risk factors of restenosis, in order of importance, in the DCB group. Both PC-PES and DCB were associated with favorable clinical outcomes within 1year in patients with femoropopliteal artery disease. Furthermore, several factors that could predict restenosis within 1year following the use of each device were detected.

Comparison of Drug-Coated Balloons to Bare Metal Stents in the Treatment of Symptomatic Vertebral Artery-Origin Stenosis: A Prospective Randomized Trial

We sought to compare the angiographic and clinical outcomes of drug-coated balloon (DCB) with distal embolic protection devices (EPDs) versus bare metal stent (BMS) without EPD in the treatment of symptomatic vertebral artery origin stenosis (VAOS). Between January 2017 and December 2018, a prospective randomized trial was conducted involving 95 patients with symptomatic VAOS randomly assigned to treatment with DCB+ EPD (n= 49) or BMS without EPD (n= 46). Target vessel restenosis (RS) >50% detected by computed tomography angiography was the primary endpoint. Technical success, clinical success, and signal intensity abnormalities on diffusion-weighted imaging within 3 days after operation were compared. The 30-day technical success rate was 93.9% for DCB group versus 95.7% for the BMS group (P= 0.094). Diffusion-weighted imaging within 3 days postoperative showed asymptomatic embolization in 2 (4.1%) patients in the DCB group and 9 (19.6%) patients in the BMS group (P= 0.004). At a mean 16-month follow-up, the clinical success rate was 89.8% for the DCB group versus 91.3% (42/46) for the BMS group (P= 0.125). The RS was seen in 5/49 (10.2%) in the DCB group and 6/46 (13.0%) in the BMS group (P= 0.082). Target vessel revascularization was performed in 4 (8.7%) BMS group versus 3 (6.1%) in the DCB group (P= 0.091). DCB with EPD in the treatment of symptomatic VAOS is technically feasible and safe and significantly reduced thromboembolic events on imaging when compared with BMS without EPD. There was no significant difference between the 2 groups in the rate of RS during 12 months after surgery.

Clinical outcome of drug-coated balloon versus scaffold device in patients with superficial femoral artery chronic total occlusion.

The demand for endovascular therapy is increasing in an aging society, but the problem of restenosis in the chronic phase has not been resolved in femoropopliteal occlusive disease. Few studies have compared drug-coated balloon (DCB) and scaffold devices in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare DCBs with scaffold in patients with CTO of the SFA. This was a single-center, retrospective study. From June 2018 to December 2019, we compared 31 patients and 33 limbs treated with DCBs and 44 patients and 45 limbs treated with a stent or stent-graft (scaffold) for SFA CTO. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR) and 12-month freedom from re-occlusion. The DCBs were performed using an intravascular ultrasound (IVUS)-guided approach or a non-loop wire technique. Baseline characteristics were similar between the groups. An intraluminal approach was performed to use all DCBs. The bailout stent rate was 0% in the DCB group. Kaplan-Meier analysis showed that rates of 12-month primary patency tended to be higher in the DCB than in the scaffold group (92.7 vs. 76.6%, p = 0.073) and that freedom from CD-TLR also did not differ significantly between the two groups (96.8 vs. 86.3%, p = 0.17). Kaplan-Meier analysis also showed that the 12-month freedom from re-occlusion rate was significantly less in the Scaffold than in the DCB group (96.8 vs. 79.3%, p = 0.045). Therefore, we concluded that in treatment for CTO of the SFA, a DCB with intraluminal angioplasty without bailout stenting was less re-occlusion compared with scaffold.

Roles of Angioplasty With Drug-Coated Balloon for Chronic Ischemia in Wound Healing

Purpose: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called “downstream effect,” is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. Materials and Methods: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. Results: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). Conclusion: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.

Comparison of Clinical Outcomes With Drug Coated Balloons Versus Plain Balloon Angioplasty In Chronic Limb-Threatening Ischemia.

The use of drug coated balloon (DCB) for angioplasty has shown superior efficacy against plain balloons for treating complex infrainguinal arterial disease. We report and compare the clinical outcomes following application of DCB(Paclitaxel) and plain angioplasty (POBA) in our tertiary care centre. A retrospective, single centre analysis of 301 patients with chronic limb-threatening ischemia involving the infrainguinal segment was conducted between September 2014 and September 2018, after approval from the Institutional review board. We analyzed clinical outcomes by measuring postoperative ABI improvement, restenosis requiring reintervention procedure, minor and major amputations at the end of 18 months. . To find the association between the group variables (POBA and DCB) and other risk variables, Chi-square test/Fisher's exact test was used. Multivariable logistic regression analysis was used. Patients who underwent treatment with plain balloon (POBA) and DCB(Paclitaxel) angioplasty were 246(81.7%) and 55(18.3%) respectively. Our study group was predominantly male (Male: Female = 6.7:1), most patients were more than 50 years of age (n = 251, 83.4%). Smoking (n = 199, 66.1%) and diabetes (n = 210, 69.8%) were the most common atherosclerotic risk factors. Postoperative Ankle Brachial Pressure Index (ABI) improvement were similar in both groups (POBA = 57.7%; DCB = 69.8%; p = 0.103). Minor and major amputations following POBA were 26% and 22%; and DCB were 12.7% and 16.4% respectively. Re-stenosis requiring a re-interventional procedure within 18 months was 15%, (n = 37) following POBA; and 12.7% (n = 7) following DCB (p = 0.661). This retrospective study shows similar clinical limb related outcomes following POBA and DCB at 18 months. However, our comparative analysis between the POBA and DCB groups was totally unadjusted and not adjusted for common confounders such as age and sex. Hence, for one to draw definitive conclusions leading to changes in clinical practice; a randomized, prospective study with a larger patient cohort is needed.

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone (P=0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P=0.475), respectively. At 1 year, the target lesion revascularization rates were 30% (n=10) versus 43% (n=12; P=0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P=0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P=0.618) in the DA+DCB group and the DCB group, respectively. Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. https://www.clinicaltrials.gov; Unique identifier: NCT01763476.

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group (n = 30) or percutaneous transluminal angioplasty group (n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.

This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions. Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness. Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1month of the index procedure), and patient outcomes were analyzed. Mean lesion length was 82.5 ± 48.9mm for the Ranger DCB group (n=278) and 79.9 ± 49.3mm for the control group (n=98). Ranger DCB was superior to PTA (82.9% [n=194 of 234] vs. 66.3% [n=57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p=0.0013). Noninferior freedom from major adverse events (94.1% [n=241 of 256] vs. 83.5% [n=76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p<0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p=0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively. The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).

Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.

Background Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) of small-vessel coronary artery disease (SVD) is related to an increased risk of in-stent restenosis (ISR) and stent thrombosis (ST). The application of the drug-coated balloon (DCB) for patients with SVD remains controversial. Objectives Assess the outcomes of DCB in the treatment of SVD compared with DES in patients with SVD. Methods A meta-analysis of randomized controlled trials (RCTs) published up to June 2020, reporting the outcomes of DCB versus DES in the treatment of SVD, was performed. Results Four RCTs with 1227 patients were included. The results indicated that DCB was associated with the decreased risk for myocardial infarction (MI) compared with the DES, but the difference showed no significance (OR 0.50, 95% CI 0.24–1.03, P=0.06). And, there was no significant difference in death (OR 0.76, 95% CI 0.17–3.43, P=0.72), cardiac death (OR 1.92, 95% CI 0.74–4.98, P=0.18), target vessel revascularization (TVR) (OR 0.81, 95% CI 0.51–1.28, P=0.36), target lesion revascularization (TLR) (OR 1.29, 95% CI 0.66–2.52, P=0.46), and major adverse cardiac events (MACE) (OR 0.92, 95% CI 0.61–1.38, P=0.69) between the DCB group and DES group. Conclusion Compared with DES, DCB was associated with a decreased risk of MI among patients with SVD, but the difference showed no significance. The application of DCB in SVD is associated with comparable outcomes of death, TVR, and MACE when compared with DES.

A randomized comparison of two paclitaxel-coated balloons for the treatment of in-stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB).

This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR). Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB. This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow-up. A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow-up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups. In this multicenter, head-to-head, randomized trial, the new-generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.

Early coronary healing in ST segment elevation myocardial infarction: sirolimus-eluting stents vs. drug-coated balloons after bare-metal stents. The PEBSI-2 optical coherence tomography randomized study.

Drug-coated balloons (DCBs) have theoretical advantages over drug-eluting stents (DESs) to facilitate stent healing. We studied whether, in patients undergoing primary coronary interventions (pPCIs), a strategy of DCB after bare-metal stent improves early healing as determined by optical coherence tomography (OCT) compared with new-generation DES. pPCI patients were randomized (1:1) to treatment with new-generation sirolimus-eluting stents (DES group) or DCB-strategy. Vessel healing was assessed by OCT at 90 days. Fifty-three patients were randomized (26 DES vs. 27 DCB). At 90 days, both strategies showed a low rate of uncovered struts (3.2 vs. 3.2%, P = 0.64) and a very high and similar rate of covered and apposed struts (96.6 vs. 96.1%, respectively; P = 0.58). However, DCB group had a significantly lower rate of major coronary evaginations (68 vs. 37%, P = 0.026), and more frequently developed a thin homogeneous neointimal layer (20 vs. 70.4%, P = 0.001) suggesting distinct superior healing at 3 months compared to DES. In pPCI both, sirolimus-DES and DCB-strategy, provide excellent strut coverage at 3 months. However, DCB ensures more advanced and optimal stent healing compared to sirolimus-DES. Further research is needed to determine whether, in patients undergoing pPCI, DCB offers superior long-term clinical and angiographic outcomes than new-generation DES (NCT03610347).

Avoiding revascularization strategy versus revascularization with drug-coated balloon for the treatment of superficial femoral artery occlusive disease

ObjectiveThe aim of this study was to compare the efficacy, safety and treatment costs of superficial femoral artery revascularization (SFA) with drug-coated balloon(DCB) versus avoiding revascularization strategy for the treatment of symptomatic SFA disease. MethodsThis retrospective single-center study reviewed 96 patients (113 limbs) with severe stenosis and occlusive SFA disease. All patients underwent either DCB(Group 1: n ​= ​55 limbs) or nonrevascularization (Group 2: n ​= ​58 limbs) between March 2015 and June 2019. The improvement of Rutherford class, walking impairment questionnaire score(WIQ), target limb reintervention, perioperative major adverse events, the catheterization laboratory cost and length of hospital stay were compared. The limb salvage and survival rates were calculated using the Kaplan-Meier method. Univariate and multivariate logistic regression analysis were performed to assess the association between factors and the improvement of Rutherford category at 12 months. ResultsThe median follow-up time of Groups 1 and 2 was 17 and 33 months, respectively. At 12 months, the Rutherford category significantly decreased in both groups (P ​< ​0.001), with no significant difference (79.7% vs. 64.3%, P ​= ​0.074). Furthermore, multivariate analysis showed that the selected therapeutic method was not an influential factor for the improvement of Rutherford class at 12 months. The WIQ overall score as well as three subscales scores (distance, speed and stair-climbing), the survival rate, limb salvage rate and the length of stay between the two groups were comparable. The perioperative adverse events rate and catheterization laboratory cost in Group 2 was significantly lower compared to Group 1 [(34253.69 ​± ​28172.87) yuan vs. (56936.76 ​± ​41278.36) yuan, P ​= ​0.001]. ConclusionsThis study suggests that avoiding superficial femoral artery revascularization strategy has favorable efficacy and safety outcomes compared to combining revascularization with DCB in selected patients.

Long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the AcoArt I trial

ObjectiveWe evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). MethodsIn this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. ResultsDuring the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. ConclusionsWe found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.

Drug-Coated Balloon versus Bare Nitinol Stent in Femoropopliteal Artery: 12 Months Outcome from a Single Center in China

The study sought to compare the safety and effectiveness of drug-coated balloon (DCB) with bare nitinol stent in patients with complex femoropopliteal(FP) lesions in real-world practice. Patients with symptomatic (Rutherford stage 2 to 5) femoropopliteal lesions who underwent DCB or bare nitinol stent implantation at the Department of Cardiovascular Surgery of China-Japan Friendship Hospital from June 2016 to September 2017 were included. Demographics, angiographic and procedural variables were included. Freedom from target lesion revascularization (TLR), primary patency and major adverse events were obtained from follow-up results at 3,6 and12 months. Descriptive analysis was performed on all variables. A total of 90 eligible patients were enrolled, which included 51 DCB subjects (mean age, 63.1 ± 13.2 years; 76.5% male) with 55 lesions and 39 nitinol stent subjects (mean age, 66.5 ± 10.5 years; 61.5% male) with 42 lesions. Significant higher primary patency was observed in the DCB group compared with the stent group (74.5% vs. 52.4%; log-rank test P = 0.018; HR 0.335, 95%CI 0.124-0.903, P = 0.031). The rates of freedom from TLR (f-TLR) were 78.2% and 59.5% (log-rank test P = 0.032) for the DCB group and the stent group, respectively, at 12 months. CD-TLR rates were 18.2% vs. 38.1% with a P-value of 0.023. Female sex (HR 6.122, 95%CI 1.880-19.934, P = 0.003), lesion length over 20 cm (HR 5.514, 95%CI 2.312-13.148, P < 0.001) and renal insufficiency (HR 2.609, 95%CI 1.087-6.260, P = 0.032) were suggested as independent risk factors of reducing primary patency. There were no significant differences in major adverse events between the 2 groups. The result above demonstrates that DCB treatment has higher primary patency and lower TLR at 12 months than nitinol stent. These data confirm the safety and effectiveness of the DCB for patients with complex femoropopliteal lesions.

Atherectomy plus drug-coated balloon versus drug-coated balloon only for treatment of femoropopliteal artery lesions: A systematic review and meta-analysis.

To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34-0.71, P < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51-8.38, P = 0.31), perforation (RR: 2.04, 95%CI: 0.43-9.71, P = 0.37), hematoma (RR: 1.75, 95%CI: 0.43-7.09, P = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98-1.21, P = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41-1.14, P = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13-2.23, P = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71-6.64, P = 0.17). Sensitivity analysis had no effect on our findings. The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.

Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone

PurposeTo assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). Materials and MethodsThis prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. ResultsLLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). ConclusionsDespite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial

Previous studies have illustrated the potential superiority of drug-coated balloons (DCBs) in maintaining patency after initial angioplasty for arteriovenous fistula (AVF) dysfunction due to stenosis. Our trial evaluated the efficacy and safety of DCBs for preventing fistula restenosis in Chinese hemodialysis patients. Multicenter, prospective, randomized, open-label, blinded end point, controlled trial. A total of 161 hemodialysis patients with fistula dysfunction from 10 centers in China. Participants were randomized 1:1 to treatment with initial dilation followed by DCB angioplasty or conventional high-pressure balloon (HPB) angioplasty. The primary end point was target lesion primary patency defined as the target lesion intervention-free survival in conjunction with an ultrasonography-measured peak systolic velocity ratio (PSVR)≤2.0 at 6 months. The secondary end points included 1) device, technical, clinical, and procedural success; 2) major adverse events; 3) degree of target lesion stenosis at 6 months; and 4) clinically driven target lesion and target shunt revascularization within 12 months. The percentage with target lesion primary patency as defined by a PSVR≤2.0 was higher in the DCB group than in the control group (65% vs 37%, respectively; rate difference, 28% [95% CI, 13%-43%]; P<0.001) at 6 months. The target lesion and target shunt intervention-free survival of the DCB group were not superior to those of the control group at 6 months (P= 0.3 and P= 0.2, respectively) but were superior at 12 months (target lesion intervention-free survival: 73% for DCB vs 58% for control [P= 0.04]; target shunt intervention-free survival: 73% for DCB vs 57% for control [P= 0.04]). The average degree of target lesion stenoses at 6 months was not significantly different between the 2 groups (44% ± 16% for DCB vs 49% ± 18% for control; P= 0.09). There were no significant differences in major adverse events or in device, technical, clinical, or procedural success rates between the groups. Small sample size; short follow-up period; procedural differences between the 2 groups such as unequal inflation times and balloon lengths. Compared to conventional HPB angioplasty, DCB treatment achieved superior primary patency defined using PSVR measured at 6 months and superior intervention-free survival of both the target lesion and the target shunt at 12 months without evidence of greater adverse events. Funded by ZhuHai Cardionovum Medical Device Co., Ltd. Registered at ClinicalTrials.gov with study number NCT02962141.

Efficacy and safety of a magnesium stearate paclitaxel coated balloon catheter in the porcine coronary model

BackgroundLocal administration of growth-inhibiting substances such as paclitaxel or sirolimus could reduce the risk of restenosis. In the drug coated balloon (DCB) technology the coating and the applied dose seem to play a major role. The aim of the present preclinical studies was to investigate the efficacy and safety of a specific DCB with paclitaxel as active ingredient and magnesium stearate as excipient. MethodsEvaluation of the coating, drug release and transfer was done ex vivo and in vivo on peripheral arteries. A porcine coronary stent model was chosen to provoke intimal thickening. Conventional uncoated balloons were compared with paclitaxel urea and paclitaxel magnesium stearate coated balloons. QCA and histomorphometry was performed on treated vessels. Three areas of the heart were histologically examined for pathological changes. ResultsQCA and histomorphometry revealed no differences in baseline data between treatment groups. All DCB groups showed a significant reduction of angiographic and histologic parameters describing neointimal formation 4 weeks after treatment (e.g. mean angiographic late lumen loss all coated 0.31 ± 0.18 mm versus 0.91 ± 0.37 mm in the uncoated balloon group). There were no device-related animal deaths or clinical abnormalities. In spite of very slight-to-slight microscopic findings limited to small arterial vessels in downstream tissue there was no change in left ventricular ejection fraction or angiographic presentation of small side branches of treated arteries. ConclusionPaclitaxel DCB using stearate as excipient show a high efficacy in reducing neointima formation after experimental coronary intervention. No evidence of myocardial damage resulting from distal embolization was found.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.

This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions. Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes. The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12months. Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17mm; p=0.001 for noninferiority; p=0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p=0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p=0.23) and vessel thrombosis (1.8% vs. 0%; p=0.15) in the DES arm. In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generationDCBwas found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinicaloutcome.(DrugEluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Drug Eluting Stent vs. Drug Coated Balloon for Native Femoropopliteal Artery Disease: A Two Centre Experience

There have been limited clinical trials comparing drug eluting stents (DESs) and drug coated balloons (DCBs) in the treatment of femoropopliteal artery disease. This two centre retrospective and prospective cohort study sought to compare DES with DCB for the treatment of native femoropopliteal artery disease. A total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with DESs (Zilver PTX; 102 limbs) or DCBs (IN.PACT Admiral; 186 limbs) in two Korean endovascular centres between 19 January 2013 and 5 May 2018 and followed for a median duration of 19.6 months. The primary endpoint was primary clinical patency. Propensity score matching (PSM, 162 limbs) and inverse probability weighted (IPW) adjustment were performed to adjust for confounding baseline characteristics. The DCB group had fewer lesions with Trans-Atlantic Inter-Society Consensus (TASC) II type C/D (55.9% vs. 70.6%, p=.021) or total occlusions (43.5% vs. 77.5%, p<.001) and showed shorter lesion lengths (164.2±105.4mm vs. 194.8±86.8mm, p=.009) than the DES group. After PSM, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the DES group (5.4±0.6 vs. 5.1±0.7, p=.025). Adjunctive atherectomy was performed in 32.1% of the DCB group and in 2.5% of the DES group (p<.001). The provisional stenting was required in 14.8% of the DCB group. At two year follow up, the DCB group showed higher primary clinical patency (74.6% vs. 56.7%, hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.27-0.96, p=.032) and freedom from target lesion revascularisation (85.9% vs. 71.3%, HR 0.39, 95% CI 0.17-0.89, p=.021) than the DES group. Survival from all cause death did not differ between groups (87.6% vs. 92.1%, HR 1.85, 95% CI 0.62-5.52, p=.26). In this two centre cohort, DCBs with selective use of adjunctive atherectomy achieved more favourable outcomes than DESs for native femoropopliteal artery disease.