Drug-Coated Balloon Angioplasty Compared with Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions: 6-Month Results of a Randomized, Multi-Centers, Single-Blind, and Superiority Trial

2019 ◽  
Author(s):  
Xin Jia ◽  
Baixi Zhuang ◽  
Feng Wang ◽  
Yongquan Gu ◽  
Wei Guo ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Infrapopliteal Artery ◽  
Superiority Trial ◽  
Drug Coated Balloon ◽  
Single Blind

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

2021 ◽  
Author(s):  
Aljoscha Rastan ◽  
Marianne Brodmann ◽  
Tanja Böhme ◽  
Roland Macharzina ◽  
Elias Noory ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Primary Study ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Infrapopliteal Artery ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Background: 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. Methods: 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. Results: 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 TLR 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. Conclusions: 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. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

scholarly journals SAFETY AND EFFICACY OF DRUG COATED BALLOON ANGIOPLASTY FOR PERIPHERAL ARTERY REVASCULARIZATION. A META-ANALYSIS

2021 ◽  
Vol 77 (18) ◽  
pp. 1150
Author(s):  
Waqas Ullah ◽  
Mohamed Zghouzi ◽  
Bachar Ahmad ◽  
Yasar Sattar ◽  
Zeeshan Sattar ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Peripheral Artery ◽  
Safety And Efficacy ◽  
Drug Coated Balloon

scholarly journals Healing of femoral artery dissection after drug-coated balloon angioplasty: A case report with intravascular ultrasonography and angioscopy images

2019 ◽  
Vol 7 ◽  
pp. 2050313X1983415
Author(s):  
Taketsugu Tsuchiya ◽  
Minako Oda ◽  
Takaaki Takamura ◽  
Katsuhide Kitagawa ◽  
Koji Kajinami ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Balloon Angioplasty ◽  
Iliac Artery ◽  
Superficial Femoral Artery ◽  
External Iliac Artery ◽  
Artery Dissection ◽  
Intravascular Ultrasonography ◽  
Stent Deployment ◽  
Atherosclerotic Stenosis ◽  
Drug Coated Balloon

Early 80s male with intermitted claudication underwent endovascular therapy for atherosclerotic stenosis at left external iliac artery and middle of superficial femoral artery. Patient also had chronic atrial fibrillation, diabetes mellitus, and hypertension. After stent deployment for external iliac artery lesion, a short superficial femoral artery lesion was performed with angioplasty using drug-coated balloon. The drug-coated balloon angioplasty resulted in 50% residual stenosis with linear dissection; however, provisional stenting was not performed as decent ante-grade blood flow allowed 10 extra minutes. Medication involved ongoing use of aspirin 100 mg and rivaroxaban 15 mg. Angiography post 3 months from index procedure showed external iliac artery and superficial femoral artery patency and healing of intimal dissection at superficial femoral artery lesion was estimated by intravascular ultrasonography. In angioscopy findings, red thrombus was seen in dissection cavity.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

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