Comparison of Clinical Effectiveness and Safety of Drug-Coated Balloons versus Percutaneous Transluminal Angioplasty in Arteriovenous Fistulae: A Review of Systematic Reviews and Updated Meta-Analysis.

PURPOSE: To evaluate the clinical effectiveness and safety of drug-coated balloons (DCBs) compared with those of percutaneous transluminal angioplasty (PTA) for arteriovenous fistula (AVF) stenosis via a review of systematic reviews (SRs) and an update of the current meta-analysis. MATERIALS AND METHODS: Literature was searched to retrieve SRs comparing DCBs and PTA for AVFs. A narrative review of SRs and pooled analysis were performed. RESULTS: Eleven SRs were included. DCBs demonstrated favorable outcomes at 6 and 12 months compared with PTA, with improved patency in 7 SRs and a trend toward favorable outcomes without statistical significance in 3 SRs. Target lesion revascularization (TLR) was reported in 3 SRs; 2 reviews reported a significantly lower incidence in the DCB group than in the PTA group, whereas 1 review reported no significant differences at 12 months. Four studies reporting all-cause mortality revealed no significant difference between the 2 treatments. In the updated meta-analysis including 23 studies, DCBs demonstrated improved primary patency at 6 months (risk ratio [RR], 1.27; 95% CI, 1.07-1.50) and 12 months (RR, 1.36; 95% CI, 1.19-1.55) and were associated with a lower incidence of TLR at 6 months (RR, 0.54; 95% CI, 0.41-0.73) and 12 months (RR, 0.78; 95% CI, 0.62-0.99). There was no difference in mortality between the 2 groups for 24 months. CONCLUSIONS: A review of SRs and meta-analysis update revealed the consistent benefits of DCBs over PTA in treating AVFs in terms of primary patency and TLR. Compared with PTA, DCBs do not increase mortality risk.

MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial.

BACKGROUND: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.

Balloon-mounting stent versus balloon angioplasty for intracranial arterial stenosis: A systematic review and meta-analysis.

BACKGROUND: Intracranial artery atherosclerotic stenosis (ICAS) is a major cause of stroke, especially in Asian countries. Current treatment options, including balloon-mounted stent (BMS) and balloon angioplasty (BA), lack sufficient evidence to determine a preferred approach. This systematic review and meta-analysis aimed to compare the efficacy and safety of BMS and BA in treating ICAS. METHODS: Following PRISMA 2020 guidelines, we conducted a comprehensive search in PubMed, Web of Science, and Scopus up to December 1, 2023. Eligible studies compared BMS with BA in patients diagnosed with ICAS. Primary outcomes included the success rate and occurrence of stroke (ischemic or hemorrhagic). Secondary outcomes were perforator occlusion, in-stent thrombosis, death, and restenosis. Statistical analysis was conducted using R software version 4.3.1, employing a random-effects model. RESULTS: Five high-quality studies involving 707 patients (515 males, 192 females) were included. BMS had a significantly higher success rate compared to BA (Risk Ratio [RR]: 1.13; CI: 1.03 to 1.24, p < 0.01; I2 = 14 %). The overall risk for stroke (ischemic and hemorrhagic) was significantly higher in BMS (RR: 2.97; CI: 1.32 to 6.67, p < 0.01; I2 = 0 %). However, no significant difference was found between BMS and BA regarding ischemic stroke (RR: 2.33; CI: 0.80 to 6.74, p = 0.12; I2 = 0 %). Additionally, no significant differences were observed in terms of perforator occlusion, in-stent thrombosis, dissection, minor and major strokes, and mortality rates. BMS was associated with a lower risk of restenosis (RR: 0.31; 95 % CI: 0.12 to 0.83, p = 0.02; I2 = 0 %). CONCLUSION: Our results indicate that BMS might be associated with higher success and lower restenosis rates than BA in the treatment of ICAS but with an increased overall risk of stroke. No significant differences were observed in ischemic stroke, perforator occlusion, in-stent thrombosis, dissection, minor and major strokes, and mortality rates. The choice of treatment should consider these findings, alongside the technical challenges and desired angiographic outcomes. Future randomized controlled trials are necessary to further elucidate these results.

Seria a valvuloplastia percutânea transluminar uma boa alternativa da substituiçäo valvular cirúrgica na estenose aórtica do paciente idoso? / Is percutaneous transluminal valvuloplasty a good alternative to surgical valvular replacement in aortic stenosis of elderly patients?

Valvuloplastia aórtica transluminar percutânea (VTP) foi realizada em 10 pacientes de 68 a 85 anos (média 78), com estenose aórtica calcificada. O gradiente transvalvar aórtico diminuiu, em média, de 50 mmHg + ou - 17 (p < 0,001) e foi de 33 mmHg depois da VTP. A superfície valvar aórtica era, em média, no início, de 0,38 + ou - 0,10 cm2, e passou a 0,78 + ou - 0,12 cm2, depois da VTP. O débito cardíaco aumentou de 4,28 + ou - 1,12 l/min para 4,81 + ou - 1,23 l/min, depois da VTP. Um dos pacientes faleceu em decorrência de problemas ligados à via de acesso do cateter munido de baläo. A VTP parece uma alternativa válida do tratamento da estenose aórtica grave nos pacientes idosos