Kush Modi, Tony Joseph, Ruhi Shah, Raghav Ranga, Lawrence Markel
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引用次数: 0
Abstract
Background: Drug-coated balloon angioplasty (DCB) is an emerging alternative to percutaneous transluminal angioplasty (PTA) for below-the-knee (BTK) revascularization in patients with chronic limb-threatening ischemia (CLTI). DCBs deliver antiproliferative agents to reduce neointimal hyperplasia, but results are mixed. This review assessed the clinical outcomes of DCB vs. PTA in BTK interventions for CLTI.
Methods: This systematic review and meta-analysis was registered with PROSPERO (CRD420251073999). PubMed and CENTRAL were searched for randomized controlled trials and clinical trials comparing DCB and PTA in adult CLTI patients undergoing BTK intervention. Studies until June 2025 were included in the review. Outcomes included clinically driven target lesion revascularization (CD-TLR), major amputation, all-cause mortality, primary patency, and late lumen loss (LLL). Risk of bias was assessed using the Cochrane RoB 2 tool, with most studies judged to have low or some concerns but no critical sources of bias. Random-effects model was used to calculate pooled odds ratios (ORs) and standardized mean differences (SMDs).
Results: Ten studies were included in the review; seven were eligible for meta-analysis. DCB significantly reduced CD-TLR compared to PTA at 12 months (OR: 0.39; 95% CI: 0.04-0.73), but not at 5 years. No significant differences were observed in major amputations or all-cause mortality at 12 months or 5 years, though mortality trended lower with DCB in the long term (OR: 0.57; 95% CI: 0.13-1.01). No significant differences between DCB and PTA were found for 6-month primary patency or LLL.
Conclusion: DCB reduces early revascularization compared to PTA, but shows no significant long-term benefit in amputation or mortality. DCB may be selectively useful in certain patients at high risk of restenosis. Further long-term, risk-stratified studies are needed to optimize DCB use in CLTI management.
期刊介绍：
Annals of Vascular Surgery, published eight times a year, invites original manuscripts reporting clinical and experimental work in vascular surgery for peer review. Articles may be submitted for the following sections of the journal:
Clinical Research (reports of clinical series, new drug or medical device trials)
Basic Science Research (new investigations, experimental work)
Case Reports (reports on a limited series of patients)
General Reviews (scholarly review of the existing literature on a relevant topic)
Developments in Endovascular and Endoscopic Surgery
Selected Techniques (technical maneuvers)
Historical Notes (interesting vignettes from the early days of vascular surgery)
Editorials/Correspondence
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