This paper shows that DCB is not just a technical upgrade over POBA, but a consistently stronger strategy for restenosis-prone vascular disease, with better patency and fewer repeat interventions across coronary ISR, femoropopliteal lesions, BTK disease, and dialysis access. The full paper is worth reading because it reveals where that advantage is most convincing, where technique and vessel preparation change the outcome, and how much of DCB’s real-world value lies in selecting the right lesion, not just the device.
Abstract: This paper aims to systematically compare the clinical efficacy and safety outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty for the treatment of various vascular stenoses, synthesizing findings from human and animal studies. The review utilises 50 original studies with 133077 total participants (topic deduplicated ΣN). Across the mapped evidence, DCB angioplasty shows a consistent signal of improved patency-related outcomes and reduced reintervention compared with POBA across coronary ISR, femoropopliteal disease, infrapopliteal/BTK interventions, and dialysis access stenosis, aligning with a mechanistic theme of attenuated neointimal hyperplasia after local antiproliferative drug delivery. The evidence base also highlights that procedural context—particularly vessel preparation and lesion characteristics—may modify observed benefit, supporting a role for optimized preparation strategies when deploying DCBs. Interpretation is tempered by the scoping design and the absence of formal risk-of-bias assessment, which limits certainty about the magnitude and consistency of effects across heterogeneous settings. Practically, the mapped literature supports considering DCB as a preferred option in several high-restenosis contexts (notably coronary ISR, femoropopliteal disease, and dialysis access dysfunction) while emphasizing careful technique and patient/lesion selection. Future work should prioritize well-stratified, head-to-head trials and standardized outcome reporting to clarify where DCB offers the greatest incremental value over POBA.
Final search date and database lock: 2026-03-11 13:34:12 CET
Plan: Pro (expanded craft tokens; source: Semantic Scholar)
Source: Semantic Scholar
Total Abstracts/Papers: 161
Downloaded Abstracts/Papers: 161
Included original and non-original Abstracts/Papers (all): 76
Included original Abstracts/Papers (Vote counting by direction of effect): 50
Reference Index (links used in paper): 45
Total participants (topic deduplicated ΣN): 133077
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Reference Index (46)
[1] Response to pre-dilatation with POBA can predict target lesion revascularization after DCB angioplasty for de novo small coronary artery lesions — https://doi.org/10.1177/03000605221113779
[2] Multicenter randomized controlled trial to assess the effectiveness of PASSEO-LUX DCB® drug coated balloon compared to plain balloon angioplasty of arteriovenous fistulae for hemodialysis: Two-years results — https://doi.org/10.1177/11297298241272259
[4] Long‐Term Clinical Outcomes of Treatments for In‐Stent Chronic Total Occlusions: A Real‐World Study Based on Different Strategies of Revascularization — https://doi.org/10.1002/mef2.70011
[6] Vessel preparation with FLEX Vessel Prep device prior to paclitaxel-coated angioplasty improves outcomes of hemodialysis vascular access — https://doi.org/10.1177/11297298251352690
[7] Drug-Eluting Stent, Drug-Coated Balloon, or Plain Old Balloon Angioplasty for In-Stent Coronary Restenosis: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials. — https://doi.org/10.1161/circinterventions.125.015161
[11] Drug‐Coated Balloons Versus Other Percutaneous Coronary Intervention Strategies in De Novo Coronary Artery Disease: A Systematic Review, Meta‐Analysis With Trial Sequential Analysis — https://doi.org/10.1155/cdr/5568664
[12] Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting. — https://doi.org/10.1016/j.carrev.2024.01.004
[13] Vessel Wall Histologic Changes in a Porcine Model of Arteriovenous Fistula Stenosis Treated with Percutaneous Transluminal Angioplasty. — https://doi.org/10.1016/j.jvir.2024.12.023
[15] Comparative Efficacy and Safety of Different Balloon Angioplasty Procedures for Infrapopliteal Artery Lesions in Chronic Limb-Threatening Ischemia Patients: A Systematic Review and Network Meta-Analysis. — https://doi.org/10.1177/15266028241292954
[17] A Retrospective Comparative Study of Mid‐Term Outcomes of Atherectomy, Drug‐Coating Balloon Angioplasty, and Plain Old Balloon Angioplasty for Isolated Atherosclerotic Popliteal Artery Lesions — https://doi.org/10.1111/jch.14908
[18] The Consideration of Appropriate Surrogate Endpoint in Premarket Clinical Trials of Drug-Coated Balloon Catheter for the Treatment of Femoropopliteal Artery Stenosis. — https://doi.org/10.1177/15266028241300861
[21] Combined treatment of dysfunctional dialysis access with cutting balloon and paclitaxel-coated balloon in real world. — https://doi.org/10.1024/0301-1526/a001063
[22] Ultrasound-Assessed Lesion Morphology and Drug-Coated Balloon Treatment for de novo Dysfunctional Arteriovenous Fistula in Hemodialysis Patients — https://doi.org/10.1177/15266028231215225
[25] Drug‐Coated Balloon and Drug‐Eluting Stent Safety in Patients With Femoropopliteal and Severe Chronic Kidney Disease — https://doi.org/10.1161/jaha.122.028622
[26] Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials — https://doi.org/10.1002/ccd.28176
[27] Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial. — https://doi.org/10.1148/radiol.2020191619
[28] Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World. — https://doi.org/10.1016/j.jcin.2020.04.050
[30] Use of drug-coated balloons and stents in patients with femoropopliteal artery disease and severe chronic kidney disease — https://doi.org/10.1177/1358863x221148521
[32] Improvement of Outcome for Treatment of ‘Restenosis-prone’ Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries — https://doi.org/10.1007/s00270-022-03277-x
[36] Angioplasty of Dysfunctional Dialysis Fistula or Graft with Resveratrol-Excipient and Paclitaxel-Coated Balloon Improves Primary Patency Rates Compared to Plain Angioplasty Alone — https://doi.org/10.3390/jcm11247405
[39] Efficacy and Safety of a Novel Paclitaxel-Nano-Coated Balloon for Femoro-Popliteal Angioplasty: 1-Year Results of EffPac Trial. — https://doi.org/10.4244/eij-d-19-00292
[40] Randomized Controlled Trial for Paclitaxel Coated Balloon Versus Plain Balloon Angioplasty in Dysfunctional Haemodialysis Vascular Access: 12-month outcome from a non-sponsored trial. — https://doi.org/10.1016/j.avsg.2020.10.005
[43] Drug coated balloon supported Supera stent versus Supera stent in intermediate and long-segment lesions of the superficial femoral artery: 2-year results of the RAPID trial. — https://doi.org/10.23736/s0021-9509.19.11109-3
[48] Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results — https://doi.org/10.1177/15266028211057089
[49] Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials — https://doi.org/10.1155/2020/4158363
[50] Angioplasty or bare metal stent versus drug-eluting endovascular treatment in femoropopliteal artery disease: a systematic review and meta-analysis. — https://doi.org/10.23736/s0021-9509.19.11115-9
[51] Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience. — https://doi.org/10.1024/0301-1526/a000910
[58] Comparative Study between Simple Percutaneous Transluminal Angioplasty and Drug-Coated Balloons in Chronic Total Occlusion of The Femoro-popliteal Artery — https://doi.org/10.21608/ejhm.2020.121013
[72] Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials — https://doi.org/10.1080/07853890.2026.2623329
[73] Comparing Endovascular Approaches in Lower Extremity Artery Disease: Insights from a Network Meta-Analysis — https://doi.org/10.3390/jcm13041024
[75] A Systematic Review and Meta-analysis of Atherectomy Plus Balloon Angioplasty Versus Balloon Angioplasty Alone for Infrapopliteal Arterial Disease — https://doi.org/10.1177/15266028231209236
