SAIMSARA Journal

Machine Generated Science • ISSN 3054-3991

DCB and Mortality: Scoping Review with ☸️SAIMSARA.

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Cardiac & Vascular Health

Issue 1, Volume 1, 2026

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DOI: 10.62487/saimsarafb65eabf

Editorial note
• Last update: 2026-03-25 08:48:20
What is this paper about
The paper tackles one of endovascular medicine’s most controversial questions: whether DCBs truly carry a late mortality risk. Mapping 170 original studies, it shows why the feared signal largely fades in broader evidence, where comorbidity and indication matter more than the device itself — and reveals the few settings where uncertainty still remains.
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Abstract: The aim of this paper is to evaluate the long-term safety profile of DCBs by synthesizing mortality outcomes across diverse clinical settings, including femoropopliteal disease, coronary interventions, and arteriovenous fistula (AVF) maintenance. The review utilises 170 original studies with 515578 total participants (topic deduplicated ΣN). The mapped evidence suggests that DCB use is generally not associated with increased long-term mortality across peripheral, coronary, and dialysis-access practice, with representative randomized findings showing 15.6% versus 15.2% mortality at 4 years and 80.1% versus 80.2% at 5 years for DCB versus comparator strategies in key peripheral datasets. This neutral safety signal is reinforced by large real-world analyses, including a 5-year HR of 1.01 for mortality in femoropopliteal disease and an 11-year national analysis that did not identify excess late death with paclitaxel-based devices. Within the evidence map, the most consistent modifiers of mortality were patient-level factors such as CLTI, CKD, diabetes, and hemodialysis rather than DCB exposure itself, while coronary ISR and some high-risk coronary cohorts showed signals of comparable or occasionally lower mortality with DCB-based approaches. Clinically, these findings support continued use of DCB where restenosis reduction or stent avoidance is desirable, provided mortality interpretation remains anchored to baseline comorbidity and indication-specific context. Future research should focus on long-term, indication-stratified comparative studies that better resolve residual uncertainty around paclitaxel dose exposure, high-risk CLTI populations, and heterogeneous real-world case mix.

Keywords: Drug-coated balloons; All-cause mortality; Paclitaxel safety; Peripheral artery disease; Coronary artery disease; In-stent restenosis; Drug-eluting stents; Endovascular therapy; Femoropopliteal disease; Long-term outcomes

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