Comparison of safety and efficacy of femoropopliteal arterial disease using different dose drug-coated balloons: Systematic review and meta-analysis
Bibliographic record
Abstract
Background Endovascular therapy with balloon percutaneous angioplasty (PTA) in the femoro-popliteal segment is frequently performed, however, long-term favorable outcomes and patency remain challenging, with restenosis rates reaching 60% post-standard balloon angioplasty. Drug-coated balloons (DCBs) have shown promise in improving these outcomes; Paclitaxel, used in DCBs, inhibits hyperplasia and smooth muscle cell proliferation, reducing restenosis; however, the optimal dose of Paclitaxel remains unclear, with high-dose (HD-DCB [>3 mg/mm 2 ]) and low-dose (LD-DCB [<2.0 mg/mm 2 ]) options available. This meta-analysis aims to compare the efficacy and safety of HD-DCB and LD-DCB in treating femoropopliteal arterial disease. Methods We followed PRISMA guidelines and conducted a comprehensive search of PubMed, EMBASE, Cochrane, Scopus, and Mendeley up to May 27, 2024. We included randomized controlled trials and cohort studies comparing HD-DCB and LD-DCB in patients with femoropopliteal arterial disease. Data were extracted on baseline characteristics, outcomes, and study quality. The Newcastle–Ottawa Scale and ROB2 tool were used for bias assessment. Outcomes included overall survival (OS), limb salvage (LS), freedom from clinically driven target lesion revascularization (CD-TLR), and major amputation. Results Six studies comprising 2563 patients were included. HD-DCB showed a significant benefit in limb salvage at 6 months (RR = 0.38, 95% CI = 0.18-0.78, p = .009) but not at 12 months (RR = 3.08, 95% CI = 0.14–67.13, p = .47). No significant difference was observed in overall survival between HD-DCB and LD-DCB at either 6 months (RR = 1.53, 95% CI = 0.25–9.57, p = .65) or 12 months (RR = 1.21, 95% CI = 0.17–8.84, p = .85). HD-DCB was associated with an increased risk of perioperative complications (RR = 1.90, 95% CI = 1.14–3.17, p = .01) and a higher, though not statistically significant, risk of major amputation (RR = 4.73, 95% CI = 0.54–41.52, p = .16). Conclusion HD-DCB may offer advantages in limb salvage over LD-DCB in the short term, but this comes with an increased risk of perioperative complications. These findings underscore the need for careful patient selection when considering HD-DCB for femoropopliteal artery disease.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.036 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.023 | 0.037 |
| Bibliometrics | 0.008 | 0.008 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".