Trial reportThe British journal of surgery2025
Long-term mortality rate and clinical outcomes associated with femoro-popliteal drug-coated balloon angioplasty and drug-eluting stents in chronic limb-threatening ischaemia: an analysis of the BASIL-3 RCT.
Trial report in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Plain balloon angioplasty +/- bare metal stenting versus drug-coated balloon angioplasty +/- bare metal stenting versus primary drug-eluting stenting in patients with chronic limb-threatening ischaemia: BASIL-3, an open-label, three-arm, randomised, multi-centre, phase 3 trial.Health technology assessment (Winchester, England) · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
introductionIn recent years there have been a plethora of new endovascular devices have entered the market, including paclitaxel (PTX) drug-coated balloons (DCB) and drug-eluting stents (DES) for treating patients with chronic limb-threatening ischaemia (CLTI). There have been concerns that the use of PTX is associated with increased all-cause mortality rate in this patient population.
methodsIn the BASIL-3 trial (ISRCTN14469736) UK patients with CLTI were randomized (1:1:1) to receive femoro-popliteal (FP) plain balloon angioplasty (PBA; with or without bailout bare metal stenting (BMS), DCB angioplasty (DCBA) (with or without BMS), or primary DES. Here, data from the DCBA and DES arms have been pooled into a single 'drug technologies' (DT) group and compared with PBA ± BMS. The primary outcome was overall survival (OS). Secondary outcomes included amputation-free survival (AFS), major amputations, major adverse limb events, major adverse cardiovascular events, reinterventions, and 30-day mortality and morbidity rates.
resultsFour hundred and eighty-one participants were randomized (PBA: n = 160; DT: n = 321). At a median follow-up in survivors of 5.6 years, OS was similar between the pooled DT and PBA groups (adjusted hazard ratio (HR): 0.83; 95% c.i.: 0.64 to 1.07). There was no evidence of a statistically significant difference in AFS between the groups (adjusted HR: 0.84; 95% c.i.: 0.66 to 1.06), or other secondary outcomes.
conclusionsThis further pooled analysis of the BASIL-3 RCT does not support the notion that the use of drug-eluting technologies, when compared to plain balloon angioplasty, increases all-cause mortality rate, or has other clinically important adverse effects, when used in patients with CLTI.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.