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Randomized Controlled Trial
. 2025 Nov 6;112(11):znaf251.
doi: 10.1093/bjs/znaf251.

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

Matthew Popplewell  1   2 , Jack Hall  3 , Lewis Meecham  4 , Gareth Bate  5 , Lisa Kelly  5 , Jon J Deeks  2 , Catherine A Moakes  3 , Andrew Bradbury  6 ; BASIL-3 Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Matthew Popplewell et al. Br J Surg. .

Abstract

Introduction: In 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.

Methods: In 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.

Results: Four 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.

Conclusions: This 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.

Plain language summary

The BASIL-3 trial compared plain balloons with drug-coated ballons and drug-coated stents in a three-way comparison, which were used to stretch or reopen narrowed or blocked arteries in the leg below the groin. The main trial did not show any differences between these three devices in patients with chronic limb-threatening ischaemia. Due to concerns regarding an increased risk of death with drug-coated devices from other studies we have performed another analysis adding together both drug-coated balloons and stents into one group and comparing with the plain balloons and bare metal stents. This supplementary analysis did not show an increased risk of death with these drug devices in BASIL-3 participants.

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Figures

Fig. 1
Fig. 1
Overall survival—intention to treat analysis
Fig. 2
Fig. 2
Overall survival—per protocol analysis
Fig. 3
Fig. 3
Amputation-free survival—intention to treat analysis
Fig. 4
Fig. 4
Amputation-free survival—per protocol analysis
See this image and copyright information in PMC

References

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