JOURNAL CLUB PRESENTATION BASIL TRIALS.pptx

Summary Journal club presentation of the 3 BASIL Lower Limb revascularisation trials evaluated in relation to BEST-CLI & SWEDEPAD trials.

1. TOPIC: BASIL TRAILS A “QUICK” REVIEW Presenter: KIRENGO T. MBChB, MBA, MSc, MRCS(ed) VASC SURG JOURNAL CLUB

2. BASIL-1 (2010 Long-term Follow-up) Title: Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial: An Intention-to-Treat Analysis of Amputation-Free and Overall Survival in Patients Randomised to Bypass-First or Angioplasty-First Strategy Location of study: 27 hospitals across the United Kingdom Authors: Andrew W. Bradbury, Donald J. Adam, Jocelyn Bell, John F. Forbes, F. Gerry R. Fowkes , Ian Gillespie, Charles Vaughan Ruckley , Gillian M. Raab, on behalf of the BASIL trial participants Year of Publication: 2010 Ethics: Approved by the Multi-centre Research Ethics Committee (MREC) for Scotland; informed consent obtained from all participants. Conflict of interest: Authors declared no conflicts. Journal Publication: Journal of Vascular Surgery , Supplement, May 2010; 51(5S): 5S-17STitle:

3. Journal of Vascular Surgery Official journal of the Society for Vascular Surgery . Publishes monthly, featuring research in vascular, endovascular, and related disciplines. Founded in 1984 , headquartered in Chicago, Illinois, USA . Impact Factor: 5.3 ; CiteScore: 7.4 . One of the leading journals in the field of vascular surgery worldwide.

4. BASIL-2 (2023) Title: A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial Location of study: multicentre, 41 vascular surgery units across the United Kingdom (n=39), Sweden (n=1), and Denmark (n=1) Authors: A.W. Bradbury, C.A. Moakes , M. Popplewell, L. Meecham , G.R. Bate, L. Kelly, I. Chetter , A. Diamantopoulos, A. Ganeshan, J. Hall, S. Hobbs, K. Houlind , H. Jarrett, S. Lockyer, J. Malmstedt , J.V. Patel, S. Patel, S.T. Rashid, A. Saratzis , G. Slinn , D.J.A. Scott, H. Zayed, J.J. Deeks, on behalf of the BASIL-2 Investigators Year of Publication: May 2023 Ethics: National Research Ethics Service, West Midlands, Coventry, UK (reference 14/WM/0057. Conflict of interest: all other authors declared no conflicts. Journal Publication: The Lancet 2023; 401: 1798–1809 ( doi : 10.1016/S0140-6736(23)00462-2)

5. The Lancet Weekly general medical journal published by Elsevier Ltd. Started 1823 by Thomas Wakley. Location: London, UK. Covers global health, clinical trials, and health-policy research. Impact Factor of ≈ 168 (2024 Journal Citation Reports), ranking among the highest of all medical journals. CiteScore of ≈ 125 (Scopus 2024), placing it among the top two general medical journals worldwide.

6. BASIL-3 (2025) Title: Plain versus Drug Balloon and Stenting in Severe Ischaemia of the Leg (BASIL-3): Open-label, Three-Arm, Randomised, Multicentre, Phase 3 Trial Location of study: Multicentre, 35 NHS vascular units across the United Kingdom Authors: Andrew W. Bradbury, Jack A. Hall, Matthew A. Popplewell, Lewis Meecham , Gareth R. Bate, Lisa Kelly, Jon J. Deeks, Catherine A. Moakes , on behalf of the BASIL-3 Investigators Year of Publication: 2025 Ethics: Approved by the National Research Ethics Committee, North of Scotland (15/NS/0070). Conflict of interest: None declared; funded by the UK NIHR Health Technology Assessment (HTA) Programme. Journal Publication: BMJ (BMJ 2025;388:e080881, DOI:10.1136/bmj-2024-080881)

7. The BMJ (British Medical Journal) Weekly international peer-reviewed medical journal published by the BMJ Publishing Group . Covers clinical research, health policy, and global health. Established in 1840 , based in London, UK . Impact Factor: 105.7 , ranking among the top general medical journals worldwide. CiteScore: 93.2 , indexed in MEDLINE, PubMed, and Scopus.

8. LEVEL OF EVIDENCE

9. BASIL-1: BACKGROUND Research question: What are the outcomes of a surgery-first strategy and an angioplasty-first strategy in patients with severe limb ischaemia? BASIL-1 was the first RCT to compare bypass-first (BSX) vs balloon angioplasty-first (BAP) strategies for severe limb ischaemia (SLI) due to infra-inguinal disease, recruiting across 27 UK hospitals (1999–2004). Why “SLI” not “CLI”: Trial intentionally used SLI to include limb-threatening ischaemia without enforcing ankle pressure ≤50 mmHg; equipoise required for inclusion. 2005 interim finding: Short-term AFS/OS similar for BSX vs BAP; BSX more morbid and ~⅓ more expensive in year 1 Post-hoc analysis demonstrated a significantly lower hazard ratio for surgery relative to angioplasty in amputation free survival beyond 2 years (HR=0.37) and in all-cause mortality beyond 2 years (HR=0.34). 

10. BASIL-1: OBJECTIVES 2010 extension aim: Test the suggested post-2-year advantage of BSX with pre-specified time-dependent analyses over a further 2.5-year follow-up. Primary endpoint: Amputation-Free Survival (AFS) – defined as survival free from major (above-ankle) amputation of the trial leg. Secondary Objectives Overall survival (OS) between the two revascularisation strategies. Limb salvage rates and the incidence/timing of major amputation . Health-related quality of life ( HRQoL ) following each strategy. Cost-effectiveness of bypass-first versus angioplasty-first, considering initial and follow-up costs. Durability of benefit beyond two years and assess whether any late survival advantage exists for bypass-first patients Sub-group analyses on: Patients receiving vein vs prosthetic grafts. Patients undergoing secondary (salvage) bypass after failed angioplasty.

11. BASIL-1: PICO Population: 452 patients with severe lower limb ischaemia due to infra-inguinal arterial disease. All had rest pain and/or tissue loss (ulcers or gangrene >2 weeks) requiring revascularisation Patients were included only if equipoise between surgical bypass and endovascular rx Exclusion: Unsuitable for both revascularisation strategies, <2 weeks onset, non-atherosclerotic disease, previous ipsi bypass, unfit for BSX or BAP, life expectancy <6-mo Intervention (I): Bypass-first strategy – Autologous vein graft was used when available (preferred conduit), though prosthetic grafts were used if vein was unavailable. Comparator (C): Angioplasty-first strategy – Initial endovascular revascularisation (typically balloon angioplasty) performed first. Bypass surgery was reserved as a secondary option if angioplasty failed or if severe ischaemia persisted. Outcomes (O): Primary outcome: Amputation-Free Survival (AFS) – defined as survival free from major amputation of the affected limb (death or major amputation) Secondary outcomes: Overall Survival (OS) , incidence of major limb amputation (limb salvage rate), health-related quality of life ( HRQoL ) , and cost-effectiveness of the two strategies

12. BASIL-1: DESIGN Design: Pragmatic multicentre RCT ; 228 randomised to BSX-first; 224 to BAP-first; minimum 3-year follow-up , follow-up >5 years. Randomisation: By centre; further stratified by presentation (rest pain vs tissue loss) and ankle pressure (≤/ >50 mmHg) . Conduct: Centres used usual practice for work-up, procedure, and follow-up (pragmatic). Intention to Treat Analysis. Ethics/consent: MREC Scotland ; written informed consent; ISRCTN 45398889

13. BASIL-1: DEMOGRAPHICS Category Details Total participants 452 patients – 228 (Bypass-first), 224 (Angioplasty-first) Study period 1999–2004 Centres 27 vascular units across the United Kingdom Mean age ~70 years (range 40–89) Sex distribution 65 % male  Key comorbidities Diabetes mellitus ≈ 45 % • Hypertension > 60 % • Ischaemic heart disease ≈ 45 % • Chronic kidney disease ≈ 20 % • Current/former smokers > 70 % Clinical presentation Rest pain only ≈ 25 % • Tissue loss (ulcer/gangrene) ≈ 75 % Severity Ankle pressure ≤ 50 mmHg in ≈ 55 % (severe ischaemia) Disease distribution Femoropopliteal ± infrapopliteal ≈ 70 % • Isolated tibial disease ≈ 30 % Eligibility requirement Both bypass and angioplasty technically feasible; equipoise confirmed before randomisation Follow-up Minimum 3 years; median ≈ 5 years; > 95 % follow-up completion

14. BASIL-1: FINDINGS Status at final follow-up: 56% dead (250/452) ; 38% alive without amputation ; 7% alive with amputation ; 4 lost to follow-up. QoL: similar in both groups by 6–12 months. <2 yrs: No significant difference in amputation-free survival (AFS) or overall survival (OS) between Bypass-first (BSX) and Angioplasty-first (BAP). Time-dependent effect: Among those surviving ≥2 years: OS benefit for BSX-first (adjusted HR ~0.61; P = 0.009 ); +7.3 months restricted mean survival. AFS results BSX-first showed a trend toward improvement (+ 5.9 months), P ≈ 0.06 (not statistically significant).

15. BASIL-1: FINDINGS

16. BASIL-1: DISCUSSION Clinical interpretation: For a ≤2-year horizon , BAP-first is reasonable (similar AFS/OS; lower early morbidity/cost). basil 1 paper 2 For patients likely to live >2 years , BSX-first (preferably with vein) offers meaningful long-term OS benefit and a trend to better AFS . Patient selection: Emphasises individualised strategy based on prognosis and conduit availability . Guiding principle: “ If they’ll live >2 years and have good vein → consider bypass first; otherwise → angioplasty first .”

17. BASIL-1: LIMITATIONS Era/technology: Endovascular arm used plain balloon angioplasty ; no DCB/DES/atherectomy— may underestimate modern endovascular outcomes . Selection/generalisation: Only patients with clear equipoise were randomised; SLI rather than strict CLI definition. Heterogeneity: Pragmatic conduct allowed prosthetic grafts and variable techniques, which can dilute surgical arm performance. Power in subgroups: Some long-term/endovascular-distal subgroups underpowered ; post-2-year AFS improvement not statistically significant

18. BASIL-1: CONCLUSION Bottom line (2010): Up to ~2 years: Bypass-first (BSX) and angioplasty-first (BAP) had similar amputation-free survival (AFS) and overall survival (OS). BSX had higher early morbidity and was ~⅓ more costly in year 1. Follow-up was extended by ~2.5 years specifically to confirm or refute the suggested late benefit of BSX, No overall AFS difference across total follow-up. After 2 years , BSX-first associated with better OS (+7.3 months)

19. BASIL-1: CRITICAL APPRAISAL Endovascular tech has advanced —BASIL-1’s BAP may not reflect modern “best endovascular” care; hence effect sizes may differ today. BASIL 2 TRIAL Generalisation limited to equipoise/SLI population. Only ~30% of eligibles were randomised in period audits (potential selection bias). Pragmatic heterogeneity (incl. prosthetic grafts ) may have under-represented “best surgical” outcomes Demographics: 2/3 male, predominately elderly, highly-co-morbid Poor compliance/ data on BMT

20. BASIL-1: RECOMMENDATIONS: Short horizon (~1–2 years) or high surgical risk: BAP-first to treat ischaemia with lower upfront morbidity/cost. Longer horizon (>2 years) and good conduit: The 2010 data confirm a meaningful OS advantage with BSX-first.

21. BASIL-1 VS BEST CLI BASIL 1(1999-2004), JVS 2010 452 patients with severe limb ischaemia (SLI) suitable for either bypass or angioplasty (plain balloon). Primary end-point: Amputation-Free Survival (AF + death). Median follow-up ≈ 5 yrs. <2yr results: No difference in AFS or OS between BSX and BAP >2yr results: bypass-first = better OS Mean age: 70 years, Male: 65%, DM: 45%, IHD-45%, Smoker: >70%, CKD-20% Prior to routine BMT, poor Rx compliance BEST CLI (2014-2021), Lancet 2025 1,830 patients with CLTI. Modern endovascular technology allowed. Cohort 1: GSV available. Cohort 2: alternative conduit. Primary end-point: Composite of major adverse limb event (MALE) — (amputation or major re-intervention) — or death Median follow-up ≈ 2.7 yrs. <2yr results: Cohort 1 (with vein): MALE + death 42.6 % surgery vs 57.4 % endo → HR 0.68, P < 0.001 (surgery superior). Cohort 2 (no vein): No difference (HR 0.79, P = 0.12). Death 33 % surgery vs 38 % endo (HR 0.98; no difference). >2yr results: no extended-phase analysis. Mean age: 67 years, Male: 72%, DM: 66%, IHD-50%, Smoker: >79%, CKD-36% Modern BMT available, high compliance

22. BASIL-2: QUESTION You are reviewing in clinic a 59-year-old non-diabetic ex-smoker with severe, short-distance claudication in the right lower limb . Background of CABG. Duplex ultrasound and CTA demonstrate a 10 cm occlusive lesion in the superficial femoral artery (SFA) with good distal run-off. Based on the BASIL trial findings , outline your management plan. Discuss: The role of best medical therapy , Indications for revascularisation , and Your choice between endovascular and surgical options in this scenario.

23. BASIL-2: BACKGROUND Multicentre, randomised, open-label, phase 3 trial comparing vein bypass-first vs best endovascular treatment-first in chronic limb-threatening ischaemia (CLTI) requiring infra-popliteal revascularisation. Growing T2DM prevalence with CLTI affecting infra-popliteal vessels Bypass-first advantage seen in BASIL-1 BEST-CLI incidence of a composite endpoint (MALE or death from any cause) was significantly lower in the vein bypass group   Determine whether, in such patients, which strategy was associated with a better clinical outcome: major (above the ankle) amputation or death from any cause (amputation-free survival) 

24. BASIL-2: OBJECTIVES Primary objective: To determine whether a vein bypass-first strategy improves amputation-free survival (AFS) compared with a best endovascular-first approach in patients with CLTI needing infra-popliteal revasc . Secondary objectives: Compare overall survival (OS) between the two strategies. Assess major amputation , re-intervention rates , and quality of life . Evaluate cost-effectiveness of surgical vs endovascular strategies in the current NHS environment.

25. BASIL-2: PICO Component Description Population: 345 patients (173 bypass-first, 172 endovascular-first) Patients with chronic limb-threatening ischaemia (CLTI) requiring infra-popliteal ± proximal infra-inguinal revascularisation to restore limb perfusion. Excluded: Unsuitable for both procedures,<14 days, Non-atherosclerotic disease, unfit for procedure, <6mo life expectancy Intervention Vein bypass-first strategy (autologous vein conduit preferred). Comparator Best endovascular-first strategy , including plain or drug-coated balloons , stents , or atherectomy as clinically appropriate. Outcome (Primary) Amputation-Free Survival (AFS) – composite of all-cause mortality or major (above-ankle) amputation. Secondary Outcomes Overall survival, limb salvage, major re-intervention, health-related quality of life, and cost-effectiveness.

26. BASIL-2: DESIGN Type: Open-label, randomised, multicentre, pragmatic phase 3 RCT . Participants: 345 patients (173 bypass-first, 172 endovascular-first). Randomisation: 1:1 allocation using web-based stratified blocks by centre. Follow-up: Median 2 years (IQR 1–3). Primary endpoint: AFS at 2 years analysed by intention-to-treat, superiority study Ethics: Approved by UK National Research Ethics Service (14/WM/0057). Funding: UK NIHR HTA Programme .

27. BASIL-2: DEMOGRAPHICS Category Details Total participants 345 patients (173 bypass-first vs 172 best endovascular-first) Recruitment period 2015 – 2022 Centres 41 vascular units (39 UK, 1 Sweden, 1 Denmark) Mean age 72 years (range 43 – 93) Sex distribution 72 % male Comorbidities Diabetes mellitus 62 % • Hypertension ≈ 80 % • Coronary artery disease ≈ 45 % • Chronic kidney disease 29 % • Current/former smokers 79 % Clinical presentation 85 % tissue loss (ulcer/gangrene) • 15 % rest pain only Anatomical level of disease All required infra-popliteal revascularisation (majority tibial or pedal target vessels) Conduit availability Autologous vein available in ≈ 65 % of those allocated to surgery Baseline medical therapy > 90 % antiplatelet agent • > 80 % statin • Good uptake of best medical therapy Follow-up duration Median 2 years (IQR 1 – 3) > 95 % follow-up completion

28. BASIL-2: FINDINGS Primary outcome: Amputation-Free Survival at 2 years: Bypass-first: 53 % (95 % CI 45–60) Endovascular-first: 57 % (95 % CI 49–64) Hazard ratio (HR): 1.35 (95 % CI 1.02–1.80); P = 0.037 → Endovascular-first superior . Overall survival: No significant difference between groups. Major amputation: Fewer in the endovascular-first arm. Re-intervention rates: Similar between arms. Perioperative morbidity: Higher in bypass-first patients.

29. BASIL-2: FINDINGS

30. BASIL-2: DISCUSSION Interpretation: Contrary to BASIL-1, the endovascular approach achieved better AFS at 2 years. Improved endovascular technologies (DCB, stents, atherectomy) likely contributed to enhanced outcomes? In the contemporary CLTI population with infra-pop dx, best endovascular therapy is a valid and often preferable first-line option. Long-term (>3 yr) durability remains unknown—late divergence in favour of surgery (as in BASIL-1) cannot yet be excluded

31. BASIL-2: LIMITATIONS Early termination due to funding constraints, difficulty to recruit & follow-up, ? COVID → smaller sample than planned (reduced power). Short median follow-up (2 yrs) limits assessment of long-term graft durability or survival trends. Cross-overs and treatment heterogeneity (varied devices and operator expertise). High mortality (~40 % at 2 yrs) complicates limb-specific endpoint interpretation. Mean age 72 years ; most had significant comorbidities (62 % diabetes, 29 % CKD), only 28% female, Advanced dx (85% pts with tissue loss)

32. BASIL-2: CONCLUSION Primary endpoint: AFS significantly better in endovascular-first group at 2 years. No difference in overall survival or re-intervention rates. Suggests a paradigm shift from “bypass-first” to “endovascular-first” for infra-popliteal CLTI. Long-term outcomes (>3–5 years) needed

33. BASIL-2: CRITICAL APPRAISAL Strengths: Pragmatic, multicentre NHS design → high external validity. Modern devices represent real-world “best endovascular” practice. Reinforces evolution of revascularisation strategy based on lesion level and comorbidity. Weaknesses: Limited follow-up and smaller sample. Early stop reduces statistical power for subgroup analyses. Lack of detailed QoL and cost-effectiveness reporting.

34. BASIL-2: RECOMMENDATIONS For infra-popliteal CLTI , adopt a best endovascular-first strategy where anatomy and expertise permit. Reserve vein bypass-first for patients: Where surgical risk is acceptable. Continue best medical therapy (antiplatelet, statin, risk-factor optimisation) for all patients. Future studies should extend follow-up to evaluate durability beyond 3 years

35. BASIL-2 VS BEST CLI BASIL-2 (2015-2022), Lancet 2023 345 patients with infra-popliteal CLTI, Sx vs Endo Primary end-point: Amputation-Free Survival (AF + death). Median follow-up ≈ 2 yrs. 2yr results: AFS better in endovascular-first at 2 years (HR 1.35; p=0.037)  53% mortality in vein bypass group vs 45% in best endo (adjusted HR 1·37 [95% CI 1·00–1·87]; non-significant >2yrs: no results Mean age: 72 years, Male: 78%, DM: 62%, Smoker: >79%, CKD-29% On BMT, high Rx compliance (90% antiplatelets, >80% statins) BEST CLI (2014-2021), Lancet 2025 1,830 patients with CLTI. Modern endovascular technology allowed. Cohort 1: GSV available. Cohort 2: alternative conduit. Primary end-point: Composite of major adverse limb event (MALE) — (amputation or major re-intervention) — or death Median follow-up ≈ 2.7 yrs. <2yr results: Cohort 1 (with vein): MALE + death 42.6 % surgery vs 57.4 % endo → HR 0.68, P < 0.001 (surgery superior). Cohort 2 (no vein): No difference (HR 0.79, P = 0.12). Death 33 % surgery vs 38 % endo (HR 0.98; no difference). >2yr results: no extended-phase analysis. Mean age: 67 years, Male: 72%, DM: 66%, IHD-50%, Smoker: >79%, CKD-36% Modern BMT available, high compliance (95% antiplatelets, >85% statins)

36. BASIL-3: BACKGROUND To determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro -popliteal, with or without infra-popliteal, revascularisation. Designed to address uncertainty from BASIL-1/2 & BEST- CLIabout optimal endovascular modality in infra-inguinal disease Multicentre, open-label, phase 3 RCT comparing, for femoropopliteal arterial disease causing chronic limb-threatening ischaemia (CLTI): plain balloon angioplasty (PBA) , drug-coated balloon (DCB) , and drug-eluting stent (DES)

37. BASIL-3: OBJECTIVES Primary objective: Compare amputation-free survival (AFS) among patients undergoing PBA, DCB, or DES for femoropopliteal CLTI. Secondary objectives: Assess overall survival (OS) , major adverse cardiovascular events , major adverse limb events, and 30 day mortality & morbidity. Evaluate Health related quality of life ( HRQoL ) and cost-effectiveness between the three approaches. .

38. BASIL-3: PICO Component Description Population: 513 patients (172 PBA, 171 DCB, 170 DES) Adults with chronic limb-threatening ischaemia (rest pain or tissue loss) due to femoropopliteal arterial disease , suitable for endovascular revascularisation. Intervention Plain balloon angioplasty (PBA) +/- BMS Comparator 1 Drug-coated balloon (DCB) angioplasty +/- BMS Comparator 2 Drug-eluting stent (DES) implantation +/- BMS Outcome (Primary) Amputation-Free Survival (AFS) – time to major (above-ankle) amputation or all-cause death. Secondary outcomes Overall survival, Major amputation, target-lesion re-intervention, health-related QoL, and cost-effectiveness.

39. BASIL-3: DESIGN Type: Open label, pragmatic, three-arm, multicentre, superiority, phase 3, randomised controlled trial Participants: 513 patients (172 PBA, 171 DCB, 170 DES). 35 of the major UK NHS vascular units Randomisation: 1:1:1 allocation; web-based central randomisation by site. Follow-up: Median 2 years (IQR 1–3). Primary endpoint: AFS analysed by intention-to-treat. Ethics: Approved by the North of Scotland Research Ethics Committee (15/NS/0070) . Funding: UK NIHR Health Technology Assessment (HTA) Programme.

40. BASIL-3: DEMOGRAPHICS Characteristic Data Mean age 72 years Sex 75 % male Diabetes mellitus 63 % Chronic kidney disease 30 % Current/former smokers 78 % Clinical presentation 83 % tissue loss, 17 % rest pain Lesion length Median 11 cm (femoropopliteal segment) Baseline BMT use > 90 % antiplatelet, > 85 % statin Follow-up completeness > 95 % at 2 years

41. BASIL-3: FINDINGS Primary outcome (AFS): 66% PBA, 60% DCB, 58% DES No statistically significant difference between groups. HR (DCB vs PBA) = 0.84 (97.5 % CI 0.61–1.16, P=0.22). HR (DES vs PBA) = 0.83 (97.5 % CI 0.60–1.15, P=0.2). Overall survival: Similar Death from any cause: 60% PBA, 56% DCB, 50% DES Major amputation: Comparable between groups: 14% PBA, 11% DCB, 16% DES HRQoL : No material difference. Safety: No excess mortality with drug-eluting devices (contrary to earlier observational concerns). No significant reduction in opiate usage across 24 months

42. BASIL-3: FINDINGS

43. BASIL-3: DISCUSSION Demonstrated no clinical advantage of drug-eluting over plain old balloon angioplasty in CLTI. Contrasts earlier assumptions that DCB or DES would improve survival or limb outcomes. Refutes increased mortality risk associated with drug-eluting devices as per Katsanos et al. meta-analysis (2018) BASIL-3 does not support a role for drug coated balloons or drug eluting stents in the femoro -popliteal segment in the management of patients with chronic limb threatening ischaemia undergoing endovascular revascularisation

44. BASIL-3: LIMITATIONS Underpowered to detect small survival differences among three arms. Difficult recruitment Stop for nearly 1-year due to Katsanos et al. meta-analysis (2018) Short median follow-up (2 years) ; long-term patency not yet known. Treatment heterogeneity: Different DCB and DES brands used, variable operators. High event rate (death/amputation) in all groups may mask minor efficacy differences. Predominantly UK, White male cohort – limits global generalisability.

45. BASIL-3: CONCLUSION No significant difference in amputation-free or overall survival between PBA, DCB, and DES in femoropopliteal CLTI. No evidence of harm from paclitaxel-coated technologies. Clinical implication: No clinical benefit in using Drug-coated devices, vs a higher cost

46. BASIL-3: CRITICAL APPRAISAL Strengths: Pragmatic NHS-based trial with real-world generalisability. First RCT to directly compare three modern endovascular modalities in CLTI. Weaknesses: Limited follow-up duration Limited sample size (difficulty in recruiting) AFS was questioned as the primary end-point Lacked imaging-confirmed patency endpoints (angiographic or duplex-based).

47. BASIL-3: RECOMMENDATIONS For femoropopliteal CLTI , plain, drug-coated, or drug-eluting endovascular strategies offer comparable outcomes at 2 years. Individualise treatment by lesion characteristics, device availability, and surgical risk. Continue comprehensive best medical therapy and multidisciplinary follow-up .

48. BASIL-3 VS SWEDEPAD 1/2 Feature BASIL-3 (2016-2021) (BMJ 2025) SWEDEPAD 1 (2014-2023) (Lancet 2025) SWEDEPAD 2 (2014-2023) (Lancet 2025) Population 513 pts with CLTI (femoropopliteal disease) randomised to PBA vs DCB vs DES 2,355 pts with CLTI (Rutherford 4–6) undergoing infra-popliteal & femoropopliteal endo revascularisation — paclitaxel-coated vs uncoated devices 1,136 pts with intermittent claudication (Rutherford 1–3) undergoing infra-popliteal endo revascularisation — paclitaxel-coated vs uncoated devices Trial design Multicentre UK phase 3 RCT (35 NHS centres); open-label, 3-arm comparison Nationwide Swedish registry-based RCT (22 centres); participant-masked, 1:1 randomisation Parallel registry-based RCT (22 centres); participant-masked, 1:1 randomisation Primary end-point Amputation-Free Survival (AF + death) Ipsilateral major amputation (above ankle) Disease-specific QoL (VascuQoL-6) at 1 year Follow-up Median 2 yrs (IQR 1–3) Median 2.7 yrs (IQR 1.1–4.8) (max 5 yrs) Median 7.1 yrs (IQR 3.9–8.2) (max 10 yrs) Mean age / sex 72 yrs / 75 % male 77 yrs / 56 % male 73 yrs / 54 % male Diabetes / CKD prevalence DM 63 %, CKD 30 % DM 53 %, CKD 24 % DM 34 %, CKD not specified Lesion level Femoropopliteal +/- infrapopliteal (10%) Femoropopliteal 53 %, Infrapopliteal 23 %, both 24 % Femoropopliteal 96 % Intervention PBA vs DCB vs DES Paclitaxel-coated vs uncoated balloons/stents Paclitaxel-coated vs uncoated balloons/stents Primary results No AFS difference between groups (HR ≈ 0.9) No difference in major amputation (HR 1.05, p=0.61) No mortality difference (HR 1.04) No QoL benefit ( Δ –0.02, p=0.96); 5-yr mortality ↑ with paclitaxel (HR 1.47, p=0.01) Mortality 60% PBA, 56% DCB, 50% DES 56% Paclitaxel-coated, 55% uncoated balloons/stents 5-yr HR 1.47 (sig. ↑ with paclitaxel); Long-term HR 1.18 (non-significant) ie . 27% paclitaxel, 26% uncoated

49. THANK YOU ANY QUESTIONS