Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial - PubMed (original) (raw)
Randomized Controlled Trial
. 2005 Dec 3;366(9501):1925-34.
doi: 10.1016/S0140-6736(05)67704-5.
- PMID: 16325694
- DOI: 10.1016/S0140-6736(05)67704-5
Randomized Controlled Trial
Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial
D J Adam et al. Lancet. 2005.
Abstract
Background: The treatment of rest pain, ulceration, and gangrene of the leg (severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients.
Methods: We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first (n=228) or an angioplasty-first (n=224) strategy. The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register (NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889.
Findings: The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy.
Interpretation: In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty.
Comment in
- Life and limb: bypass versus angioplasty in the ischaemic limb.
Goy JJ, Urban P. Goy JJ, et al. Lancet. 2005 Dec 3;366(9501):1905-6. doi: 10.1016/S0140-6736(05)67705-7. Lancet. 2005. PMID: 16325681 No abstract available. - Bypass surgery and balloon angioplasty did not differ for amputation-free survival in severe limb ischemia.
Legemate DA. Legemate DA. ACP J Club. 2006 May-Jun;144(3):69. ACP J Club. 2006. PMID: 16646613 No abstract available. - Bypass versus angioplasty in severe ischaemia of the leg.
Bradley L, Kirker S. Bradley L, et al. Lancet. 2006 Jun 3;367(9525):1814; author reply 1815-6. doi: 10.1016/S0140-6736(06)68794-1. Lancet. 2006. PMID: 16753476 No abstract available. - Bypass versus angioplasty in severe ischaemia of the leg.
Takagi H, Furukawa M, Kato T, Matsuno Y, Umemoto T. Takagi H, et al. Lancet. 2006 Jun 3;367(9525):1815; author reply 1815-6. doi: 10.1016/S0140-6736(06)68795-3. Lancet. 2006. PMID: 16753478 No abstract available.
Similar articles
- Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCT.
Moakes CA, Bradbury AW, Abdali Z, Bate GR, Hall J, Jarrett H, Kelly L, Kigozi J, Lockyer S, Meecham L, Patel S, Popplewell M, Slinn G, Deeks JJ; BASIL-2 Investigators. Moakes CA, et al. Health Technol Assess. 2024 Oct;28(65):1-72. doi: 10.3310/YTFV4524. Health Technol Assess. 2024. PMID: 39397484 Free PMC article. Clinical Trial. - 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.
Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, Chetter I, Diamantopoulos A, Ganeshan A, Hall J, Hobbs S, Houlind K, Jarrett H, Lockyer S, Malmstedt J, Patel JV, Patel S, Rashid ST, Saratzis A, Slinn G, Scott DJA, Zayed H, Deeks JJ; BASIL-2 Investigators. Bradbury AW, et al. Lancet. 2023 May 27;401(10390):1798-1809. doi: 10.1016/S0140-6736(23)00462-2. Epub 2023 Apr 25. Lancet. 2023. PMID: 37116524 Clinical Trial. - Bypass surgery for chronic lower limb ischaemia.
Antoniou GA, Georgiadis GS, Antoniou SA, Makar RR, Smout JD, Torella F. Antoniou GA, et al. Cochrane Database Syst Rev. 2017 Apr 3;4(4):CD002000. doi: 10.1002/14651858.CD002000.pub3. Cochrane Database Syst Rev. 2017. PMID: 28368090 Free PMC article. Review.
Cited by
- Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.
Toth GG, Brodmann M, Kanoun Schnur SS, Bartus S, Vrsalovic M, Krestianinov O, Kala P, Bil J, Gil R, Kanovsky J, Di Serafino L, Paolucci L, Barbato E, Mangiacapra F, Ruzsa Z. Toth GG, et al. Clin Res Cardiol. 2024 Jul 11. doi: 10.1007/s00392-024-02487-2. Online ahead of print. Clin Res Cardiol. 2024. PMID: 38990250 - In vivo electroporation of constitutively expressed HIF-1α plasmid DNA improves neovascularization in a mouse model of limb ischemia.
Ouma GO, Rodriguez E, Muthumani K, Weiner DB, Wilensky RL, Mohler ER 3rd. Ouma GO, et al. J Vasc Surg. 2014 Mar;59(3):786-93. doi: 10.1016/j.jvs.2013.04.043. Epub 2013 Jul 11. J Vasc Surg. 2014. PMID: 23850058 Free PMC article. - Ephrin-B2-activated peripheral blood mononuclear cells from diabetic patients restore diabetes-induced impairment of postischemic neovascularization.
Broquères-You D, Leré-Déan C, Merkulova-Rainon T, Mantsounga CS, Allanic D, Hainaud P, Contrères JO, Wang Y, Vilar J, Virally M, Mourad JJ, Guillausseau PJ, Silvestre JS, Lévy BI. Broquères-You D, et al. Diabetes. 2012 Oct;61(10):2621-32. doi: 10.2337/db11-1768. Epub 2012 May 17. Diabetes. 2012. PMID: 22596048 Free PMC article. - Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial.
Menard MT, Farber A, Assmann SF, Choudhry NK, Conte MS, Creager MA, Dake MD, Jaff MR, Kaufman JA, Powell RJ, Reid DM, Siami FS, Sopko G, White CJ, Rosenfield K. Menard MT, et al. J Am Heart Assoc. 2016 Jul 8;5(7):e003219. doi: 10.1161/JAHA.116.003219. J Am Heart Assoc. 2016. PMID: 27402237 Free PMC article. Clinical Trial. - Always contact a vascular interventional specialist before amputating a patient with critical limb ischemia.
Met R, Koelemay MJ, Bipat S, Legemate DA, van Lienden KP, Reekers JA. Met R, et al. Cardiovasc Intervent Radiol. 2010 Jun;33(3):469-74. doi: 10.1007/s00270-009-9687-3. Epub 2009 Aug 18. Cardiovasc Intervent Radiol. 2010. PMID: 19688364 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Miscellaneous