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
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| 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 |
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| Authors: | Bradbury, Andrew W (AUTHOR), Moakes, Catherine A (AUTHOR), Popplewell, Matthew (AUTHOR), Meecham, Lewis (AUTHOR), Bate, Gareth R (AUTHOR), Kelly, Lisa (AUTHOR), Chetter, Ian (AUTHOR), Diamantopoulos, Athanasios (AUTHOR), Ganeshan, Arul (AUTHOR), Hall, Jack (AUTHOR), Hobbs, Simon (AUTHOR), Houlind, Kim (AUTHOR), Jarrett, Hugh (AUTHOR), Lockyer, Suzanne (AUTHOR), Malmstedt, Jonas (AUTHOR), Patel, Jai V (AUTHOR), Patel, Smitaa (AUTHOR), Rashid, S Tawqeer (AUTHOR), Saratzis, Athanasios (AUTHOR), Slinn, Gemma (AUTHOR) |
| Source: | Lancet. May/Jun2023, Vol. 401 Issue 10390, p1798-1809. 12p. |
| Subjects: | Endovascular surgery, Drug-eluting stents, Ankle brachial index, Saphenous vein, Vascular surgery, Ischemia, Veins, Gangrene, Fournier gangrene |
| Geographic Terms: | Sweden |
| Abstract: | Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in 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. Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7–79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02–1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00–1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more 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 should be considered for a best endovascular treatment first revascularisation strategy. UK National Institute of Health Research Health Technology Programme. [ABSTRACT FROM AUTHOR] |
| Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 163933336 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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 – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Bradbury%2C+Andrew+W%22">Bradbury, Andrew W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Moakes%2C+Catherine+A%22">Moakes, Catherine A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Popplewell%2C+Matthew%22">Popplewell, Matthew</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Meecham%2C+Lewis%22">Meecham, Lewis</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bate%2C+Gareth+R%22">Bate, Gareth R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kelly%2C+Lisa%22">Kelly, Lisa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chetter%2C+Ian%22">Chetter, Ian</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Diamantopoulos%2C+Athanasios%22">Diamantopoulos, Athanasios</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ganeshan%2C+Arul%22">Ganeshan, Arul</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hall%2C+Jack%22">Hall, Jack</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hobbs%2C+Simon%22">Hobbs, Simon</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Houlind%2C+Kim%22">Houlind, Kim</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Jarrett%2C+Hugh%22">Jarrett, Hugh</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lockyer%2C+Suzanne%22">Lockyer, Suzanne</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Malmstedt%2C+Jonas%22">Malmstedt, Jonas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Patel%2C+Jai+V%22">Patel, Jai V</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Patel%2C+Smitaa%22">Patel, Smitaa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rashid%2C+S+Tawqeer%22">Rashid, S Tawqeer</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Saratzis%2C+Athanasios%22">Saratzis, Athanasios</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Slinn%2C+Gemma%22">Slinn, Gemma</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. May/Jun2023, Vol. 401 Issue 10390, p1798-1809. 12p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Endovascular+surgery%22">Endovascular surgery</searchLink><br /><searchLink fieldCode="DE" term="%22Drug-eluting+stents%22">Drug-eluting stents</searchLink><br /><searchLink fieldCode="DE" term="%22Ankle+brachial+index%22">Ankle brachial index</searchLink><br /><searchLink fieldCode="DE" term="%22Saphenous+vein%22">Saphenous vein</searchLink><br /><searchLink fieldCode="DE" term="%22Vascular+surgery%22">Vascular surgery</searchLink><br /><searchLink fieldCode="DE" term="%22Ischemia%22">Ischemia</searchLink><br /><searchLink fieldCode="DE" term="%22Veins%22">Veins</searchLink><br /><searchLink fieldCode="DE" term="%22Gangrene%22">Gangrene</searchLink><br /><searchLink fieldCode="DE" term="%22Fournier+gangrene%22">Fournier gangrene</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22Sweden%22">Sweden</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in 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. Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7–79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02–1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00–1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more 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 should be considered for a best endovascular treatment first revascularisation strategy. UK National Institute of Health Research Health Technology Programme. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/S0140-6736(23)00462-2 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 12 StartPage: 1798 Subjects: – SubjectFull: Endovascular surgery Type: general – SubjectFull: Drug-eluting stents Type: general – SubjectFull: Ankle brachial index Type: general – SubjectFull: Saphenous vein Type: general – SubjectFull: Vascular surgery Type: general – SubjectFull: Ischemia Type: general – SubjectFull: Veins Type: general – SubjectFull: Gangrene Type: general – SubjectFull: Fournier gangrene Type: general – SubjectFull: Sweden Type: general Titles: – TitleFull: 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 Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Bradbury, Andrew W – PersonEntity: Name: NameFull: Moakes, Catherine A – PersonEntity: Name: NameFull: Popplewell, Matthew – PersonEntity: Name: NameFull: Meecham, Lewis – PersonEntity: Name: NameFull: Bate, Gareth R – PersonEntity: Name: NameFull: Kelly, Lisa – PersonEntity: Name: NameFull: Chetter, Ian – PersonEntity: Name: NameFull: Diamantopoulos, Athanasios – PersonEntity: Name: NameFull: Ganeshan, Arul – PersonEntity: Name: NameFull: Hall, Jack – PersonEntity: Name: NameFull: Hobbs, Simon – PersonEntity: Name: NameFull: Houlind, Kim – PersonEntity: Name: NameFull: Jarrett, Hugh – PersonEntity: Name: NameFull: Lockyer, Suzanne – PersonEntity: Name: NameFull: Malmstedt, Jonas – PersonEntity: Name: NameFull: Patel, Jai V – PersonEntity: Name: NameFull: Patel, Smitaa – PersonEntity: Name: NameFull: Rashid, S Tawqeer – PersonEntity: Name: NameFull: Saratzis, Athanasios – PersonEntity: Name: NameFull: Slinn, Gemma IsPartOfRelationships: – BibEntity: Dates: – D: 27 M: 05 Text: May/Jun2023 Type: published Y: 2023 Identifiers: – Type: issn-print Value: 01406736 Numbering: – Type: volume Value: 401 – Type: issue Value: 10390 Titles: – TitleFull: Lancet Type: main |
| ResultId | 1 |
