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.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: UK National Institute of Health Research Health Technology Programme.

Minimal-preparation CT colon in detection of colonic cancer, the Oxford experience.

BACKGROUND: the main colonic imaging modalities, including barium enema, colonoscopy and computed tomography colonography, require bowel preparation. Performing these imaging procedures in the elderly can difficult due to immobility, incontinence and poor tolerance of bowel cleansing. Minimal preparation CT (MPCT) colon was introduced in the early 1990s in the UK. Much of the published literature on MPCT colon is limited by small patient numbers and short duration of follow-up. OBJECTIVE: the aim of this study is to review our experience with the MPCT technique involving a large consecutive cohort of patients with long follow-up. METHODS: all studies of MPCT performed in a 1-year period between July 2000 and July 2001 at our institution were reviewed retrospectively. MPCT reports were cross-referenced with the cancer registry to allow for an average period of 30 months follow-up. A definite diagnosis of cancer was only given following the appearance on the cancer registry. Those patients who had negative MPCT colon were assumed to be true negatives if no corresponding name was identified on the cancer registry. In the event of data mismatch, patient notes were reviewed to ascertain a diagnosis. RESULTS: 391 MPCT examinations were performed during the period of the study (209 males, median age 82: age range 56-91 years). Thirty-four patients who had MPCT colon during the study period appeared on the cancer registry. A further three patients with disseminated colorectal malignancy identified on MPCT colon died without histological confirmation (tumour prevalence = 9.5%). Thirty-two of the registry confirmed 34 cases were detected on MPCT colon, giving a sensitivity of 0.94 (95% confidence interval 0.86-1.00). Including the three cases without histological confirmation gives a slightly higher sensitivity of 0.95. There were seven patients with definitely abnormal MPCT colons, who did not appear on the registry, resulting in specificity for definite abnormality of 0.98 (confidence interval 0.97-1.0). However, three of these seven are those who died of disseminated colorectal malignancy as above, raising the specificity to 0.99. Fourteen cases (3.5%) of extra-colonic malignancies were observed in this study. CONCLUSION: even with the longer follow-up of this large cohort of patients the sensitivity and specificity in our study for the diagnosis of colorectal cancer with MPCT remains comparable with that of other studies and this technique competes well with other common colonic imaging modalities.