To compare outcomes in patients randomized to infrapopliteal (IP) plain balloon angioplasty (PBA) for chronic limb-threatening ischemia within the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL)-1 trial between 1999 and 2004 with outcomes in consecutive patients undergoing IP PBA at an academic vascular unit a decade later (2009-2013, Contemporary series [CS]).Individual patient data were obtained from prospective BASIL-1 (48 patients) and CS databases (73 patients). All had a minimum of 3-years of follow-up. Outcomes studied were amputation-free survival (AFS), overall survival (OS), major (above ankle) limb amputation, arterial reintervention, immediate technical success, and length of hospital stay for the index procedure and during the following 12-month period. Statistical analysis was performed using SAS version 9.4.The BASIL and CS cohorts were well matched for gender, age, diabetes, previous stroke, myocardial infarction and arterial intervention, and presence of tissue loss. More patients in BASIL-1 underwent concomitant treatment of the superficial femoral (60% vs 37%, P = .01) and above knee popliteal (60% vs 34%, P = .005) arteries. Immediate technical success increased from 73% in BASIL-1 to 90% in the CS (P = .01). Between the two cohorts, there were no differences in AFS (hazard ratio [HR] = 1.00, 95% confidence interval [CI]: 0.65-1.54, P = 1.0), OS (HR = 1.04, 95% CI: 0.66-1.62, P = .9), major amputation (HR = 0.86, 95% CI: 0.37-1.97, P = .7), or reintervention (HR = 0.61, 95% CI: 0.29-1.27, P = .2). Contemporary series patients spent significantly fewer days in hospital following the index procedure (P = .02) and also over the following 12 months (P = .002).Despite improvements in the immediate technical angiographic success of IP PBA between BASIL and the CS, there were no significant improvements in survival outcomes. Results from BASIL-2 and BEST-CLI are required in order to properly define the clinical and cost-effectiveness of endovascular treatment in such patients.
Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources. The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with 'multilevel' disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years. BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease. ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.
Objective: To investigate the feasibility, acceptability and potential efficacy of group exercise for residents in care homes. Design: Exploratory cluster randomized controlled trial. Setting: Five randomly selected care homes in South Birmingham, UK. Participants: Fifty-six care home residents (mean age 84.5, 71% female), 39 (70%) with cognitive impairments. Intervention: Two homes (n = 28) were randomized to group exercise held twice weekly for five weeks. The remaining three homes (n = 28) formed the control group and received usual care, with no person specifically responsible for exercise training. Outcome measures: Assessments were conducted at zero (pre-intervention), three (post-intervention) and six months (follow-up) using the Rivermead Mobility Index and Hospital Anxiety and Depression Scale or Stroke Aphasic Depression Questionnaire (depending on cognitive impairment). Adherence to group exercise and retention to the study were also documented. Results: No statistically significant improvements in mobility or depression were found in favour of group exercise. Retention to the study was high with 46 (82%) participants completing all assessments. Adherence to group exercise was somewhat lower with participants attending a mean of 3.61 out of 8.5 prescribed sessions (42.5%). Conclusions: Group exercise can be delivered to care home residents with reduced mobility but it is not suitable for residents with severe cognitive impairment. An estimated sample size of 240 participants would be required to detect a clinically significant difference in the Rivermead Mobility Index with 90% power.
Background Chronic limb-threatening ischaemia with ischaemic pain and/or tissue loss. Objective To examine the clinical and cost-effectiveness of a vein bypass-first compared to a best endovascular treatment-first revascularisation strategy in preventing major amputation or death. Design Superiority, open, pragmatic, multicentre, phase III randomised trial. Setting Thirty-nine vascular surgery units in the United Kingdom, and one each in Sweden and Denmark. Participants Patients with chronic limb-threatening ischaemia due to atherosclerotic peripheral arterial disease who required an infra-popliteal revascularisation, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion. Interventions A vein bypass-first or a best endovascular treatment-first infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation strategy. Main outcome measures The primary outcome was amputation-free survival. Secondary outcomes included overall survival, major amputation, further revascularisation interventions, major adverse limb event, health-related quality of life and serious adverse events. Methods Participants were randomised to a vein bypass-first or a best endovascular treatment-first revascularisation strategy. The original sample size of 600 participants (247 events) was based on a hazard ratio of 0.66 with amputation-free survival rates of 0.72, 0.62, 0.53, 0.47 and 0.35 in years 1–5 in the best endovascular treatment-first group with 90% power and alpha at p = 0.05. The sample size was revised to an event-based approach as a result of increased follow-up time due to slower than anticipated recruitment rates. Participants were followed up for a minimum of 2 years. A cost-effectiveness analysis was employed to estimate differences in total hospital costs and amputation-free survival between the groups. Additionally, a cost–utility analysis was carried out and the total cost and quality-adjusted life-years, 2 and 3 years after randomisation were used. Results Between 22 July 2014 and 30 November 2020, 345 participants were randomised, 172 to vein bypass-first and 173 to best endovascular treatment-first. Non-amputation-free survival occurred in 108 (63%) of 172 patients in the vein bypass-first group and 92 (53%) of 173 patients in the best endovascular treatment-first group [adjusted hazard ratio 1.35 (95% confidence interval 1.02 to 1.80); p = 0.037]. Ninety-one (53%) of 172 patients in the vein bypass-first group and 77 (45%) of 173 patients in the best endovascular treatment-first group died [adjusted hazard ratio 1.37 (95% confidence interval 1.00 to 1.87)]. Over follow-up, the economic evaluation discounted results showed that best endovascular treatment-first was associated with £1690 less hospital costs compared to vein bypass-first. The cost utility analysis showed that compared to vein bypass-first, best endovascular treatment-first was associated with £224 and £2233 less discounted hospital costs and 0.016 and 0.085 discounted quality-adjusted life-year gain after 2 and 3 years from randomisation. Limitations Recruiting patients to the Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 trial was difficult and the target number of events was not achieved. Conclusions A best endovascular treatment-first revascularisation strategy was associated with better amputation-free survival, which was largely driven by fewer deaths. Overall, the economic evaluation results suggest that best endovascular treatment-first dominates vein bypass-first in the cost-effectiveness analysis and cost–utility analysis as it was less costly and more effective than a vein bypass-first strategy. Future work The Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 investigators have a data sharing agreement with the BEst Surgical Therapy in patients with Chronic Limb threatening Ischaemia investigators. One output of this collaboration will be an individual patient data meta-analysis. Study registration Current Controlled Trials ISRCTN27728689. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/35/45) and is published in full in Health Technology Assessment ; Vol. 28, No. 65. See the NIHR Funding and Awards website for further award information.
Obstructive sleep apnea (OSA) is associated with an increased risk of diabetes-related complications. Hence, it is plausible that continuous positive airway pressure (CPAP) could have a favorable impact on these complications. We assessed the feasibility of conducting a randomized control trial in patients with type 2 diabetes and OSA over 2 years.
Speech-related problems are common in Parkinson's disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®).The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6-8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings.Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: - 12.5 points; 95% CI - 26.2, 1.2) and SLT (difference at 3 months compared with control: - 9.8 points; 95% CI - 23.2, 3.7) which needs to be confirmed in an adequately powered trial.Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial.International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012.
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