Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication

BACKGROUND: To compare angioplasty (PTA), supervised exercise (SEP) and PTA + SEP in the treatment of intermittent claudication (IC) due to femoropopliteal disease. METHODS: Over a 6-year period, 178 patients (108 men; median age, 70 years) with femoropopliteal lesions suitable for angioplasty were randomized to PTA, SEP, or PTA + SEP. Patients were assessed prior to and at 1 and 3 months post treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and quality of life (QoL) questionnaires (SF-36 and VascuQoL) were analyzed. RESULTS: All groups were well matched at baseline. Twenty-one patients withdrew. Results are as follows: Intragroup analysis: All groups demonstrated significant clinical and QoL improvements (Friedman test, p 0.05). CONCLUSION: SEP should be the primary treatment for the patients with claudication and PTA should be supplemented by an SEP

Early result: randomized controlled trial of treatment for intermittent claudication

Objective: To compare angioplasty (PTA), supervised exercise (SEP) and PTA + SEP in the treatment of intermittent claudication (IC) due to femoro-popliteal disease Methods: Over a 6 years period, 178 patients (108 men, median age 70 years) with angioplastiable femoro-popliteal lesions were randomized to: PTA, SEP or PTA + SEP. Patients were assessed prior to and at 1 & 3 month post treatment. ISCVS outcome criteria (Ankle pressures, treadmill walking distances) and Quality of Life (QoL) questionnaires (SF36 and VascuQoL) were analysed. Results: All groups were well matched at baseline. 21 patients withdrew. Intra group analysis: All groups demonstrated significant clinical and QoL improvements (Friedman test, p < 0·05). SEP (59 patients, 8 withdrew) – 62·7% of patients (n = 32) improved following treatment [20 mild, 9 moderate, 3 marked], 27·4% (n = 14) no improvement and 9·8% (n = 5) deteriorated. PTA (60 patients, 3 withdrew) – 66·6% of patients (n = 38) improved following treatment [19mild, 10 moderate, 9 marked], 22·8% (n = 13) no improvement and 10·5% (n = 6) deteriorated. PTA + SEP (59 patients, 10 withdrew) – 81·6% of patients (n = 40) improved following treatment. [10 mild, 17 moderate, 13 marked], 14·2%% (n = 7) no improvement and 4·0% (n = 2) deteriorated Inter group Analysis: PTA + SEP produce a much greater improvement in clinical outcome measures than PTA or SEP alone, but there was no significant Q0L advantage (Kruskal Wallis test, p > 0·05). Conclusion: SEP should be the primary treatment for the patients with claudication and PTA should be supplemented by a SEP

The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study

Background: Immediate breast reconstruction (IBR) is routinely offered to improve quality-of-life for women requiring mastectomy, but there are concerns that more complex surgery may delay adjuvant oncological treatments and compromise long-term outcomes. High-quality evidence is lacking. The iBRA-2 study aimed to investigate the impact of IBR on time to adjuvant therapy. Methods: Consecutive women undergoing mastectomy ± IBR for breast cancer July–December, 2016 were included. Patient demographics, operative, oncological and complication data were collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR were compared and risk factors associated with delays explored. Results: A total of 2540 patients were recruited from 76 centres; 1008 (39.7%) underwent IBR (implant-only [n = 675, 26.6%]; pedicled flaps [n = 105,4.1%] and free-flaps [n = 228, 8.9%]). Complications requiring re-admission or re-operation were significantly more common in patients undergoing IBR than those receiving mastectomy. Adjuvant chemotherapy or radiotherapy was required by 1235 (48.6%) patients. No clinically significant differences were seen in time to adjuvant therapy between patient groups but major complications irrespective of surgery received were significantly associated with treatment delays. Conclusions: IBR does not result in clinically significant delays to adjuvant therapy, but post-operative complications are associated with treatment delays. Strategies to minimise complications, including careful patient selection, are required to improve outcomes for patients

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Abstract: Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions: The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown

A randomized placebo controlled trial of the effect of preoperative statin use on matrix metalloproteinases and tissue inhibitors of matrix metalloproteinases in areas of low and peak wall stress in patients undergoing elective open repair of abdominal aortic aneurysm

BACKGROUND: A double-blind, randomized controlled trial was carried out to study the effects of statins on matrix metalloproteinases (MMPs) and tissue inhibitors of matrix metalloproteinases (TIMPs) in areas of peak and low abdominal aortic aneurysm (AAA) wall stress. METHODS: A total of 40 patients undergoing elective open AAA repair were randomized to receive either atorvastatin 80 mg (n = 20) or placebo (n = 20) for 4 weeks preoperatively. Finite element analysis was used to determine AAA wall stress distribution. Full thickness aortic samples were obtained at surgery from areas of low and peak wall stress, snap-frozen, and stored at -80°C for subsequent MMP-2, -8, and -9 and TIMP-1 and -2 analyses. Statistical analysis was performed using SPSS 16.0 (SPSS Inc, Chicago, IL). RESULTS: Both groups were well matched (p > 0.05) regarding age, gender, comorbidities, and duration of hospital stay. There were no statistically significant differences in levels of MMPs and TIMPs between the statin and placebo group and between areas of low and peak AAA wall stress. CONCLUSION: The short-term use of statins is not associated in reducing levels of MMP 2, 8, and 9 and TIMP-1 and -2 in areas of low and peak wall stress in patients with AAA

A RCT of non-surgical treatment for intermittent claudication in femoro-popliteal disease: 12-month results

Objective To compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined therapy (PTA + SEP) in the treatment of intermittent claudication (IC) due to femoro‐popliteal disease. Method Over a 6‐year period, 178 patients (108 men, median age 70 years) with angioplastiable femoro‐popliteal lesions were randomised to: PTA, SEP or PTA + SEP. Patients were assessed prior to and at 1, 3 6 and 12 months post‐treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and Quality of Life (QoL) questionnaires (SF‐36 and VascuQoL) were analysed. Results All groups were well matched at baseline. Thirty‐three patients withdrew. Intra‐group analysis: all groups demonstrated significant clinical and QoL improvements (Friedman test, p 0·05). Conclusion For patients with claudication, SEP should be the primary treatment and PTA should be supplemented by a SEP