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A W Bradbury - One of the best experts on this subject based on the ideXlab platform.

  • contemporary 2009 2014 clinical outcomes after femoropopliteal bypass surgery for chronic limb threatening ischemia are inferior to those reported in the uk bypass versus angioplasty for severe ischaemia of the leg basil trial 1999 2004
    Journal of Vascular Surgery, 2019
    Co-Authors: Lewis Meecham, Matthew Popplewell, Gareth Bate, Smitaa Patel, A W Bradbury
    Abstract:

    BACKGROUND Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to Infrainguinal Disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to Infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1. METHODS Data for patients who underwent femoropopliteal (FP) BS in BASIL-1 (1999-2004) were retrieved from trial case record forms. The comparator contemporary series (CS) comprised all patients undergoing FP BS for CLTI in our unit between 2009 and 2014. Demographic and clinical outcome data on patients in the CS were collected from the prospectively collected hospital electronic notes. Anatomic patterns of Disease in the BASIL-1 and CS cohorts were scored using the Bollinger and GLASS criteria. Statistical analysis was performed in SAS v9.4. RESULTS There were 128 patients from BASIL-1 and 50 patients in the CS. Baseline age, gender, affected limb, and diabetes prevalence were similar, as were days spent in hospital out to 12 months and length of follow-up. BASIL-1 patients were more likely to be current smokers (P = .000) and had a higher creatinine (P = .04). The 30-day morbidity and mortality were higher in BASIL-1 (45.3% vs 22%; P = .004). There was no significant difference between BASIL-1 and CS with regard to run-off Bollinger (37.7 vs 32.1; P = .167) and IP GLASS (0 vs 0; P = .390) scores, with both groups having a median of two runoff vessels. Amputation-free survival (62% vs 28%; hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.18-2.93; P = .007), limb salvage (85% vs 69%; HR, 2.31; 95% CI, 1.14-4.68; P = .02), overall survival (69% vs 35%; HR, 1.66; 95% CI, 1.00-2.74; P = .05) and major adverse limb events (67% vs 47%; HR, 1.93; 95% CI, 1.15-3.22; P = .01) were all significantly better in BASIL-1. CONCLUSIONS Although 30-day mortality and morbidity were significantly lower, all of the examined longer term clinical outcomes after FP BS were significantly worse in the CS group a decade on from BASIL-1. Further research in the form of prospective cohort studies and randomized controlled trials is urgently required to determine if the CS data reported herein are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected outcomes.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial an intention to treat analysis of amputation free and overall survival in patients randomized to a bypass surgery first or a balloon angioplasty first revascularization strategy
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    BACKGROUND: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to Infrainguinal Disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). METHODS: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. RESULTS: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). CONCLUSIONS: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial analysis of amputation free and overall survival by treatment received
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of randomized Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial data showed that initial randomization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. We describe the nature and timing of first, crossover, and reinterventions and examine AFS and OS by first treatment received. We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty (BAP) and examine outcomes from BSX after failed BAP. Methods: We randomly assigned 452 patients with SLI due to Infrainguinal Disease in 27 United Kingdom hospitals to a BSX first (n 228) or a BAP first (n 224) revascularization strategy. All patients have been monitored for 3 years and more than half for >5 years. We prospectively collected data on every procedure, major amputation, and death. Results: Patients randomized to BAP were more likely to have their assigned treatment first (94% vs 85%, P .01, 2 test). BAP had a higher immediate technical failure rate of 20% vs 2.6% (P .01, 2 test). By 12 weeks after randomization 9 BAP (4%) vs 23 BSX (10%) patients had not undergone revascularization; 3 BAP (1.3%) vs 13 BSX (5.8%) had undergone the opposite treatment first; and 35 BAP (15.6%) and 2 (0.9%) BSX had received the assigned treatment and then undergone the opposite treatment. BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries; most originated from the common femoral artery. About 25% of the grafts were prosthetic and >90% of vein BSX used ipsilateral great saphenous vein. Most (80%) BAP patients underwent treatment of the SFA alone (38%) or combined with the popliteal artery (42%) and crural arteries (20%). Outcome of vein BSX was better for AFS (P 0.003) but not OS (P 0.38, log-rank tests) than prosthetic BSX. There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP. AFS (P0.006) but not OS (P0.06, log rank test) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt. Conclusions: BAP was associated with a significantly higher early failure rate than BSX. Most BAP patients ultimately required surgery.BSXoutcomesafterfailedBAParesignificantlyworsethanforBSXperformedasafirstrevascularizationattempt.BSXwith vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX. (J Vasc Surg 2010;51:18S-31S.)

  • bypass versus angioplasty in severe ischaemia of the leg basil trial a survival prediction model to facilitate clinical decision making
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, Ian Gillespie, C V Ruckley, Gerry F R Fowkes, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to Infrainguinal Disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making. Methods: Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model. Results: At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status. Conclusions: Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely—and not likely—to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. (J Vasc Surg 2010;51:52S-68S.)

  • multicentre randomised controlled trial of the clinical and cost effectiveness of a bypass surgery first versus a balloon angioplasty first revascularisation strategy for severe limb ischaemia due to Infrainguinal Disease the bypass versus angioplast
    Health Technology Assessment, 2010
    Co-Authors: A W Bradbury, D J Adam, Jocelyn Bell, John F Forbes, F G R Fowkes, Ian Gillespie, Gillian M Raab, C V Ruckley
    Abstract:

    Objective To compare a 'bypass-surgery-first' with a 'balloon-angioplasty-first' revascularisation strategy in patients with severe limb ischaemia (SLI) due to Infrainguinal Disease requiring immediate/early revascularisation. Design A stratified randomised controlled trial. A Delphi consensus study of vascular surgeons' and interventional radiologists' views on SLI treatment was performed before the trial. Setting Twenty-seven UK hospitals. Participants Patients presenting with SLI as the result of Infrainguinal atherosclerosis and who, in the opinion of the responsible consultant vascular surgeon and interventional radiologist, required and were suitable for both surgery and angioplasty. Interventions Patients were randomised to either 'bypass-surgery-first' or 'balloon-angioplasty-first' revascularisation strategies. Main outcome measures The primary end point was amputation-free survival (AFS); secondary end points were overall survival (OS), health-related quality of life (HRQoL) and cost-effective use of hospital resources. Results AFS at 1 and 3 years was not significantly different for surgery and angioplasty. Interim analysis showed that surgery was associated with significantly lower immediate failure, higher 30-day morbidity and lower 12-month reintervention rates than angioplasty; 30-day mortality was similar. Beyond 2 years from randomisation, hazard ratios (HRs) were significantly reduced for both AFS (adjusted HR 0.37; 95% CI 0.17 to 0.77; p = 0.008) and OS (HR 0.34; 95% CI 0.17 to 0.71; p = 0.004) for surgery relative to angioplasty. By 2008 all but four patients had been followed for 3 years, some for over 7 years: 250 (56%) were dead, 168 (38%) were alive without amputation and 30 (7%) were alive with amputation. Considering the follow-up period as a whole, AFS and OS did not differ between treatments but for patients surviving beyond 2 years from randomisation, bypass was associated with reduced HRs for AFS (HR 0.85; 95% CI 0.50 to 1.07; p = 0.108) and OS (HR 0.61; 95% CI 0.50 to 0.75; p = 0.009), equating to an increase in restricted mean OS of 7.3 months (p = 0.02) and AFS of 5.9 months (p = 0.06) during the subsequent follow-up period. Vein bypasses and angioplasties performed better than prosthetic bypasses. HRQoL was non-significantly better in the surgery group; amputation was associated with a significant reduction in HRQoL. Over the first year, hospital costs for bypass were significantly higher (difference 5420 pounds; 95% CI 1547 pounds to 9294 pounds) than for angioplasty. However, by 3 and at 7 years the differences in cost between the two strategies were no longer significant. Patients randomised to surgery lived, on average, 29 days longer at an additional average cost of 2310 pounds. A 36-month perspective showed not significantly different mean quality-adjusted life times for angioplasty and surgery. The Delphi study revealed substantial disagreement between and among surgeons and radiologists on the appropriateness of bypass surgery or balloon angioplasty. Conclusions The findings of our study suggest that in patients with SLI due to Infrainguinal Disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy. Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost, and such patients are unlikely to enjoy the longer-term benefits of surgery. By contrast, those patients expected to live beyond 2 years should usually be offered bypass surgery first, especially where a vein is available as a conduit. Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass. The failure rate of angioplasty in SLI is high (c. 25%) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure. The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation. Further research is required to confirm or refute the BASIL findings and recommendations; validate the BASIL survival prediction model in a separate cohort of patients with SLI; examine the clinical and cost-effectiveness of new endovascular techniques and devices; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects. Trial registration Current Controlled Trials ISRCTN45398889.

Gillian M Raab - One of the best experts on this subject based on the ideXlab platform.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial analysis of amputation free and overall survival by treatment received
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of randomized Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial data showed that initial randomization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. We describe the nature and timing of first, crossover, and reinterventions and examine AFS and OS by first treatment received. We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty (BAP) and examine outcomes from BSX after failed BAP. Methods: We randomly assigned 452 patients with SLI due to Infrainguinal Disease in 27 United Kingdom hospitals to a BSX first (n 228) or a BAP first (n 224) revascularization strategy. All patients have been monitored for 3 years and more than half for >5 years. We prospectively collected data on every procedure, major amputation, and death. Results: Patients randomized to BAP were more likely to have their assigned treatment first (94% vs 85%, P .01, 2 test). BAP had a higher immediate technical failure rate of 20% vs 2.6% (P .01, 2 test). By 12 weeks after randomization 9 BAP (4%) vs 23 BSX (10%) patients had not undergone revascularization; 3 BAP (1.3%) vs 13 BSX (5.8%) had undergone the opposite treatment first; and 35 BAP (15.6%) and 2 (0.9%) BSX had received the assigned treatment and then undergone the opposite treatment. BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries; most originated from the common femoral artery. About 25% of the grafts were prosthetic and >90% of vein BSX used ipsilateral great saphenous vein. Most (80%) BAP patients underwent treatment of the SFA alone (38%) or combined with the popliteal artery (42%) and crural arteries (20%). Outcome of vein BSX was better for AFS (P 0.003) but not OS (P 0.38, log-rank tests) than prosthetic BSX. There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP. AFS (P0.006) but not OS (P0.06, log rank test) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt. Conclusions: BAP was associated with a significantly higher early failure rate than BSX. Most BAP patients ultimately required surgery.BSXoutcomesafterfailedBAParesignificantlyworsethanforBSXperformedasafirstrevascularizationattempt.BSXwith vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX. (J Vasc Surg 2010;51:18S-31S.)

  • bypass versus angioplasty in severe ischaemia of the leg basil trial an intention to treat analysis of amputation free and overall survival in patients randomized to a bypass surgery first or a balloon angioplasty first revascularization strategy
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    BACKGROUND: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to Infrainguinal Disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). METHODS: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. RESULTS: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). CONCLUSIONS: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial a survival prediction model to facilitate clinical decision making
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, Ian Gillespie, C V Ruckley, Gerry F R Fowkes, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to Infrainguinal Disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making. Methods: Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model. Results: At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status. Conclusions: Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely—and not likely—to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. (J Vasc Surg 2010;51:52S-68S.)

  • multicentre randomised controlled trial of the clinical and cost effectiveness of a bypass surgery first versus a balloon angioplasty first revascularisation strategy for severe limb ischaemia due to Infrainguinal Disease the bypass versus angioplast
    Health Technology Assessment, 2010
    Co-Authors: A W Bradbury, D J Adam, Jocelyn Bell, John F Forbes, F G R Fowkes, Ian Gillespie, Gillian M Raab, C V Ruckley
    Abstract:

    Objective To compare a 'bypass-surgery-first' with a 'balloon-angioplasty-first' revascularisation strategy in patients with severe limb ischaemia (SLI) due to Infrainguinal Disease requiring immediate/early revascularisation. Design A stratified randomised controlled trial. A Delphi consensus study of vascular surgeons' and interventional radiologists' views on SLI treatment was performed before the trial. Setting Twenty-seven UK hospitals. Participants Patients presenting with SLI as the result of Infrainguinal atherosclerosis and who, in the opinion of the responsible consultant vascular surgeon and interventional radiologist, required and were suitable for both surgery and angioplasty. Interventions Patients were randomised to either 'bypass-surgery-first' or 'balloon-angioplasty-first' revascularisation strategies. Main outcome measures The primary end point was amputation-free survival (AFS); secondary end points were overall survival (OS), health-related quality of life (HRQoL) and cost-effective use of hospital resources. Results AFS at 1 and 3 years was not significantly different for surgery and angioplasty. Interim analysis showed that surgery was associated with significantly lower immediate failure, higher 30-day morbidity and lower 12-month reintervention rates than angioplasty; 30-day mortality was similar. Beyond 2 years from randomisation, hazard ratios (HRs) were significantly reduced for both AFS (adjusted HR 0.37; 95% CI 0.17 to 0.77; p = 0.008) and OS (HR 0.34; 95% CI 0.17 to 0.71; p = 0.004) for surgery relative to angioplasty. By 2008 all but four patients had been followed for 3 years, some for over 7 years: 250 (56%) were dead, 168 (38%) were alive without amputation and 30 (7%) were alive with amputation. Considering the follow-up period as a whole, AFS and OS did not differ between treatments but for patients surviving beyond 2 years from randomisation, bypass was associated with reduced HRs for AFS (HR 0.85; 95% CI 0.50 to 1.07; p = 0.108) and OS (HR 0.61; 95% CI 0.50 to 0.75; p = 0.009), equating to an increase in restricted mean OS of 7.3 months (p = 0.02) and AFS of 5.9 months (p = 0.06) during the subsequent follow-up period. Vein bypasses and angioplasties performed better than prosthetic bypasses. HRQoL was non-significantly better in the surgery group; amputation was associated with a significant reduction in HRQoL. Over the first year, hospital costs for bypass were significantly higher (difference 5420 pounds; 95% CI 1547 pounds to 9294 pounds) than for angioplasty. However, by 3 and at 7 years the differences in cost between the two strategies were no longer significant. Patients randomised to surgery lived, on average, 29 days longer at an additional average cost of 2310 pounds. A 36-month perspective showed not significantly different mean quality-adjusted life times for angioplasty and surgery. The Delphi study revealed substantial disagreement between and among surgeons and radiologists on the appropriateness of bypass surgery or balloon angioplasty. Conclusions The findings of our study suggest that in patients with SLI due to Infrainguinal Disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy. Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost, and such patients are unlikely to enjoy the longer-term benefits of surgery. By contrast, those patients expected to live beyond 2 years should usually be offered bypass surgery first, especially where a vein is available as a conduit. Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass. The failure rate of angioplasty in SLI is high (c. 25%) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure. The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation. Further research is required to confirm or refute the BASIL findings and recommendations; validate the BASIL survival prediction model in a separate cohort of patients with SLI; examine the clinical and cost-effectiveness of new endovascular techniques and devices; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects. Trial registration Current Controlled Trials ISRCTN45398889.

D J Adam - One of the best experts on this subject based on the ideXlab platform.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial an intention to treat analysis of amputation free and overall survival in patients randomized to a bypass surgery first or a balloon angioplasty first revascularization strategy
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    BACKGROUND: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to Infrainguinal Disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). METHODS: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. RESULTS: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). CONCLUSIONS: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial analysis of amputation free and overall survival by treatment received
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of randomized Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial data showed that initial randomization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. We describe the nature and timing of first, crossover, and reinterventions and examine AFS and OS by first treatment received. We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty (BAP) and examine outcomes from BSX after failed BAP. Methods: We randomly assigned 452 patients with SLI due to Infrainguinal Disease in 27 United Kingdom hospitals to a BSX first (n 228) or a BAP first (n 224) revascularization strategy. All patients have been monitored for 3 years and more than half for >5 years. We prospectively collected data on every procedure, major amputation, and death. Results: Patients randomized to BAP were more likely to have their assigned treatment first (94% vs 85%, P .01, 2 test). BAP had a higher immediate technical failure rate of 20% vs 2.6% (P .01, 2 test). By 12 weeks after randomization 9 BAP (4%) vs 23 BSX (10%) patients had not undergone revascularization; 3 BAP (1.3%) vs 13 BSX (5.8%) had undergone the opposite treatment first; and 35 BAP (15.6%) and 2 (0.9%) BSX had received the assigned treatment and then undergone the opposite treatment. BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries; most originated from the common femoral artery. About 25% of the grafts were prosthetic and >90% of vein BSX used ipsilateral great saphenous vein. Most (80%) BAP patients underwent treatment of the SFA alone (38%) or combined with the popliteal artery (42%) and crural arteries (20%). Outcome of vein BSX was better for AFS (P 0.003) but not OS (P 0.38, log-rank tests) than prosthetic BSX. There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP. AFS (P0.006) but not OS (P0.06, log rank test) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt. Conclusions: BAP was associated with a significantly higher early failure rate than BSX. Most BAP patients ultimately required surgery.BSXoutcomesafterfailedBAParesignificantlyworsethanforBSXperformedasafirstrevascularizationattempt.BSXwith vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX. (J Vasc Surg 2010;51:18S-31S.)

  • bypass versus angioplasty in severe ischaemia of the leg basil trial a survival prediction model to facilitate clinical decision making
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, Ian Gillespie, C V Ruckley, Gerry F R Fowkes, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to Infrainguinal Disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making. Methods: Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model. Results: At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status. Conclusions: Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely—and not likely—to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. (J Vasc Surg 2010;51:52S-68S.)

  • multicentre randomised controlled trial of the clinical and cost effectiveness of a bypass surgery first versus a balloon angioplasty first revascularisation strategy for severe limb ischaemia due to Infrainguinal Disease the bypass versus angioplast
    Health Technology Assessment, 2010
    Co-Authors: A W Bradbury, D J Adam, Jocelyn Bell, John F Forbes, F G R Fowkes, Ian Gillespie, Gillian M Raab, C V Ruckley
    Abstract:

    Objective To compare a 'bypass-surgery-first' with a 'balloon-angioplasty-first' revascularisation strategy in patients with severe limb ischaemia (SLI) due to Infrainguinal Disease requiring immediate/early revascularisation. Design A stratified randomised controlled trial. A Delphi consensus study of vascular surgeons' and interventional radiologists' views on SLI treatment was performed before the trial. Setting Twenty-seven UK hospitals. Participants Patients presenting with SLI as the result of Infrainguinal atherosclerosis and who, in the opinion of the responsible consultant vascular surgeon and interventional radiologist, required and were suitable for both surgery and angioplasty. Interventions Patients were randomised to either 'bypass-surgery-first' or 'balloon-angioplasty-first' revascularisation strategies. Main outcome measures The primary end point was amputation-free survival (AFS); secondary end points were overall survival (OS), health-related quality of life (HRQoL) and cost-effective use of hospital resources. Results AFS at 1 and 3 years was not significantly different for surgery and angioplasty. Interim analysis showed that surgery was associated with significantly lower immediate failure, higher 30-day morbidity and lower 12-month reintervention rates than angioplasty; 30-day mortality was similar. Beyond 2 years from randomisation, hazard ratios (HRs) were significantly reduced for both AFS (adjusted HR 0.37; 95% CI 0.17 to 0.77; p = 0.008) and OS (HR 0.34; 95% CI 0.17 to 0.71; p = 0.004) for surgery relative to angioplasty. By 2008 all but four patients had been followed for 3 years, some for over 7 years: 250 (56%) were dead, 168 (38%) were alive without amputation and 30 (7%) were alive with amputation. Considering the follow-up period as a whole, AFS and OS did not differ between treatments but for patients surviving beyond 2 years from randomisation, bypass was associated with reduced HRs for AFS (HR 0.85; 95% CI 0.50 to 1.07; p = 0.108) and OS (HR 0.61; 95% CI 0.50 to 0.75; p = 0.009), equating to an increase in restricted mean OS of 7.3 months (p = 0.02) and AFS of 5.9 months (p = 0.06) during the subsequent follow-up period. Vein bypasses and angioplasties performed better than prosthetic bypasses. HRQoL was non-significantly better in the surgery group; amputation was associated with a significant reduction in HRQoL. Over the first year, hospital costs for bypass were significantly higher (difference 5420 pounds; 95% CI 1547 pounds to 9294 pounds) than for angioplasty. However, by 3 and at 7 years the differences in cost between the two strategies were no longer significant. Patients randomised to surgery lived, on average, 29 days longer at an additional average cost of 2310 pounds. A 36-month perspective showed not significantly different mean quality-adjusted life times for angioplasty and surgery. The Delphi study revealed substantial disagreement between and among surgeons and radiologists on the appropriateness of bypass surgery or balloon angioplasty. Conclusions The findings of our study suggest that in patients with SLI due to Infrainguinal Disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy. Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost, and such patients are unlikely to enjoy the longer-term benefits of surgery. By contrast, those patients expected to live beyond 2 years should usually be offered bypass surgery first, especially where a vein is available as a conduit. Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass. The failure rate of angioplasty in SLI is high (c. 25%) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure. The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation. Further research is required to confirm or refute the BASIL findings and recommendations; validate the BASIL survival prediction model in a separate cohort of patients with SLI; examine the clinical and cost-effectiveness of new endovascular techniques and devices; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects. Trial registration Current Controlled Trials ISRCTN45398889.

  • the constitutive procoagulant and hypofibrinolytic state in patients with intermittent claudication due to Infrainguinal Disease significantly improves with percutaneous transluminal balloon angioplasty
    Journal of Vascular Surgery, 2006
    Co-Authors: S D Hobbs, Tim Marshall, Chris Fegan, D J Adam, A W Bradbury
    Abstract:

    Background Patients with intermittent lower limb claudication (IC) exhibit a prothrombotic diathesis that is acutely exacerbated by exercise. This may occur because of ischemia/reperfusion injury within the leg muscles during walking and may contribute to the increased risk of thrombotic vascular events in this group of patients. This randomized study compared the effect of lower limb revascularization by percutaneous transluminal balloon angioplasty (PTA), supervised exercise, and best medical therapy (BMT) alone on this prothrombotic state. Methods Twenty-three patients (16 men and 7 women; median age, 67 years; range, 57-77 years) with IC due to Infrainguinal Disease were randomized to receive BMT alone (n = 7), BMT plus PTA (n = 9), or BMT plus supervised exercise (n = 7) as part of the Health Technology Assessment–funded EXercise vs Angioplasty in Claudication Trial (EXACT). Patients were assessed at baseline and at 3 and 6 months. Thrombin-antithrombin complex (TAT) was determined as a marker of thrombin generation, and plasminogen activator inhibitor (PAI) antigen was determined as a marker of fibrinolysis. Increased TAT indicates a procoagulant state, and increased PAI antigen indicates a hypofibrinolytic state. Results At 6 months, subjects randomized to BMT plus PTA demonstrated a significant improvement in ankle-brachial pressure index ( P = .013) and maximal walking distance ( P = .008), a significant decline in resting thrombin generation (median [interquartile range] TAT, 6.4 μg/L [2.7-13.5 μg/L] to 1.5 μg/L [0.3-2.9 μg/L]; P = .038), and an improvement in resting fibrinolysis (median [interquartile range] PAI-1, 10.0 ng/mL [1.0-20.5 ng/mL] to 1.0 ng/mL [1.0-14.8 ng/mL]; P = .043). There was no significant change in any of these parameters in patients randomized to BMT plus supervised exercise or to BMT alone. Conclusions The addition of lower limb revascularization by PTA to BMT in patients with IC due to infra-inguinal Disease results in a medium-term improvement in the resting procoagulant and hypofibrinolytic state. This may translate into a reduction in morbidity and mortality from thrombotic vascular events in this group of patients.

C V Ruckley - One of the best experts on this subject based on the ideXlab platform.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial analysis of amputation free and overall survival by treatment received
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of randomized Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial data showed that initial randomization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. We describe the nature and timing of first, crossover, and reinterventions and examine AFS and OS by first treatment received. We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty (BAP) and examine outcomes from BSX after failed BAP. Methods: We randomly assigned 452 patients with SLI due to Infrainguinal Disease in 27 United Kingdom hospitals to a BSX first (n 228) or a BAP first (n 224) revascularization strategy. All patients have been monitored for 3 years and more than half for >5 years. We prospectively collected data on every procedure, major amputation, and death. Results: Patients randomized to BAP were more likely to have their assigned treatment first (94% vs 85%, P .01, 2 test). BAP had a higher immediate technical failure rate of 20% vs 2.6% (P .01, 2 test). By 12 weeks after randomization 9 BAP (4%) vs 23 BSX (10%) patients had not undergone revascularization; 3 BAP (1.3%) vs 13 BSX (5.8%) had undergone the opposite treatment first; and 35 BAP (15.6%) and 2 (0.9%) BSX had received the assigned treatment and then undergone the opposite treatment. BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries; most originated from the common femoral artery. About 25% of the grafts were prosthetic and >90% of vein BSX used ipsilateral great saphenous vein. Most (80%) BAP patients underwent treatment of the SFA alone (38%) or combined with the popliteal artery (42%) and crural arteries (20%). Outcome of vein BSX was better for AFS (P 0.003) but not OS (P 0.38, log-rank tests) than prosthetic BSX. There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP. AFS (P0.006) but not OS (P0.06, log rank test) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt. Conclusions: BAP was associated with a significantly higher early failure rate than BSX. Most BAP patients ultimately required surgery.BSXoutcomesafterfailedBAParesignificantlyworsethanforBSXperformedasafirstrevascularizationattempt.BSXwith vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX. (J Vasc Surg 2010;51:18S-31S.)

  • bypass versus angioplasty in severe ischaemia of the leg basil trial an intention to treat analysis of amputation free and overall survival in patients randomized to a bypass surgery first or a balloon angioplasty first revascularization strategy
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, C V Ruckley, Gerry F R Fowkes, I Gillespie, Gillian M Raab
    Abstract:

    BACKGROUND: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to Infrainguinal Disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). METHODS: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. RESULTS: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). CONCLUSIONS: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS.

  • bypass versus angioplasty in severe ischaemia of the leg basil trial a survival prediction model to facilitate clinical decision making
    Journal of Vascular Surgery, 2010
    Co-Authors: D J Adam, A W Bradbury, Jocelyn Bell, John F Forbes, Ian Gillespie, C V Ruckley, Gerry F R Fowkes, Gillian M Raab
    Abstract:

    Background: An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to Infrainguinal Disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making. Methods: Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model. Results: At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status. Conclusions: Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely—and not likely—to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. (J Vasc Surg 2010;51:52S-68S.)

  • multicentre randomised controlled trial of the clinical and cost effectiveness of a bypass surgery first versus a balloon angioplasty first revascularisation strategy for severe limb ischaemia due to Infrainguinal Disease the bypass versus angioplast
    Health Technology Assessment, 2010
    Co-Authors: A W Bradbury, D J Adam, Jocelyn Bell, John F Forbes, F G R Fowkes, Ian Gillespie, Gillian M Raab, C V Ruckley
    Abstract:

    Objective To compare a 'bypass-surgery-first' with a 'balloon-angioplasty-first' revascularisation strategy in patients with severe limb ischaemia (SLI) due to Infrainguinal Disease requiring immediate/early revascularisation. Design A stratified randomised controlled trial. A Delphi consensus study of vascular surgeons' and interventional radiologists' views on SLI treatment was performed before the trial. Setting Twenty-seven UK hospitals. Participants Patients presenting with SLI as the result of Infrainguinal atherosclerosis and who, in the opinion of the responsible consultant vascular surgeon and interventional radiologist, required and were suitable for both surgery and angioplasty. Interventions Patients were randomised to either 'bypass-surgery-first' or 'balloon-angioplasty-first' revascularisation strategies. Main outcome measures The primary end point was amputation-free survival (AFS); secondary end points were overall survival (OS), health-related quality of life (HRQoL) and cost-effective use of hospital resources. Results AFS at 1 and 3 years was not significantly different for surgery and angioplasty. Interim analysis showed that surgery was associated with significantly lower immediate failure, higher 30-day morbidity and lower 12-month reintervention rates than angioplasty; 30-day mortality was similar. Beyond 2 years from randomisation, hazard ratios (HRs) were significantly reduced for both AFS (adjusted HR 0.37; 95% CI 0.17 to 0.77; p = 0.008) and OS (HR 0.34; 95% CI 0.17 to 0.71; p = 0.004) for surgery relative to angioplasty. By 2008 all but four patients had been followed for 3 years, some for over 7 years: 250 (56%) were dead, 168 (38%) were alive without amputation and 30 (7%) were alive with amputation. Considering the follow-up period as a whole, AFS and OS did not differ between treatments but for patients surviving beyond 2 years from randomisation, bypass was associated with reduced HRs for AFS (HR 0.85; 95% CI 0.50 to 1.07; p = 0.108) and OS (HR 0.61; 95% CI 0.50 to 0.75; p = 0.009), equating to an increase in restricted mean OS of 7.3 months (p = 0.02) and AFS of 5.9 months (p = 0.06) during the subsequent follow-up period. Vein bypasses and angioplasties performed better than prosthetic bypasses. HRQoL was non-significantly better in the surgery group; amputation was associated with a significant reduction in HRQoL. Over the first year, hospital costs for bypass were significantly higher (difference 5420 pounds; 95% CI 1547 pounds to 9294 pounds) than for angioplasty. However, by 3 and at 7 years the differences in cost between the two strategies were no longer significant. Patients randomised to surgery lived, on average, 29 days longer at an additional average cost of 2310 pounds. A 36-month perspective showed not significantly different mean quality-adjusted life times for angioplasty and surgery. The Delphi study revealed substantial disagreement between and among surgeons and radiologists on the appropriateness of bypass surgery or balloon angioplasty. Conclusions The findings of our study suggest that in patients with SLI due to Infrainguinal Disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy. Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost, and such patients are unlikely to enjoy the longer-term benefits of surgery. By contrast, those patients expected to live beyond 2 years should usually be offered bypass surgery first, especially where a vein is available as a conduit. Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass. The failure rate of angioplasty in SLI is high (c. 25%) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure. The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation. Further research is required to confirm or refute the BASIL findings and recommendations; validate the BASIL survival prediction model in a separate cohort of patients with SLI; examine the clinical and cost-effectiveness of new endovascular techniques and devices; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects. Trial registration Current Controlled Trials ISRCTN45398889.

Michael S Conte - One of the best experts on this subject based on the ideXlab platform.

  • Society for Vascular Surgery practice guidelines for atherosclerotic occlusive Disease of the lower extremities: Management of asymptomatic Disease and claudication
    Journal of Vascular Surgery, 2015
    Co-Authors: Michael S Conte, Richard J. Powell, Mohammad H. Murad, James F Mckinsey, Frank B. Pomposelli, Gregory L Moneta, Patrick J Geraghty, Joseph L Mills, Daniel G. Clair, Amy B. Reed
    Abstract:

    Peripheral arterial Disease (PAD) continues to grow in global prevalence and consumes an increasing amount of resources in the United States health care system. Overall rates of intervention for PAD have been rising steadily in recent years. Changing demographics, evolution of technologies, and an expanding database of outcomes studies are primary forces influencing clinical decision making in PAD. The management of PAD is multidisciplinary, involving primary care physicians and vascular specialists with varying expertise in diagnostic and treatment modalities. PAD represents a broad spectrum of Disease from asymptomatic through severe limb ischemia. The Society for Vascular Surgery Lower Extremity Practice Guidelines committee reviewed the evidence supporting clinical care in the treatment of asymptomatic PAD and intermittent claudication (IC). The committee made specific practice recommendations using the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system. There are limited Level I data available for many of the critical questions in the field, demonstrating the urgent need for comparative effectiveness research in PAD. Emphasis is placed on risk factor modification, medical therapies, and broader use of exercise programs to improve cardiovascular health and functional performance. Screening for PAD appears of unproven benefit at present. Revascularization for IC is an appropriate therapy for selected patients with disabling symptoms, after a careful risk-benefit analysis. Treatment should be individualized based on comorbid conditions, degree of functional impairment, and anatomic factors. Invasive treatments for IC should provide predictable functional improvements with reasonable durability. A minimum threshold of a >50% likelihood of sustained efficacy for at least 2 years is suggested as a benchmark. Anatomic patency (freedom from restenosis) is considered a prerequisite for sustained efficacy of revascularization in IC. Endovascular approaches are favored for most candidates with aortoiliac Disease and for selected patients with femoropopliteal Disease in whom anatomic durability is expected to meet this minimum threshold. Conversely, caution is warranted in the use of interventions for IC in anatomic settings where durability is limited (extensive calcification, small-caliber arteries, diffuse Infrainguinal Disease, poor runoff). Surgical bypass may be a preferred strategy in good-risk patients with these Disease patterns or in those with prior endovascular failures. Common femoral artery Disease should be treated surgically, and saphenous vein is the preferred conduit for Infrainguinal bypass grafting. Patients who undergo invasive treatments for IC should be monitored regularly in a surveillance program to record subjective improvements, assess risk factors, optimize compliance with cardioprotective medications, and monitor hemodynamic and patency status.

  • risk stratification in critical limb ischemia derivation and validation of a model to predict amputation free survival using multicenter surgical outcomes data
    Journal of Vascular Surgery, 2008
    Co-Authors: Andres Schanzer, Jessica L Mega, Judith L Meadows, Russell H Samson, Dennis F Bandyk, Michael S Conte
    Abstract:

    Background: Patients with critical limb ischemia (CLI) are a heterogeneous population with respect to risk for mortality and limb loss, complicating clinical decision-making. Endovascular options, compared with bypass, offer a tradeoff between reduced procedural risk and inferior durability. Risk stratified data predictive of amputation-free survival (AFS) may improve clinical decision making and allow for better assessment of new technology in the CLI population. Methods: This was a retrospective analysis of prospectively collected data from patients who underwent Infrainguinal vein bypass surgery for CLI. Two datasets were used: the PREVENT III randomized trial (n 1404) and a multicenter registry (n 716) from three distinct vascular centers (two academic, one community-based). The PREVENT III cohort was randomly assigned to a derivation set (n 953) and to a validation set (n 451). The primary endpoint was AFS. Predictors of AFS identified on univariate screen (inclusion threshold, P 75 (HR 1.64, P .001), hematocrit 8 [8.8% of cohort]). Stratification of the patients, in each dataset, according to risk category yielded three significantly different Kaplan-Meier estimates for 1-year AFS (86%, 73%, and 45% for low, medium, and high risk groups, respectively). For a given risk category, the AFS estimate was consistent between the derivation and validation sets. Conclusion: Among patients selected to undergo surgical bypass for Infrainguinal Disease, this parsimonious risk stratification model reliably identified a category of CLI patients with a >50% chance of death or major amputation at 1 year. Calculation of a “PIII risk score” may be useful for surgical decision making and for clinical trial designs in the CLI population. (J Vasc Surg 2008;48:1464-71.) Critical limb ischemia (CLI), the most advanced form of peripheral arterial Disease (PAD), is associated with a high risk of cardiovascular events that include major limb loss, myocardial infarction, stroke, and death. 1-4 The estimated rate of all-cause mortality in patients with CLI has been reported to be as high as 20% within 6 months of diagnosis and surpasses 50% at 5 years post diagnosis. 5,6

  • risk stratification in critical limb ischemia derivation and validation of a model to predict amputation free survival using multicenter surgical outcomes data
    Journal of Vascular Surgery, 2008
    Co-Authors: Andres Schanzer, Jessica L Mega, Russell H Samson, Dennis F Bandyk, Judith Meadows, Michael S Conte
    Abstract:

    Background: Patients with critical limb ischemia (CLI) are a heterogeneous population with respect to risk for mortality and limb loss, complicating clinical decision-making. Endovascular options, compared with bypass, offer a tradeoff between reduced procedural risk and inferior durability. Risk stratified data predictive of amputation-free survival (AFS) may improve clinical decision making and allow for better assessment of new technology in the CLI population. Methods: This was a retrospective analysis of prospectively collected data from patients who underwent Infrainguinal vein bypass surgery for CLI. Two datasets were used: the PREVENT III randomized trial (n 1404) and a multicenter registry (n 716) from three distinct vascular centers (two academic, one community-based). The PREVENT III cohort was randomly assigned to a derivation set (n 953) and to a validation set (n 451). The primary endpoint was AFS. Predictors of AFS identified on univariate screen (inclusion threshold, P 75 (HR 1.64, P .001), hematocrit 8 [8.8% of cohort]). Stratification of the patients, in each dataset, according to risk category yielded three significantly different Kaplan-Meier estimates for 1-year AFS (86%, 73%, and 45% for low, medium, and high risk groups, respectively). For a given risk category, the AFS estimate was consistent between the derivation and validation sets. Conclusion: Among patients selected to undergo surgical bypass for Infrainguinal Disease, this parsimonious risk stratification model reliably identified a category of CLI patients with a >50% chance of death or major amputation at 1 year. Calculation of a “PIII risk score” may be useful for surgical decision making and for clinical trial designs in the CLI population. (J Vasc Surg 2008;48:1464-71.) Critical limb ischemia (CLI), the most advanced form of peripheral arterial Disease (PAD), is associated with a high risk of cardiovascular events that include major limb loss, myocardial infarction, stroke, and death. 1-4 The estimated rate of all-cause mortality in patients with CLI has been reported to be as high as 20% within 6 months of diagnosis and surpasses 50% at 5 years post diagnosis. 5,6