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.
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, χ2 test). BAP had a higher immediate technical failure rate of 20% vs 2.6% ( P = .01, χ2 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 ( P = 0.006) but not OS ( P = 0.06, 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. BSX outcomes after failed BAP are significantly worse than for BSX performed as a first revascularization attempt. BSX with vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX.
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.
Background The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived ...postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis. Methods We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects. Results No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs. Conclusions Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes.
Background The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed in patients with severe lower limb ischemia (rest pain, tissue loss) who survive for 2 years after ...intervention that initial randomization to bypass surgery, compared with balloon angioplasty, was associated with an improvement in subsequent amputation-free survival and overall survival of about 6 and 7 months, respectively. The aim of this report is to describe the angiographic severity and extent of infrainguinal arterial disease in the BASIL trial cohort so that the trial outcomes can be appropriately generalized to other patient cohorts with similar anatomic (angiographic) patterns of disease. Methods Preintervention angiograms were scored using the Bollinger method and the TransAtlantic Inter-Society Consensus (TASC) II classification system by three consultant interventional radiologists and two consultant vascular surgeons unaware of the treatment received or patient outcomes. Results As was to be expected from the randomization process, patients in the two trial arms were well matched in terms of angiographic severity and extent of disease as documented by Bollinger and TASC II. In patients with the least overall disease, it tended to be concentrated in the superficial femoral and popliteal arteries, which were the commonest sites of disease overall. The below knee arteries became increasingly involved as the overall severity of disease increased, but the disease in the above knee arteries did not tend to worsen. The posterior tibial artery was the most diseased crural artery, whereas the peroneal appeared relatively spared. There was less interobserver disagreement with the Bollinger method than with the TASC II classification system, which also appears inherently less sensitive to clinically important differences in infrapopliteal disease among patients with severe leg ischemia. Conclusions Anatomic (angiographic) disease description in patients with severe leg ischemia requires a reproducible scoring system that is sensitive to differences in crural artery disease. The Bollinger system appears well suited for this purpose, but the TASC II classification system less so. We hope this detailed analysis will facilitate appropriate generalization of the BASIL trial data to other groups of patients affected by similar anatomic (angiographic) patterns of disease.
Lack of Level I evidence from randomized controlled trials (RCT) means that the relative merits of surgical and endovascular revascularization strategies for severe limb ischemia (SLI) due to ...infrainguinal disease remain unclear. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial remains the only multicenter RCT to have compared the clinical and cost-effectiveness of bypass surgery (BSX)-first and balloon angioplasty (BAP)−first revascularization strategies for infrainguinal SLI. An intention to treat analysis shows that out to 2 years both strategies were associated with similar amputation-free (AFS) and overall survival (OS) rates, as well as improvements in health-related quality of life. In the short-term, BSX was significantly more morbid and expensive. However, for those patients who survived for 2 years after randomization, initial randomization to a BSX-first strategy was associated with a significant increase in subsequent OS of about 7 months and a nonsignificant increase in subsequent AFS of about 6 months. Vein BSX performed significantly better than prosthetic BSX in terms of AFS but not OS. For most patients BAP also appears preferable to prosthetic BSX. Patients who underwent BSX after a failed BAP-first strategy did not fare as well as those who received BSX as their first procedure. Patients who are expected to live less than 2 years should usually be offered BAP first, especially when the alternative is prosthetic BSX. Those expected to survive beyond this time horizon (approximately 75% of the BASIL cohort) should usually be offered BSX first, especially where vein is available. Further RCTs to confirm or refute these findings and recommendations are required.
Objective To test the hypothesis that ultrasound-guided foam sclerotherapy (UGFS) is a safe and durable treatment for superficial venous reflux (SVR) associated with CEAP clinical grade 2-6 disease. ...Methods This was an interrogation of a prospectively gathered computerized database. Results Between March 23, 2004 and December 31, 2009, 977 patients (1252 legs) underwent UGFS for unilateral (702 legs) or bilateral (550 legs) SVR in association with CEAP clinical grade 2-3 (n = 868), 4 (n = 232), or 5/6 (n = 152) disease. The following reflux in 1417 venous segments was treated: primary great saphenous vein (GSV) (n = 745); recurrent GSV (n = 286), primary small saphenous vein (SSV) (n = 189), recurrent SSV (n = 50); primary anterior accessory saphenous vein (AASV) (n = 93); recurrent AASV (n = 46); vein of the popliteal fossa (VOPF) (n = 5), and Giacomini vein (GV) (n = 3). Three hundred forty-eight legs (27.8%) had undergone previous surgery. Three patients suffered post-UGFS deep vein thrombosis (DVT) and one a pulmonary embolus (PE), all within the first month (0.4% venous thrombo-embolic complication rate). Five patients (0.5%) had transient visual disturbance at the time of, or shortly after, treatment. No other neurologic or serious complications were reported. During a mean (range) follow-up of 28 (<1 to 68) months, 161 (12.9%) legs underwent a further session of UGFS for truncal VV at a mean (range) of 17 (<1 to 63) months following the first treatment. In 52 legs, retreatment was due to the development of new SVR and in 109 legs was for true recurrence (8.7% complete or partial recanalization rate leading to treatment). There was no significant difference in retreatment rates between UGFS for GSV and SSV reflux or between UGFS for primary or recurrent disease. Conclusion UGFS for CEAP 2-6 SVR is associated with a low complication and retreatment rate. However, as patients are at risk of developing recurrent and new SVR they should be kept under review. Further UGFS for new or recurrent disease is simple, safe, and effective.
Background Endovascular aneurysm repair (EVAR) is associated with an improved perioperative mortality compared to open surgical repair. This benefit may reflect reduced incidence of microvascular and ...macrovascular thrombotic complications after EVAR. Purpose The purpose of this study was to review and compare the effects of abdominal aortic aneurysm (AAA), open surgical repair, and EVAR on coagulation, fibrinolysis, and platelet activation. Methods A MEDLINE (1966-2010) and Cochrane library search for articles relating to the effects of AAA, open surgical repair, and EVAR on hemostasis was performed utilizing and cross-linking terms such as clotting, fibrinolysis, AAA, EVAR, and open surgical repair. Studies with a small cohort of patients (less than 7) or in which values of assessed biomarkers were not included were rejected. Results AAA is associated with increased thrombin generation, activity, and fibrin turnover as evidenced by increased plasma levels of thrombin-antithrombin III-complex (TAT), activated protein C-protein C inhibitor (APC-PCI), fibrin-monomer-fibrinogen (FM-F), F1+2, fibrinogen, and D-dimer. The extent of hemostatic derangement correlates with the volume of intraluminal thrombus. This procoagulant state is exaggerated in the immediate perioperative period after both open surgical repair and EVAR, but is attenuated at medium-term follow-up although not normalized. Conclusion The resultant prothrombotic diathesis after open surgical repair and EVAR may account for the high level of perioperative thrombotic complications.
Background Abdominal aortic aneurysm (AAA) is a chronic inflammatory condition associated with a prothrombotic, hypofibrinolytic diathesis that may increase the risk of cardiovascular events. The ...effect of endovascular aneurysm repair (EVAR) on this prothrombotic diathesis is not fully understood, especially over the medium and long term. A better understanding of these postintervention changes may improve the risk of cardiovascular complications in the long term. The purpose of this study was to examine thrombin generation, fibrinolysis, platelet and endothelial activation, and the inflammatory response during the 12 months following EVAR. Methods Twenty-nine patients (mean age, 76.9 years) undergoing EVAR for AAA (mean diameter 6.9 cm) had prothrombin fragment (PF) 1 + 2, thrombin-antithrombin complex (TAT), plasminogen activator inhibitor (PAI) activity, tissue plasminogen activator (t-PA) activity and antigen, soluble P- and E-selectin, and highly sensitive C-reactive protein (hsCRP) measured before and at 24 hours, and 1, 6, and 12 months after surgery. Results PF1 + 2 were markedly elevated prior to EVAR and remained so at 24 hours and 1 month, but had decreased significantly at 6 and 12 months. TAT was also elevated prior to EVAR and increased still further by 24 hours, but fell to below baseline levels thereafter. PAI activity and t-PA antigen were normal prior to EVAR, increased significantly at 24 hours, and then fell to baseline levels. t-PA activity was only detectable at 1 and 6 months; there was a significant rise in soluble P- and E-selectin after EVAR, which was sustained for 12 months. hsCRP increased transiently in response to EVAR but returned to preoperative levels by 1 month. Conclusions The prothrombotic, hypofibrinolytic diathesis associated with AAA is normalized 12 months after EVAR. This beneficial systemic effect of EVAR for AAA disease may help protect patients against future thromboembolic cardiovascular events.
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