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Endovascular stents for intermittent claudication.

ABSTRACT: BACKGROUND:Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. This is an update of a Cochrane review published in 2002. OBJECTIVES:The null hypothesis to be tested by this review is that for individuals with claudication the use of an endovascular stent, in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication when compared to percutaneous angioplasty alone. SEARCH STRATEGY:For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched August 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched 2009, Issue 3). SELECTION CRITERIA:Randomised trials comparing angioplasty alone versus angioplasty with endovascular stents in patients with intermittent claudication. DATA COLLECTION AND ANALYSIS:Two authors independently assessed trial quality and extracted the data. Only published trial data were used but unpublished data were sought for the update. Effectiveness was measured by the pre-defined primary outcome measures restenosis or reocclusion rates and maximum walking distance. MAIN RESULTS:Two studies were included involving a total of 104 participants. Both studies included only individuals with femoro-popliteal disease. They compared angioplasty and stenting with the Palmaz stent against angioplasty alone. Although one study showed a slight statistical advantage in arterial patency after angioplasty alone, this was not found when the two studies were combined. No differences in the secondary outcomes were detected in either study. AUTHORS' CONCLUSIONS:The small number of relevant studies identified together with the small sample sizes and methodological weaknesses severely limit the usefulness of this review in guiding practice. The results from larger multicentre trials are needed.

SUBMITTER: Bachoo P

PROVIDER: S-EPMC7144684 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature

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Endovascular stents for intermittent claudication.

Bachoo Paul P Thorpe P A PA Maxwell Heather H Welch Karen K

The Cochrane database of systematic reviews 20100120 1

<h4>Background</h4>Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. This is an update of a Cochrane review published in 2002.<h4>Objectives</h4>The null hypothesis to be tested by this review is that for individuals with claudication the use of an endovascular stent, in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication when compared to ...[more]

PMID: 20091540

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Project description:ImportanceSmoking is a key modifiable risk factor in the development and progression of peripheral artery disease, which often manifests as intermittent claudication (IC). Smoking cessation is a first-line therapy for IC, yet a minority of patients quit smoking prior to elective revascularization.ObjectiveTo assess if preprocedural smoking is associated with an increased risk of early postprocedural complications following elective open and endovascular revascularization.Design, setting, and participantsThis retrospective cohort study used nearest-neighbor (1:1) propensity score matching of 2011 to 2019 data from the Veterans Affairs Surgical Quality Improvement Program, including all cases with a primary diagnosis of IC and excluding emergent cases, primary procedures that were not lower extremity revascularization, and patients with chronic limb-threatening ischemia within 30 days of the intervention. All data were abstracted June 18, 2020, and analyzed from July 26, 2020, to June 30, 2021.ExposuresPreprocedural cigarette smoking.Main outcomes and measuresAny and organ system-specific (ie, wound, respiratory, thrombosis, kidney, cardiac, sepsis, and neurological) 30-day complications and mortality, overall and in prespecified subgroups.ResultsOf 14 350 included cases of revascularization, 14 090 patients (98.2%) were male, and the mean (SD) age was 65.7 (7.0) years. A total of 7820 patients (54.5%) were smoking within the preprocedural year. There were a total of 4417 endovascular revascularizations (30.8%), 4319 hybrid revascularizations (30.1%), and 5614 open revascularizations (39.1%). A total of 1594 patients (11.1%) had complications, and 57 (0.4%) died. Among 7710 propensity score-matched cases (including 3855 smokers and 3855 nonsmokers), 484 smokers (12.6%) and 34 nonsmokers (8.9%) experienced complications, an absolute risk difference (ARD) of 3.68% (95% CI, 2.31-5.06; P < .001). Compared with nonsmokers, any complication was higher for smokers following endovascular revascularization (26 [4.3%] vs 52 [2.1%]; ARD, 2.19%; 95% CI, 0.77-3.60; P = .003), hybrid revascularization (204 [17.3%] vs 163 [14.1%]; ARD, 3.18%; 95% CI, 0.23-6.13; P = .04), and open revascularization (228 [15.4%] vs 153 [10.3%]; ARD, 5.18%; 95% CI, 2.78-7.58; P < .001). Compared with nonsmokers, respiratory complications were higher for smokers following endovascular revascularization (20 [1.7%] vs 6 [0.5%]; ARD, 1.17%; 95% CI, 0.35-2.00; P = .009), hybrid revascularization (33 [2.8%] vs 10 [0.9%]; ARD, 1.93%; 95% CI, 0.85-3.02; P = .001), and open revascularization (32 [2.2%] vs 19 [1.3%]; ARD, 0.89%; 95% CI, 0-1.80; P = .06). Wound complications and graft failure were higher for smokers compared with nonsmokers following open interventions (wound complications: 146 [9.9%] vs 87 [5.8%]; ARD, 4.05%; 95% CI, 2.12-5.99; P < .001; graft failure: 33 [2.2%] vs 11 [0.7%]; ARD, 1.50%; 95% CI, 0.63-2.37; P = .001). In a sensitivity analysis, compared with active smokers (n = 5173; smoking within 2 weeks before the procedure), the risk of any complication was decreased by 65% for never smokers (n = 1197; adjusted odds ratio, 0.45; 95% CI, 0.34-0.59) and 29% for former smokers (n = 4755; cessation more than 1 year before the procedure; adjusted odds ratio, 0.71; 95% CI, 0.61-0.83; P = .001 for interaction).Conclusions and relevanceIn this cohort study, more than half of patients with IC were smoking prior to elective revascularization, and complication risks were higher across all modalities of revascularization. These findings stress the importance of smoking cessation to optimize revascularization outcomes.

Project description:BackgroundIntermittent claudication (IC) is a commonly treated vascular condition. Patient sex has been shown to influence outcomes of interventions for other vascular disorders; however, whether outcomes of interventions for IC vary by sex is unclear. We sought to assess the association of patient sex with outcomes after IC interventions.MethodsThe Vascular Quality Initiative was queried from 2010-2020 for all peripheral endovascular interventions (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for any degree IC. Univariable and multivariable analyses compared peri-operative and long-term outcomes by patient sex.ResultsThere were 24,701 female and 40,051 male patients undergoing PVI, 2,789 female and 6,525 male patients undergoing IIB, and 1,695 female and 2,370 male patients undergoing SIB for IC. Guideline-recommended pre-operative medical therapy differed with female patients less often prescribed aspirin for PVI (73.4% vs. 77.3%), IIB (71.5% vs. 74.8%), and SIB (70.9% vs. 74.3%) or statins for PVI (71.8% vs. 76.7%) and IIB (73.1% vs. 76.0%) (all P < 0.05). Female compared with male patients had lower 1-year reintervention-free survival after PVI (84.4% ± 0.3% vs. 86.3% ± 0.2%, P < 0.001), IIB (79.0% ± 0.9% vs. 81.2% ± 0.6%, P = 0.04), and SIB (89.4% ± 0.9% vs. 92.6% ± 0.7%, P = 0.005), but similar amputation-free survival and survival across all procedures. Multivariable analysis confirmed that female sex was associated with increased 1-year reintervention for PVI (HR 1.16, 95% CI 1.09-1.24, P < 0.001), IIB, (HR 1.16, 95% CI 1.03-1.31, P = 0.02), and SIB (HR 1.60, 95% CI 1.20-2.13, P = 0.001).ConclusionsFemale patients undergoing interventions for IC were less often pre-operatively medically optimized than male patients, though the difference was small. Furthermore, female sex was associated with more reinterventions after interventions. Interventionists treating female patients should increase their efforts to maximize medical therapy. Future research should clarify reasons for poorer intervention durability in female patients.

Project description:BackgroundDiabetes mellitus (DM) is an established risk factor for intermittent claudication (IC) and other manifestations of atherosclerotic peripheral arterial disease. Indications for surgery in infrainguinal IC are debated, and there are conflicting reports regarding its outcomes in patients with DM. Aims of this study were to compare both short- and long-term effects on total- and cardiovascular (CV) mortality, major adverse cardiovascular events (MACEs), acute myocardial infarction (AMI), stroke, and major amputation following infrainguinal endovascular surgery for IC in patients with and without DM. We also evaluated potential relationships between diabetic control and outcomes in patients with DM.MethodsNationwide observational cohort study of patients registered in the Swedish Vascular Registry and the Swedish National Diabetes Registry. Propensity score adjusted comparison of total and CV mortality, MACE, AMI, stroke, and major amputation after elective infrainguinal endovascular surgery for IC in 626 patients with and 1112 without DM at 30 postoperative days and after median 5.2 [interquartile range (IQR) 4.2-6.3] years of follow-up for patients with DM, and 5.4 (IQR 4.3-6.5) years for those without.ResultsIn propensity score adjusted Cox regression after 30 postoperative days, there were no differences between groups in morbidity or mortality. At last follow-up, patients with DM showed higher rates of MACE [hazard ratio (HR) 1.26, confidence interval (CI) 1.07-1.48; p < 0.01], AMI (HR 1.48, CI 1.09-2.00; p = 0.01), and major amputation (HR 2.31, CI 1.24-4.32; p < 0.01). Among patients with DM, higher HbA1c was associated with higher total mortality during follow-up (HR 1.01, CI 1.00-1.03; p = 0.045).ConclusionPatients with DM have higher rates of MACE, AMI, and major amputation in propensity score adjusted analysis during 5 years of follow-up after infrainguinal endovascular surgery for IC. Furthermore, HbA1c is associated with total mortality in patients with DM. Prevention and treatment of DM is important to improve cardiovascular and limb outcomes.

Project description:BackgroundGuidelines recommend cardiovascular risk reduction and supervised exercise therapy as the first line of treatment in intermittent claudication, but implementation challenges and poor patient compliance lead to significant variation in management and therefore outcomes. The development of a precise risk stratification tool is proposed through a machine-learning algorithm that aims to provide personalized outcome predictions for different management strategies.MethodsFeature selection was performed using the least absolute shrinkage and selection operator method. The model was developed using a bootstrapped sample based on patients with intermittent claudication from a vascular centre to predict chronic limb-threatening ischaemia, two or more revascularization procedures, major adverse cardiovascular events, and major adverse limb events. Algorithm performance was evaluated using the area under the receiver operating characteristic curve. Calibration curves were generated to assess the consistency between predicted and actual outcomes. Decision curve analysis was employed to evaluate the clinical utility. Validation was performed using a similar dataset.ResultsThe bootstrapped sample of 10 000 patients was based on 255 patients. The model was validated using a similar sample of 254 patients. The area under the receiver operating characteristic curves for risk of progression to chronic limb-threatening ischaemia at 2 years (0.892), risk of progression to chronic limb-threatening ischaemia at 5 years (0.866), likelihood of major adverse cardiovascular events within 5 years (0.836), likelihood of major adverse limb events within 5 years (0.891), and likelihood of two or more revascularization procedures within 5 years (0.896) demonstrated excellent discrimination. Calibration curves demonstrated good consistency between predicted and actual outcomes and decision curve analysis confirmed clinical utility. Logistic regression yielded slightly lower area under the receiver operating characteristic curves for these outcomes compared with the least absolute shrinkage and selection operator algorithm (0.728, 0.717, 0.746, 0.756, and 0.733 respectively). External calibration curve and decision curve analysis confirmed the reliability and clinical utility of the model, surpassing traditional logistic regression.ConclusionThe machine-learning algorithm successfully predicts outcomes for patients with intermittent claudication across various initial treatment strategies, offering potential for improved risk stratification and patient outcomes.

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Endovascular stents for intermittent claudication.

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Endovascular stents for intermittent claudication.

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