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- Nordanstig, Joakim, et al.
(författare)
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Improved Quality of Life After 1 Year With an Invasive Versus a Noninvasive Treatment Strategy in Claudicants One-Year Results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial
- 2014
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Ingår i: Circulation. - : Ovid Technologies (Wolters Kluwer Health). - 0009-7322 .- 1524-4539. ; 130:12, s. 939-947
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Tidskriftsartikel (refereegranskat)abstract
- Background-The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. Methods and Results-After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group. Overall, Vascular Quality of Life Questionnaire score (P<0.01) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group. Intermittent claudication distance improved significantly in the invasive (+124 m) versus the noninvasive (+50 m) group (P=0.003), whereas the change in maximum walking distance was not significantly different between groups. Conclusions-An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management. Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication.
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| 2. |
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| 3. |
- Nordanstig, Joakim, et al.
(författare)
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Six-minute walk test closely correlates to "real-life" outdoor walking capacity and quality of life in patients with intermittent claudication
- 2014
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Ingår i: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 60, s. 404-409
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Tidskriftsartikel (refereegranskat)abstract
- Objective We used outdoor walking distance measured during 40 minutes as "real-life" outdoor walking capacity in 49 patients with intermittent claudication (IC). The outdoor walking distance was measured by a global positioning system application for a smartphone. The relationships of self-reported maximum walking distance (SR-MWD), the MWD on a graded treadmill test, and the 6-minute maximum walk distance (6MWD) vs outdoors walking capacity were investigated. Also studied were the associations of SR-MWD, MWD, and 6MWD with health-related quality of life assessed with the disease-specific instrument the Vascular Quality of Life Questionnaire (VascuQoL). Methods In this prospective observational cohort study, 49 IC patients underwent an outdoor walking capacity test for 40 minutes, and MWD and 6MWD were measured. SR-MWD was recorded, and all subjects completed the VascuQoL questionnaire. Associations between the different walk estimates and outdoor walking capacity and health-related quality of life were investigated by correlation analysis (Spearman ρ). Results Outdoor walking distance during 40 minutes was a median 2495 m (range, 1110-3300 m). SR-MWD correlated moderately and MWD correlated strongly to outdoor walking capacity (r = 0.56 and r = 0.65; P <.001, respectively). The 6MWD test showed the largest correlation to the outdoor walking capacity (r = 0.78; P <.001). The 6MWD was the only test that showed correlations with the VascuQoL sum score (r = 0.53; P <.01) and all of the domain scores, whereas SR-MWD and MWD showed weak correlations to the VascuQoL. Conclusions The distance walked during the 6-minute walk test is closely correlated to outdoor walking capacity and health-related quality of life in IC patients. Our data support the use of 6MWD for routine clinical evaluation of walking capacity in IC patients. Copyright © 2014 by the Society for Vascular Surgery.
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| 4. |
- Nordanstig, Joakim, et al.
(författare)
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Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication
- 2016
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Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 103:10, s. 1290-1299
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundIntermittent claudication is associated with significant impairment of health-related quality of life. The use of revascularization techniques to improve health-related quality of life remains controversial. MethodsPatients with intermittent claudication due to iliac or femoropopliteal peripheral artery disease were enrolled in the IRONIC trial. They were randomized to either best medical therapy (BMT), including a structured, non-supervised exercise programme, or revascularization with either endovascular or open techniques in addition to BMT. The primary outcome was health-related quality of life at 2years assessed using the Short Form 36 (SF-36((R))) questionnaire. Secondary outcomes included VascuQoL questionnaire results, treadmill walking distances and achievement of patient-specified treatment goals. ResultsBoth randomized groups had improved health-related quality of life and treadmill walking distance at 2-year follow-up. Overall SF-36((R)) physical component summary score, three SF-36((R)) physical domain scores, overall VascuQoL score, and three of five VascuQoL domain scores showed significantly greater improvement in the group that also received invasive treatment. Intermittent claudication distance on a graded treadmill improved more in the revascularization + BMT group (117 versus 55m; P=0003) whereas maximum walking distance and 6-min walk test distance were similar. Some 44 per cent of patients in the revascularization + BMT group reported they had fully achieved their treatment goal versus 10 per cent in the BMT group. ConclusionA revascularization strategy with unsupervised exercise improved health-related quality of life and intermittent claudication distance more than standard BMT and an unsupervised exercise programme in patients with lifestyle-limiting claudication. Registration number: NCT01219842 (http://www.clinicaltrials.gov).
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| 5. |
- Perlander, Angelica, et al.
(författare)
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Amputation-free survival, limb symptom alleviation, and reintervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia
- 2020
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Ingår i: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214. ; 72:6, s. 1987-1995
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Tidskriftsartikel (refereegranskat)abstract
- Background: The optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study, we investigated outcomes after open and endovascular revascularization in the femoropopliteal segment for CLTI. Methods: Between March 2011 and January 2015, there were 190 patients presenting with CLTI with the principal target lesion in the superficial femoral or popliteal segment who underwent endovascular intervention (n = 117) or bypass surgery (n = 73) and were observed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were observed for 2 years. The primary end point was amputation-free survival (AFS) assessed with Kaplan-Meier estimates; secondary end points included CLTI symptom alleviation rates and reintervention rates. A Cox proportional hazards regression model was used to investigate risk factors for amputation and death. Results: AFS at 2 years was 59% in the endovascular group and 76% in the bypass group (P =.020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis, the observed difference in AFS between the groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (hazard ratio, 2.38; 95% confidence interval, 1.14-4.96). At 2 years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% vs 45%; P =.009). The proportions of patients who underwent reintervention within 2 years were similar in the two groups (38% vs 39%; P =.90), but repeated reinterventions were more frequent in the bypass group. Conclusions: At 2 years, bypass surgery was associated with higher AFS than endovascular intervention, a finding that could not be explained only by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both 1 year and 2 years after revascularization. Reinterventions to maintain patency were equally common after bypass and endovascular intervention. © 2020 Society for Vascular Surgery
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| 6. |
- Perlander, Angelica, et al.
(författare)
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Cost-Effectiveness of Endovascular Intervention Versus Bypass Surgery in Patients With Chronic Limb-Threatening Ischemia and Principal Target Lesion in the Femoropopliteal Segment
- 2022
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Ingår i: Journal of Critical Limb Ischemia. - 2694-3026. ; 2:1
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Tidskriftsartikel (refereegranskat)abstract
- Background. Chronic limb-threatening ischemia (CLTI) commonly requires revascularization to alleviate symptoms and prevent amputation. This study investigates the cost-effectiveness of bypass surgery vs endovascular intervention in CLTI with femoropopliteal lesions. Methods. Between March 2011 and January 2015, a total of 160 CLTI patients, undergoing bypass surgery (n = 55) or endovascular intervention (n = 105), were included in a prospective cohort study. The main study endpoint was quality-adjusted life years (QALYs) based on self-registered EQ-5D-3L questionnaires. Costs were retrieved from the hospi-tal’s cost-per-patient system. The incremental cost-effectiveness ratio (ICER) was calculated as costs per gained QALY and per avoided amputation. Results. QALYs during 2 years of follow-up were 1.04 years (95% CI, 0.89-1.18) in the bypass group and 0.95 years (95% CI, 0.84-1.07) in the endovascular group, with no significant intergroup difference. Amputation-free survival was 78% in the bypass group and 59% in the endovascular group (P<.05). The mean total cost per patient was $42,900 (95% CI, 32,400-53,500) for bypass surgery and $22,200 (95% CI, 17,800-26,600) for endovascular treatment. The cost per gained QALY and per avoided amputation with bypass surgery vs endovascular intervention was $730,000 and $104,000, respec-tively. Conclusion. At 2 years, the mean total hospital cost post bypass surgery was almost twice the cost post endovascular intervention. Although amputation-free survival was higher after bypass surgery, there was no corresponding gain in generic health status. This led to a high additional cost per QALY gained and per amputation avoided with bypass surgery compared with endovascular intervention.
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| 7. |
- Perlander, Angelica, et al.
(författare)
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Disease Specific Health Related Quality of Life in Patients With Chronic Limb Threatening Ischaemia Undergoing Revascularisation of Femoropopliteal Lesions.
- 2023
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Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - 1078-5884 .- 1532-2165. ; 66:2, s. 245-251
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Tidskriftsartikel (refereegranskat)abstract
- Patients with chronic limb threatening ischaemia (CLTI) suffer from pain and non-healing ulcers, which impact negatively on both their physical and mental health. While maintaining and improving quality of life is a principal aim with all treatments, little is known about the health related quality of life (HRQoL) of CLTI patients and how revascularisation procedures impact on HRQoL endpoints. The aim of this study was to investigate disease specific HRQoL before and after revascularisation in patients with CLTI undergoing femoropopliteal revascularisation.HRQoL was prospectively analysed in 190 CLTI patients with main atherosclerotic target lesions in the femoropopliteal segment, who were planned for endovascular or open revascularisation. The choice of revascularisation method was made by the vascular team, represented by both open and endovascular expertise. The Vascular Quality of Life (VascuQoL) questionnaire was used to assess disease specific HRQoL before revascularisation and one month, one year, and two years after the procedure. Main endpoints were mean VascuQoL score changes, effect sizes of observed changes and the proportion reaching a minimally important difference (half a standard deviation change from baseline) during two years after revascularisation.Patient reported VascuQoL scores were low at baseline (mean 2.68, 95% CI 1.18 - 4.17). After revascularisation, the mean VascuQoL score improved statistically significantly over time, with the largest improvement observed after one year (difference from baseline 2.02, 95% CI 1.75 - 2.29; p < .001). No differences in HRQoL change over time were observed between patients treated with endovascular approaches compared with bypass surgery. Approximately half the patients reached the minimally important threshold at one year (53%), which was largely maintained also at two years (41%).While CLTI profoundly affected HRQoL, a large and clinically meaningful HRQoL increase was observed after revascularisation. This confirms the value of CLTI revascularisation on HRQoL and underlines the importance of including patient reported outcomes when evaluating revascularisation procedures in CLTI patients.
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| 8. |
- Perlander, Angelica
(författare)
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Outcomes of invasive treatment in chronic limb-threatening ischaemia
- 2023
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background In chronic limb-threatening ischaemia (CLTI), obstruction of the arterial blood flow causes ischaemic rest pain, ulcers or gangrene in the lower extremities. Patients with CLTI have a substantial risk of amputation unless the blood flow is improved, which requires invasive treatment through either open surgery or endovascular intervention. Methods This thesis aimed to analyse the outcomes of invasive CLTI treatments in terms of survival, major amputation rates, development of ischaemic symptoms, disease-specific health-related quality of life (HRQoL) and cost-effectiveness. An observational study was conducted in 190 patients with CLTI whose main vessel lesion was located in the femoropopliteal artery. The patients underwent either bypass surgery or endovascular intervention according to existing treatment guidelines and were followed up prospectively. Results The amputation-free survival (AFS) rates were 65% at 2 years, 41% at 5 years and 17% at 10 years after intervention. Survival and regression analyses showed worse AFS in patients who underwent endovascular intervention compared with those who underwent bypass surgery (adjusted hazard ratio 1.51). Most non-amputated survivors were free from CLTI symptoms at both 2 years (98/121) and 5 years (48/56) after intervention and reported substantially improved disease-specific HRQoL, which remained relatively constant during follow-up (mean VascuQoL scores of 2.68 at baseline, 4.58 at 2 years and 4.63 at 5 years after intervention). The cumulative hospital cost at 2 years of follow-up was approximately twice as high in the bypass cohort as in the endovascular cohort (SEK 355 000 versus SEK 184 000), whereas the corresponding gain in quality adjusted life years (QALYs) was small (1.04 versus 0.95), resulting in a very high incremental cost-effectiveness ratio. Conclusions In this study, patients with CLTI who underwent femoropopliteal revascularisation reported low baseline HRQoL levels, had a low average survival time and sustained a high risk of major limb amputation. However, those who remained alive with a preserved leg were to a large extent free from CLTI symptoms and reported enduring positive effects on disease-specific HRQoL after revascularisation. Bypass surgery was associated with a favourable AFS compared with endovascular intervention, also after controlling for baseline intergroup differences, but the incremental cost-effectiveness ratio for bypass surgery was very high.
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