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- Jivegård, Lennart, 1950, et al.
(författare)
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Effects of three months of low molecular weight heparin (dalteparin) treatment after bypass surgery for lower limb ischemia--a randomised placebo-controlled double blind multicentre trial.
- 2005
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Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1078-5884. ; 29:2, s. 190-8
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To test the hypothesis that long-term postoperative dalteparin (Fragmin), Pharmacia Corp) treatment improves primary patency of peripheral arterial bypass grafts (PABG) in lower limb ischemia patients on acetylsalicylic acid (ASA) treatment. DESIGN: Prospective randomised double blind multicenter study. MATERIALS AND METHODS: Using a computer algorithm 284 patients with lower limb ischemia, most with pre-operative ischemic ulceration or partial gangrene, from 12 hospitals were randomised, after PABG, to 5000 IU dalteparin or placebo injections once daily for 3 months. All patients received 75 mg of ASA daily for 12 months. Graft patency was assessed at 1, 3 and 12 months. RESULTS: At 1 year, 42 patients had died or were lost to follow-up. Compliance with the injection schedule was 80%. Primary patency rate, in the dalteparin versus the control group, respectively, was 83 versus 80% (n.s.) at 3 months and 59% for both groups at 12 months. Major complication rates and cardiovascular morbidity were not different between the two groups. CONCLUSIONS: In patients on ASA treatment, long-term postoperative dalteparin treatment did not improve patency after peripheral artery bypass grafting. Therefore, low molecular weight heparin treatment cannot be recommended for routine use after bypass surgery for critical lower limb ischemia.
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| 2. |
- 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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| 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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| 6. |
- Nordanstig, Joakim, et al.
(författare)
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Walking Performance and Health-related Quality of Life after Surgical or Endovascular Invasive versus Non-invasive Treatment for Intermittent Claudication - A Prospective Randomised Trial
- 2011
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884. ; 42, s. 220-227
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Despite limited scientific evidence for the effectiveness of invasive treatment for intermittent claudication (IC), revascularisation procedures for IC are increasingly often performed in Sweden. This randomised controlled trial compares the outcome after 2 years of primary invasive (INV) versus primary non-invasive (NON) treatment strategies in unselected IC patients. Materials/Methods: Based on arterial duplex and clinical examination, IC patients were randomised to INV (endovascular and/or surgical, n=100) or NON (n=101). NON patients could request invasive treatment if they deteriorated during follow-up. Primary outcome was maximal walking performance (MWP) on graded treadmill test at 2 years and secondary outcomes included health-related quality of life (HRQL), assessed with Short Form (36) Health Survey (SF-36). Results: MWP was not significantly (p=0.104) improved in the INV versus the NON group. Two SF-36 physical subscales, Bodily Pain (p<0.01) and Role Physical (p<0.05) improved significantly more in the INV versus the NON group. There were 7% crossovers against the study protocol in the INV group. Conclusions: Although invasive treatment did not show any significant advantage regarding MWP, the HRQL improvements associated with invasive treatment tentatively suggest secondary benefits of this regimen. On the other hand, a primary non-invasive treatment strategy seems to be accepted by most IC patients.
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