PMID- 21397530 OWN - NLM STAT- MEDLINE DCOM- 20110930 LR - 20151119 IS - 1532-2165 (Electronic) IS - 1078-5884 (Linking) VI - 42 IP - 2 DP - 2011 Aug TI - Walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication--a prospective randomised trial. PG - 220-7 LID - 10.1016/j.ejvs.2011.02.019 [doi] AB - 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. CI - Copyright (c) 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. FAU - Nordanstig, J AU - Nordanstig J AD - Department of Vascular Surgery, Sahlgrenska University Hospital, Sweden. joakim.nordanstig@vgregion.se FAU - Gelin, J AU - Gelin J FAU - Hensater, M AU - Hensater M FAU - Taft, C AU - Taft C FAU - Osterberg, K AU - Osterberg K FAU - Jivegard, L AU - Jivegard L LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110311 PL - England TA - Eur J Vasc Endovasc Surg JT - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JID - 9512728 RN - 0 (Cardiovascular Agents) SB - IM CIN - Eur J Vasc Endovasc Surg. 2011 Aug;42(2):228-9. PMID: 21531592 MH - Adult MH - Aged MH - Aged, 80 and over MH - Angiography, Digital Subtraction MH - Ankle Brachial Index MH - Cardiovascular Agents/*therapeutic use MH - *Endovascular Procedures MH - Exercise Test MH - *Exercise Therapy MH - Female MH - Humans MH - Intermittent Claudication/diagnosis/physiopathology/psychology/*surgery MH - Logistic Models MH - Male MH - Middle Aged MH - Patient Selection MH - Prospective Studies MH - *Quality of Life MH - Recovery of Function MH - Risk Reduction Behavior MH - Surveys and Questionnaires MH - Sweden MH - Time Factors MH - Treatment Outcome MH - Ultrasonography, Doppler, Duplex MH - *Vascular Surgical Procedures MH - *Walking EDAT- 2011/03/15 06:00 MHDA- 2011/10/01 06:00 CRDT- 2011/03/15 06:00 PHST- 2010/09/14 00:00 [received] PHST- 2011/02/13 00:00 [accepted] PHST- 2011/03/15 06:00 [entrez] PHST- 2011/03/15 06:00 [pubmed] PHST- 2011/10/01 06:00 [medline] AID - S1078-5884(11)00096-7 [pii] AID - 10.1016/j.ejvs.2011.02.019 [doi] PST - ppublish SO - Eur J Vasc Endovasc Surg. 2011 Aug;42(2):220-7. doi: 10.1016/j.ejvs.2011.02.019. Epub 2011 Mar 11.